6_7_4_glossary_of_terms-itok=cCYeLF9T

Glossary of Terms

The definitions as provided here are not meant to include all possible definitions but only those that are typically applicable within the field of Pharmacyclics’ activities. The definitions can only provide a first understanding of technical terms, further study may be required.

The definitions provided here are not intended to diagnose or offer medical advice.

Math | Abbr | A | B | C | D | E | F | G | H | I | J | K | L | M | N | O | P | Q | R | S | T | U | V | W | X | Y

Mathematical and other Symbols:

Note: Many of the following definitions apply to the context of the FDA Product Insert

>: Greater than.

≥: Greater than or equal to.

<: Less than.

≤: Less than or equal to.

%: Percent. (See Percent above as needed.)

+: Plus or minus. This is most commonly used to give a quantity with a tolerance or margin of error. For example, "10 ± 2" is a quantity that is specified or estimated to be within 2 units of 10; it may be anywhere in the range from 8 to 12, because (10 – 2 = 8) and (10 + 2 = 12).

°C: Degree Celsius (see C below).

°F: Degree(s) Fahrenheit (see F below).

1:1: One to one, for every one patient that is selected for one group, one patient is selected for the other group, evenly distributed.

17p Deletion: A deleted portion of chromosome 17. (See Chronic Lymphocytic Leukemia (CLL) with 17p Deletion).

70 kg: About 154 pounds.

90% Occupancy (of the BTK active site): This loosely translates to 90% of the BTK being inhibited or blocked because the active sites are occupied by ibrutinib.

90% of the radioactivity was excreted within 168 hours: For purposes of tracing the path of Ibrutinib in the body, it was labeled with a radioactive trace (carbon 14 is used in place of a normal carbon atom, which is a common practice in research). Ibrutinib is mainly metabolized in the liver and 90% of what was traced was excreted in the feces within 168 hours of taking it orally.

95% CI (%) (56.2, 7.5): Confidence intervals = a 95%. The probability of seeing a value outside of this range is less than 5%.The interval covers 95% of the expected values in a range from 56.2 to 7.5.

5,000/mcL: 5,000 (lymphocytes) per microliter of blood. A microliter is a unit of liquid volume equal to one millionth of a liter, or approximately a volume of 1 cubic millimeter (1 mm3.).

400,000/mcL: 400,000 (lymphocytes) per microliter of blood. A microliter is a unit of liquid volume equal to one millionth of a liter, or approximately a volume of 1 cubic millimeter (1 mm3.).

C:Celsius or Centigrade. Two names for essentially the same temperature scale in which there are 100 degrees from the freezing point (0°C) and boiling point (100°C) of water. The word centigrade comes from "centi-" for 100 and "grade" for gradients or degrees. The scale was later named Celsius after Swedish scientist Anders Celsius (1701-1744), who originally developed a similar scale with 100 degrees between the freezing and the boiling points of water. This is the most common temperature scale in the world and the simplest to understand.

C25H24N6O2: The empirical formula for ibrutinib; literally, the elements that make up an ibrutinib molecule in terms of the relative numbers and kinds of atoms in the simplest ratio: Carbon (25), Hydrogen (24), Nitrogen (6) and Oxygen (2).

[14C]-Ibrutinib: Ibrutinib containing radio-labeled carbon 14. It is a common practice in drug research and discovery in order to determine the pathway that a drug follows and the major changes it goes through as it metabolizes in the body. The technique is called carbon labeling: carbon 14 atoms (which are radioactive) can be used to replace nonradioactive carbon in a compound or drug (for example, ibrutinib) in order to trace reactions and pathways. One way to trace it or view it is with x-rays. The doses of carbon 14 utilized are very small with reportedly little or no radiation risks.

F: Farenheit, which is a temperature scale in which the freezing point of water is 32°F and the boiling point is 212°F. The scale is named after its originator Gabriel Fahrenheit (1686-1736). Fahrenheit is still in everyday use in the USA and preferred by older people in the UK.

I/Ki: A ratio that tells the amount that a substance will inhibit the activity of an enzyme. (Ki is a constant.)

I/Ki < 0.07 using mean Cmax at 560 mg: The amount of ibrutinib in the blood, per the 560 mg dose, does not have a meaningful effect on the activity of major CYP enzymes in vitro (outside the body, in a test tube, or sample/culture of some sort).

L: Liters, a metric unit of capacity, formerly defined as the volume of 1 kilogram of water under standard conditions, now equal to 1,000 cubic centimeters.

PCI-45227: Biopharmaceutical companies will assign a number to their proprietary molecules for record keeping. PCI-45227 is an active metabolite of ibrutinib. An active metabolite is a product of the metabolism of a drug that retains therapeutic activity similar to the original drug. Another example of this system is PCI-32765, which later was given the commercial name IMBRUVICA. (Additional Notes/Definitions: Molecules are the smallest particles of a substance that retains the chemical and physical properties of the substance and is composed of two or more atoms; a group of like or different atoms held together by chemical forces. Atoms are the smallest basic unit and building block of matter.)

Pharmacyclics Commonly Encountered Abbreviations, Acronyms & Symbols

Cladribine chemotherapy
AACR
American Association of Cancer Research
Abs
Antibodies
ADCC
Antibody-Dependent Cell-mediated Cytotoxicity
ADR
Adverse Drug Reaction
AE
Adverse Event
AFP
Alpha-Fetal Protein
AIHA
AutoImmune Hemolytic Anemia
AMCP
Academy of Managed Care Pharmacy
AOR
Agency of Record
AP
Accounts Payable
API
Active Phamaceutical Ingredient
APRs
Acute Phase Reactants
ASCO
American Society of Clinical Oncology
ASH
American Society of Hematology
ATU
Ambulatory Treatment Unit
BA
Bioavailability
BMB
Bone Marrow Biopsy
BMT
Bone Marrow Transplant
BP
Business Plan
CAPA
Corrective and Preventive Action
CAT / CT
Computerized Axial Tomography
CBC
Complete Blood Count
CD Markers
Cluster of Differentiation
CDC
Complement-Dependent Cytotoxicity (not Centers for Disease Control)
CDT
Compound Development Team
Cytoxan, Hydroxydoxorubicin (also called Doxorubincin or Adriamycin), Oncovin (vincristine), and Prednisone chemotherapy
CIP
Clinical Insight Panel
Class I MHC
(MHC Class I) Class I Major Histocompatibility Complex Molexules
Class II MHC
(MHC Class II) Class II Major Histocompatibility Complex Molexules
CLL
Chronic Lymphocytic Leukemia
CME
Continued Medical Education
CNS
Central Nervous System
COA
Certificate of Analysis
COGS
Cost of Goods Sold
CPC
Corporate Pricing Committee
CPR
Cytoxan, Prednisone, and Rituxan chemotherapy (not Cardio-Pulmonary Resuscitation)
CQA
Clinical Quality Assurance
CPPs
Critical Process Parameters
CR
Complete Response
CRA
Clinical Research Associate
CRADA
Cooperative Research and Development Agreements
CRO
Contract/Clinical Research Organization
0CSR
Clinical Study Report
CSFs
Colony-Stimulating Factors
CTL
Clinical Trial Leader
CTMS/CTT
Clinical Trial Monitoring System/Clinical Trial Tracking
CVA
Core Visual Aid
CVP
Same as CHOP but without the Hydroxydoxorubicin
DDI
Drug-Drug Interaction
DEC
Disease Education
DNA
DeoxyriboNucleic Acid
DOME
Department of Medical Education
DSMB
Drug Safety Monitoring Board
DTC
Direct to Consumer
Dx
Diagnosis
EAP
Expanded Access Program
EDI
Electronic Data Interchange
ENT
Ear, Nose, and Throat
EPO
ErythroPOietin
ESR
Erythrocyte Sedimentation Rate
FCM
Flow CytoMetry
FCR
Fludarabine, Cytoxan, and Rituxan chemotherapy
FDA
Food & Drug Administration
FMV
Fair Market Value
FPI
First Patient In
FTE
Full-Time Equivalent
G-CSF
Granulocyte-Colony Stimulating Factor
GERD
GastroEsophageal Reflux Disease
GGT
Gamma Glutamyl Transferase
GI
GastroIntestinal
GMP
General Manufacturing Procedures
GP
General Practitioner
HAV
Hepatitis A Virus (also known as Hep A)
HBV
Hepatitis B Virus (also known as Hep B)
HCP
Health Care Professional
HCT
HematoCriT
HCV
Hepatitis C Virus (also known as Hep C)
HDV
Hepatitis D Virus (also known as Hep D)
HECOR
Health Care Economics Outcomes Research
Hem
Hematologist
Hem-Onc
A Hematology and Oncology specialist
HemoGloBin
HHV
Human Herpes Viruses
HSCs
Hematopoietic Stem Cells
HSM
HepatoSplenoMegaly
ICF
Informed Consent Form
InterFeroNs
IgA
Immunoglobulin A
IgD
Immunoglobulin D
IgE
Immunoglobulin E
IgG
Immunoglobulin G
IgM
Immunoglobulin M
Igs
Immunoglobulins
IIS
Investigator Initiated Studies
ILs
InterLeukins
IRB
Independent Review Board
ISS
Investigator Sponsored Study
IV
IntraVenous
IVIG
IntraVenous Immunoglobulin G
JPA
Janssen Patient Assistance
KOL
Key Opinion Leader
LCDD
Light Chain Deposition Disease
LCM
Life Cycle Management
LDH
Lactate DeHydrogenase
LPI
Last Patient In
LPL
LymphoPlasmacytic Lymphoma
LPLV
Last Patient Last Visit
LPO
Last Patient Out
LRFP
Long Range Financial Plan
LSD
Last Subject Dosed
LSDs
Lysosomal Storage Diseases
LSLSFUDs
Last Subject Follow Up
LSO
Last Subject Out
LT
Long Term
MAD
Multiple Ascending Dose
MALT
Mucosa-Associated Lymphoid Tissue
MC
Mixed Cryoglobulinemia
MfMN / MMN
Multi-focal Motor Neuropathy
MGUS
Monoclonal Gammopathy of Undetermined Significance
MHC
Major Histocompatibility Complex
MM
Multiple Myeloma
MR / RM
Maintenance Rituxan
MRL
Medical Regulatory Legal
MMRx
Medical Marketing Research
MSA
Master Service Agreement
NCE
New Chemical Entity
NDA
New Drug Application
NHL
Non-Hodgkin's Lymphoma
NK cells
Natural Killer cells
NME
New Molecular Entity
NP
Nurse Practitioner
ODAC
Oncology Drug Advisory Committee (FDA)
Onc
Oncologist
OOP
Out of Pocket
OOS
Out of Specification
OPDP
Office of Prescription Drug Promotion
OPEX
Operating Expense
OSQMV
On Site Quality Monitoring Visit
OTC
Over the Counter
PA
Physician Assistance
PAI
Pre Approval Inspection
P&L
Profit & Loss Statement (Income Statement)
PCB
Primary Care Physician
PCP
Primary Care Physician
PCR
Polymerase Chain Reaction
PD
Pharmacodynamics
PDMS
Pharmaceutical Development & Manufacturing Sciences
PET Scan
Positron Emission Tomography
PK
Pharmacokinetics
PLTs
PLaTelets
PN
Peripheral Neuropathy
PO
Purchase Order
POC
Proof of Concept
POP
Proof of Principle
POS
Probability of Success
PP
PlasmaPheresis
PRC
Promotional Review Process
PTH
ParaThyroid Hormone
PTRS
Probability of Technical & Regulatory Success
QA
Quality Assurance
QD
Once Daily
QOD
Once Every Other Day
QTD
Quarter to Date
R&D
Research & Development
RA
Regulatory Affairs
RBD
Regional Business Director
RBC
Red Blood Cell
Rituxan, Cytoxan, Hydroxydoxorubicin (or Doxorubicin or Adriamycin), Oncovin (or Vincristine) and Prednisone
R-CHOP without Hydroxydoxorubicin
RF
Rheumatoid Factor(s)
RFLP
Restriction Fragment Length Polymorphism
REMS
Risk Evaluation and Mitigation Strategy
ROI
Return on Investment
ROW
Rest of World
RM / MR
Maintenance Rituxan
Rx
A medical prescription (Rx is usually said to stand for latin word recipe meaning “to take”)
SAD
Single Ascending Dose
SCG
Strategic Customer Group
SCT
Stem Cell Transplant
SF
Screen Failure
SFN
Small Fiber Neuropathy
SIV
Site Initiation Visit
SOP
Standard Operating Procedures
SOW
Statement of Work
SOX
Sarbanes Oxley
SPEP
Serum Protein ElectroPhoresis
SSV
Site Selection Visit
SV
Serum Viscosity
SW / SWM
Smoldering Waldenstrom's Macroglobulinemia
SWG
Scientific Working Group
SWM / SW
Smoldering Waldenstrom's Macroglobulinemia
T4
Thyroxine
TA
Therapeutic Area
T&E
Travel and Entertainment
TC cells
T-Cytotoxic cells
TCRs
T-Cell Receptors
TGFs
Transforming Growth Factors
TH1 cells
T-Helper-1 cells
TH2 cells
T-Helper-2 cells
TNF
Tumor Necrosis Factor
TPP
Target Product Profile
TSH
Thyroid-Stimulating Hormone
Tx
Treatment
VAB
Virtual Ad Boards
VZV
Varicella-Zoster Virus
W&W
Watch and Wait
WBC
White Blood Cell
WHO
World Health Organization
WM
Waldenstrom's Macroglobulinemia
X4
4 infusions
YTD
Year to Date
AACR:

American Association for Cancer Research, the largest professional cancer organization in the world.

Abdominal Pain:

Abdominal pain is pain that you feel anywhere between your chest and groin (the area of the body where your legs come together). This is often referred to as the stomach region or belly.

Abide:

Accept or act in accordance with (a rule, decision, or recommendation).

Abnormality:

A condition, feature, characteristic, or occurrence that is not normal; malformation, deviation from what is normal or usual, typically in a medical context.

ABO Incompatibility:

A condition when blood types are not compatible. Human blood is classified by dividing it into four groups: A, B, AB and O. The blood types are based on small substances (molecules) on the surface of the blood cells. When people who have one blood type receive blood from someone with a different blood type, it may cause their immune system to react as if the new blood is a dangerous foreign substance and attack it which can cause severe symptoms and even death. This is called ABO incompatibility. This data is important when a patient needs a procedure such as a blood transfusion or an organ transplant. Careful testing of donor and patient blood types before transfusion or transplant can prevent this problem. (Additional Notes/Definitions: Molecules are the smallest particles of a substance that retains the chemical and physical properties of the substance and is composed of two or more atoms; a group of like or different atoms held together by chemical forces. Atoms are the smallest basic unit and building block of matter.)

Absolute Lymphocyte Counts:

Absolute lymphocyte count is the number of lymphocytes (a certain type of infection fighting white blood cell) in a given volume of blood. There are other tests that check the percentage of white blood cells that are lymphocytes. With absolute lymphocyte counts it can be determined whether the total lymphocyte count is low, normal or elevated. Abnormal levels could indicate certain types of infections, disorders and some types of cancer.

Absorption:

The act or process of absorbing or assimilating substances into cells or across the tissues and organs, as in absorption of nutrients by the digestive system, or absorption of drugs into the bloodstream. (Additional Notes/Definitions: Assimilate means to take in and incorporate as one's own; absorb; to convert (food) to substances suitable for incorporation into the body and its tissues. Cells are the basic units of living organisms which can only be seen under a microscope. They are seen in tissue, blood and other fluids. Tissue is a part of the body of a living thing that is made of similar cells.)

Accelerated Approval:

The United States Food and Drug Administration initiated the FDA Accelerated Approval Program in 1992 to allow faster approval of drugs for serious conditions that fill an unmet medical need. Drugs approved under the FDA Accelerated Approval Program still need to be tested in clinical trials using endpoints that demonstrate clinical benefit, and those trials are known as Phase 4 confirmatory trials. If the drug later proves unable to demonstrate clinical benefit to patients, the FDA may withdraw approval.

ACCME:

Accreditation Council for Continuing Medical Education: Serves as the body accrediting institutions and organizations offering continuing medical education.

Accompany:

Be present or occur at the same time as (something else).

Accounted (for):

Found, located, given a satisfactory record of or have an explanation (for something).

Accreditation:

A process in which colleges, universities and other institutions of higher learning are evaluated in regards to curriculum, qualifications and educational levels of the faculty, sufficient numbers of faculty, administration, facilities, books and materials, and other criteria. The standards for accreditation are set by a peer review board whose members include faculty from various accredited colleges and universities. Being accredited indicates that the institution meets these standards.

Accurate:

(Of information, measurements, statistics, etc.) correct in all details; exact.

Acid:

A compound that donates a proton (H+) when dissolved in a solution. (A proton is one of the subatomic particles in a nucleus of an atom that has a positive charge. A proton in solution is also designated as H+, which is a hydrogen atom minus its electron and therefore carrying a unit positive charge – a positive charge the value of 1 – which will then combine with those with a negative charge.)

Acquired Character:

A characteristic (distinguishing feature or quality) an organism develops in response to its environment and cannot be passed on to the next generation.

Acquired Immunity:

Immunity developed in response to factors in the environment (for instance, infection, vaccination or transfer from a donor).

Acquired Immune Deficiency Syndrome (AIDS):

A disease of the immune system characterized by increased susceptibility to infections, to certain cancers, and to neurological disorders. AIDS is caused by a virus that is transmitted chiefly through blood or bodily fluids, especially by sexual contact or contaminated hypodermic needles. The virus, called Human Immunodeficiency Virus (HIV), attacks specific cells which are a key part of the immune system and uses these as a host to reproduce itself, eventually destroying these host cell, greatly compromising the immune system. As the disease progresses the individual becomes increasingly susceptible to infections and complications. AIDS is considered the final stage of HIV.

Action(s):

The fact or process of doing something, typically to achieve an aim.

Activation Energy:

Energy input necessary to initiate a chemical reaction. Chemical reactions are the processes by which substances are changed into different substances through the breaking and forming of chemical bonds. A chemical bond is a mutual attraction between atoms, the building blocks of matter, which allows them to be organized into different and more complex chemicals or substances and then later reorganized into other substances. This process is vital to life organisms, from the level of individual cells up to the human body as a whole. Energy is required to break existing bonds. When bonds are formed or reformed energy is given off. Activation energy is the energy input necessary to break some of the existing bonds to initiate a chemical reaction.

Activation of Pathway:

When a stimulus initiates a series of chemical reactions occurring within a cell. In each pathway, a principal chemical is modified by a series of chemical reactions. One example is the pathway that transmits a signal to activate B Cells. (Additional Notes/Definitions: A chemical reaction is a process in which atoms of the same or different elements rearrange themselves to form a new substance. While they do so, they either absorb heat or give it off. Cells are the basic units of living organisms which can only be seen under a microscope. They are seen in tissue, blood and other fluids. Tissue is a part of the body of a living thing that is made of similar cells. B Cells are a type of white blood cell that helps the body fight infections and foreign substances that could be dangerous to the body.

Active Ingredient:

The substance or component in a pharmaceutical drug that is biologically active, that helps directly in achieving its performance objectives.

Active Metabolite:

When a drug undergoes chemical changes in the organism, called metabolism, it is changed into various products called metabolites. If one of these metabolites retain a therapeutic activity that is similar to the original drug it is called an active metabolite.

Active Site:

The part of an enzyme where a molecule binds (attaches) and a chemical reaction occurs. An enzyme is a type of protein with specific characteristics. Proteins not only make up the majority of cellular structures of the body, but carry out most of the chemical processes vital to life as well. When molecules bind to an active site they create a complex which lowers the amount of energy required to either combine the molecules into more complex substances or break up the molecule into simpler substances. (Additional Notes/Definitions: An enzyme lowers the energy level required to activate or initiate chemical reactions and thereby increases the rates of these reactions inside and outside cells without itself being changed in the process. Almost all chemical reactions in living organisms need enzymes in order to occur at rates sufficient for life. Molecules are the smallest particle of a substance that retains the chemical and physical properties of the substance and is composed of a group of two or more like or different atoms held together by chemical forces. Atoms are the smallest basic units and building blocks of matter. A complex is an entity composed of molecules in which the constituents maintain much of their chemical identity.)

Active Transport:

Active transport describes what happens when a cell uses energy to transport individual molecules across the cell membrane. Proteins embedded in the cell's membrane are positioned to cross the membrane so one part is on the inside of the cell and one part is on the outside. Only when they are so positioned in this manner are they able to move molecules and ions in and out of the cell. (Additional Notes/Definitions: Cells are the main unit of organization in biology. All cells are contained by a cell membrane made of millions of smaller molecules that create a flexible and porous container. Proteins not only make up the majority of cellular structures of the body, but carry out most of the chemical processes vital to life as well. Some specific proteins are found near small holes within the cell membrane and they help move molecules in and out of the cell. There are also proteins attached to the inner and outer surfaces of the membrane. Molecules are the smallest particles of a substance that retains the chemical and physical properties of the substance and is composed of two or more atoms; a group of like or different atoms held together by chemical forces. Atoms are the smallest basic unit and building block of matter. An ion is an atom or molecule with a net electric charge due to the loss or gain of one or more electrons.)

Acute:

Severe and of short duration; used to describe a condition or disease that is brief, severe, and rapidly comes to a crisis.

Acute Infections:

An infection that develops rapidly and only lasts a short time.

Acute Phase Reactants:

Specific types of protein in the blood. Proteins not only make up the majority of cellular structures of the body, but carry out most of the chemical processes vital to life as well. Acute phase reactants are proteins in the blood that increase or decrease in number in response to an acute condition, which is a condition that is severe and of short duration, such as infection, injury, tissue destruction, some cancers, burns, surgery, or trauma. Hence, test results showing an increase or decrease of acute phase reactants might indicate one of these conditions.

Adaptive Immune System:

That part of the immune system that helps recognize and combat new foreign substances and infections. Following the initial response, the adaptive immune system then has the ability to respond to a particular foreign substance or infection much more efficiently in the future having created an immunity to it.

Adenocarcinoma:

Cancer that originates in the glands or glandular cells or tissues and may affect various organs. In addition to existing within the glands themselves, glandular cells are found in tissue that lines certain internal organs and makes and releases substances in the body, such as mucus, digestive juices, or other fluids. Most cancers of the breast, pancreas, lung, prostate, and colon are adenocarcinomas.

Adherence:

The obeying of a rule or law; the act of doing what is required by a rule, belief, etc.

Adhesion:

In general, the term means the physical attraction or joining of two substances, especially the attraction of dissimilar substances due to the molecular attraction between them. When cells stick to each other and/or their surroundings it is called cell adhesion. This is accomplished by cell adhesion molecules (CAMs) which are proteins located on the cell surface which bind with the proteins on other cells or substances that are in the surroundings, called the is called the extracellular matrix (ECM), which is a collection of extracellular molecules (molecules outside of the cells) which are secreted by cells that provides structural and biochemical support to the surrounding cells. Cell adhesion is a normal function and crucial for multicellular life. Not only does it allow cells to physically interact with each other and their surroundings to form tissues, but cell adhesion also allows cells to sense their environment and respond accordingly, such as with the immune system. However, cell adhesion is also involved in the process in which malignant/cancerous cells attach themselves to each other and develop into tumors, and how malignant cells are able to attach to tissues in new areas of the body as cancer spreads.
(Additional Notes/Definitions: A molecule is the smallest particle of a substance that retains the chemical and physical properties of the substance and is composed of two or more atoms; a group of like or different atoms held together by chemical forces. An atom is the smallest basic unit and building block of matter. Cells are the basic units of living organisms which can only be seen under a microscope. The body is made up of many types of cells, making up structures like tissues and nerves, circulating in the blood & bodily fluids, etc. Proteins not only make up most of the structures of the body but carry out most of the chemical processes as well. Extracellular means outside the cell. A matrix is an environment or material in which something develops; a surrounding medium or structure. Cancer is a term used for diseases in which abnormal cells divide without control and are able to spread and invade other parts of the body. A tumor is a swelling of a part of the body, generally without inflammation, caused by an abnormal growth of tissue, whether benign, which is non-cancerous, or malignant, which is cancerous and able to spread to other tissue or parts of the body.)

Adjuvant:

Any substance that enhances the immune system’s response to a particle or substance that is foreign to the body and perceived as a possible threat. Adjuvants may be included in vaccines to boost their effectiveness. (Additional Notes/Definitions: A vaccine is a preparation of killed microorganisms, living attenuated organisms (organisms that are kept alive but altered so that it is less harmful or capable of causing disease), or living fully virulent organisms (organisms that are actively capable of causing rapid onset of disease) that is administered to produce or artificially increase immunity to a particular disease.

Administer:

A general term meaning to dispense a drug or therapeutic agent to treat a condition. It can be given orally, with injection, or intravenously (IV).

Administration:

A general term for the dispensing of a drug or therapeutic agent to treat some condition. It can be given orally, with injection, or intravenously (IV).

Administrative Site Conditions:

Refers to a reaction at the site (location on the body) where medications are administered either by injection (shot) or infusion (intravenously, IV).

ADR Term:

Adverse Drug Reaction Term; a term from a codified list of terms to describe undesirable and unintentional effects caused by a drug administered at the normal therapeutic dose. It is based on the Medical Dictionary for Regulatory Activities (MedDRA) which is an internationally used set of terms related to medical conditions, medicines and medical devices.

Advance:

1. Progress; to further the progress or improvement of something. 2. Move forward, typically in a purposeful way.

Adverse:

Contrary to one's interests or welfare; harmful or unfavorable; preventing success or development.

Adverse Drug Reaction:

An undesirable and unintentional effect caused by a drug administered at the normal therapeutic dose.

Adverse Event:

Any unexpected side effect. Any unfavorable occurrence or change in the health of a patient (symptom, laboratory finding, etc.) happening at or near the time of use of a medicinal product. The unexpected side effect is therefore considered associated, whether or not the occurrence is caused by the product or even related to its use.

Adverse Event Rate:

The number of adverse events (unexpected side effects) reported or the percentage of patients who report an unexpected side effect at or near the time of taking a medication.

Adverse Reaction:

A harmful, unintended effect of a medication, diagnostic test, or therapeutic intervention.

Aerobic:

1. Process that requires oxygen to occur. An example of this is the process by which living organisms produce energy from the breakdown of food substances, generally sugars. This is done in individual cells – the basic units of a living organisms which can only be seen under a microscope. Typically this is done with the intake of oxygen and the release of carbon dioxide, hence the term used is cellular respiration (breathing). When the process requires oxygen, as it does in most cases in the human body, it is known as aerobic. 2. (Of an organism or tissue) requiring the presence of air or free oxygen for life. (Additional Notes/Definitions: If oxygen is not required for a process or organism the term is anaerobic.)

Afamin:

One of the proteins in the blood. Proteins are the true workhorses of the body, not only making up the majority of cellular structures, but also carrying out most of the chemical processes as well. Research evidence suggests that Afamin may be active in transporting vitamin E, which plays a crucial role in protecting against disease and possibly even aging. It may also help protect neurons (nerve cells). Tests which show decreasing amounts of Afamin may help diagnose ovarian cancer.

Affinity:

An attraction or force between particles that causes them to combine. There is a specific use of the term affinity in relation to the immune system. Proteins are the true workhorses of the body, not only making up the majority of cellular structures, but carrying out most of the chemical processes vital to life as well. The body's immune system produces antibodies which are proteins designed to combat foreign substances that are perceived as dangerous (called antigens, which is short for antibody generator). Due to chemical makeup and shape the combining sites of antibodies and their targeted antigens fit together almost like a lock and key. Affinity is a measure of the binding force, or strength, of a single site where an antibody and antigen combine.

Agammaglobulinemia:

A genetic disease in humans. Genes are the basic unit of heredity and help determine not only visible physical characteristics such as the color of eyes or hair, but also characteristics of an organism such as the functioning of chemical processes within the organism which are critical to life. Agammaglobulinemia is a result of mutation and inactivity of a gene that is essential for the growth and functioning of B cells, which are a type of white blood cell which help fight infection. Hence, this can result in a severely weakened immune system making the individual susceptible to illness and infections. In some cases it also inhibits growth so the individual will not grow as rapidly or be as tall.

Agent:

Something capable of producing an effect, either chemically, physically, or biologically.

Agglutination:

Proteins are the true workhorses of the body, not only making up the majority of cellular structures, but carrying out most of the chemical processes vital to life as well. The body's immune system produces antibodies which are proteins designed to combat foreign substances that are perceived as dangerous (called antigens, which is short for antibody generator). When an antibody binds several of these antigens into a large complex or clump it is called agglutination. This could occur with foreign particles/substances, or with cells, such as bacteria or even foreign red blood cells (blood cells from another person). Agglutination prevents these foreign substances from being able to move freely and combine with other substances (preventing or slowing the spread of illness, etc.).

Agglutination test:

A blood test used to identify unknown foreign substances. Proteins are the true workhorses of the body, not only making up the majority of cellular structures, but carrying out most of the chemical processes vital to life as well. The body's immune system produces antibodies which are proteins designed to combat foreign substances that are perceived as dangerous (called antigens, which is short for antibody generator). When an antibody binds several of these antigens into a large complex or clump it is called agglutination. It is important to note that each specific type of antibody can only bind to a specific antigen. In agglutination tests, blood with the unknown antigen is mixed with a known antibody and if agglutination occurs it helps to identify the antigen. This is used in the diagnosis of infections. It is also used in tissue matching and blood grouping, since the immune system can tend to respond to blood and/or tissue that does not match the recipient’s as a potentially dangerous foreign substance.

AIDS (Acquired Immune Deficiency Syndrome):

A disease of the immune system characterized by increased susceptibility to infections, to certain cancers, and to neurological disorders. AIDS is caused by a virus that is transmitted chiefly through blood or bodily fluids, especially by sexual contact or contaminated hypodermic needles. The virus, called Human Immunodeficiency Virus (HIV), attacks specific cells which are a key part of the immune system and uses these as a host to reproduce itself, eventually destroying these host cell, greatly compromising the immune system. As the disease progresses the individual becomes increasingly susceptible to infections and complications. AIDS is considered the final stage of HIV.

Alanine Transaminase (ALT):

An enzyme found in the blood; used to test for liver damage. If the liver is damaged or diseased it releases Alanine Transaminase (ALT) into the bloodstream. Most increases in ALT levels of are caused by liver damage. (Enzymes are a type of protein with specific characteristics. Proteins are the true workhorses of the body, not only making up the majority of cellular structures, but carrying out most of the chemical processes as well. These chemical reactions are the processes by which various substances are changed into different substances and energy is gained, both vital to life. An enzyme lowers the energy level required to activate or initiate chemical reactions and increases the rates of these reactions inside and outside cells without itself being changed in the process. Almost all chemical reactions in living organisms need enzymes in order to occur at rates sufficient for life.)

Albumin:

A class of simple, water-soluble proteins. Proteins are the true workhorses of the body, not only making up the majority of cellular structures, but carrying out most of the chemical processes as well. Albumin is the most abundant protein in human blood. Albumin is produced in the liver. It helps move many small molecules through the blood. It also plays an important role in creating pressure that tends to pull water into the circulatory system and keeps the fluid of the blood from leaking out into the tissues. Albumin is also found in egg white, milk, and many other animal and plant tissues. (Additional Notes/Definitions: Molecules are the smallest particles of a substance that retains the chemical and physical properties of the substance and is composed of two or more atoms; a group of like or different atoms held together by chemical forces. Atoms are the smallest basic unit and building block of matter.)

Alimentary Canal:

The tubular passage that extends from mouth to anus, functions in digestion and absorption of food and elimination of residual waste. It includes the stomach and intestines.

Alimta:

A drug used to fight cancer. In 2004, Alimta was approved to treat mesothelioma, a rare cancer associated with asbestos exposure in the lungs and to treat lung cancer patients who failed initial therapy. Alimta® is marketed by Eli Lilly & Company.

Alkaloid:

Chemical produced by plants that contains nitrogen, many of which are used in medicines. Some alkaloids, such as caffeine, are fairly mild. But many are quite powerful – an example is morphine. Some alkaloids interfere with cell division and have been used as anti-cancer medicines.

Alkylating Agent:

An active chemical (agent) that is widely used in chemotherapy which blocks cell division by damaging DNA, which is the molecule that carries genetic information in all living systems. Cancer cells contain abnormal expression of DNA, leading to uncontrolled cell division and growth. Alkylating agents are used to treat several cancers. However, they are also toxic to normal cells, leading to damage, in particular to cells that divide frequently, as those in the gastrointestinal tract, bone marrow, testicles and ovaries (which can cause loss of fertility). Most of the alkylating agents are also carcinogenic (capable of causing cancer). (Additional Notes/Definitions: Molecules are the smallest particles of a substance that retains the chemical and physical properties of the substance and is composed of two or more atoms; a group of like or different atoms held together by chemical forces. Atoms are the smallest basic unit and building block of matter. Cells are the basic units of living organisms which can only be seen under a microscope. The body is made up of many types of cells, making up structures like tissues and nerves, circulating in the blood & bodily fluids, etc.)
Some commonly used alkylating agents are nitrogen mustards (chlorambucil and cyclophosphamide), cisplatin, nitrosoureas (carmustine, lomustine, and semustine), alkylsulfonates (busulfan), ethyleneimines (thiotepa), and triazines (dacarbazine).

Allergen:

An allergen is a substance that can cause an allergic reaction in which the immune system starts fighting substances that are usually harmless, or at least do not cause a disease (such as dust, pollen, or a medicine) as though these substances were trying to attack the body. This overreaction can cause a rash, itchy eyes, a runny nose, trouble breathing, nausea, and diarrhea.

Allergy:

A damaging immune response by the body to a substance, especially pollen, fur, a particular food, dust, or certain medications or anesthetics to which it has become abnormally or excessively sensitive. Possible symptoms include a rash, itchy eyes, a runny nose, trouble breathing, nausea, and diarrhea.

Allogeneic:

Having a genetic dissimilarity, not genetically identical. For example, in an allogeneic transplant the donor would not be the person themselves or an identical twin, but the donor could be a brother, sister, parent, or someone who is not related. (Genes are the basic unit of heredity. They help determine not only the obvious characteristics of an organism, such as color of eyes or hair, but also the chemical processes within the organism which affect its ability to live. And for a transplant genes need to be compatible.)

Allogeneic Transplantation:

A procedure in which a patient receives bone marrow or blood-forming stem cells from a donor who is not genetically identical (someone other than the person themselves or an identical twin). Bone marrow is the flexible tissue found in the hollow interior of bones, which in adults produces new blood cells. Blood-forming stem cells are the cells from which all blood cells develop. Bone marrow transplantation and blood stem cell transplantation are procedures that restore stem cells that were destroyed by high doses of chemotherapy and/or radiation therapy. With such transplantations care must be taken to ensure that what is received from the donor is compatible with the patient, so the more genetically similar the donor the better the chances that the procedure will be successful. (Genes are the basic unit of heredity and help determine not only visible physical characteristics such as the color of eyes or hair, but also characteristics of an organism such as the functioning of chemical processes within the organism which are critical to life.)

Allograft:

A tissue transplant (graft) between two genetically non-identical members of a species. Genes are the basic unit of heredity. They help determine not only the obvious characteristics of an organism, such as color of eyes or hair, but also the chemical processes within the organism which affect its ability to live. So in the case of an allograft, the tissue transplant would not be from the patient themselves or an identical twin. The donor could be a brother, sister, parent, or someone who is not related.

Alopecia:

Hair loss, often a result of chemotherapy. Chemotherapy, also known as chemo, is a treatment often given for cancer that involves application of one or more drugs which is intended to attack and kill the cancer cells, but is often accompanied by serious side effects.

Allosome:

A sex chromosome. (Additional Notes/Definitions: A chromosome is a threadlike structure that contains the “blueprint” for the functioning and reproduction of the cells and characteristics of the organism as a whole. Chromosomes are located in a central portion of the cell called a nucleus. A cell’s nucleus is a membrane-bound structure that contains the cell’s hereditary information and controls the cell’s growth and reproduction. In humans most cells contain 23 pairs of chromosomes, a set of 23 given by each parent, that are designated 1 to 22 in order of decreasing size with the female and male chromosomes designated X and Y respectively. (A normal female has a pair of X chromosomes; a male has an X and Y pair.)

AFP:

Alpha-fetoprotein (see below).

Alpha-1-Fetoprotein:

Also known as Alpha-fetoprotein (see below).

Also known as Alpha-fetoprotein (see below).

Alpha-Fetoprotein (AFP):

A protein normally produced in a developing baby during pregnancy. Proteins make up the majority of cellular structures, and carry out most of the chemical processes in the body as well. AFP is primarily produced in the unborn child by the liver and yolk sac (a membranous sac that is attached to the unborn child providing early nourishment and circulation before internal circulation begins). It is a protein found in plasma (the liquid part of the blood) of the unborn child and, through circulation, also in the mother. AFP levels are typically fairly high during pregnancy, drop after birth and are virtually undetectable after a year of age under normal circumstances. In adults it can appear at elevated levels in certain diseases, such as liver, testicular and ovarian cancer. A test can be done to measure the amount of AFP in your blood. (Also sometimes called alpha-fetal protein, alpha-1-fetoprotein, or alpha-fetoglobulin, and abbreviated AFP.)

Alpha-Fetoglobulin:

Also known as Alpha-fetoprotein (see above).

Alternative Agent:

An agent (something capable of producing an effect) being used or occurring in place of another; acting as a substitute.

ALT/SGPT:

ALT stands for alanine transaminase which is an enzyme found in the blood, used to test for liver damage. If the liver is damaged or diseased it releases ALT into the bloodstream. Most increases in levels of Alanine Transaminase (ALT) are caused by liver damage. (SGPT is an abbreviation for serum glutamic pyruvic transaminase, an earlier term for the same enzyme.) The purpose of an enzyme in a cell is to allow the cell to carry out chemical reactions very quickly. Almost all chemical reactions in living organisms need enzymes in order to occur.

Alzheimer Disease:

A type of dementia that causes problems with memory, thinking and behavior. Symptoms usually develop slowly and get worse over time, becoming severe enough to interfere with daily tasks. Alzheimer's is the most common form of dementia, a general term for memory loss and other intellectual abilities serious enough to interfere with daily life. Alzheimer's disease accounts for 60 to 80 percent of dementia cases. Alzheimer's is not a normal part of aging, although the greatest known risk factor is increasing age, and the majority of people with Alzheimer's are 65 and older. But Alzheimer's is not just a disease of old age. Up to 5 percent of people with the disease have early onset Alzheimer's (also known as younger-onset), which often appears when someone is in their 40s or 50s.

Ameliorate:

To make better, in this case to reduce symptoms.

Amino Acid:

The building block of proteins. Amino acids are molecules that are linked together in various combinations to make up the long molecular chains that are proteins. Even though scientists have discovered over 50 amino acids, only 20 are used to make something called proteins in your body. Of those twenty, nine are defined as essential, which means that they cannot be created by the body so have to be part of the diet. The other eleven can be synthesized by an adult body. Thousands of combinations of those twenty are used to make all of the proteins in your body. (Additional Notes/Definitions: Proteins are the true workhorses of the body, not only making up the majority of cellular structures, but carrying out most of the chemical processes as well. Proteins are complex structures built of smaller units, molecules called amino acids. Molecules are the smallest particles of a substance that retain the chemical and physical properties of the substance and is composed of two or more atoms; a group of like or different atoms held together by chemical forces. Atoms are the smallest basic unit and building block of matter.)

Amniotic Sac:

Fluid-filled organ that cushions and protects the developing unborn child. Reptiles, birds and some mammals utilize amniotic sacs for this purpose in addition to humans.

Amprenavir:

An oral medication that is used for treating infections with the human immunodeficiency virus (HIV). Agenerase® is a discontinued brand name for Amprenavir manufactured by GSK.

Amyloidosis:

A variety of conditions wherein normally soluble proteins become insoluble fine protein fibers (amyloids) and accumulate in various organs and tissues of the body such that vital function is compromised. This can be on a local basis, affecting a specific organ, etc., or on a more generalized or systemic basis. (Proteins not only make up the majority of cellular structures of the body, but carry out most of the chemical processes vital to life as well.)

Anabolism:

One type of metabolism. Metabolism is all the chemical processes that occur within a living organism in order to maintain life. Metabolism essentially means “change”. Anabolism is the building up of things - a succession of chemical reactions that constructs or synthesizes molecules from smaller components, utilizing a few simple chemicals and molecules to manufacture (synthesize) a vast array of finished products, usually requiring energy in the process. Anabolism allows the body to grow new cells and maintain all the tissues. (Additional Notes/Definitions: A molecule is the smallest particle of a substance that retains the chemical and physical properties of the substance. The opposite process which breaks down complex substances to form simpler ones, together with the release of energy, is called catabolism.)

Anaerobic:

1. Process that does not require oxygen to occur. Certain microscopic organisms, such as certain bacteria, do not need oxygen to create or release energy from “food” substances – a process known as cellular respiration. An example of this is in the fermentation of alcohol. In the human body the main utilization of this type of anaerobic process is in the muscles during exercise, which is useful because it is not usually possible to get enough oxygen transported there quickly enough. (Additional Notes/Definitions: If the process or organism requires oxygen the term is aerobic.)

Analog/Analogue:

A chemical substance or compound with a similar structure to another but differing slightly in composition, often by a single component. The smallest basic unit of matter is called an atom. Two or more like or different atoms held together by chemical forces make a molecule. Molecules can combine with other atoms or molecules to form larger, more complex structures or compounds. An analog is a molecular structure similar to another molecular structure, but it can differ in one or more atoms, groups of atoms that function together, molecule or structure.

Anaphylactic Shock:

A widespread and very severe, potentially life-threatening allergic reaction. Symptoms include dizziness, loss of consciousness, labored breathing, swelling of the tongue and breathing tubes, blueness of the skin, low blood pressure, heart failure, and death. It can occur within seconds or minutes of exposure to something an individual is allergic to, for example certain foods such as certain nuts, the venom from a bee sting, or medications. Immediate emergency treatment is required for this type of shock. (Additional Notes/Definitions: Medically, shock is defined as a condition where the tissues in the body don't receive enough blood flow, oxygen and nutrients to allow the cells to function properly. This ultimately leads to cellular death, progressing to organ failure, multiple organ damage, and finally, if untreated, whole body failure and death.)

Anaphylaxis:

A serious allergic reaction to a foreign substance in the body causing a strong immune response in which the immune system reacts to the foreign substance as if it is a serious threat to the body. This excessive response typically causes a number of symptoms including an itchy rash, throat swelling, difficulty breathing, and low blood pressure. The reaction is rapid in onset and may cause death. Common causes include insect bites/stings, foods, and medications.

Anaplasia:

A condition whereby the cells divide rapidly but do not bear any resemblance to the normal cells, whether in structure or function. Most cells are differentiated from one to another and have specialized functions. Tumors are often formed by cells that become less differentiated and do not resemble the normal cells. Lack of differentiation and an increased capacity for multiplication is considered a hallmark of aggressive malignancies (cancers).

Anaplastic:

A term used to describe cells that divide rapidly and have little or no resemblance to normal cells, whether in structure or function. Most cells are differentiated from one another and have specialized functions. Cancer is a disease in which abnormal cells divide without control and are able to spread and invade other parts of the body. Extra cells may form a mass of tissue called a tumor. If they are also able to invade other tissues or create new tumors, they are considered cancerous or malignant. Tumors are often formed by cells that become less differentiated and do not resemble the normal cells. Lack of differentiation and an increased capacity for multiplication is considered a hallmark of aggressive malignancies (cancers).

Anemia:

A condition in which the number of red blood cells or the amount of hemoglobin in the blood is abnormally low. Red blood cells are responsible to provide oxygen to the body tissue. Hemoglobin is an iron-containing protein in red blood cells that transports oxygen (up to four molecules of oxygen per hemoglobin) from the lungs to the tissues. In addition to making up the majority of cellular structures, proteins carry out most of the chemical processes as well. Symptoms common to many types of anemia include easy fatigue and loss of energy, unusually rapid heartbeat, shortness of breath and/or headache, particularly with exercise, and difficulty concentrating. (Additional Notes/Definitions: Molecules are the smallest particles of a substance that retains the chemical and physical properties of the substance and is composed of two or more atoms; a group of like or different atoms held together by chemical forces. Atoms are the smallest basic unit and building block of matter.)

Aneuploidy:

An abnormal number of chromosomes in a cell. Cells, though small enough to be visible only with a microscope, are the basic units of living organisms, being the building block of tissue as well as being key components in blood and other fluids. Chromosomes contain the “blueprint” for the functioning and reproduction of the cells and characteristics of the organism as a whole. They are located in a central portion of the cell called a nucleus. A cell’s nucleus is a membrane-bound structure that contains the cell’s hereditary information and controls the cell’s growth and reproduction. There are normally 23 pairs of chromosomes in humans; an increase is called hyperploidy and a decrease is hypoploidy.

Angioedema:

Swelling that is similar to hives, but the swelling is under the skin instead of on the surface. Often triggered by an allergic reaction, the swelling, caused by an accumulation of fluid, can be severe and can affect any part of the body, including the hands, feet, genitals, lips and eyes. (Additional Notes/Definitions: Hives is an allergic skin reaction causing localized redness, swelling, and itching.)

Angiogensis:

The formation of new blood vessels which supplies more oxygen and nutrients to an area, a process that is essential to tumor growth. This is increasingly becoming an important target for biological-targeted cancer therapy. (Additional Notes/Definitions: A tumor is a swelling of a part of the body, generally without inflammation, caused by an abnormal growth of tissue, whether benign (non-cancerous) or malignant (cancerous and able to spread to other tissue or parts of the body). Biological therapy uses living organisms, substances derived from living organisms, or synthetic versions of such substances to treat cancer. Some types of biological therapy exploit the immune system’s natural ability to detect and kill cancer cells, whereas other types target cancer cells directly. Cancer is a term used for diseases in which abnormal cells divide without control and are able to spread and invade other parts of the body. The extra cells may form a mass of tissue called a tumor. If they are also able to invade other tissues or create new tumors, they are considered cancerous.)

Arthropathy:

A collective term for any disease of the joints.

Antiangiogenesis:

The destruction of blood vessels; the prevention of angiogenesis, which is the formation of new blood vessels, a process that is essential to tumor growth. This is increasingly becoming an important target for biological-targeted cancer therapy. (Additional Notes/Definitions: A tumor is a swelling of a part of the body, generally without inflammation, caused by an abnormal growth of tissue, whether benign (non-cancerous) or malignant (cancerous and able to spread to other tissue or parts of the body). Biological therapy uses living organisms, substances derived from living organisms, or synthetic versions of such substances to treat cancer. Some types of biological therapy exploit the immune system’s natural ability to detect and kill cancer cells, whereas other types target cancer cells directly. Cancer is a term used for diseases in which abnormal cells divide without control and are able to spread and invade other parts of the body. The extra cells may form a mass of tissue called a tumor. If they are also able to invade other tissues or create new tumors, they are considered cancerous.)

Antibacterials:

Medications that are used to treat infections caused by bacteria and are typically natural products or modified versions of natural products that either kill or slow the growth of bacteria. Bacteria are microscopic organisms (organisms that are so small as to be visible only with a microscope), some of which may cause illness. The word bacteria is the plural of bacterium. The Greek word anti means "against", and the Greek word bios means "life" (bacteria are life forms), also known as antibiotics.

Antibiotic Resistance:

Process by which bacteria mutate so that they are no longer affected by an antibiotic. Bacteria are microscopic organisms (organisms that are so small as to be visible only with a microscope), some of which may cause illness. Mutation is a genetic change that causes new and different characteristics. Genes are the basic unit of heredity and help determine not only visible physical characteristics such as the color of eyes or hair in humans, but also characteristics of an organism such as the functioning of chemical processes within an organism which are critical to life. Antibiotics are medications that are used to treat infections caused by bacteria and are typically natural products or modified versions of natural products that either kill or slow the growth of bacteria. The Greek word anti means "against", and the Greek word bios means "life" (bacteria are life forms). Antibiotics are also known as antibacterials.

Antibiotics:

Medications that are used to treat infections caused by bacteria and are typically natural products or modified versions of natural products that either kill or slow the growth of bacteria. Bacteria are microscopic organisms (organisms that are so small as to be visible only with a microscope), some of which may cause illness. The word bacteria is the plural of bacterium. The Greek word anti means "against", and the Greek word bios means "life" (bacteria are life forms), also known as antibacterials.

Antibody:

A protein produced by the body's immune system in response to foreign substances that are perceived as threats. Proteins are the true workhorses of the body, not only making up the majority of cellular structures but carrying out most of the chemical processes as well. Certain white blood cells, called B Cells, and are key components of the immune system. Some of our B cells turn into specialized cells called plasma cells whose role it is to produce specific proteins called antibodies.

Anticoagulant:

A substance that inhibits the clotting of blood. One side-effect could be that the person would be more likely to have problems with excess bleeding and not heal easily.

Antifungal:

A medicine used to treat infections caused by a fungus. Most fungal infections are superficial and mild, but some may become systemic and life threatening.

Antigen:

A substance that is recognized as foreign and perceived as a threat by the immune system. It stimulates the generation of antibodies which are proteins produced by the body's immune system to combat these foreign substances whether they be bacteria, viruses, chemicals, particles, etc. Proteins are the true workhorses of the body, not only making up the majority of cellular structures but carrying out most of the chemical processes as well. Antibodies are produced by a type of white blood cell called B Cells which are key components of the immune system. Antigen is short for antibody generator.

Antigen-Presenting Cells:

Specialized types of cells which help trigger additional steps in the immune system and allow it to adapt to new threats. This type of cell binds to a foreign substance perceived as a threat, called an antigen, and then engulfs and ingests it, breaking it up. Some portion of the antigen is then brought back to the surface membrane of the cell. Presenting a portion of the antigen in this way helps activate other cells and parts of the immune system. This function is also useful in the process of immunization.

Antiparasitic:

A compound that is used to treat a class of diseases transmitted by parasites such as Lyme disease or trichinosis.

Antiplatelet:

Any agent or action that destroys or inhibits the function of platelets. Platelets are disc-shaped cells formed in the bone marrow that circulate in the blood and are necessary to help the blood clot and control bleeding. One side-effect of antiplatelets could be that the person would be more likely to have problems with excess bleeding and not heal easily. (Platelets are often called cell fragments rather than cells because they do not have a definite nucleus. A cell’s nucleus is a membrane-bound structure that contains the cell’s hereditary information and controls the cell’s growth and reproduction.)

Antiseptic:

Chemical for external use (such as soap, vinegar, or rubbing alcohol) that destroys a bacteria, virus, or other microorganisms that can cause disease.

Anxiety:

A feeling of worry, nervousness, or unease, typically about an imminent event or something with an uncertain outcome.

Aorta:

The largest and main artery of the body, supplying oxygenated blood to the circulatory system. In humans it passes over the heart from the left ventricle, one of the two larger chambers in the lower portion of the heart, and runs down in front of the backbone. (Additional Notes/Definitios: An artery is a blood vessel (an elastic tubular structure) that carries oxygen-rich blood from the heart to the body.)

Apparent:

The evidence according to test results, etc.

Apparent Clearance (CL/F):

Clearance is how fast the drug is removed (or cleared) from the body. In some pharmacokinetic trials, the actual amount of the original dose of the drug that reaches systemic circulation in an unchanged form (bioavailability) is not known. This is particularly true when the drug is not administered intravenously, but orally or by some other method. The apparent clearance is a calculation that reflects the drug’s clearance but does not take into account the actual bioavailability. It is calculation resulting from the dose divided by the AUC – Area Under the Curve, which is a calculation that is dependent on the rate of elimination of the drug from the body and the dose administered.

Apparent Oral Clearance:

Refers to the how fast the drug is removed (or cleared) from the body when it is administered orally. In some pharmacokinetic trials, the actual amount of the original dose of the drug that reaches systemic circulation in an unchanged form (bioavailability) is not known. This is particularly true when the drug is not administered intravenously, but orally or by some other method. The apparent clearance is a calculation that reflects the drug’s clearance but does not take into account the actual bioavailability. It is calculation resulting from the dose divided by the AUC – Area Under the Curve, which is a calculation that is dependent on the rate of elimination of the drug from the body and the dose administered.

Appearance:

The way that someone or something looks.

Appetite:

In medicine an appetite normally refers to a desire for food; a natural desire to satisfy the bodily need for food.

Apprised:

Informed or given notice about something.

Aprepitant:

A drug given with two other types of anti-nausea drugs to prevent immediate and delayed nausea and vomiting after highly vomit-inducing chemotherapy.

Approve:

Officially agree to or accept as satisfactory.

Arm (In a clinical trial):

A group or subgroup of participants in a clinical trial who receives specific interventions (medicine, treatment, etc.), or no intervention, according to the study protocol. This is decided before the start of the trial.

Arrangements:

Plans or preparations for a future event.

Arrhythmia:

A disturbance in the rhythm of the heartbeat. The heart can beat too fast, too slow, or with an irregular rhythm. Most arrhythmias are harmless, but some can be serious or even life threatening. During an arrhythmia, the heart may not be able to pump enough blood to the body. Lack of blood flow can damage the brain, heart, and other organs.

Arrhythmic Symptoms:

An abnormal heart rhythm. In an arrhythmia the heartbeats may be too slow, too rapid, too irregular, or too early. This can cause many other symptoms such as dizziness, lightheadedness, shortness of breath, etc.

Arterial thrombosis:

Thickening or clotting of the blood within an artery (one of the vessels that carry blood from the heart to the tissues of the body) which can obstruct the flow of blood to major organs. Depending on where the clot forms, arterial thrombosis can cause several serious conditions, including: heart attack – when the blood flow to the heart is affected, or stroke – when the blood flow to the brain is affected.

Arteriole:

A small diameter blood vessel that extends and branches out from an artery and leads to capillaries. (Additional Notes/Definitions: Arteries are the blood vessels (elastic tubular structures) that carry oxygen-rich blood from the heart to the body. And veins are the blood vessels that carry blood to the heart after the cells have extracted the oxygen from the blood. Capillaries are the fine, branching blood vessels that form a network between artery and vein systems that enables the actual exchange of water, chemicals, and oxygen between the blood and the tissues. Capillaries have an internal diameter of hair-like thickness. The size of arterioles is between that of the arteries and that of the capillaries.)

Artery:

A blood vessel (an elastic tubular structure) that carries oxygen-rich blood from the heart to the body.

Arthralgia:

Joint pain.

Arthritis:

Inflammation of the joints which can cause pain, swelling and stiffness.

ASCO:

American Society of Clinical Oncology. (Oncology is a branch of science that deals with tumors and cancer.)

ASH:

American Society of Hematologists, a professional organization that studies blood related disorders.

Assimilate:

To take in and incorporate as one's own; absorb. To convert (food) to substances suitable for incorporation into the body and its tissues. (Additional Notes/Definitions: Tissue is a part of the body of a living thing that is made of similar cells. Cells are the basic units of living organisms which can only be seen under a microscope. They are seen in tissue, blood and other fluids.)

Aspartate Transaminase (AST/ASAT):

An enzyme that can be used to test for heart or liver damage. The purpose of an enzyme is to allow chemical reactions to be carried out very quickly. Almost all chemical reactions in living organisms need enzymes in order to occur. AST is normally present in body tissues, especially in the heart and liver, but is released into the blood as the result of tissue injury. Hence an increase of levels in the blood may indicate a heart attack or liver damage. (Also known as AspAT/AAT or an earlier name for the same enzyme, SGOT, which stands for serum glutamic oxaloacetic transaminase.)

Assess:

Evaluate or estimate the nature, ability, or quality of an item or object.

Association:

A connection or cooperative link between people or organizations.

AST/ASAT (Aspartate Transaminase):

An enzyme that can be used to test for heart or liver damage. The purpose of an enzyme is to allow chemical reactions to be carried out very quickly. Almost all chemical reactions in living organisms need enzymes in order to occur. AST is normally present in body tissues, especially in the heart and liver, but is released into the blood as the result of tissue injury. Hence an increase of levels in the blood may indicate a heart attack or liver damage. (Also known as AspAT/AAT or an earlier name for the same enzyme, SGOT, which stands for serum glutamic oxaloacetic transaminase.)

Asthenia:

Chronic fatigue or muscle weakness, a side effect of chemo therapy.

Asthma:

Condition in which air pathways in the lungs constrict, making breathing difficult.

Asymptomatic:

Without symptoms.

Ataxia:

Loss of muscle coordination.

Atazanavir:

An oral medication that is used for treating infections with the human immunodeficiency virus (HIV). Marketed under the trade name Reyataz by Bristol Myers.

Atom:

Smallest basic unit and building block of matter.

Atopic Dermatitis:

An allergic disorder of the skin, a type of eczema, with an itchy inflammation of the skin which can turn into a rash. It's a long-lasting (chronic) condition but tends to flare periodically and then subside and may be accompanied by asthma or hay fever. It may affect any area of your skin, but it typically appears on your arms and behind your knees. The cause of atopic dermatitis is unknown, but it may result from a combination of inherited tendencies for sensitive skin and malfunction in the body's immune system.

Atrial:

Having to do with an atrium, which is either of the upper chambers of the heart that receive the blood and forces it into one of the lower chambers, called a ventricle.

Atrial Fibrillation:

An irregular rhythm in the heart beat that effects blood flow into the heart and, hence, prevents the heart from pumping blood efficiently to the rest of the body resulting in restricted flow of blood to the rest of the body.

Atrial Flutter:

An abnormality in the beating of the heart, whether in the rhythm or speed.

Atrium:

Either of the small upper chambers in the human heart that receive the blood and forces it into one of the lower chambers, called a ventricle.

Attendee:

A person who attends a conference or other gathering.

AUC:

An abbreviation for Area Under the Curve; reflects the amount of drug the body is exposed to; a calculation that depends on the dose of medication given and how fast it is metabolized (cleared from the body). (Additional Notes/Definitions: A more complete wording for the definition AUC is: The Area Under the plasma drug concentration-time Curve. As noted, it reflects the actual body exposure to drug after administration of a dose of the drug and is based on calculations that include the dosage given and the rate of clearance from the body. The amount cleared can be measured at various points in time after the administration of the drug. The higher the clearance, the less time the drug spends in the systemic circulation and the faster the decline in the plasma drug concentration. These calculations can be represented on graph as a curve which indicates the maximum exposure at any given time, thus the area under the curve represents the actual exposure.)

Autoantibody:

An antibody is a protein produced by the body's immune system in response to what it considers foreign substances that could be harmful. However an autoantibody, it is an antibody that attacks the cells, tissues, or native proteins of its own organism.

Autograft:

A tissue transplant from one site to another in a single individual.

Autoimmune:

When the immune system, which is normally designed to attack foreign invaders, like illness causing bacteria, mistakenly attacks its own cells or tissues.

Autoimmune Disease:

An illness that occurs when the body tissues are attacked by its own immune system. The immune system is a complex organization within the body that is designed normally to "seek and destroy" invaders of the body, including infectious agents. Patients with autoimmune diseases frequently have unusual antibodies circulating in their blood that target their own body tissues. (Additional Noted/Definitions: An antibody is a protein produced by the body's immune system in response to foreign substances that are perceived as threats. Proteins are the true workhorses of the body, not only making up the majority of cellular structures but carrying out most of the chemical processes as well. Certain white blood cells, called B Cells, and are key components of the immune system. Some of our B cells turn into specialized cells called plasma cells whose role it is to produce specific proteins called antibodies.)

Autoimmune Hemolytic Anemia:

Autoimmune Hemolytic Anemia is the destruction of red blood cells by autoantibodies. Antibodies are produced by the body's immune system in order to combat or neutralize foreign substances deemed harmful. An antibody that an organism produces against any of its own tissues, cells, or cell components is called an autoantibody. Anemia is a condition in which the body does not have enough healthy red blood cells. Red blood cells provide oxygen to body tissues. As the condition progresses some of the symptoms include fatigue, dizziness, shortness of breath, and can increase to causing difficulty with the heart, other organs and other conditions. This is seen in certain diseases including lymphomas, after use of certain drugs, and for often unexplained reasons.

Autologous:

Derived from the same individual; “self”.

Autologous transplantation:

A procedure in which bone marrow or blood-forming stem cells are removed, stored, and later given back to the same person. Bone marrow is the flexible tissue found in the hollow interior of bones, which produces new blood cells. Blood-forming stem cells are the cells from which all blood cells develop. Bone marrow transplantation and blood stem cell transplantation are procedures that restore stem cells. A couple of reasons this procedure might be done is that cancer has affected the bone marrow, or that bone marrow or blood-forming stem cells were destroyed by high doses of chemotherapy and/or radiation therapy, treatments that are often done for cancer. (Additional Notes/Definitions: Cells are the basic units of a living organism which can only be seen under a microscope. In addition to being the building blocks of tissue, cells are in blood and other fluids. Each type of blood cell has specific functions such as transporting oxygen and nutrients to other cells in the body, helping to fight infection, and helping blood to clot so a person can heal from an injury.)

Autonomic Nervous System:

The part of the nervous system responsible for control of the bodily functions not consciously directed, such as breathing, the heartbeat, and digestive processes.

Autosome:

Any chromosome that is not a sex chromosome. (Additional Notes/Definitions: A chromosome is a threadlike structure that contains the “blueprint” for the functioning and reproduction of the cells and characteristics of the organism as a whole. Chromosomes are located in a central portion of the cell called a nucleus. A cell’s nucleus is a membrane-bound structure that contains the cell’s hereditary information and controls the cell’s growth and reproduction. In humans most cells contain 23 pairs of chromosomes, a set of 23 given by each parent, that are designated 1 to 22 in order of decreasing size with the female and male chromosomes designated X and Y respectively. (A normal female has a pair of X chromosomes; a male has an X and Y pair.)

Avidity:

The summation of multiple affinities; the combined strength of multiple points of attraction. To give more specifics, the body's immune system produces antibodies which are designed to combat foreign substances that are perceived as dangerous, such as a chemical, bacteria or virus. These foreign substances are called antigens because they stimulate the generation of antibodies, (Antigen is short for antibody generator). When an antibody binds to an antigen at multiple areas on both antibody and antigen, the multiple attractions or affinities summed together would be the avidity.

Axilla:

The underarm or armpit.

Bacterial Mutagenicity (Ames) Assay:

A test (assay) that uses bacteria to determine whether a chemical (e.g., drug) can cause cancer; literally, it checks to see if the chemical or drug causes mutations in the bacteria used in the test. Bacteria are microscopic organisms (organisms that are so small as to be visible only with a microscope), some of which may cause illness. A mutation is a change within the genetic instructions (blueprint used in the development and functioning of all known living organisms) resulting in the creation of a new character or trait not found in the parental type. Some mutations can lead to cancer.

Bacteria:

Microscopic organisms (organisms that are so small as to be visible only with a microscope), some of which may cause illness.

Balance:

A condition in which different elements are equal or in the correct proportions.

Baseline:

Information found at the beginning of a study or therapy which is used for comparison with later data. This is used to evaluate the relative changes that occur during the course of the study or therapy.

Baseline ECOG Performance Status:

The condition that the patient was at the beginning of the treatment (baseline) evaluated based on scales and criteria established by the Eastern Cooperative Oncology Group (ECOG) which are used to assess the degree of severity of their disease, how it is progressing, etc. The status is listed by Grades from 0 - 5, which cover from a state of being fully active through increasing severity up to death. (Oncology is the field of medical science devoted to cancer.)

Baseline Hepatic Impairment:

A pre-existing or chronic liver deficiency or failure. (Additional Notes/Definitions: The liver is a large important organ in the abdomen that has many functions including detoxification, the creation of certain blood proteins, and many processes having to do with digestion and metabolism. Specific to drug therapy, this includes a key function of helping to metabolize, break down and excrete, drugs or medications.)

Baseline (Recovery):

A recovery to the condition that the patient was at the beginning of the treatment (baseline). In other words, there may have been changes that occurred during the treatment but the patient’s functions have at least returned to the level that they were when the treatment started.

Basophil:

A type of white blood cell that is part of the immune system that normally protects your body from infection or foreign substances that are perceived as hazardous. When stimulated basophils release histamine, a chemical that helps fight infections and other potentially harmful substances that enter the body, and other substances that create changes in the body and signal other types of white blood cells in the immune system to help fight the foreign substances.

Basophil Degranulation:

When basophils release histamines. Basophils are white blood cells with large granules that contain histamine which is a chemical that helps fight infections and other potentially harmful substances that enter the body. Histamine triggers certain physical responses such as increased blood and fluid to the area, helping to prevent the spreading of the infection or foreign substance, and alerting other parts of the immune system such as other types of white blood cells and directing them to the location to fight the intruders. Unfortunately, histamine also causes many of the symptoms of allergies, such as a runny nose or sneezing, or even asthma.
(Additional Notes/Definitions: Basophils are created in the bone marrow, the spongy tissue occupying the hollow central cavity of bones, and then go into circulation as needed. They only represent about 0.01% to 0.3% of circulating white blood cells, increasing in response to parasitic infections or substances that the body is allergic to. Cells are the basic units of a living organism which can only be seen under a microscope. In addition to being the building blocks of tissue, cells are in blood and other fluids. A granule is a small particle in a cell. It can be any structure barely visible by a light microscope, but the term granule is most often used to describe a membrane-bound structure that secretes a specialized substance such as enzymes and other substances - for example inflammatory chemicals like histamine - that are made by the white blood cells that help them perform their function. The name basophil comes from the fact that they have granules that stain blue with specific basic dyes (dyes that are not acidic) because the derivation means “love of base”.)

B Cell:

One of the types of white blood cells in the immune system that defends against foreign substances and helps fight infection. B cells are formed in the bone-marrow, the spongy tissue occupying the hollow central cavity of bones, and develop as needed. One of their key functions is to make and release antibodies which are proteins which defend against foreign substances such as a chemical, bacteria or virus. (Proteins not only make up the majority of cellular structures but carry out most of the chemical processes as well.) After such an encounter, some B cells also provide a long-termed memory so that the immune system will be able to efficiently respond to any future encounter with that specific chemical, bacteria, virus, etc. (B cells are also known as B lymphocytes.)

B-cell Antigen Receptor/B-cell Receptor (BCR):

B cells are one of the types of white blood cells in the immune system that defend against foreign substances such as a chemical, bacteria or virus, and help fight infection. They do this by recognizing these foreign substances through the use of receptors (BCRs) on the surface of their cell membranes, and then making and releasing anti-bodies which defend against to these foreign substances called antigens (short for anti-body generator). A receptor is a complex protein with a structure that matches the shape of the antigen to which it is specific, much like a lock and key. Proteins not only make up the majority of cellular structures but carry out most of the chemical processes as well. When an antigen engages (binds to) the BCR it causes the B cell to grow and develop, and create and release antibodies. Engaging the BCR is also known as “activating” the BCR.

B-cell Malignancies (For example: MCL, CLL, WM):

Any of a group of malignancies (cancers) involving B cells, a type of white blood cell that is part of the immune system and helps protect against foreign invaders or substances, such as bacteria and viruses. Cancer is a term used for diseases in which abnormal cells divide without control and are able to spread and invade other parts of the body. Mantle Cell Lymphoma (MCL), Chronic Lymphocytic Leukemia (CLL) and Waldenström’s Macroglobulinemia (WM) all have malignant B cells as a common factor.
(Additional Notes/Definitions: Cells are the basic units of living organisms which can only be seen under a microscope. They are seen in tissue, blood and other fluids.)

B-cell Receptor/B-cell Antigen Receptor (BCR):

B cells are one of the types of white blood cells in the immune system that defend against foreign substances such as a chemical, bacteria or virus, and help fight infection. They do this by recognizing these foreign substances through the use of receptors (BCRs) on the surface of their cell membranes, and then making and releasing anti-bodies which defend against to these foreign substances called antigens (short for anti-body generator). A receptor is a complex protein with a structure that matches the shape of the antigen to which it is specific, much like a lock and key. Proteins not only make up the majority of cellular structures but carry out most of the chemical processes as well. When an antigen engages (binds to) the BCR it causes the B cell to grow and develop, and create and release antibodies. Engaging the BCR is also known as “activating” the BCR.

B-cell Surface Receptor:

A receptor/protein that is found on the surface of B cells that when engaged (i.e., bound) by specific proteins causes the B cell to grow and develop. (Also called B-cell Antigen Receptor/B-cell Receptor (BCR).)

B-cell Lymphoma:

Non-Hodgkin's Lymphomas caused by cancerous (over proliferating and congregating) B-cells, which are one of the group of white blood cells called lymphocytes that are part of the immune system.

B-cell Trafficking:

How B Cells move through the body. B cells are one of the type of white blood cells that help the body respond to foreign substances and fight infection and disease. They are produced in the bone marrow (the spongy tissue occupying the hollow central cavity of bones) and circulate in the blood plasma (the fluid part of blood) and lymph (the almost colorless fluid that carries B cells and other cells that are part of the immune system).

BCR:

B-cell Receptor or B-cell Antigen Receptor (see above).

BCR Transduction:

Transduction (also known as signal transduction) is any process by which a biological cell converts one kind of signal or stimulus into another. BCR transduction specifically refers to the activating signaling system or pathway within one of the types of white blood cells in the immune system called B cells that defend against foreign substances such as a chemical, bacteria or virus, and help fight infection. They do this by recognizing these foreign substances through the use of receptors on the surface of their cell membranes, and then making and releasing anti-bodies which defend against to these foreign substances called antigens (short for anti-body generator). These receptors are called B-cell Receptors or B-cell Antigen Receptor (BCRs). They are complex proteins with a structure that matches the shape of the antigen to which it is specific, much like a lock and key. (Proteins not only make up the majority of cellular structures but carry out most of the chemical processes as well.) When an antigen engages (binds to) the BCR it is known as “activating” the BCR. Signal transduction (also known as cell signaling is the transmission from a cell’s exterior to its interior to and must be done effectively to ensure an appropriate response. It is initiated by cell-surface receptors. BCR transduction is a protein-to-protein signaling pathway within the B cell when the BCR is activated. This then, activates the B cell to proliferate, mobilize, and create and release anti-bodies specifically designed to defend against the intruder.

Bence-Jones Proteins:

Antibodies, which are part of the immune system and help fight infections and disease, consist of complex protein molecules that are made of 2 pairs of different amino acid chains. The smaller of these two types of amino acid chains are called light chains, or Bence-Jones proteins. In the case of some Waldenström’s Macroglobulinemia patients these partial antibodies are created and secreted and may be deposited in the kidneys which can lead to kidney damage and kidney failure. (Additional Notes/Defintitions: Waldenström’s Macroglobulinemia (WM) is a cancer of cells that are part of our immune system which are white blood cells called B cells that normally help the body to fight infections. Normally, some of our B cells turn into specialized cells called plasma cells whose role it is to produce antibodies which help fight infections and harmful substances that get into the body. Antibodies are made up of a protein called immunoglobulin (abbreviated Ig). Proteins not only make up structures of the body but assist in bringing about most of the chemical reactions that are vital to living organisms. Amino acids are the building blocks of proteins. One of the characteristics of WM is that the malignant (cancerous) plasma cells create an overabundance of one particular immunoglobulin. The malignant plasma cells of some WM patients also produce and secrete partial immunoglobulins called light chains, or Bence-Jones proteins. These Bence-Jones proteins that go into circulation may be deposited in the kidneys. There they can plug up the tiny tubules that form the filtering system of the kidneys. This can lead to kidney damage and kidney failure.)

Benefit-Risk:

A determination of whether the benefits outweigh the risks of a particular treatment.

Benign:

Non-cancerous; not having the tendency or ability to invade neighboring tissues, create new tumors or spread to other parts of the body.

Benign Tumors:

Tumors that aren't cancerous. They can often be removed, and, in most cases, they do not come back. Cells in benign tumors do not spread to other parts of the body.
(Additional Notes/Definitions: A tumor is a swelling of a part of the body, generally without inflammation, caused by an abnormal growth of tissue, whether benign (non-cancerous) or malignant (cancerous and able to spread to other tissue or parts of the body). Tissue is part of the body of a living thing that is made of similar cells. Cells are the basic units of a living organism which can only be seen under a microscope. Cells are the building block of tissue as one brick is part of a brick wall. There are also cells with specialized functions in various other places in the body, such as the blood and other fluids. Cancer is a term used for diseases in which abnormal cells divide without control and are able to spread and invade other parts of the body.)

Bile:

A yellowish or greenish fluid produced in the liver that gets released into the small intestine where it aids in the digestion of fats/lipids. (Lipids is the broader technical term and includes fats.)

Biliary

: Having to do with bile or any of the organs connected with it. Bile is a yellowish or greenish fluid that aids in the digestion of fats. Bile is created in the liver, which is a large, important organ in the abdomen with many functions including the creation and secretion of bile. The bile then flows through long tube-like structures called bile ducts into the gallbladder, a pear-shaped, muscular sac attached to the undersurface of the right lobe of the liver, in which bile is stored and concentrated, before it is released into the small intestine where it helps with the digestion of fats. The term biliary means: having to do with the gallbladder, bile ducts, or bile.

Bilirubin:

The yellow breakdown product of one specific type of metabolism. Metabolism essentially means “change”, and is all chemical processes in an organism that allow it to either synthesize (build up compounds/substances needed) or breakdown complex substances to form simpler ones, together with the release of energy. Bilirubin occurs from the breakdown of heme (pronounced h?m) which is an iron-containing compound found in several substances including hemoglobin, a principal component of red blood cells which transports oxygen to the cells and tissues. Bilirubin is excreted in bile (which is a substance created in the liver and used in the small intestine to help the body digest fats), urine and feces. Elevated levels may indicate certain diseases. It is responsible for the yellow color of bruises, the yellow color of urine, and the brown color of feces. (Bilirubin was formerly referred to as hematoidin due to it being a product of the metabolism of heme, which is the deep red, oxygen-carrying, non-protein, ferrous (iron) component of hemoglobin. Also called reduced hematin. This is the iron-containing molecule in hemoglobin that serves as the site for oxygen binding.) (Additional Notes/Defnitions: Molecules are the smallest particles of a substance that retains the chemical and physical properties of the substance and is composed of two or more atoms; a group of like or different atoms held together by chemical forces. Atoms are the smallest basic unit and building block of matter.)

Bioavailability:

Fraction of a dose of drug that is absorbed from its site of administration and reaches, in an unchanged form, the systemic circulation. Bioavailability of a drug administered intravenously is by definition 100%. Bioavailability is less or equal to 100% for any other route of administration. In essence, it is the extent to which a medication or nutrient can be used by the body.

Biologic:

Any medicinal product manufactured in or extracted from biological sources, such as plant or animal cells, or a microorganism (an organism that is so small that it can only be viewed through a microscope). This is in contrast to a medicinal product called a drug, which is typically manufactured through chemical synthesis, which means that it is made by combining specific chemical ingredients in an ordered process. (Also known as a biopharmaceutical or biologic medical product.)

Biological Marker:

(Often shortened to Biomarker.) Anything that can be used as an indicator of the physiological state of an organism and any function or process within it, whether normal or abnormal, the presence of a disease, the progress of the disease, response to treatment, etc. This could be as simple as monitoring body temperature or more advanced, such as monitoring a specific substance in the body or even introducing a measurable substance into the body which can then be monitored. (Also called molecular marker and signature molecule.)

Biologic Medical Product:

Any medicinal product manufactured in or extracted from biological sources, such as plant or animal cells, or a microorganism (an organism that is so small that it can only be viewed through a microscope). This is in contrast to a medicinal product called a drug, which is typically manufactured through chemical synthesis, which means that it is made by combining specific chemical ingredients in an ordered process. (Also known as a biologic or biopharmaceutical.)

Biomarker:

(Short for biological marker.) Anything that can be used as an indicator of the physiological state of an organism and any function or process within it, whether normal or abnormal, the presence of a disease, the progress of the disease, response to treatment, etc. This could be as simple as monitoring body temperature or more advanced, such as monitoring a specific substance in the body or even introducing a measurable substance into the body which can then be monitored. (Also called molecular marker and signature molecule.)

Biopharmaceutical:

Any medicinal product manufactured in or extracted from biological sources, such as plant or animal cells, or a microorganism (an organism that is so small that it can only be viewed through a microscope). This is in contrast to a medicinal product called a drug, which is typically manufactured through chemical synthesis, which means that it is made by combining specific chemical ingredients in an ordered process. (Also known as a biologic or biologic medical product.)

Biopsy:

Surgical removal of a small piece of tissue or bone for microscopic evaluation.

Biotechnology:

The use of living organisms or their products to modify human health and the human environment. The term can include the creation of products that are genetically engineered or modified. Genes are essentially where the blueprint used in the development and functioning of the organism is stored and passed on. Therefore, a manipulation of genes could result in the creation of a new, and hopefully beneficial, characteristic or trait in that type of organism. Some examples include vaccines and blood components.

Black Ink:

Ink the color of black, often used to mark drug/medication capsules. For example, it is used to mark IMBRUVICA capsules with “ibr 140 mg” which designates that the capsule contains 140 mg of the active ingredient, ibrutinib.

Bleeding Event:

An instance of bleeding or loss of blood. It can be major or minor, internal or external.

Blood:

A specialized bodily fluid that delivers necessary substances such as nutrients and oxygen to the various cells of the body and transports waste products away from those same cells. In humans, blood it is composed of blood cells suspended in a liquid called blood plasma. (Additional Notes/Definitions: Cells are the basic units of living organisms which can only be seen under a microscope. They are seen in tissue, blood and other fluids.)

Blood Cell:

Any of the kinds of cells normally found circulating in the blood. They begin their life as stem cells, which are the immature cells created in the bone marrow that can develop, differentiate, and mature into three main types of cells—red blood cells, white blood cells, and platelets. Red blood cells transport oxygen from the lungs to the cells and tissues of the body and carbon dioxide back to the lungs so it can be exhaled. White blood cells are specialized, nearly colorless cells that circulate in the blood and lymph and help defend the body against disease and infection. There are several specific types that are essential for a properly functioning immune system. Platelets are a type of blood cell that is disc-shaped which allows it to get caught on openings in veins, such as from a cut, causing or allowing a blood clot to form in order to control or stop bleeding.
(Additional Notes/Definitions: Cells are the basic units of a living organism which can only be seen under a microscope. In addition to those that are the building block of tissue there are cells with specialized functions in various other places in the body, such as the blood and other fluids. Bone marrow is the spongy tissue occupying the hollow central cavity of bones. There are two types of bone marrow. Red bone marrow contains tissue that is responsible for the formation and development of most of the blood cells – approximately 500 billion per day. Red blood cells contain a special protein called hemoglobin, which helps carry oxygen from the lungs to the rest of the body and then returns carbon dioxide from the body to the lungs so it can be exhaled. Blood appears red because of the large number of red blood cells, which get their color from the hemoglobin which contains iron which turns red when combined with oxygen. Proteins not only make up most of the cellular structures of the body but also help carry out most of the chemical reactions that are vital to a living organism. Lymph is the thin clear fluid that circulates through the lymphatic vessels which are thin-walled, valved structures and carries certain types of white blood cells that fight infection and disease. It is a key part of the immune system which is the body's defense against infectious organisms and other invaders. Through a series of steps called the immune response, the immune system attacks organisms and substances that invade body systems and cause disease. As covered above, Platelets are a type of blood cell that is disc-shaped which allows it to get caught on openings in veins, such as from a cut, causing or allowing a blood clot to form in order to control or stop bleeding. Platelets are the smallest cell-like structures in the blood and are often called cell fragments because they do not have a definite nucleus. A vein is a blood vessel of varying size that carries blood to the heart after the cells have extracted the oxygen from the blood. A blood vessel is an elastic tube or passage in the body through which blood circulates. A cell nucleus is a membrane-bound structure that contains the cell’s hereditary information and controls the cell’s growth and reproduction.)

Blood Cell Counts:

The results of a blood count, which is a test panel (a group or battery of tests) that gives information about the quantity and quality of cells in a patient's blood. Abnormally high or low counts may indicate the presence of many forms of disease, and hence blood counts are amongst the most commonly performed blood tests in medicine, as they can provide an overview of a patient's general health status.

Blood Clots (Coughing up):

A blood clot is a thickened mass in the blood, normally formed to stop bleeding, such as at the site of cut. Coughing up blood clots indicates there may be internal bleeding.

Blood Count:

A test panel (a group or battery of tests) that gives information about the quantity and quality of cells in a patient's blood. Abnormally high or low counts may indicate the presence of many forms of disease, and hence blood counts are amongst the most commonly performed blood tests in medicine, as they can provide an overview of a patient's general health status.

Blood Fractionation:

The process of separating whole blood into its component parts, called fractionating. This is typically done by centrifuging the blood.

Blood in Stools or Urine:

An indication of internal bleeding. (Additional Notes/Definitions: Stools is a common term normally used in reference to human feces, the waste matter eliminated from the bowels; excrement. Urine is the waste product secreted by the kidneys that in mammals is a yellow to amber-colored, slightly acid fluid discharged from the body through the urethra, the canal through which urine is discharged from the bladder in most mammals. The kidneys are a pair of organs that are found on either side of the spine, just below the rib cage in the back. The kidneys perform the essential function of removing waste products from the blood and produce urine for excretion.)

Blood Plasma Fractionation:

Refers to the general processes of separating the various components of blood plasma, which in turn is a component of blood obtained through blood fractionation, which is a process of separating whole blood into its component parts, typically done by centrifuging the blood.

Blood Platelet Count:

The calculated number of platelets in a volume of blood, usually expressed as platelets per cubic millimeter of whole blood. Platelets are the smallest cell-like structures in the blood and are important for blood clotting and plugging damaged blood vessels.(Additional Notes/Definitions: Platelets are a type of blood cell that is disc-shaped which allows it to get caught on openings in veins, such as from a cut, causing or allowing a blood clot to form in order to control or stop bleeding. They are formed in the bone marrow and then circulate in the blood. They are often called cell fragments because they do not have a definite nucleus. Cells are the basic units of a living organism which can only be seen under a microscope. Cells are the building block of tissue as one brick is part of a brick wall. There are also cells with specialized functions in various other places in the body, such as the blood and other fluids. A vein is a blood vessel of varying size that carries blood to the heart after the cells have extracted the oxygen from the blood. A blood vessel is an elastic tube or passage in the body through which blood circulates. Bone marrow is the spongy tissue occupying the hollow central cavity of bones. It contains immature blood-forming stem cells which develop into the different types of blood cells. The nucleus is a membrane-bound structure that contains the cell’s hereditary information and controls the cell’s growth and reproduction.)

Blood Pressure:

The pressure of the blood within the arteries. It is produced primarily by the contraction of the heart muscle, but is also affected by the diameter and elasticity of the walls of the arteries. If either too high or too low it can lead to complications.

Blood Test:

An analysis of a sample of blood, especially for diagnostic or therapeutic purposes.

Blood Thinner Medicine:

A common name for a drug used to prevent the formation of blood clots by hindering coagulation of the blood. Blood-thinners do not really thin the blood.

Blood Vessel:

An elastic tubular structure that is part of the circulatory system. Blood vessels transport blood throughout the body, carrying blood through the tissues and organs. There are three types of blood vessels, arteries, veins and capillaries. An artery is a blood vessel that carries oxygen-rich blood from the heart to the body. A vein is a blood vessel of varying size that carries blood to the heart after the cells have extracted the oxygen from the blood. And a capillary is any of the fine, branching blood vessels that form a network between artery and vein systems that enables the actual exchange of water, chemicals, and oxygen between the blood and the tissues.

Blood (Whole):

A specialized bodily fluid that delivers necessary substances such as nutrients and oxygen to the various cells of the body and transports waste products away from those same cells. In humans, blood it is composed of blood cells suspended in a liquid called blood plasma. Whole blood is that from which none of the components have been removed, sometimes drawn from a specific donor, to be used in transfusions. (Additional Notes/Definitions: Cells are the basic units of living organisms which can only be seen under a microscope. They are seen in tissue, blood and other fluids.)

Boceprevir:

A medication that is used to treat hepatitis C virus (HCV). Merck drug trade name is VICTRELIS®

Bone marrow:

Spongy tissue occupying the hollow central cavity of bones. There are two types of bone marrow. Red bone marrow contains tissue that is responsible for the formation and development of most of the blood cells – approximately 500 billion per day. Yellow bone marrow contains more fat cells and only produces a few blood cells. At birth, all bone marrow is red. With age more and more is converted to the yellow type. As an adult, the marrow located in the spine, ribs, breastbone, hip, shoulders, and skull is most active in blood cell formation, and the bones of the hands, feet, legs and arms are not, having been converted to yellow marrow.
(Additional Notes/Definitions: Cells are the basic units of a living organism which can only be seen under a microscope. In addition to being the building blocks of tissue, cells are in blood and other fluids. Each type of blood cell has specific functions such as transporting oxygen and nutrients to other cells in the body, helping to fight infection, and helping blood to clot so a person can heal from an injury.

Bone Marrow Ablation:

Bone marrow is the spongy tissue occupying the hollow central cavity of bones. It is where the formation and development of new blood cells occurs. When there is cancer in the bone marrow, bone marrow ablation is a procedure that can be used to destroy bone marrow using radiation or high doses of anticancer drugs. Blood-forming stem cells are the cells from which all blood cells develop. Bone marrow transplantation and blood stem cell transplantation are procedures that restore stem cells. Bone marrow ablation can be done before a bone marrow or blood stem cell transplant to kill cancer cells and bone marrow cells. This makes room for healthy stem cells. (Additional Notes/Definitions: Cells are the basic units of a living organism which can only be seen under a microscope. In addition to being the building blocks of tissue, cells are in blood and other fluids. Each type of blood cell has specific functions such as transporting oxygen and nutrients to other cells in the body, helping to fight infection, and helping blood to clot so a person can heal from an injury.)

Bone Marrow Aspiration:

A bone marrow aspiration is the removal by needle of fluid and cells from the bone marrow, which is the spongy tissue occupying the hollow central cavity of bones where new blood cells are produced. This test is done to determine the reason for a blood disorder or some other analysis, and may be used to -find out if cancer or infection has spread to the bone marrow. A bone marrow aspiration can also be done to collect bone marrow for medical procedures, such as a blood stem cell transplant. Blood-forming stem cells are the cells from which all blood cells develop. Bone marrow transplantation and blood stem cell transplantation are procedures that restore stem cells. (Additional Notes/Definitions: Cells are the basic units of a living organism which can only be seen under a microscope. In addition to being the building blocks of tissue, cells are in blood and other fluids. Each type of blood cell has specific functions such as transporting oxygen and nutrients to other cells in the body, helping to fight infection, and helping blood to clot so a person can heal from an injury.)

Bone Marrow Biopsy (BMB):

A bone marrow biopsy is the removal of soft tissue, called marrow. Bone marrow is found in the hollow part of most bones and is where new blood cells are produced. The sample is usually taken from the hip bone. Often some of the bone is removed as well. It is then studied under a microscope. (Additional Notes/Definitions: Cells are the basic units of a living organism which can only be seen under a microscope. In addition to being the building blocks of tissue, cells are in blood and other fluids. Each type of blood cell has specific functions such as transporting oxygen and nutrients to other cells in the body, helping to fight infection, and helping blood to clot so a person can heal from an injury.)

Bone Marrow Involvement:

Medical complications in bone marrow such as when cancer has affected the bone marrow and its ability to function correctly. Bone marrow is the spongy tissue occupying the hollow central cavity of bones. It contains immature blood-forming stem cells which develop into the different types of blood cells. Cancer in the bone marrow could affect the ability to properly create new blood cells. It could also have an effect on the spreading of cancer.
(Additional Notes/Definitions: Cells are the basic units of a living organism which can only be seen under a microscope. In addition to being the building blocks of tissue, and are in blood and other fluids. Each type of blood cell has specific functions such as transporting oxygen and nutrients to other cells in the body, helping to fight infection, and helping blood to clot so a person can heal from an injury.)

Bone Marrow Microenvironment:

Bone marrow is the spongy tissue occupying the hollow central cavity of bones. It contains immature blood-forming stem cells which develop into the different types of blood cells. Bone marrow microenvironment is the immediate environment of these stem cells, which helps these stem cells survive and contains other types of cells that facilitate these stem cells differentiating into the different types of blood cells needed and proliferating. (Additional Notes/Definitions: Cells are the basic units of a living organism which can only be seen under a microscope. In addition to being the building blocks of tissue, cells are in blood and other fluids. Each type of blood cell has specific functions such as transporting oxygen and nutrients to other cells in the body, helping to fight infection, and helping blood to clot so a person can heal from an injury.)

Bone Marrow Micronucleus Assay:

A bone marrow test (assay) used to diagnose a number of bone and blood diseases, and for testing for compounds that could generate genetic changes and cause cancer. Bone marrow is the spongy tissue occupying the hollow central cavity of bones. It contains immature blood-forming stem cells which develop into the different types of blood cells.
(Additional Notes/Definitions: Cells are the basic units of a living organism which can only be seen under a microscope. In addition to being the building blocks of tissue, cells are in blood and other fluids. Each type of blood cell has specific functions such as transporting oxygen and nutrients to other cells in the body, helping to fight infection, and helping blood to clot so a person can heal from an injury. Genes carry the basic blueprint for the organism and changes would cause some changed characteristic in the next generation. Some changes could cause cancer.)

Bone marrow transplant:

A procedure to replace damaged or destroyed bone marrow with healthy bone marrow or blood-forming stem cells. Bone marrow is the flexible tissue found in the hollow interior of bones, which produces new blood cells. Blood-forming stem cells are the cells from which all blood cells develop. There are three kinds of bone marrow transplants; the differentiation is based on the donor. Depending on the scenario, the person might receive the transplant from their own bone marrow or stem cells, from another donor, or from a newborn baby’s umbilical cord. (Additional Notes/Definitions: Cells are the basic units of a living organism which can only be seen under a microscope. In addition to being the building blocks of tissue, cells are in blood and other fluids. Each type of blood cell has specific functions such as transporting oxygen and nutrients to other cells in the body, helping to fight infection, and helping blood to clot so a person can heal from an injury.)

Brain Metastasis (Brain Mets):

Metastasis is a cancer or tumor that spreads from its original location to other areas in the body. Brain Metastasis is a cancer or tumor that has spread to the brain from another site in the body, commonly the lung or breast. (Additional Notes/Definitions: Cancer is a term used for diseases in which abnormal cells divide without control and are able to spread and invade other parts of the body. Normally, cells grow and divide in a controlled way to produce more cells as they are needed to replace cells that die because they become old or damaged. However, the genetic material (DNA) of a cell can become damaged or changed, producing mutations that affect normal cell growth and division. When this happens, cells do not die when they should and new cells form when the body does not need them. The extra cells may form a mass of tissue called a tumor.)

Breastfeeding

: Nursing; the baby ingesting milk from its mother’s breasts.

Bruising:

A reddish-purple discoloration of the skin caused by leaking from local blood vessels damaged by pressure or impact. When a bruise fades, it becomes green and brown, as the body metabolizes the blood cells in the skin. It is best treated with local application of a cold pack immediately after injury.

Bruton’s Tyrosine Kinase (BTK):

A Kinase is an enzyme that activates other enzymes. Enzymes are responsible for selectively accelerating the rate of chemical reactions that sustain life, called metabolic processes. A Tyrosine Kinase is a type of enzyme involved primarily in signaling across a cell membrane or within a cell. Bruton’s Tyrosine Kinase (BTK), named after Dr. Bruton who discovered it, is an enzyme found specifically inside B Cells, which are one of the types of white blood cells in the immune system that defend against foreign substances such as a chemical, bacteria or virus, and help fight infection. They do this by recognizing these foreign substances through the use of receptors on the surface of their cell membranes, and then making and releasing anti-bodies which defend against these foreign substances called antigens (short for anti-body generator). BTK transmits signals from the receptor to activate B-cells. Without BTK, B-cells also cannot grow and do not function. It functions as an "on" or "off" switch in many cellular functions. But BTK can become mutated, stuck in the "on" position, and cause unregulated growth of the cell, which can bring about the development of cancer. (Additional Notes/Definitions: An enzyme is a protein which lowers the energy level required to activate or initiate chemical reactions and increases the rates of these reactions inside and outside cells without itself being changed in the process. Almost all chemical reactions in living organisms need enzymes in order to occur at and rates sufficient for life. Cells are the basic units of a living organism which can only be seen under a microscope. They make up tissue, and have vital functions in blood and other fluids.)

Bruton’s Tyrosine Kinase (BTK) Inhibitor:

If systems are functioning normally, BTK, in response to stimuli, signals the activation and growth of B Cells, which are one of the types of white blood cells in the immune system that defend against foreign substances and help fight infection. However, if B Cells become malignant (cancerous) they proliferate (grow and reproduce rapidly) in an uncontrolled and unchecked manner, migrate to other parts of the body, and adhere or clump together (which can cause tumors). In this scenario, a substance that inhibits BTK could inhibit activation and proliferation of malignant B Cells. (See Bruton’s Tyrosine Kinase above if more information is required.)

BTK:

Bruton’s tyrosine kinase (above).

BTK Active Site:

The part of BTK (Bruton’s Tyrosine Kinase) where a molecule binds and a chemical reaction occurs. BTK is found specifically inside B Cells, which are one of the types of white blood cells in the immune system that defend against foreign substances such as a chemical, bacteria or virus, and help fight infection. The BTK active site is key to the BTK’s ability to facilitate the chemical reaction that signals and activates the functioning, growth and proliferation of the B Cells.
(Additional Notes/Definitions: BTK is an enzyme, which is a protein which lowers the energy level required to activate or initiate chemical reactions and thereby increases the rates of these reactions which is vital to the functioning of an organism. A molecule is the smallest particle of a substance that retains the chemical and physical properties of the substance and is composed of two or more atoms, which are the smallest basic unit and building block of matter. See also Bruton’s Tyrosine Kinase if you require more data.)

BTK Enzymatic Activity:

The action of an enzyme, in this case BTK (Bruton’s Tyrosine Kinase), on its target. The chemical reaction that BTK enables is the way that it signals and activates the functioning, growth and proliferation of the B cells. (Additional Notes/Definitions: BTK is found specifically inside B cells, which are one of the types of white blood cells in the immune system that defend against foreign substances such as a chemical, bacteria or virus, and help fight infection. BTK is an enzyme, which is a protein which lowers the energy level required to activate or initiate chemical reactions and thereby increases the rates of these reactions which is vital to the functioning of an organism. See Bruton’s Tyrosine Kinase if more data is required.)

BTK Inhibitor (Bruton’s Tyrosine Kinase Inhibitor):

If systems are functioning normally, BTK, in response to stimuli, signals the activation and growth of B Cells, which are one of the types of white blood cells in the immune system that defend against foreign substances and help fight infection. However, if B Cells become malignant (cancerous) they proliferate (grow and reproduce rapidly) in an uncontrolled and unchecked manner, migrate to other parts of the body, and adhere or clump together (which can cause tumors). In this scenario, a substance that inhibits BTK could inhibit activation and proliferation of malignant B Cells. (See Bruton’s Tyrosine Kinase above if more information is required.)

Bulky Disease:

A term for a cancer with large tumors or lymph nodes which is usually more resistant to conventional therapy. (Additional Notes/Definitions: Lymph nodes are key parts of the immune system. They are bean-shaped organs found in the underarms, groin, neck, and abdomen that act as filters for the lymph fluid, which contains types of white blood cells called lymphocytes that fight infection and disease. A tumor is a swelling of a part of the body, generally without inflammation, caused by an abnormal growth of tissue, whether benign (non-cancerous) or malignant (cancerous and able to spread to other tissue or parts of the body). Tissue is part of the body of a living thing that is made of similar cells. Cells are the basic units of a living organism which can only be seen under a microscope. Cells are the building block of tissue as one brick is part of a brick wall. There are also cells with specialized functions in various other places in the body, such as the blood and other fluids)

Bulky Tumor:

When individual tumor masses are about 10 cm in diameter or larger.
(Additional Notes/Definitions: A tumor is a swelling of a part of the body, generally without inflammation, caused by an abnormal growth of tissue, whether benign (non-cancerous) or malignant (cancerous and able to spread to other tissue or parts of the body). Tissue is part of the body of a living thing that is made of similar cells. Cells are the basic units of a living organism which can only be seen under a microscope. Cells are the building block of tissue as one brick is part of a brick wall. There are also cells with specialized functions in various other places in the body, such as the blood and other fluids.)

Cancer:

A term used for diseases in which abnormal cells divide without control and are able to spread and invade other parts of the body. Normally, cells grow and divide in a controlled way to produce more cells as they are needed to replace cells that die because they become old or damaged. However, the genetic material (DNA) of a cell can become damaged or changed, producing mutations that affect normal cell growth and division. When this happens, cells do not die when they should and new cells form when the body does not need them. The extra cells may form a mass of tissue called a tumor. If they are also able to invade other tissues or create new tumors, they are considered cancerous. Cancer cells can also spread to other parts of the body through the blood and lymph systems. Cancer is not just one disease but many diseases. There are more t100 known different types of cancer. Most cancers are named for the organ or type of cell in which they start - for example, cancer that begins in the colon is called colon cancer. Cancer types can be grouped into broader categories. The main categories of cancer include:
Carcinoma - cancer that begins in the skin or in tissues that line or cover internal organs.
Sarcoma - cancer that begins in bone, cartilage, fat, muscle, blood vessels, or other connective or supportive tissue.
Leukemia - cancer that starts in blood-forming tissue such as the bone marrow and causes large numbers of abnormal blood cells to be produced and enter the blood.
Lymphoma and myeloma - cancers that begin in the cells of the immune system.
Central nervous system cancers - cancers that begin in the tissues of the brain and spinal cord.
(Additional Notes/Definitions: Cells are the basic units of living organisms which can only be seen under a microscope. The body is made up of many types of cells, making up structures like tissues and nerves, circulating in the blood & bodily fluids, etc. DNA (Deoxyribonucleic acid) encodes the genetic instructions or “blueprint” used in the development and functioning of all known living organisms. Mutation is any change in the DNA of a cell or an organism resulting in the creation of a new character or trait not found in the parental type. Blood is a specialized bodily fluid that delivers necessary substances such as nutrients and oxygen to the various cells of the body and transports waste products away from those same cells. In humans, blood it is composed of blood cells suspended in a liquid called blood plasma. Lymph is the thin clear fluid that circulates through the body and carries certain types of white blood cells called lymphocytes that fight infection and disease. Bone marrow is the spongy tissue occupying the hollow central cavity of bones. It is responsible for the formation and development of most of the blood cells – approximately 500 billion per day.)

Capillary:

Any of the fine, branching blood vessels that form a network between artery and vein systems that enables the actual exchange of water, chemicals, and oxygen between the blood and the tissues. Capillaries have an internal diameter of hair-like thickness. (Additional Notes/Definitions: Arteries are the blood vessels (elastic tubular structures) that carry oxygen-rich blood from the heart to the body. And veins are the blood vessels that carry blood to the heart after the cells have extracted the oxygen from the blood.)

Capsule Shell:

A shell, usually of gelatin, for packaging something (as a drug or vitamins).

Carbamazepine:

A drug that prevents or relieves convulsion and relieves pain used in the treatment of certain forms of epilepsy and to relieve pain associated with acute pain along the path of nerves. (Additional Notes/Definitions: Epilepsy is a central nervous system (neurological) disorder in which the nerve cell activity in the brain is disturbed, causing a seizure during which the person experiences abnormal behavior, symptoms and sensations, including loss of consciousness. Seizure symptoms vary. Some people with epilepsy simply stare blankly for a few seconds during a seizure, while others might have a severe convulsion with their body stiffening and their arms or legs twitching repeatedly.) BRAND NAMES: Tegretol®, Tegretol XR®, Equetro®, Carbatrol®, Epitol®, Teril®

Carcinogenesis:

The production of cancer; the process of initiating and promoting cancer.

Carcinogenicity Studies:

Studies to determine the effect that a particular medication or substance may have on the production of cancer, and at what dosage or exposure level; studies generally conducted with animals, most frequently rats.

Carcinoma:

General name for cancer that begins in the skin or in tissues that line or cover internal organs. (Additional Notes/Definitions: Cancer is a term used for diseases in which abnormal cells divide without control and are able to spread and invade other parts of the body. A cell is a basic unit of a living organism which can only be seen under a microscope. It is the building block of tissue as one brick is part of a brick wall.)

Cardiac Adverse Event:

An unexpected side effect or symptom occurring with or in connection with the heart.

Cardiac Cycle:

As the heart beats, it pumps blood through a system of blood vessels, which are elastic tubes or passages that carry blood to every part of the body. All or any of the events that occur from the beginning of one heartbeat to the beginning of the next is called a cardiac cycle.

Cardiac Risk Factors:

Characteristics or traits that reliably predict a person's chances of developing a cardiovascular disease, for instance, an increased risk of heart attack.

Cardiovascular System:

The bodily system consisting of the heart, blood, and blood vessels (elastic tubular structures) that circulates blood throughout the body, delivers oxygen, nutrients and other essential materials to the various cells of the body, and removes waste products. (From the Latin words meaning ‘heart’ – ‘vessel’, also called circulatory system.) (Additional Notes/Definitions: Cells are the basic units of a living organism which can only be seen under a microscope. Some cells are the building block of tissue and some have specialized functions, such as in the blood and other fluids.)

Catabolism:

One type of metabolism. Metabolism is all the chemical processes that occur within a living organism in order to maintain life. Metabolism essentially means “change”. Catabolism is the breaking down of things - a series of chemical reactions that break down complex molecules into smaller units, and in most cases releasing energy in the process which provides the energy our bodies need for physical activity, from a cellular level right up to whole body movements. When we eat our body breaks down the organic nutrients - this breaking down process releases energy, which is stored inside specialized molecules in the body. (Additional Notes/Definitions: Molecules are the smallest particles of a substance that retains the chemical and physical properties of the substance. Cells are the basic units of a living organism, visible only with a microscope. Some make up tissue and others have specialized functions and are mobile, such as in blood and other fluids.)

Catalyze:

Cause or accelerate (a reaction) by acting as a catalyst, which is a substance that increases the rate of a chemical reaction without itself undergoing any permanent chemical change.

Catalyst:

A substance that increases the rate of a chemical reaction without itself undergoing any permanent chemical change.

Caucasian:

Referring to people of European origin or people who are light-skinned. (The original classification was broader than this and the term is now in question as a technical term.)

Causal Relationship:

Of, involving, or constituting a cause/effect relationship, where one factor or event (cause) brings about or has a direct relation to another event or certain phenomena occurring (effect).

CLL:

Chronic lymphocytic leukemia.

CLL with 17p Deletion:

Chronic lymphocytic leukemia with 17p deletion.

Cell:

A basic unit of a living organism which can only be seen under a microscope. Cells are the building block of tissue as one brick is part of a brick wall. There are also cells with specialized functions in various other places in the body, such as the blood and other fluids.

Cell Adhesion Molecules (CAM):

Proteins located on the cell surface involved in binding with other cells or with the extracellular matrix (ECM) in the process called cell adhesion. In essence, cell adhesion molecules help cells stick to each other and to their surroundings.
(Additional Notes/Definitions: Proteins not only make up most of the structures of the body but carry out most of the chemical processes as well. Cells are the basic units of living organisms which can only be seen under a microscope. The body is made up of many types of cells, making up structures like tissues and nerves, circulating in the blood & bodily fluids, etc. Extracellular means outside the cell. A matrix is an environment or material in which something develops; a surrounding medium or structure. The extracellular matrix (ECM) is a collection of extracellular molecules (molecules outside of the cells) which are secreted by cells that provides structural and biochemical support to the surrounding cells. Cell adhesion is a normal function and crucial for multicellular life. Not only does it allow cells to physically interact with each other and their surroundings to form tissues, but cell adhesion also allows cells to sense their environment and respond accordingly, such as with the immune system. However, cell adhesion is also involved in the process in which malignant/cancerous cells attach themselves to each other and develop into tumors, and how malignant/cancerous cells are able to attach to tissues in new areas of the body as cancer spreads. Molecules are the smallest particles of a substance that retains the chemical and physical properties of the substance and is composed of two or more atoms; a group of like or different atoms held together by chemical forces. Atoms are the smallest basic unit and building block of matter.)

Cell Culture:

The process by which cells are grown under controlled conditions, generally outside of their natural environment. (Additional Notes/Definitions: Cells are the basic units of living organisms which can only be seen under a microscope. The body is made up of many types of cells, making up structures like tissues and nerves, circulating in the blood & bodily fluids, etc.)

Cell Line:

A cell culture developed from a single cell and therefore consisting of cells with a uniform genetic makeup, a family of constantly dividing cells. They are obtained from human or animal tissues, most commonly rodents, and can replicate for long periods of time in vitro (in the lab). They are frequently used for research or the study of cancers and other diseases. (Additional Notes/Definitions: Cells are the basic units of a living organism which can only be seen under a microscope. They make up tissue and have vital functions in blood and other fluids. A cell culture is the process by which cells are grown under controlled conditions, generally outside of their natural environment.)

Cell Migration:

Movement of cells, normally in well-orchestrated (or pre-determined) ways, in response to external signals (chemical or mechanical). The process of cell migration is important in such things as wound repair and cell differentiation (less specialized cells becoming a more specialized cell type). However, it is also a factor in the spread of cancer when malignant (cancerous) cells migrate.

Cell Proliferation:

An increase in the number of cells as a result of cell growth and cell division.

Cell Substrate Adhesion/Substrate Adhesion:

Cell substrate adhesion is the attachment of one cell to another, or the attachment of a cell to some substance or chemical. This can cause cells to congregate or collect (which can result in enlargement of glands and organs, and tumors). Inhibition of B-Cell substrate adhesion would inhibit the congregation of B Cells. (This can be measured in vitro, in a test tube).

Cellulitis:

Cellulitis is a spreading bacterial infection just below the skin surface which causes an inflammation which is characterized by pain, redness, heat, and swelling. The word "cellulitis" actually means "inflammation of the cells". (Additional Notes/Definitions: Bacteria are microscopic organisms, visible only with a microscope, some of which may cause illness. Cells are the basic units of a living organism which can only be seen under a microscope. They make up tissue and have vital functions in blood and other fluids.)

Centimeter:

A unit of length, equal to one hundredth of a meter (abbreviated: cm).

Central Nervous System Cancers:

Cancers that begin in the tissues of the brain and spinal cord. (Additional Notes/Definitions: Cancer is a term used for diseases in which abnormal cells divide without control and are able to spread and invade other parts of the body.)

Certification:

Official approval to do something professionally or legally. Confirmation that an object, person, or organization has met specific criteria, often with an official document or certificate give as evidence of the fact. This confirmation is often, but not always, provided by some form of external review, education, assessment, or audit. Accreditation is a specific organization's process of certification.

Change in Speech:

Garbled speech, difficulty speaking (can be a sign of internal bleeding, particularly in the head).

Characteristic:

A distinguishing feature or quality.

Chemical Name:

A scientific name based on the compound's chemical structure, as determined by the rules of accepted systems of chemical nomenclature, and is almost never used to identify the drug in a clinical or marketing situation.

Chemical Reaction:

A process in which atoms of the same or different elements rearrange themselves to form a new substance. While they do so, they either absorb heat or give it off. A process that involves rearrangement of the molecular or ionic structure of a substance, as opposed to a change in physical form or a nuclear reaction. (Additional Notes/Definitions: Smallest basic unit of matter is called an atom. Two or more like or different atoms held together by chemical forces make a molecule. An ion is an atom or molecule with a net electric charge due to the loss or gain of one or more electrons. A nuclear reaction is a change in the identity or characteristics of an atomic nucleus that results when it is bombarded with an energetic particle, as in fission, fusion, or radioactive decay. A nuclear reaction is a process, such as fission, fusion, or radioactive decay, in which the structure of an atomic nucleus is altered through release of energy or mass or by being broken apart. The nucleus of an atom is the positively charged central core, consisting of protons and neutrons and containing nearly all its mass. Protons are subatomic particles, smaller than an atom, that have a positive charge and neutrons are neutral, giving the nucleus an overall positive charge.) An electron is a very small particle of matter that has a negative charge, the basic charge of electricity, and travels around the nucleus of an atom. An electron has a small mass, less than 0.1% the mass of an atom. Under normal circumstances, electrons move about the nucleus of an atom in orbitals that form an electron cloud bound in varying strengths to the positively charged nucleus. Electrons play a key role in creating chemical bonds to create different chemical substances. Due to attractive force of positive and negative charges many chemical substances become more stable when bonded with another substance. To form compounds atoms will lose, gain, or share electrons.

Chemotaxis:

The characteristic movement or orientation of an organism or cell toward or away from the chemical stimulus (for example, bacteria exhibit chemotaxis when they move toward a source of nutrients). (Additional Notes/Definitions: Cells are the basic units of a living organism which can only be seen under a microscope. They make up tissue and have vital functions in blood and other fluids. Bacteria are microscopic organisms, organisms that are so small as to be visible only with a microscope, some of which may cause illness.)

Chemotherapy:

The treatment of diseases, infections or other disorders by the use of chemical substances, especially the treatment of cancer by use of powerful drugs that kill cells (cytotoxic), especially intended to kill fast-growing cells.

Child-Pugh A, B, C:

This is a way to classify chronic liver disease or damage; the classifications are A, B and C, with C being the most severe (listed separately below). (Additional Notes/Definitions: The liver is a large organ in the abdomen. It is an important organ that has many functions including detoxification, the creation of certain blood proteins, and many processes having to do with digestion and metabolism. Specific to drug therapy, this includes a key function of helping to metabolize, in other words break down and excrete, drugs or medications. Proteins not only make up the majority of cellular structures but carry out most of the chemical processes as well. Metabolic reactions or metabolism includes all the physical and chemical changes that occur in organisms to allow growth and maintain body functions. These include processes that break down substances to yield energy and processes that build up other substances necessary for life.)

Child-Pugh class A:

Mild chronic hepatic (liver) impairment. (See Child-Pugh A, B, C above if more data is needed.)

Child-Pugh class B:

Moderate chronic hepatic (liver) impairment. (See Child-Pugh A, B, C above if more data is needed.)

Child-Pugh class C:

Severe chronic hepatic (liver) impairment. (See Child-Pugh A, B, C above if more data is needed.)

Child-Resistant Closure:

A closure designed to be significantly difficult for children under 5 years of age to open or obtain a harmful amount of the contents within a reasonable time and not difficult for normal adults to use properly, often accomplished by use of a special safety cap.

Chills:

A sensation of coldness, often accompanied by shivering and, at times, an unhealthy pale appearance of the skin.

CHO:

stands for Chinese Hamster Ovaries; cells from the ovary of the Chinese Hamster are collected and used in scientific research; very popular for growing cells, especially in molecular biology.

Cholesterol:

A waxy substance that’s found in fats (lipids) in your blood. Your body needs cholesterol to continue building healthy cells, but when you have high cholesterol you might develop deposits in your blood vessels that can restrict the flow of blood. This could lead to heart attack or stroke. If cholesterol levels are too low it could create other complications.

Chromosome:

A threadlike structure that contains the “blueprint” for the functioning and reproduction of the cells and characteristics of the organism as a whole. Chromosomes are located in a central portion of the cell called a nucleus. In humans most cells contain 23 pairs of chromosomes, a set of 23 given by each parent, that are designated 1 to 22 in order of decreasing size with the female and male chromosomes designated x and y respectively. (A normal female has a pair of X chromosomes; a male has an X and Y pair.) A chromosome is a long strand that contains roughly equal parts of protein and DNA. The chromosomal DNA contains an average of 150 million molecules that are building blocks, called bases. They are arranged in a double helix (a shape like a twisted ladder). DNA molecules are among the largest molecules now known. The DNA is encoded with genes. A gene is the basic physical and functional unit of heredity. Genes, which are sections of the DNA, act as instructions to make molecules called proteins. Proteins not only make up the cellular structures but carry out most of the chemical reactions necessary for life. Hence the chromosomes contain the genetic information necessary for the production of other cell components and for the reproduction of life. (Additional Notes/Definitions: The word chromosome was originally coined in German from the Greek words khroma, meaning color, and soma meaning body. In the late 1800s, a scientist, Wilhelm von Waldeyer-Hartz, gave chromosomes their name because chromosomes easily accept dye and take on patterns of light and dark when exposed to different stains that help identify the different chromosomes. Molecules are the smallest particles of a substance that retains the chemical and physical properties of the substance and is composed of two or more atoms; a group of like or different atoms held together by chemical forces. Atoms are the smallest basic unit and building block of matter.)

Chromosome Aberration Assay:

A test that detects breaks or changes (deletions or rearrangements) from normal DNA or chromosomes, which is where the blueprint used in the development and functioning of all known living organisms is stored. Disruption or breakages of DNA or chromosomes can lead to mutations and possibly cancer. A mutation is any change in the DNA of a cell or an organism resulting in the creation of a new character or trait not found in the parental type. (Additional Notes/Definitions: Cells are the basic units of a living organism which can only be seen under a microscope. They make up tissue and have vital functions in blood and other fluids. A chromosome is a threadlike structure that contains the “blueprint” for the functioning and reproduction of the cells and characteristics of the organism as a whole. Chromosomes are located in a central portion of the cell called a nucleus. A chromosome is a long strand that contains roughly equal parts of protein and DNA, Deoxyribonucleic acid. The DNA contains a large number of molecules that are arranged in a double helix, a shape like a twisted ladder. The DNA is encoded with genes. A gene is the basic physical and functional unit of heredity. Genes, which are sections of the DNA, act as instructions to make molecules called proteins. Proteins not only make up the cellular structures but carry out most of the chemical reactions necessary for life. Hence the chromosomes contain the genetic information necessary for the production of other cell components and for the reproduction of life. Molecules are the smallest particles of a substance that retains the chemical and physical properties of the substance and is composed of two or more atoms; a group of like or different atoms held together by chemical forces. Atoms are the smallest basic unit and building block of matter.)

Chronic/Chronically:

1. Persisting for a long time; of long duration. 2. Used for a disease of slow progress and long continuance. 3. Also used in connection with prescription medications to describe routine usage for a disease of slow progress and long continuance.

Chronic Lymphocytic Leukemia (CCL):

A type of cancer of the blood and bone marrow (the spongy tissue inside bones where blood cells are made). Cells are the basic units of a living organism which can only be seen under a microscope. They make up tissue and have vital functions in blood and other fluids. The term “chronic” in chronic lymphocytic leukemia comes from the fact that it typically progresses more slowly than other types of leukemia. The term "lymphocytic" refers to the cells affected by the disease — a group of white blood cells called lymphocytes, which help your body fight infection. The term “leukemia” means “white blood”. Leukemia is a type of blood cancer that begins in the bone marrow and leads to increased numbers of immature or abnormal white blood cells (leukocytes). These suppress the production of normal blood cells. The progression of symptoms can include anemia, fatigue, appetite loss, an abnormally low level of various blood cells can cause symptoms such as reduced resistance to infections, clotting of blood, etc., and there can be enlargements of certain organs such as liver and spleen. Chronic lymphocytic leukemia most commonly affects older adults.

Chronic Lymphocytic Leukemia (CLL) with 17p Deletion:

Having Chronic Lymphocytic Leukemia (CLL) (described above) and, in addition, having a disorder caused by a deleted or absent portion of chromosome 17. Chromosomes essentially carry the blueprint for the structure and functioning of the organism. Humans normally have 46 chromosomes in each cell divided into 23 pairs, often referred to by number. Chromosomes are large and complex, each one containing many genes, where more specific bits of this genetic “blueprint” are stored. A deletion in the short (p) arm of chromosome 17 involves the loss of a gene that is associated with the ability to suppress tumors. Hence, individuals that have CLL with 17p depletion are considered to be at risk of the cancer developing more rapidly, and commonly have a poor outcome with some existing therapies. They generally don’t respond well to chemotherapy or radiation therapy.

CI (Confidence Interval):

A statistical term used to define the range within which we expect the results to lie with a specified probability that a given result will lie within that range. The specified probability is called the confidence level, and the end points of the confidence interval are called the confidence limits [e.g., 95% CI, (8, 11), would indicate that 95% of the time the result would be expected to be between 8 and 11.]

[14C]-Ibrutinib:

Ibrutinib, the active ingredient in IMBRUVICA, containing radio-labeled carbon 14. It is a common practice in drug research and discovery in order to determine the pathway that a drug follows and the major changes it goes through as it metabolizes (undergoes chemical processes where it is broken down into simpler substances) in the body. The technique is called carbon labeling: carbon 14 atoms (which are radioactive) can be used to replace nonradioactive carbon in a compound or drug (for example, ibrutinib) in order to trace reactions and pathways. One way to trace it or view it is with x-rays. The doses of carbon 14 utilized are very small with reportedly little or no radiation risks.

Ciprofloxacin:

A drug used to treat bacterial infections in many different parts of the body and also to treat anthrax infection after inhalation exposure. (Additional Notes/Definitions: Bacteria are microscopic organisms, visible only with a microscope, some of which may cause illness. Anthrax is an infectious, often fatal bacterial disease of cattle, sheep, and other mammals, transmitted to humans by contaminated wool, raw meat, or other animal products.) Brand Names: Cipro®, Cipro® XR, Proquin® XR, Cipro® I.V., Cipro® Cystitis Pack.

Circulatory System:

The bodily system consisting of the heart, blood, and blood vessels (elastic tubular structures) that circulates blood throughout the body, delivers oxygen, nutrients and other essential materials to cells, and removes waste products. (Also called cardiovascular system, from the Latin words meaning ‘heart’ – ‘vessel’.) The circulatory system is often seen to be composed of both the cardiovascular system, which distributes blood, and the lymphatic system which circulates lymph, which is a thin clear fluid that circulates through the lymphatic vessels (thin walled, valved structures) and carries certain types of white blood cells called lymphocytes that fight infection and disease. The systems are connected. Although blood does not enter the lymphatic system, lymph does enter the blood system and return once filtered. Lymph is essentially like the fluid portion of the blood called blood plasma. (Additional Notes/Definitions: Cells are the basic units of a living organism which can only be seen under a microscope. Some cells are the building block of tissue and some have specialized functions, such as in the blood and other fluids.)

Circumstance:

A fact or condition connected with or relevant to an event or action.

Cladribine:

An anticancer drug, used in chemotherapy. It is of a class of drugs that interfere with a cell's growth or ability to multiply, even killing cells that are actively attempting to replicate themselves. Currently it is approved to treat hairy cell leukemia. (Cladribine is the generic name. The chemical name is 2CdA, which is an abbreviation of 2-chlorodeoxyadenosine.)
(Additional Notes/Definitions: Hairy cell leukemia is a rare, slow-growing cancer of the blood in which your bone marrow makes too many B cells (lymphocytes), a type of white blood cell that fights infection. These excess B cells are abnormal and look "hairy" under a microscope. As the number of leukemia cells increases, fewer healthy white blood cells, red blood cells, which transport oxygen to the tissues and cells, and platelets, which aid with blood clotting and healing of wounds, are produced. Another symptom of hairy cell leukemia is an abnormal enlargement of the spleen, which is an abdominal organ involved in the production and removal of blood cells and forming part of the immune system. The spleen filters out harmful substances from the blood, produces white blood cells (which help fight infections), removes worn-out red blood cells (which transport oxygen to the tissues and cells) from circulation, and maintains a reserve blood supply for the body.) Brand Names: Cladribine® Novaplus®, Leustatin®.

Claim:

State or assert that something is the case, typically without providing evidence or proof.

Clarithromycin:

A drug prescribed to treat a wide variety of bacteria. Bacteria are microscopic organisms (organisms that are so small as to be visible only with a microscope), some of which may cause illness. Brand Names: Biaxin®, Biaxin® XL, Biaxin® XL-Pak.

Clastogenic:

Causing disruption or breakages of chromosomes which can lead to mutations and possibly cancer. (Additional Notes/Definitions: Chromosomes are where the blueprint for the characteristics, development and functioning of all known living organisms are stored. A mutation is any change in this “blueprint” of a cell or an organism resulting in the creation of a new character or trait not found in the parental type. Cells are the basic units of a living organism which can only be seen under a microscope. They make up tissue and have vital functions in blood and other fluids.)

Clearance (CL/F):

How fast the drug is removed (or cleared) from the body.

Cleared Renally:

A drug being removed (or cleared) from the body by the kidneys and then excreted in urine. (Additional Notes/Definitions: The term renal pertains to the kidney, of or in the region of the kidneys. The kidneys are a pair of organs that are found on either side of the spine, just below the rib cage in the back. The kidneys perform the essential function of removing waste products from the blood.)

CLcr (Creatinine Clearance):

Creatinine is a by-product of metabolism and is excreted in urine. Creatinine clearance is the volume of blood plasma that is cleared of creatinine per unit time and is an indication of the state of the kidneys. This is measured whenever kidney disease is suspected or careful dosing of certain drugs are required.

CL/F:

Clearance; how fast the drug is removed (or cleared) from the body.

Clinical:

Of or relating to the observation and treatment of actual patients rather than theoretical or laboratory studies.

Clinical Benefit:

A treatment that demonstrates a response such as an improvement in survival in comparison to no therapy, or to a known effective therapy, or a clear improvement in the speed of disease progression with an improvement in symptoms.

Clinical Pharmacology:

The science of drugs and their clinical use. The focus is on the application in the real world and the main objective is to promote the safety of prescription, maximize the drug effects and minimize the side effects.

Clinical Practice Guidelines:

Recommendations for health care professionals about the care of patients with specific conditions. The Guidelines are, detailed to assist practitioner and patient decisions about appropriate health care for specific clinical circumstances, and the correct use of a specific product/medication. Ideally, these guidelines should be based upon the best available evidence obtained from research and in practice.

Clinical Trial/Clinical Study:

A type of research study that tests how well new medical approaches work in human beings. These studies follow a defined plan to determine the risks and benefits of a given therapy and test new methods of screening, prevention, diagnosis, or treatment of a disease.

Clotting Factors:

Any of a number of substances in blood plasma (the liquid part of the blood) that are involved in the clotting process, which helps prevent excess bleeding and heal wounds.

cm:

Centimeter; a unit of length, equal to one hundredth of a meter.

Cmax:

The maximum concentration of a drug in the body / plasma (blood fluid) after dosing.

CME (Continuing Medical Education):

Refers to a specific form of continuing education that helps those in the medical field maintain competence and learn about new and developing areas of their field. CME consists of educational activities which serve to maintain, develop, or increase the knowledge, skills, and professional performance and relationships that a physician uses to provide services for patients, the public, or the profession.

Co-Administration:

Giving or administering two or more drugs or medications concurrently.

Code:

A set of rules and standards adhered to by a society, class, or individual.

Cofactor:

A cofactor is a non-protein chemical compound that is bound to a protein and is required for the protein's biological activity. These proteins are commonly enzymes, and cofactors can be considered "helper molecules" that assist in biochemical transformations. Cofactors work by changing the shape of an enzyme or by actually participating in the enzymatic reaction. (Additional Notes/Definitions: Proteins not only make up the majority of cellular structures but carry out most of the chemical processes as well. An enzyme is a protein which lowers the energy level required to activate or initiate chemical reactions and thereby increases the rates of these reactions which is vital to the functioning of an organism. A molecule is the smallest particle of a substance that retains the chemical and physical properties of the substance and is composed of two or more atoms, which are the smallest basic unit and building block of matter.)

Commercial:

Related to or used in the buying or selling of goods and services; produced in order to be sold; related to business; concerned with or engaged in commerce.

Comorbidity:

The condition of having two or more diseases at the same time, or the effect of such disorders, particularly when chronic or persistent. The two medical conditions could be related or independent.

Compensation:

Something, typically money, awarded to someone in order to make up for loss, injury, or suffering.

Complete Blood Count (CBC):

A test panel (a group or battery of tests) that gives information about the cells in a patient's blood. Abnormally high or low counts may indicate the presence of many forms of disease, and hence blood counts are amongst the most commonly performed blood tests in medicine, as they can provide an overview of a patient's general health status. (Additional Notes/Definitions: Cells are the basic units of a living organism which can only be seen under a microscope. Some make up tissue and others have vital functions in blood and other fluids.)

Complete Response (CR):

The total disappearance of the cancer; there are no signs or symptoms of cancer as confirmed by various tests. Reconfirmation is required after a specified amount of time, for example, six weeks.

Compound:

A substance formed when two or more chemical elements are chemically bonded together; two or more atoms of differing elements are bonded together to create a molecule. The elements in any compound are always present in fixed rations. For example, pure water is a compound made from two elements – hydrogen and oxygen. The ratio in water is always 2:1, or 2 atoms of hydrogen to 1 atom of oxygen, hence the chemical compound is known as H2O. (Additional Notes/Definitions: A molecule is the smallest particle of a substance that retains the chemical and physical properties of the substance and is composed of two or more atoms, which are the smallest basic unit and building block of matter.)

Comprehensive Metabolic Panel (CMP):

A panel (group or battery) of 14 blood tests which serves as an initial broad screening tool for physicians, nurse practitioners, and physician assistants. Because it is often ordered as a routine part of an annual physical examination or check-up, over time the CMP provides an important baseline of a patient's basic physiology. The CMP provides an important gross check on the status of kidney function, liver function, and electrolyte and fluid balance. (Additional Notes/Definitions: Baseline is the information found at the beginning of a study or therapy which is used for comparison with later data. This is used to evaluate the relative changes that occur during the course of the study or therapy. Electrolytes are essential minerals that are found in the bodily fluids.)

Comply: 1.

(Of a person or group) to act or be in accordance with wishes, demands, requirements, conditions, etc.; agree. 2. (Of an article) meet specified standard.

Concentration Dependence:

A difference based on the concentration of the drug (i.e., the effect can depend on whether there is a high or low amount of the drug present).

Concomitant:

Designating two or more things occurring simultaneously; accompanying.

Concomitant Administration:

The administration or giving of two or more medicinal drugs (or other supplements) either at the same time or almost at the same time (for instance on the same day).

Concomitant Medications:

When two or more medicinal drugs are given either at the same time or almost at the same time (for instance on the same day).

Conducive:

Making a certain situation or outcome likely or possible (usually used with to).

Conduct:

1. Organize and carry out; to direct in action or course; manage. 2. Transmit (a form of energy such as heat or electricity); to serve as a channel or medium for (heat, electricity, sound, etc.). 3. The manner in which a person behaves, especially on a particular occasion or in a particular context.

Conference:

A formal meeting that typically takes place over a number of days and involves people with a shared interest, especially one held regularly by an association or organization.

Confidence Interval (CI):

A statistical term used to define the range within which we expect the results to lie with a specified probability that a given result will lie within that range. The specified probability is called the confidence level, and the end points of the confidence interval are called the confidence limits [e.g., 95% CI, (8, 11), would indicate that 95% of the time the result would be expected to be between 8 and 11.]

Confidential:

Intended to be kept secret.

Confirmatory Trials:

An adequately controlled trial where hypotheses are stated in advance and evaluated according to a protocol. This type of trial may be implemented when it is necessary to provide additional or firm evidence of efficacy or safety.

Connective tissue (CT):

A kind of biological tissue that supports, connects, or separates different types of tissues and organs of the body.

Contingent (Upon):

Occurring or existing only if (certain other circumstances) are the case, conditional (often followed by on or upon).

Continuing Medical Education (CME):

Refers to a specific form of continuing education that helps those in the medical field maintain competence and learn about new and developing areas of their field. CME consists of educational activities which serve to maintain, develop, or increase the knowledge, skills, and professional performance and relationships that a physician uses to provide services for patients, the public, or the profession.

Constipation:

A condition in which a person has fewer than three bowel movements a week or has bowel movements with stools that are hard, dry, and small, making them painful or difficult to pass.

Constitutional Symptoms:

Refers to a group of symptoms that can affect many different parts of the body. Examples include weight loss, fevers, fatigue, and malaise (a general feeling of discomfort, illness, or uneasiness whose exact cause is difficult to identify). Other examples include chills, night sweats, and decreased appetite. Generally, they are very nonspecific, with a vast number of diseases and conditions as potential causes, thereby requiring further evaluation for any diagnosis.

Consultant:

A person who provides expert advice professionally; usually involving a payment.

Consulting:

Engaged in the business of giving expert advice to people working in a professional or technical field.

Content:

1. (Often contents) Something that is contained, as in a receptacle: 2. The topics or matter treated in a written work.

Contract:

1. A legal agreement between people, companies, etc. 2. Of a muscle or muscle fiber, to cause to undergo contraction; especially, to cause to shorten and thicken; to reduce to smaller size by or as if by squeezing or drawing together. (Additional Notes/Definitions: When the heart muscles contract the heart decreases in volume in such a way that blood is forced out of heart chambers and is propelled through the body.)

Contraction:

The process in which a muscle becomes or is made shorter and tighter; the shortening and thickening of a functioning muscle or muscle fiber; a drawing together; a shortening or shrinkage. (Additional Notes/Definitions: Heart contraction is the process in which the heart muscles shorten, thicken and squeeze in such a way that the heart decreases in volume and blood is forced out of heart chambers and is propelled through the body.)

Contraindication:

In medicine, a condition or factor that serves as a reason to withhold a certain medical treatment.

Controlled Trial:

A study in which a group of the participants receive the treatment in question and another group do not. In a Controlled Trial this second group is a control group receiving placebo or another previously tested treatment which is used to evaluate the effectiveness of the treatment by comparison.

Contusion:

A region of injured tissue or skin in which blood capillaries have been ruptured; another name for a bruise.

Cooperative Groups:

The Clinical Trials Cooperative Group Program is sponsored by the National Cancer Institute and is designed to promote and support clinical trials (research studies) of new cancer treatments, explore methods of cancer prevention and early detection, and study quality-of-life and rehabilitation issues. Cooperative groups include researchers, cancer centers, and community physicians throughout the United States, Canada, and Europe.
(Additional Notes/Definitions: The National Cancer Institute (NCI) is part of the National Institutes of Health, which is one of eleven agencies that are part of the U.S. Department of Health and Human Services. The NCI coordinates the U.S. National Cancer Program and conducts and supports research, training, health information dissemination, and other activities related to the causes, prevention, diagnosis, and treatment of cancer; the supportive care of cancer patients and their families; and cancer survivorship.)

Coronary Arteries

The vessels that supply the heart muscle with blood rich in oxygen; either of two arteries that originate in the main artery in the body called the aorta, and supply blood to the muscular tissue of the heart. They are called the coronary arteries because they encircle the heart in the manner of a crown. The word "coronary" comes from the Latin corona and Greek koron meaning crown. (Additional Notes/Definitions: An artery is a blood vessel that carries oxygen-rich blood from the heart to the body. A vessel is an elastic tube or passage in the body through which blood circulates. The aorta is the largest and main artery of the body, supplying oxygenated blood to the circulatory system. In humans it passes over the heart from the left ventricle, one of the two larger chambers in the lower portion of the heart, and runs down in front of the backbone. The coronary arteries originate from the aorta.)

Cough up Blood or Blood Clots:

Indicates that there is very likely internal bleeding.

Courtesy

Consideration, cooperation, and generosity in providing something (as a gift or privilege).

Covalent Bond:

A covalent bond is the chemical bond that involves the sharing of electron pairs between atoms. The stable balance of attractive and repulsive forces between atoms when they share electrons is known as covalent bonding. (An electron is a very small particle of matter that has a negative charge and travels around the nucleus of an atom. An atom is the smallest basic unit and building block of matter with a nucleus that is the positively charged central core of an atom. Electrons play a key role in creating chemical bonds to create different chemical substances. Due to attractive force of positive and negative charges many chemical substances become more stable when bonded with another substance. Valence is the chemical combining power of atoms based on the number of electrons the atom will lose, gain, or share when it forms compounds. Hence, covalent means that both substances share one or more electrons.)

Cover:

1. Deal with (a subject) by describing or analyzing its most important aspects or events. 2. To put or spread something over something else, or to lie on the surface of something; envelop in a layer of something.

Covering:

1. A thing used to cover something else, typically in order to protect or conceal it; a layer of something that covers something else. 2. Putting or spreading something over something, lying on the surface of something; enveloping in a layer of something. 3. Dealing with (a subject) by describing or analyzing its most important aspects or events.

CR (Complete Response):

The total disappearance of the cancer; there are no signs or symptoms of cancer as confirmed by various tests. Reconfirmation is required after a specified amount of time, for example, six weeks.

C-Reactive Protein (CRP):

A protein found in the blood (proteins not only make up the majority of cellular structures but carry out most of the chemical processes in the body as well). The level of C-reactive protein rises with inflammation (swelling). Your doctor may check your C-reactive protein level after surgery or treatment for infections or other medical conditions.

Creatine:

An amino acid (building block of protein) that is found in the muscle tissue in a compound containing phosphorus and oxygen (called a phosphate) which is used to supply the burst of energy required for immediate muscle activity, that which occurs in the first 8 – 10 seconds, before oxygen and other elements from the blood have time to arrive to supply continued energy for muscle activity.

Creatinine:

A by-product of one aspect of muscle metabolism (specifically, the breaking down of a compound or substance that is in the muscle mass in order to supply energy needed by the muscles on a rapid and urgent basis, for the first 8 – 10 seconds of muscle contraction or functioning.) Creatinine is a waste product that is excreted in urine.

Creatinine Clearance (Clcr, CCr or CrCl):

Creatinine is a byproduct of one aspect of muscle metabolism. Creatinine clearance is the volume of blood plasma (the liquid part of the blood) that is cleared of creatinine per unit of time and is an indication of the state of the kidneys. This is measured whenever kidney disease is suspected or careful dosing of certain drugs are required to prevent complications.

Clcr, CCr or CrCl:

Creatinine Clearance.

Criteria:

Principles or standards by which something may be judged, evaluated, tested or decided. Something that is used as a reason for making a judgment or decision. Criteria is the plural of criterion.

Crizotinib:

A drug that is used to treat specific advanced lung cancers. (Crizotinib is the generic name and Xalkori is the trademark name in the US.)

Croscarmellose Sodium:

An inactive ingredient used in many drugs (medications); it is used in drug formulation to determine where the drug is released once it is taken (i.e., some medications may be inactivated if exposed to acid in the stomach so they are more effective if released in the intestine).

Crossed Over:

Switched from one form of treatment to another.

CTCAE:

NCI Common Terminology Criteria for Adverse Events.

CYP____ (Includes CYP2D6, CYP3A or Cytochrome P450 Enzyme 3A, and variations of Cytochrome P450 ____ and CYP ___):

A class of enzymes, essential for drug metabolism (breakdown and clearance from the body). Mainly found in the liver and also the small intestine, they are known as the cytochrome P450 superfamily of enzymes (officially abbreviated as CYP). Although this class has more than 50 enzymes, six of them metabolize 90 percent of drugs, with the two most significant enzymes being CYP3A4 and CYP2D6. (Additional Notes/Definitions: An enzyme lowers the energy level required to activate or initiate chemical reactions and thereby increases the rates of these reactions, vital for living organisms. Enzymes are key for metabolism which is all of the chemical processes within a living organism that are necessary for the maintenance of life. Drug metabolism, specifically, is when the drug is chemically broken down into simpler substances and any waste is cleared from the body.)

CYP2D6:

(See CYP ____ above.)

CYP3A:

(See CYP ____ above.)

CYP ____ Inducers:

Substances that initiate or increase the activity of the enzymes in the CYP family.

If the breakdown and clearance (metabolism) of a certain drug by these enzymes is induced or increased, then the concentration of that drug in the system (for example, ibrutinib) can decrease dramatically. (See CYP ____ above for more data.)

CYP ____ Inhibitors:

A substance that slows or stops the activity of the enzymes in the CYP family. If the breakdown and clearance (metabolism) of a certain drug by these enzymes is inhibited, then the concentration of that drug in the system (for example, ibrutinib) can increase dramatically. (See CYP ____ above for more data.)

CYP Substrates:

A molecule that is broken down/metabolized by a CYP enzyme.
(Additional Notes/Definitions: Molecules are the smallest particles of a substance that retains the chemical and physical properties of the substance and is composed of two or more atoms; a group of like or different atoms held together by chemical forces. Atoms are the smallest basic unit and building block of matter. An enzyme lowers the energy level required to activate or initiate chemical reactions and thereby increases the rates of these reactions, vital for living organisms. Enzymes are key for metabolism which is all of the chemical processes within a living organism that are necessary for the maintenance of life. A Cyp enzyme is any of a class of enzymes, essential for drug metabolism. Mainly found in the liver and also the small intestine, they are known as the cytochrome P450 superfamily of enzymes (officially abbreviated as CYP). When a drug is metabolized, it undergoes metabolism and is chemically broken down into simpler substances and any waste is cleared from the body.)

Cyst:

An abnormal growth which is a closed membranous sac or cavity that forms in tissue and is typically filled with liquid, semisolid or gaseous material - very much like a blister. They vary in size from microscopic to the size of some team-sport balls - large cysts can displace internal organs.

Cysteine Residue:

Cysteine is an amino acid that allows ibrutinib to bind to and block BTK. Residue, in this case, means a recognizable part of a larger molecule. Amino acids are essential building blocks of proteins, and as such can be referred to as residues of the larger protein chain.
(Additional Notes/Definitions: Molecules are the smallest particles of a substance that retains the chemical and physical properties of the substance and is composed of two or more atoms; a group of like or different atoms held together by chemical forces. Atoms are the smallest basic unit and building block of matter.)

Cytochrome P450 Enzyme 3A:

(See CYP ____ above.)

Cytokines:

Any number of substances that are secreted by certain cells of the immune system and have an effect on, signal and activate, other cells. Cytokines are proteins that control our response to infections, stress or injury. (Additional Notes/Definitions: Cells are the basic units of a living organism which can only be seen under a microscope. They make up tissue and have vital functions in blood and other fluids. Proteins not only make up the majority of cellular structures but carry out most of the chemical processes as well.)

Cytokine Receptor Pathways:

Receptors are proteins found on the surface of a cell or inside a cell; cytokines attach to the receptor and send signals down a pathway that tell the cell how to behave. (Additional Notes/Definitions: Cytokines are substances that are secreted by certain cells of the immune system and have an effect on, signal and activate, other cells. Cytokines are proteins that control our response to infections, stress or injury. Cells are the basic units of a living organism which can only be seen under a microscope. They make up tissue and have vital functions in blood and other fluids. Proteins not only make up the majority of cellular structures but carry out most of the chemical processes as well.)

Cytopenia:

A condition in which there is a lower-than-normal numbers of blood cells. It is a general term and could refer to a deficiency in all blood cells or to a deficient number of one or more specific types of blood cell in circulation.

Cytoreducing/Debulking:

The partial removal of a malignant tumor which cannot be completely removed with surgery. A method of reducing the number of cancer cells so as to enhance the effectiveness of radiation or chemotherapy. (Additional Notes/Definitions: A malignant tumor is cancerous, it displays uncontrolled growth and can invade adjacent tissues and even spread to other parts of the body.)

Cytotoxic:

Toxic to living cells, cell-toxic, cell-killing. Any agent or process that kills cells. For example, there are cells in the immune system that kill cells that are perceived as invading and harmful. Another example is that chemotherapy and radiotherapy are forms of cytotoxic therapy. They kill cells. (Additional Notes/Definitions: Cells are the basic units of a living organism which can only be seen under a microscope. In the human body, some cells are the building block of tissue and some have specialized functions, such as in the blood and other fluids.)

Cytotoxicity:

The quality of being toxic to cells, kills cells. For example, there are cells in the immune system that have the ability to kill cells that are perceived as invading and harmful. Another example is that chemotherapy and radiotherapy are forms of cytotoxic therapy. They kill cells. (Additional Notes/Definitions: Cells are the basic units of a living organism which can only be seen under a microscope. In the human body, some cells are the building block of tissue and some have specialized functions, such as in the blood and other fluids.)

Darunavir:

An oral medication that is used for treating infections with the human immunodeficiency virus (HIV). Brand Name: Prezista®.

Data:

Facts and statistics collected together for reference or analysis.

Debulking/Cytoreducing:

The partial removal of a malignant tumor which cannot be completely removed with surgery. A method of reducing the number of cells so as to enhance the effectiveness of radiation or chemotherapy. (Additional Notes/Definitions: A malignant tumor is cancerous, it displays uncontrolled growth and can invade adjacent tissues and even spread to other parts of the body.)

Deciliter:

A metric unit of capacity, equal to one tenth of a liter.

Decreased Appetite:

A reduced desire to eat; also known as a poor appetite or loss of appetite.

Decreased Fetal Weight:

The actual weight based on the mass of the unborn offspring or baby being less than normal.

Dedicated Drug Interaction Trial:

Trials, usually done with healthy volunteers, that are only looking at whether a drug has any interactions with another drugs (drug-drug interactions); there is no evaluation of efficacy of the drug, as the subjects are healthy.

Dehydration:

A condition when the body does not have enough water and appropriate fluids for normal functioning. This is also accompanied by a loss of electrolytes. Dehydration can be mild, moderate, or severe based on how much of the body's fluid is lost or not replenished. When it is severe, dehydration is a life-threatening emergency. The treatment is to replace lost fluids and lost electrolytes, generally this is done orally if possible.

Del 17p CLL:

See Chronic lymphocytic leukemia with 17p deletion.

 

Dental Procedure:

A procedure employed by a dentist, which can range from filling a cavity to extensive cosmetic procedures.

Deoxyribonucleic acid (DNA):

A molecule that encodes the genetic instructions (blueprint) used in the development and functioning of all known living organisms. (Additional Notes/Definitions: Molecules are the smallest particles of a substance that retains the chemical and physical properties of the substance and is composed of two or more atoms; a group of like or different atoms held together by chemical forces. Atoms are the smallest basic unit and building block of matter. Human DNA contains an average of 150 million molecules that are building blocks, called bases. They are arranged in a double helix (a shape like a twisted ladder). DNA molecules are among the largest molecules now known. The DNA is encoded with genes. A gene is the basic physical and functional unit of heredity. Genes, which are sections of the DNA, act as instructions to make molecules called proteins. Proteins not only make up the cellular structures but carry out most of the chemical reactions necessary for life. Hence DNA contains the genetic information necessary for the production of other cell components and for the reproduction of life. Most human DNA is packaged in long threadlike structures called chromosomes. Chromosomes contain roughly equal parts of protein and DNA. In most human cells there are 23 pairs of chromosomes located in a central portion of the cell called a nucleus. There is also some DNA in specialized structures within cells, called mitochondria, that convert the energy from food into a form that cells can use and create molecules that help assemble protein building blocks (amino acids) into functioning proteins.)

Descending Frequency:

Occurring less and less; listed in an order that the one that occurred most often is listed first, followed in descending order to the least frequent.

Diabetes: There are two categories of diabetes as covered below:

Diabetes Insipidus (in-SIP-ih-dus): A condition characterized by frequent and heavy urination, excessive thirst and an overall feeling of weakness. This condition may be caused by a defect in the pituitary gland or in the kidney. In diabetes insipidus, blood glucose levels are normal.
Diabetes Mellitus (MELL-ih-tus): A condition characterized by hyperglycemia (high blood glucose) resulting from the body's inability to use blood glucose for energy. In Type 1 diabetes, the pancreas no longer makes insulin and therefore blood glucose cannot enter the cells to be used for energy. In Type 2 diabetes, either the pancreas does not make enough insulin or the body is unable to use insulin correctly.

Diagnosis:

The identification of the nature of an illness or other problem by examination of the symptoms, the identification of the nature and cause of anything.

Dialysis:

Dialysis is a treatment that does some of the things done by healthy kidneys. It is needed when your own kidneys can no longer take care of your body's needs.

Diarrhea:

A condition that involves the frequent passing of loose or watery bowel movements (for example, three or more per day) - it is the opposite of constipation and can have many causes, which may be infectious or non-infectious.

Diastolic Pressure:

The minimum pressure in the arteries, which occurs between heartbeats (when the heart muscle is resting between beats and refilling with blood). (Additional Notes/Definitions: The heart pumps blood into the arteries which are blood vessels that transport blood rich in oxygen from the heart to the rest of the body. A vessel is an elastic tube or passage in the body through which blood circulates. Blood pressure is the measure of the force of blood pushing against blood vessel walls.)

Digoxin:

A medication that helps make the heart beat stronger and with a more regular rhythm. Digoxin is used to treat heart failure and symptoms such as an irregular heartbeat or rhythm (known as atrial fibrillation) that effects blood to flow into the heart and, hence, to the rest of the body. Brand Names: Lanoxin®, Lanoxicaps®, Cardoxin®, Digitek®.

Dihydrodiol:

An enzyme that stops a chemical reaction. (Additional Notes/Definitions: An enzyme is a protein which lowers the energy level required to activate or initiate chemical reactions and thereby increases the rates of these reactions which is vital to the functioning of an organism.)

Diltiazem:

A drug used to treat high blood pressure, to control angina (chest pain) and to treat irregular heart rhythms. (Additional Notes/Definitions: Blood pressure is the measure of the force of blood pushing against blood vessel walls. The heart pumps blood into the arteries (blood vessels), which carry the blood throughout the body. High blood pressure, also called hypertension, is dangerous because it makes the heart work harder to pump blood to the body and contributes to hardening of the arteries and to the development of heart failure. High blood pressure, hypertension, is when your blood pressure is 140/90 mmHg, read as "140 over 90 millimeters of mercury", or above most of the time. The top number, which is also the higher of the two numbers, measures the peak pressure in the arteries when the heart beats (when the heart muscle contracts). It is called systolic pressure. The bottom number, which is also the lower of the two numbers, measures the minimum pressure in the arteries between heartbeats (when the heart muscle is resting between beats and refilling with blood). It is called diastolic. The term millimeter of mercury, mmHg, was derived as a term from the extra pressure generated in a tube by a column of mercury one millimeter high.) Brand Names: Cardizem®, Cardizem® CD, Cardizem® LA, Cartia ®XT, Dilacor ®XR, Dilt-®CD, Dilt-®XR, Diltia®XT, Diltiazem Hydrochloride® CD, Diltiazem Hydrochloride® SR, Diltiazem Hydrochloride® XR, Diltiazem Hydrochloride® XT, Diltzac,®, Taztia® XT, Tiazac®, Cardizem® SR, Cardizem® Monovial, Matzim® LA.

Dimethyl Sulfoxide:

An organic compound that smells like garlic that is readily absorbed by the skin. Ibrutinib dissolves freely in Dimethyl Sulfoxide. (Additional Notes/Definitions: An organic compound is generally considered to be any member of a large class of gaseous, liquid, or solid chemical compounds that contains a significant amount of carbon.)

Disciplinary:

Concerning or enforcing discipline, which is the practice of training people to obey rules or a code of behavior, using punishment to correct disobedience.

Disease:

A disorder of structure or function in a human, animal, or plant, especially one that produces specific signs or symptoms or that affects a specific location and is not simply a direct result of physical injury.

Disease Progression:

In relation to cancer, this is when it continues to grow, spread or become more severe.

Disease-Related Symptoms:

Any sensations or changes in normal bodily function experienced by a patient that is associated with a particular disease.

Disorders:

An ailment that affects the function of mind or body.

Dissolution:

The action or process of dissolving or being dissolved. Tablets or capsules taken orally remain one of the most effective means of treatment but the rate dissolution is then critical because it effects where the tablet or capsule will dissolve and the amount of the drug available to the body, i.e., its bioavailability. Drug release in the human body can be measured in vivo (in a live body) by measuring the plasma or urine concentrations in the subject concerned. But for safety and practicality official drug dissolution testing is routinely used. It is rigorously and comprehensively defined to provide critical in vitro drug release information for both quality control purposes, i.e., to assess batch-to-batch consistency, and drug development, i.e., to predict drug release profiles in live subjects (in vivo). (Additional Notes/Definitions: In vivo means within the body of a human or animal. Vivo: Latin for “live”. In vitro means outside of the body, in a test tube, or sample/culture of some sort.)

Distribution:

The amount or area that a particular drug/medication is occupying in the body. For example, a drug could be distributed locally, throughout the blood system, in the cells and/or in the fat cells.

Dizziness:

A term used to describe everything from feeling faint or lightheaded to feeling weak or unsteady; a sensation of whirling and a tendency to fall.

dL:

Deciliter (one tenth of a liter).

DNA (Deoxyribonucleic Acid):

A molecule that encodes the genetic instructions (blueprint) used in the development and functioning of all known living organisms. (Additional Notes/Definitions: Molecules are the smallest particles of a substance that retains the chemical and physical properties of the substance and is composed of two or more atoms; a group of like or different atoms held together by chemical forces. Atoms are the smallest basic unit and building block of matter. Human DNA contains an average of 150 million molecules that are building blocks, called bases. They are arranged in a double helix (a shape like a twisted ladder). DNA molecules are among the largest molecules now known. The DNA is encoded with genes. A gene is the basic physical and functional unit of heredity. Genes, which are sections of the DNA, act as instructions to make molecules called proteins. Proteins not only make up the cellular structures but carry out most of the chemical reactions necessary for life. Hence DNA contains the genetic information necessary for the production of other cell components and for the reproduction of life. Most human DNA is packaged in long threadlike structures called chromosomes. Chromosomes contain roughly equal parts of protein and DNA. In most human cells there are 23 pairs of chromosomes located in a central portion of the cell called a nucleus. There is also some DNA in specialized structures within cells, called mitochondria, that convert the energy from food into a form that cells can use and create molecules that help assemble protein building blocks (amino acids) into functioning proteins.)

DOR:

Duration of Response.

Dose Modification:

Adjustment of the dosage of a drug administered based on various factors.

Dose-Normalized:

This is a method of calculating the effect of some factor on the amount of the drug that is available to the body based on its amount in the blood stream. One way it can be calculated is as a ratio of the maximum concentration of a drug in the body (Cmax) in relation to the dosage (D) given (Cmax /D).

Drug Dissolution/Drug Dissolution Testing:

The action or process of dissolving or being dissolved. Tablets or capsules taken orally remain one of the most effective means of treatment but the rate dissolution is then critical because it effects where the tablet or capsule will dissolve and the amount of the drug available to the body, i.e., its bioavailability. Drug release in the human body can be measured in-vivo (in a live body) by measuring the plasma or urine concentrations in the subject concerned. But for safety and practicality official drug dissolution testing is routinely used. It is rigorously and comprehensively defined to provide critical in vitro drug release information for both quality control purposes, i.e., to assess batch-to-batch consistency, and drug development, i.e., to predict drug release profiles in live subjects. (Additional Notes/Definitions: In vivo means within the body of a human or animal. Vivo: Latin for “live”. In vitro means outside of the body, in a test tube, or sample/culture of some sort.)

Drug Interactions:

An interaction between a drug and another substance that prevents the drug from performing as expected. This definition applies to interactions of drugs with other drugs (drug-drug interactions), as well as drugs with food (drug-food interactions) and other substances.

Duration of Response (DOR):

This defines how long a response lasts.

Dyspepsia:

Pain in the area of your stomach caused by a difficulty in digesting food.

Dyspnea:

Difficulty in breathing, often associated with lung or heart disease and resulting in shortness of breath, also called air hunger.

Ear, Nose, and Throat:

The branch of medicine and surgery that specializes in the diagnosis and treatment of disorders of the head and neck. (The technical term is Otolaryngology.)

Eastern Cooperative Oncology Group (ECOG):

A large network of private and public medical institutions that work toward the cure of cancer. It began in 1955 as one of the first publicly funded cooperative groups to perform multi-center clinical trials for cancer research.
(Additional Notes/Definitions: Oncology is the field of medical science devoted to cancer.)

Ecchymoses:

The escape of blood into the tissues from ruptured blood vessels often resulting in a discoloration of the skin (larger than 1 centimeter). It is often called a bruise, but this is technically not correct because it is not caused by an impact. (Additional Notes/Definitions: Tissue is a mass of similar cells that make up a part of an organism and perform a specific function. A blood vessel is an elastic tube or passage in the body through which blood circulates.)

ECG/EKG (Electrocardiogram):

A test used to monitor your heart. Each beat of your heart is triggered by an electrical impulse normally generated from special cells in the upper right chamber of your heart. An electrocardiogram — also called an ECG or EKG — records these electrical signals as they travel through your heart. Your doctor can use an electrocardiogram to look for patterns among these heartbeats and rhythms to diagnose various heart conditions.
(Additional Notes/Definitions: Cells are the basic units of a living organism which can only be seen under a microscope. In addition to being the building blocks of tissue, cells are in blood and other fluids, and each type has specialized functions.)

ECOG (Eastern Cooperative Oncology Group):

A large network of private and public medical institutions that work toward the cure of cancer. It began in 1955 as one of the first publicly funded cooperative groups to perform multi-center clinical trials for cancer research.
(Additional Notes/Definitions: Oncology is the field of medical science devoted to cancer.)

ECOG Performance:

Scales and criteria established by the Eastern Cooperative Oncology Group (ECOG) which are used to assess how a patient's disease is progressing, assess how the disease affects the daily living abilities of the patient, and determine appropriate treatment and prognosis. There are Grades from 0 – 5, which cover from a state of being fully active through increasing severity up to death. (Additional Notes/Definitions: The Eastern Cooperative Oncology Group (ECOG) is a large network of private and public medical institutions that work toward the cure of cancer. It began in 1955 as one of the first publicly funded cooperative groups to perform multi-center clinical trials for cancer research. Oncology is the field of medical science devoted to cancer.)

Edema:

A swelling caused by fluid in your body's tissues. It usually occurs in the feet, ankles and legs, but it can involve your entire body. (Additional Notes/Definitions: Tissue is a mass of similar cells that make up a part of an organism and perform a specific function. Cells are the basic units of a living organism which can only be seen under a microscope. In addition to being the building blocks of tissue, cells are in blood and other fluids, and each type has specialized functions.)

Educational:

Pertaining to education; providing education, tending or intended to educate, instruct, or inform.

Efavirenz:

Used with other medicines to treat human immunodeficiency virus (HIV) infection. Efavirenz does not cure HIV or AIDS, but it may slow the worsening of the disease. Brand names: Sustiva®, Stocrin®, Efavir®.

Efficacy:

Effectiveness; the ability of a treatment to produce the desired result.

e.g.:

An abbreviation meaning “for example.” It is short for the Latin exempli gratia, “for the sake of example.” A list of examples may be preceded by e.g.: “She loved exotic fruit, e.g., mangoes, passion fruit, and papayas.”

EKG/ECG (Electrocardiogram):

A test used to monitor your heart. Each beat of your heart is triggered by an electrical impulse normally generated from special cells in the upper right chamber of your heart. An electrocardiogram — also called an EKG or ECG — records these electrical signals as they travel through your heart. Your doctor can use an electrocardiogram to look for patterns among these heartbeats and rhythms to diagnose various heart conditions. (Additional Notes/Definitions: Cells are the basic units of a living organism which can only be seen under a microscope. In addition to being the building blocks of tissue, cells are in blood and other fluids, and each type has specialized functions.)

Electrocardiogram (EKG/ECG):

A test used to monitor your heart. Each beat of your heart is triggered by an electrical impulse normally generated from special cells in the upper right chamber of your heart. An electrocardiogram — also called an EKG or ECG — records these electrical signals as they travel through your heart. Your doctor can use an electrocardiogram to look for patterns among these heartbeats and rhythms to diagnose various heart conditions. (Additional Notes/Definitions: Cells are the basic units of a living organism which can only be seen under a microscope. In addition to being the building blocks of tissue, cells are in blood and other fluids, and each type has specialized functions.)

Electrolytes:

Chemicals (Salts and minerals) that dissolve in a fluid or solution and can conduct electrical impulses in the body. Some common human electrolytes are sodium chloride (sea/table salt), potassium and calcium. Electrolytes control the fluid balance are important in muscle contraction, energy generation, and almost every major biochemical reaction in the body. They are even needed at a cellular level to regulate the flow of water in and out of the cells. (Additional Notes/Definitions: A biochemical reaction is a chemical reaction occurring in or created by a living organism. Cells are the basic units of a living organism which can only be seen under a microscope. In addition to being the building blocks of tissue, cells are in blood and other fluids, and each type has specialized functions.)

Electromagnetic Waves:

Waves that contain an electric field and a magnetic field and carry energy resulting from the acceleration of an electric charge. They travel at the speed of light and exhibit a wide range of frequencies. A frequency range of electromagnetic waves includes visible light but it is only one small portion of the full spectrum.

Electron:

A very small particle of matter that has a negative charge, the basic charge of electricity, and travels around the nucleus of an atom. An atom is the smallest basic unit and building block of matter, and a nucleus is the positively charged central core of an atom, consisting of protons and neutrons and containing nearly all its mass. An electron has a small mass, less than 0.1% the mass of an atom. Under normal circumstances, electrons move about the nucleus of an atom in orbitals that form an electron cloud bound in varying strengths to the positively charged nucleus. Electrons play a key role in creating chemical bonds to create different chemical substances. Due to attractive force of positive and negative charges many chemical substances become more stable when bonded with another substance. To form compounds atoms will lose, gain, or share electrons.

Elevated:

Increased in amount or degree; higher than normal.

Elimination:

The act of discharging or excreting waste products from the body.

Embryo:

A human or animal in the early stages of development before it is born, hatched, etc. In humans, it is from the point of conception through the eighth week of development.

Embryo-Fetal Toxicity:

The degree to which a substance can be toxic to or damage an unborn child while still in the womb. Toxic effects of any substance are dependent on the dose.

Empirical Formula:

A chemical formula showing the simplest ratio of elements in a compound rather than the total number of atoms in the molecule. An example of this concept is that the empirical formula of hydrogen peroxide, or H2O2, would simply be HO. (Additional Notes/Definitions: Molecules are the smallest particles of a substance that retains the chemical and physical properties of the substance and is composed of two or more atoms; a group of like or different atoms held together by chemical forces. Atoms are the smallest basic unit and building block of matter. A compound is a substance formed when two or more chemical elements are chemically bonded together; two or more atoms of differing elements are bonded together to create a molecule. The elements in any compound are always present in fixed rations. For example, pure water is a compound made from two elements – hydrogen and oxygen. The ratio in water is always 2:1, or 2 atoms of hydrogen to 1 atom of oxygen, hence the chemical compound is known as H2O.)

Emulsifying Agents:

Chemical substances that encourages the suspension of one liquid in another that do not mix well. When the liquids are in this state it is called an emulsion. An example of this would be milk, where fat is suspended in water.

Endothelial:

Pertaining to the thin layer of cells that line the cavities of the heart and of the blood and lymph vessels (elastic tubular structures). In addition to forming an interface between the circulating fluids and the vessel walls, they have specialized functions (such as blood vessel tone, blood clotting, and filtering blood to form urine in the kidneys.) (Additional Notes/Definitions: Blood is a specialized bodily fluid that delivers necessary substances such as nutrients and oxygen to the cells and transports waste products away from those same cells. Cells are the basic units of living organisms which can only be seen under a microscope. They are seen in tissue, blood and other fluids. In humans, blood it is composed of blood cells suspended in a liquid called blood plasma. Lymph is a clear fluid that carries certain types of white blood cells called lymphocytes that fight infection and disease.)

Endpoint:

In clinical trials, an event or outcome that can be measured objectively to determine whether the intervention being studied is beneficial. Endpoints of a clinical trial are usually included in the study objectives.

Engagements:

An arrangement to do something or go somewhere at a fixed time.

Engorgement:

Filling to excess, as with blood or other fluid, to the point of congestion.

Enzyme:

A type of protein that increases the rates of chemical reactions inside and outside cells without itself being changed in the process. It does this by lowering the energy level required to activate or initiate these reactions. Almost all chemical reactions in a biological cell need enzymes in order to occur at rates sufficient for life. Enzymes are highly selective catalysts, greatly accelerating both the rate and specificity of metabolic reactions, e.g. digestion of food.
(Additional Notes/Definitions: Proteins not only make up the majority of cellular structures but carry out most of the chemical processes as well. Cells are the basic units of living organisms which can only be seen under a microscope. They are seen in tissue, blood and other fluids. A catalyst is a substance that increases the rate of a chemical reaction without itself undergoing any permanent chemical change. Metabolic reactions or metabolism includes all the physical and chemical changes that occur in cells and the organism to allow growth and maintain body functions. These include processes that break down substances to yield energy and processes that build up other substances necessary for life.)

Epilepsy:

A central nervous system (neurological) disorder in which the nerve cell activity in the brain is disturbed, causing a seizure during which the person experiences abnormal behavior, symptoms and sensations, including loss of consciousness. Seizure symptoms vary. Some people with epilepsy simply stare blankly for a few seconds during a seizure, while others repeatedly twitch their arms or legs.

Epistaxis:

Bleeding from the nose.

Epithelial Tissue:

Epithelium is one of the four basic types of animal tissue, along with connective tissue, muscle tissue and nervous tissue. Epithelial tissues line the cavities and surfaces of structures throughout the body and also form many glands. Functions of epithelial cells include secretion, selective absorption, protection, trans-cellular transport, and detection of sensation. (Additional Notes/Definitions: Cells are the basic units of living organisms which can only be seen under a microscope. They are seen in tissue, blood and other fluids.)

Erythromycin:

An antibiotic that can be used on a wide range of infections and is often prescribed for people who have an allergy to penicillin. (Additional Notes/Definitions: Antibiotics are medications that are used to treat infections caused by bacteria and are typically natural products or modified versions of natural products that either kill or slow the growth of bacteria. Bacteria are microscopic organisms (organisms that are so small as to be visible only with a microscope), some of which may cause illness. The word bacteria is the plural of bacterium. The Greek word anti means "against", and the Greek word bios means "life" (bacteria are life forms), also known as antibacterials.)

Esophagus:

A muscular passage connecting the pharynx (throat) with the stomach. It is a muscular tube that in humans is about nine inches (23 centimeters) long and lined with mucous membrane. (Additional Notes/Definitions: A mucous lining/membrane is a mucus-secreting membrane lining all bodily passages that are open to the air, as of the digestive and respiratory tracts. A membrane is a thin, soft, pliable sheet or layer, especially of animal or vegetable tissue, serving as a covering or lining, as for an organ or cell. Cells are the basic units of a living organism which can only be seen under a microscope. Cells are the building block of tissue as one brick is part of a brick wall. There are also cells with specialized functions in various other places in the body, such as the blood and other fluids.)

Event(s):

A planned occasion or activity; a thing that happens, especially one of importance.

Excipients:

Inactive substances that serve as the vehicle or medium for a drug or other active substance.

Excluded (from):

Left out; not included in; not involved in.

Excrete:

To separate and discharge waste matter from the blood, tissues, or organs and out the body through the kidneys, skin, lungs, bowels, etc., as urine, sweat, carbon dioxide, feces, etc.

Excreted in Human Milk:

Toxins (including some drugs) are eliminated or excreted through various paths in the body in addition to urine and feces. Some drugs are excreted in human milk.

Excursions:

A deviation from a regular pattern, path, or level of operation; variations.

Exposure:

The amount of a particular drug in the body at any particular time, as measured in the blood or plasma (the liquid part of the blood).

Extracellular Matrix (ECM):

A matrix is an environment or material in which something develops; a surrounding medium or structure .An extracellular matrix (ECM) is a collection of molecules outside of the cells (extracellular) which are secreted by cells that provides structural and biochemical support to the surrounding cells. An example of this can be clearly seen in connective tissue, where the extracellular matrix is frequently more plentiful than the cells. Connective tissue is found throughout your body; it serves as the scaffolding for all other tissues. (Additional Notes/Definitions: Cells are the basic units of living organisms which can only be seen under a microscope. They are seen in tissue, blood and other fluids. Molecules are the smallest particles of a substance that retains the chemical and physical properties of the substance and is composed of two or more atoms; a group of like or different atoms held together by chemical forces. Atoms are the smallest basic unit and building block of matter.)

Extranodal:

The term extranodal is used when lymphoma can be detected outside of the lymphatic system, in organs such as the skin, stomach, lungs, etc. (Additional Notes/Definitions: Lymphoma is a cancer of the lymphatic system, the system responsible for fighting infections and draining excess fluid from body. Lymphoma occurs when certain types of white blood cells (lymphocytes) reproduce in an excessive and uncontrolled manner. It can be detected in the lymph nodes and sometimes in the lymph ducts as well as in the blood. Lymph nodes are bean-shaped organs found in the underarms, groin, neck, and abdomen that act as filters for the lymph fluid as it passes through them. Lymph ducts are either of the two terminal lymph vessels (thin walled, valved structures) that convey lymph to the bloodstream: right and left. A duct.is a passage with well-defined walls, especially a tubular structure for the passage of excretions or secretions.)

Extranodal Involvement:

Term used when cancer such as lymphoma has affected areas outside of the lymphatic system, in organs such as the skin, stomach, lungs, etc. (Additional Notes/Definitions: Lymphoma is a cancer of the lymphatic system, the system responsible for fighting infections and draining excess fluid from body. Lymphoma occurs when certain types of white blood cells (lymphocytes) reproduce in an excessive and uncontrolled manner. It can be detected in the lymph nodes and sometimes in the lymph ducts as well as in the blood. Lymph nodes are bean-shaped organs found in the underarms, groin, neck, and abdomen that act as filters for the lymph fluid as it passes through them. Lymph ducts are either of the two terminal lymph vessels (thin walled, valved structures) that convey lymph to the bloodstream: right and left. A duct.is a passage with well-defined walls, especially a tubular structure for the passage of excretions or secretions.)

Eye Disorder:

Any disease or impairment in the function of the eyes or vision.

Faint:

Lose consciousness for a short time because of a temporary insufficient supply of blood or oxygen to the brain.

Fasted Condition:

This usually refers to not eating food for a defined period (often “overnight”, or approximately 4-6 hours so the stomach is empty) but may allow consumption of clear liquids (i.e., water).

Fasting:

This usually refers to not eating food for a defined period (often “overnight” or approximately 4-6 hours so the stomach is empty) but may allow consumption of clear liquids (i.e., water).

Fatal:

Causing death or capable of causing death.

Fatigue:

The state of being very tired, extreme weariness.

FDA:

U.S. Food and Drug Administration; a federal agency established in 1906 with the Federal Food and Drugs Act that is responsible for monitoring trading and safety standards in the food and drug industries.

FDA (U.S. Food and Drug Administration) Table of Pregnancy Category Definitions:

Category A: Adequate and well-controlled (AWC) studies in pregnant women have failed to demonstrate a risk to the fetus in the first trimester of pregnancy (and there is no evidence of a risk in later trimesters).
Category B: Animal reproduction studies have failed to demonstrate a risk to the fetus and there are no AWC studies in humans, AND the benefits from the use of the drug in pregnant women may be acceptable despite its potential risks. OR animal studies have not been conducted and there are no AWC studies in humans.
Category C: Animal reproduction studies have shown an adverse effect on the fetus, there are no AWC studies in humans, AND the benefits from the use of the drug in pregnant women may be acceptable despite its potential risks. OR animal studies have not been conducted and there are no AWC in humans.
Category D: There is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience or studies in humans, BUT the potential benefits from the use of the drug in pregnant women may be acceptable despite its potential risks (for example, if the drug is needed in a life-threatening situation or serious disease for which safer drugs cannot be used or are ineffective).
Category X: Studies in animals or humans have demonstrated fetal abnormalities OR there is positive evidence of fetal risk based on adverse reaction reports from investigational or marketing experience, or both, AND the risk of the use of the drug in a pregnant woman clearly outweighs any possible benefit (for example, safer drugs or other forms of therapy are available).

Feces:

Waste matter eliminated from the bowels; excrement.

Fertility:

Fertility is the natural capability to produce offspring.

Fetal:

Of or pertaining to a fetus or the period of its development which, in humans, may be defined as beginning at the eighth week after conception (or the 11th week from the first day of the last normal menstrual period).

Fetal Harm:

Injury or harm to the unborn child or its development. (Technically, a fetus is an unborn human baby more than eight weeks after conception, but fetal harm could be understood in the broader sense of an unborn human at any stage of development.)

Fetal Weight:

The actual weight of the fetus based on the mass of the unborn offspring or baby.

Fetus:

An unborn offspring of a mammal, in particular an unborn human baby more than eight weeks after conception.

Fever:

An abnormally high body temperature, usually accompanied by shivering, headache, and in severe instances, delirium. Normal body temperatures vary depending on many factors, including age, sex, time of day, ambient temperature, activity level, and more. But a body temperature reading over 37.5 °C (99.5 °F) would often be considered a fever.

Fibrillation:

Very rapid irregular contractions of the muscle fibers of the heart resulting in a lack of synchronism between heartbeat and pulse.

First-Pass Effect:

A phenomenon that can occur with drugs taken orally whereby the concentration of a drug or the amount of available active ingredient is greatly reduced before it reaches systemic circulation due to metabolism from enzymes in the gastrointestinal tract (stomach and intestines) or the liver. (Also known as first-pass metabolism or pre-systemic metabolism).

Fluconazole:

An antifungal drug used in the treatment and prevention of superficial and systemic fungal infections. (Examples of fungal infections are athlete’s foot, yeast and candida.) Brand Name: Diflucan®.

Fosamprevir/Fosamprenavir:

A drug is used in combination with other drugs to treat HIV. Brand names: Telzer®, Telzir®, Levixa®, Lexiva®.

-Fold:

It is generally used in relationship to an increase or decrease by a certain factor. In the case of an increase the original amount is multiplied by (a specified number). If there is a decrease, you would divide. For example if the original figure was 60 and there was a ten-fold increase you would multiply by ten which equals 600 (60 x 10 = 600), if there was a ten-fold decrease you would divide by ten (or multiply by 1/10) which equals 6 (60 ÷ 10 = 6).

Food and Drug Administration (FDA):

A federal agency established in 1906 with the Federal Food and Drugs Act that is responsible for monitoring trading and safety standards in the food and drug industries.

Freely Soluble:

Dissolving easily in a specified liquid; able to be dissolved well in another substance. More specifically, freely soluble refers to only needing 1 to 10 ml of liquid to dissolve 1 g of the substance that dissolves (e.g., ibrutinib is freely soluble in dimethyl sulfoxide).

Fungal Infection:

Any inflammatory condition caused by a fungus. Most fungal infections are superficial and mild, though persistent and difficult to eradicate. Some, particularly in older, debilitated, or immunosuppressed or immunodeficient people, may become systemic and life threatening. (Examples of fungal infections are athlete’s foot, yeast and candida.)

Fungus:

An organism that feeds on organic matter. Fungi can be unicellular (single-celled), multicellular, or syncytial (a mass of cytoplasm within a cell membrane that contains multiple nuclei and is often the result of cellular fusion, e.g. in certain slime molds). They reproduce asexually via spores which are small, usually one-celled reproductive structure produced by that is capable of developing into a new individual. Yeast is a microscopic fungus consisting of single oval cells that reproduce by budding or fission (splitting), and are capable of converting sugar or carbohydrates into alcohol and carbon dioxide. Yeasts include forms such as candida that can cause disease. Microscopic means it is so small that it can only be seen with a microscope. Budding is a form of asexual reproduction, reproduction without male and female fusion, in which an outgrowth of the parent becomes constricted and eventually separates to form a new individual.

Gait Instability:

An instability or abnormality in the manner or style of walking. At times it may be the result of a medication that causes confusion or loss of coordination or an eye or ear disturbance that affects the sense of balance.

Gastroesophageal Reflux Disease (GERD):

A condition in which the stomach contents (food or liquid) leak backwards from the stomach into the esophagus (the tube from the mouth to the stomach). This action can irritate the esophagus, causing heartburn and other symptoms.

g/dL:

Grams per deciliter (one tenth of a liter).

Gastrointestinal (GI):

Referring collectively to the entire digestive system and particularly the stomach and intestines.

Gastrointestinal Bleeding:

Bleeding in the digestive tract.

Gastrointestinal Disorders:

Lack of proper functioning of any portion of the entire digestive tract (and especially referring to the stomach and intestines).

Gelatin:

A translucent (partially transparent, allowing some light to pass through) and often unflavored element often used in cooking. The shells of pharmaceutical capsules are typically made of gelatin in order to make them easier to swallow.

Gender:

The sex of an individual, male or female

General Disorders and Administrative Site Conditions:

A class of disorders that encompasses conditions of a general kind that result from a disease, the treatment of disease or administration of treatment at a particular site (for example, a specific reaction or condition at the site of injection if the drug is administered that way) and are manifested by a characteristic set of symptoms and signs.

Genetic Counselor:

A genetic counselor is a health professional who specializes in telling families about the nature and risks of inherited conditions and syndromes.

Geneticist:

A geneticist specializes in the study of the genes and their influence on health, as well as the treatment of genetic disorders. (Additional Notes/Definitions: Genes are the basic unit of heredity.)

GERD (Gastroesophageal Reflux Disease):

A condition in which the stomach contents (food or liquid) leak backwards from the stomach into the esophagus (the tube from the mouth to the stomach). This action can irritate the esophagus, causing heartburn and other symptoms.

Geriatric:

Of or relating to old people, especially with regard to their health care.

GI Tract:

Gastrointestinal tract, which is the entire length of the digestive system including the stomach, small intestine and large intestine.

Globulin:

A group of proteins that make up a large portion of the proteins in blood serum, the liquid part of the blood. Some are produced by the liver, while others by the immune system. Globulins can play many key roles including enzymes which help speed up chemical reactions vital to life, carrier proteins such as hemoglobin that transports oxygen from the lungs to muscle tissue and other cells, and antibodies which help the immune system of the body fight infections and other substances that may pose threats to the body. This last group are called immunoglobulins. Globulins are a family of a larger class called globular proteins, one of the three main classes of proteins. Globular proteins are formed by compacted amino acid chains, which are folded into intricate shapes that often roughly resemble spheres or “globes”.

Grades/ECOG Performance:

Scales and criteria established by the Eastern Cooperative Oncology Group (ECOG) which are used to assess how a patient's disease is progressing, assess how the disease affects the daily living abilities of the patient, and determine appropriate treatment and prognosis. There are Grades from 0 – 5, which cover from a state of being fully active through increasing severity up to death. They are included here for further information:
Grade 0: Fully active, able to carry on all pre-disease performance without restriction
Grade 1: Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work
Grade 2: Ambulatory and capable of all self-care but unable to carry out any work activities. Up and about more than 50% of waking hours
Grade 3: Capable of only limited self-care, confined to bed or chair more than 50% of waking hours
Grade 4: Completely disabled. Cannot carry on any self-care. Totally confined to bed or chair
Grade 5: Dead

Grade for Adverse Event:

An adverse event is any unfavorable occurrence (symptom, etc.) happening at or near the time of use of a medicinal product. It becomes associated with the treatment or product whether or not the occurrence is caused by the product or even related to its use. Grade refers to the severity of the adverse event (AE) as follows:
Grade 1: Mild AE
Grade 2: Moderate AE
Grade 3: Severe AE
Grade 4: Life-threatening or disabling AE
Grade 5: Death related to AE
(Additional Notes/Definitions: These Grades are per the National Cancer Institute (NCI) which is part of the National Institutes of Health, which is one of eleven agencies that are part of the U.S. Department of Health and Human Services. The NCI coordinates the U.S. National Cancer Program and conducts and supports research, training, health information dissemination, and other activities related to the causes, prevention, diagnosis, and treatment of cancer; the supportive care of cancer patients and their families; and cancer survivorship.)

Grade 3 or higher bleeding events:

Severe to life threatening bleeding events.

Grade 3 or greater infections:

Severe to life threatening infections.

Grade 3 or 4 Cytopenia:

Severe to life threatening condition in which there is a lower-than-normal numbers of blood cells. (Cytopenia is a general term and could refer to a deficiency in all blood cells or to a deficient number of one or more specific types of blood cell in circulation.)

Granule:

In cell biology, a granule is a small particle in a cell. It can be any structure barely visible by a light microscope, but the term granule is most often used to describe a membrane-bound structure that secretes a specialized substance.

Grapefruit/Juice/Products:

Grapefruits are large, round, usually yellow citrus fruit with an acid, juicy pulp. In addition to the fruit itself and juice, grapefruit products include some sodas, marmalade, and dietary supplements, including those with grapefruit seed extract. Grapefruit contains a specific substance that inhibits an enzyme that helps the body breakdown and dispose of many drugs, which can result in excess amounts of a drug remain in the blood, increasing the amount of the drug in circulation.

Hairy Cell Leukemia:

A rare, slow-growing cancer of the blood in which your bone marrow makes too many   B cells (lymphocytes), a type of white blood cell that fights infection. These excess B cells are abnormal and look "hairy" under a microscope. As the number of leukemia cells increases, fewer healthy white blood cells, red blood cells, which transport oxygen to the tissues and cells, and platelets, which aid with blood clotting and healing of wounds, are produced. Another symptom of hairy cell leukemia is an abnormal enlargement of the spleen, which is an abdominal organ involved in the production and removal of blood cells and forming part of the immune system. The spleen filters out harmful substances from the blood, produces white blood cells (which help fight infections), removes worn-out red blood cells (which transport oxygen to the tissues and cells) from circulation, and maintains a reserve blood supply for the body.

Half-Life:

The time it takes a drug to drop to half of its maximum concentration in blood.

Hazard:

A danger or risk.

Hazard Ratio (HR):

A measure of how often a particular event happens in one group compared to how often it happens in another group, over time. This is expressed as a ratio. In cancer research, hazard ratios are often used in clinical trials to compare the survival rate between the group of patients who have been given a specific treatment and a control group given another treatment or a placebo. A hazard ratio of 1 means that there is no difference in survival between the groups. A hazard ratio of greater than 1 or less than 1 means that survival was better in one of the groups.

HDPE Bottles:

HDPE (High-density polyethylene) is a thermoplastic made from petroleum. Known for its large strength to density ratio, HDPE is commonly used in the production of bags, bottles, and household products. IMBRUVICA is shipped in containers made of HDPE.

Heart Rhythm Problems:

An abnormal heartbeat; a variation from the normal heartbeat, which can prevent the heart from pumping blood efficiently to the rest of the body.

Heavy Chains:

Antibodies, which are part of the immune system and help fight infections and disease, consist of complex protein molecules called immunoglobulins that are made of 2 pairs of different amino acid chains. The larger of these two types of amino acid chains are called heavy chains. Antibodies bind to specific bacteria, viruses or substances that are deemed foreign and dangerous by the immune system. The portions of these antibodies called heavy chains have a variable amino acid sequence that allows them to bind to the foreign intruder, and a constant region that is used to define the class of antibody. There are five basic classes.
(Additional-Notes/Defintitions: Antibodies are made up of a protein called immunoglobulin (abbreviated Ig). Proteins not only make up structures of the body but assist in bringing about most of the chemical reactions that are vital to living organisms. Amino acids are the building blocks of proteins.)

Hematological:

Having to do with blood or the study of blood, blood-forming organs, and blood diseases.

Hematological Toxicity:

Toxic substances can cause unwanted side effects which may have an effect on blood cells. (Additional Notes/Definitions: Cells are the basic units of living organisms which can only be seen under a microscope. They are seen in tissue, blood and other fluids. In humans, blood it is composed of blood cells suspended in a liquid called blood plasma. The blood cells have specialized functions such as helping to deliver necessary substances such as nutrients and oxygen to the various cells and tissues of the body, transporting waste products away, helping to fight infections, and stopping bleeding and healing of injuries.)

Hematoma:

A solid swelling of clotted blood within the tissues. A mass, usually consisting of clotted blood that forms in a tissue, organ, or body space as a result of a broken blood vessel.

Hematuria:

Hematuria is blood in the urine. Two types of blood in the urine exist. Blood that can be seen in the urine is called gross hematuria. Blood that cannot be seen in the urine, except when examined with a microscope, is called microscopic hematuria. Most people with microscopic hematuria do not have symptoms. People with gross hematuria have urine that is pink, red, or cola-colored due to the presence of red blood cells.

Heme:

The deep red, oxygen-carrying, non-protein, ferrous (iron) component of hemoglobin. This is the iron-containing molecule in hemoglobin that serves as the site for oxygen binding.
(Additional Notes/Definitions: Molecules are the smallest particles of a substance that retains the chemical and physical properties of the substance and is composed of two or more atoms; a group of like or different atoms held together by chemical forces. Atoms are the smallest basic unit and building block of matter.)

Hemoglobin:

The protein molecule in red blood cells that carries oxygen from the lungs to the body's tissues and returns carbon dioxide from the tissues back to the lungs. The iron contained in hemoglobin is also responsible for the red color of blood when it is combined with oxygen. (Additional Notes/Definitions: Proteins not only make up most of the structures of the body but carry out most of the chemical processes as well. A molecule is the smallest particle of a substance that retains the chemical and physical properties of the substance and is composed of two or more atoms; a group of like or different atoms held together by chemical forces. An atom is the smallest basic unit and building block of matter. Cells are the basic units of living organisms which can only be seen under a microscope. They are seen in tissue, blood and other fluids.)

Hemorrhage:

To bleed in a very fast and uncontrolled way. The bleeding may be internal (inside the body) or external (outside the body).

Hepatic:

Refers to the liver; of or relating to the liver. The liver plays important roles: It stores energy from food, makes proteins, and aids in digestion. The liver also helps remove toxins. In relation to drugs, this includes a key function of helping to metabolize (break down and excrete) drugs or medications. (Additional Notes/Definitions: Proteins not only make up most of the structures of the body but carry out most of the chemical processes as well.)

Hepatic Impairment:

Partial or complete loss of the function of the liver. The liver plays important roles: It stores energy from food, makes proteins, and aids in digestion. The liver also helps remove toxins. In relation to drugs, this includes a key function of helping to metabolize (break down and excrete) drugs or medications. (Additional Notes/Definitions: Proteins not only make up most of the structures of the body but carry out most of the chemical processes as well.)

Hepatic Impairment Study/Trial:

A clinical study or trial to assess the influence that hepatic impairment (partial or complete loss of the function of the liver) has in regard to the use of a specific drug or medication. A group of subjects with hepatic impairment is often compared with a control group of with healthy liver functions. The liver plays important roles: It stores energy from food, makes proteins, and aids in digestion. The liver also helps remove toxins. In relation to drugs, this includes a key function of helping to metabolize (break down and excrete) drugs or medications.

Hepatic Impairment Trial/Study:

A clinical study or trial to assess the influence that hepatic impairment (partial or complete loss of the function of the liver) has in regard to the use of a specific drug or medication. A group of subjects with hepatic impairment is often compared with a control group of with healthy liver functions. The liver plays important roles: It stores energy from food, makes proteins, and aids in digestion. The liver also helps remove toxins. In relation to drugs, this includes a key function of helping to metabolize (break down and excrete) drugs or medications.

Hepatitis C Virus (HCV):

An infection caused by a virus that attacks the liver and leads to inflammation. It is passed through contact with contaminated blood — most commonly through needles shared during illegal drug use, and is the most common chronic blood-borne infection in the United States; approximately 3.2 million persons are chronically infected. Most people infected with the hepatitis C virus have no symptoms and don’t know they have it until decades later unless spotted during routine medical tests. (Additional Notes/Definitions: A virus is a microorganism that is smaller than bacteria that cannot grow or reproduce apart from a living cell. A virus invades living cells and can infect them and change how the cells function while it uses the cell’s chemical machinery to keep itself alive and to replicate itself. The liver is a large important organ in the abdomen that has many functions including detoxification, the creation of certain blood proteins, and many processes having to do with digestion and metabolism.)

Herbal Supplements/Products:

Supplements or products, particularly medications prepared from plants, including most of the world's traditional herbal remedies for disease. Some of these should be used as carefully as prescription medicines, taking care to avoid overdose, interactions with other medications, and misuse.

High Blood Pressure:

Blood pressure is the measure of the force of blood pushing against blood vessel walls. The heart pumps blood into the arteries (blood vessels), which carry the blood throughout the body. High blood pressure, also called hypertension, is dangerous because it makes the heart work harder to pump blood to the body and contributes to hardening of the arteries and to the development of heart failure. (Additional Notes/Definitions: High blood pressure (hypertension) is when your blood pressure is 140/90 mmHg (Read as "140 over 90 millimeters of mercury") or above most of the time. The top number, which is also the higher of the two numbers, measures the peak pressure in the arteries when the heart beats (when the heart muscle contracts). It is called systolic pressure. The bottom number, which is also the lower of the two numbers, measures the minimum pressure in the arteries between heartbeats (when the heart muscle is resting between beats and refilling with blood). It is called diastolic. The term millimeter of mercury (mmHg) was derived as a term from the extra pressure generated in a tube by a column of mercury one millimeter high.)

High Cholesterol:

Cholesterol is a waxy substance that’s found in fats (lipids) in your blood. Your body needs cholesterol to continue building healthy cells, but when you have high cholesterol you might develop deposits in your blood vessels that can restrict the flow of blood. This could lead to heart attack or stroke.

Highest Indicated Dose:

Highest dose that is indicated, specified or prescribed for a given usage.

High First-Pass Effect:

A phenomenon that can occur with drugs taken orally whereby the concentration of a drug or the amount of available active ingredient is greatly reduced before it reaches systemic circulation due to metabolism from enzymes in the gastrointestinal tract (stomach and intestines) or the liver. (Also known as first-pass metabolism or pre-systemic metabolism). (Additional Notes/Definitions: Metabolism is all the physical and chemical changes that occur in cells and the organism to allow growth and maintain body functions. These include processes that break down substances to yield energy and processes that build up other substances necessary for life. An enzyme is a type of protein that increases the rates of chemical reactions inside and outside cells without itself being changed in the process. It does this by lowering the energy level required to activate or initiate these reactions. Almost all chemical reactions in a biological cell need enzymes in order to occur at rates sufficient for life. The gastrointestinal (GI) tract refers collectively to the entire digestive system and particularly the stomach and intestines.

Highlights:

Most important details; especially significant or interesting details.

Histiocyte:

A large white blood cell, part of the immune system, that helps the body fight infection and react to injury. Histiocytes do not travel in the blood. Instead, they remain in one part of the body, particularly in connective tissue which connects, supports, binds, or separates other tissues or organs. Histiocytes are found in many organs and tissues, including the following: brain, breast tissue, liver, lymph nodes, placenta, spleen, and tonsils. When stimulated by infection or inflammation they become active, attacking and ingesting bacteria, viruses and other foreign matter in the body. After ingesting, they can also potentially present a portion of the foreign invader on their surface in order to stimulate other parts of the immune system. Histiocytes originate as “immature” cells in the bone marrow (the spongy tissue occupying the hollow central cavity of bones) and then travel through the body in the blood and later differentiate and develop into a number of different types of cells. Those that become histiocytes remain in place in the tissue or organ. (histio, diminutive of histo, meaning tissue, and cyte, meaning cell)
(Additional Notes/Definitions: Lymph nodes are bean-shaped organs found in the underarms, groin, neck, and abdomen that act as filters for the lymph fluid as it passes through them. Lymph nodes are part of the lymphatic system, a key part of the immune system which carries a fluid containing types of white blood called lymphocytes that fight infection and disease. The placenta is an organ that connects the developing fetus to the uterine wall to allow nutrient uptake, waste elimination, and gas exchange via the mother's blood supply, fights against internal infection and produces hormones to support pregnancy. The spleen is an abdominal organ involved in the production and removal of blood cells and forming part of the immune system. It usually lies in the left upper quadrant of the human abdomen, below the heart and diaphragm. The spleen filters out harmful substances from the blood, produces white blood cells (which help fight infections), removes worn-out red blood cells (which transport oxygen to the tissues and cells) from circulation, and maintains a reserve blood supply for the body.)

Histiocytic Sarcoma:

A form of cancer that arises from histiocytes which are a type of large white blood cell, part of the immune system, that helps the body fight infection and react to injury. Histiocytes do not travel in the blood. Instead, they remain in one part of the body, particularly in connective tissue which connects, supports, binds, or separates other tissues or organs. Histiocytes can be found in many organs and locations in the body. When stimulated they respond to and engulf foreign substances and infections in the body, such as viruses and bacteria. Histiocytic sarcomas have very aggressive tumors, and can therefore become very invasive (destroy normal surrounding tissues) as well as spreading to other areas of the body. (Additional Notes/Definitions: Viruses and bacteria are microscopic organisms (organisms that are so small as to be visible only with a microscope), which may cause illness.

Hives:

An allergic skin reaction causing localized redness, swelling, and itching. The body’s immune system is normally responsible for protection from foreign invaders. When it becomes sensitized to normally harmless substances, the resulting reaction is called an allergy. An attack of hives is set off when such a substance, called an allergen, is ingested, inhaled, or otherwise contacted. It interacts with immune cells called mast cells, which reside in the skin, airways, and digestive system. When mast cells encounter an allergen, they release histamine and other chemicals, both locally and into the bloodstream. These chemicals cause blood vessels to become more porous, allowing fluid to accumulate in tissue and leading to the swollen and reddish appearance of hives. Some of the chemicals released sensitize pain nerve endings, causing the affected areas to become itchy and sensitive.

Hodgkin’s Disease:

A malignant (cancerous) form of lymphoma marked by progressive enlargement of the lymph nodes and spleen and sometimes of the liver (named after Thomas Hodgkin, the British pathologist who was the first person to detect the glandular disease of the lymph tissue). (Additional Notes/Definitions: Lymphomas are cancers that begin in the cells of the immune system. Lymph nodes are bean-shaped organs found in the underarms, groin, neck, and abdomen that act as filters for the lymph fluid as it passes through them. Lymph nodes are part of the lymphatic system, a key part of the immune system which carries a fluid containing types of white blood called lymphocytes that fight infection and disease. The spleen is an abdominal organ involved in the production and removal of blood cells and forming part of the immune system. It usually lies in the left upper quadrant of the human abdomen, below the heart and diaphragm. The spleen filters out harmful substances from the blood, produces white blood cells (which help fight infections), removes worn-out red blood cells (which transport oxygen to the tissues and cells) from circulation, and maintains a reserve blood supply for the body. The liver is a large, important organ in the abdomen that has many functions including detoxification, the creation of certain blood proteins, and many processes having to do with digestion and metabolism. Metabolism includes all the physical and chemical changes that occur in cells and the organism to allow growth and maintain body functions. These include processes that break down substances to yield energy and processes that build up other substances necessary for life. Specific to drug therapy, this includes a key function of helping to metabolize (break down and excrete) drugs or medications. A gland is an organ that secretes particular chemical substances for use in the body or for discharge into the surroundings. The term gland is sometimes used for structures that resemble this but may not specifically be glands, such as the lymph nodes.)

HR (Hazard Ratio):

A measure of how often a particular event happens in one group compared to how often it happens in another group, over time. This is expressed as a ratio. In cancer research, hazard ratios are often used in clinical trials to compare the survival rate between the group of patients who have been given a specific treatment and a control group given another treatment or a placebo. A hazard ratio of 1 means that there is no difference in survival between the groups. A hazard ratio of greater than 1 or less than 1 means that survival was better in one of the groups.

Human Immunodeficiency Virus (HIV):

A disease of the immune system characterized by increased susceptibility to infections, to certain cancers, and to neurological disorders. It is caused by a virus that is transmitted chiefly through blood or bodily fluids, especially by sexual contact or contaminated hypodermic needles. The virus attacks specific cells which are a key part of the immune system and uses these as a host to reproduce itself, eventually destroying these host cell, greatly compromising the immune system. As the disease progresses the individual becomes increasingly susceptible to infections and complications. AIDS (Acquired Immune Deficiency Syndrom) is considered the final stage of HIV.

Human Milk:

Milk produced by the breasts of a human female for her infant offspring. 

Human Plasma Protein:

Proteins found in the blood plasma, the clear, protein-rich fluid which is left behind when the blood cells are remove from the blood of a human.

Human Plasma Protein Fraction:

A sterile solution of selected proteins derived from the blood plasma of adult human donors, containing 4.5 – 5.5 g of protein per 100 mL, of which 83–90% is albumin and the remaining proteins are used as blood volume supporter. Blood plasma is the clear, protein-rich fluid which is left behind when the blood cells are remove from the blood of a human. A sterile solution of selected proteins removed by fractionation from the blood plasma

Humoral Immune System:

The portion of the immune system that helps the body fight infections and other substances that may be a threat to the body. This involves the transformations of certain white blood cells, called B cells, into plasma cells that produce and secrete antibodies. (Additional Noted/Definitions: An antibody is a protein produced by the body's immune system in response to foreign substances that are perceived as threats. Proteins are the true workhorses of the body, not only making up the majority of cellular structures but carrying out most of the chemical processes as well. Certain white blood cells, called B Cells, and are key components of the immune system. Some of our B cells turn into specialized cells called plasma cells whose role it is to produce specific proteins called antibodies. The antibodies are created specifically in response to the foreign subject that is perceived as a threat, for example bacteria, which is called an antigen. Antigen is short for antibody generator.)

Humoral Immunity:

The component of the immune response involving the transformations of certain white blood cells, called B cells, into plasma cells that produce and secrete antibodies. (Additional Noted/Definitions: An antibody is a protein produced by the body's immune system in response to foreign substances that are perceived as threats. Proteins are the true workhorses of the body, not only making up the majority of cellular structures but carrying out most of the chemical processes as well. Certain white blood cells, called B Cells, and are key components of the immune system. Some of our B cells turn into specialized cells called plasma cells whose role it is to produce specific proteins called antibodies. The antibodies are created specifically in response to the foreign subject that is perceived as a threat, for example bacteria, which is called an antigen. Antigen is short for antibody generator.)

Hydrate:

Supply water in order to restore or maintain fluid balance; replenish the body fluids (often termed rehydrate).

Hydration:

Supply water in order to restore or maintain fluid balance; replenish the body fluids (often termed rehydration).

Hyperploidy:

An increase in the number of chromosomes in a cell. Cells, though small enough to be visible only with a microscope, are yet the basic units of living organisms, being the building block of tissue as well as being key components in blood and other fluids. Chromosomes contain the “blueprint” for the functioning and reproduction of the cells and characteristics of the organism as a whole. They are located in a central portion of the cell called a nucleus. There are normally 23 pairs of chromosomes in humans. The general term for an abnormal number of chromosomes in a cell is defined as an aneuploidy, a decrease is a hypoploidy.)

Hypersensitivity Reactions:

A set of undesirable reactions produced by the normal immune system, including allergies and autoimmunity; an inappropriate and excessive reaction to an allergen (as pollen or dust or animal hair or certain foods). These reactions may be damaging, uncomfortable, or occasionally fatal; severity ranges from mild allergy to severe systemic reactions leading to anaphylactic shock. (Also called hypersensitivity reaction or intolerance.)
(Additional Notes/Definitions: Anaphylactic shock is a widespread and very severe, potentially life-threatening allergic reaction. Symptoms include dizziness, loss of consciousness, labored breathing, swelling of the tongue and breathing tubes, blueness of the skin, low blood pressure, heart failure, and death.)

Hypertension:

High blood pressure. Blood pressure is the measure of the force of blood pushing against blood vessel walls. The heart pumps blood into the arteries (blood vessels), which carry the blood throughout the body. High blood pressure, also called hypertension, is dangerous because it makes the heart work harder to pump blood to the body and contributes to hardening of the arteries and to the development of heart failure. (Additional Notes/Definitions: Hypertension (high blood pressure) is when your blood pressure is 140/90 mmHg (Read as "140 over 90 millimeters of mercury") or above most of the time. The top number, which is also the higher of the two numbers, measures the peak pressure in the arteries when the heart beats (when the heart muscle contracts). It is called systolic pressure. The bottom number, which is also the lower of the two numbers, measures the minimum pressure in the arteries between heartbeats (when the heart muscle is resting between beats and refilling with blood). It is called diastolic. The term millimeter of mercury (mmHg) was derived as a term from the extra pressure generated in a tube by a column of mercury one millimeter high.)

Hyperuricemia:

An excess of uric acid in the blood. Uric acid is waste product of metabolism that is carried in the blood, filtered by the kidneys and excreted in urine.

Hyperviscosity:

A thickening (viscosity) of the serum, or liquid part of the blood, caused by the accumulation of large proteins, such as immunoglobulins, which are antibodies normally produced by the body's immune system in response to foreign substances that are perceived as threats. Symptoms of high blood viscosity include spontaneous bleeding from mucous membranes, excess bleeding in general, problems with vision particularly from damage to the small blood vessels in the retina or back of the eye, poor blood circulation in the extremities, and nervous system problems, which can range from headaches and dizziness to seizures and coma. (Additional Notes/Definitions: A mucous lining/membrane is a mucus-secreting membrane lining all bodily passages that are open to the air, as of the digestive and respiratory tracts. A membrane is a thin, soft, pliable sheet or layer, especially of animal or vegetable tissue, serving as a covering or lining, as for an organ or cell. Cells are the basic units of a living organism which can only be seen under a microscope. Cells are the building block of tissue as one brick is part of a brick wall. There are also cells with specialized functions in various other places in the body, such as the blood and other fluids.)

Hypoploidy:

A decrease in the number of chromosomes in a cell. Cells, though small enough to be visible only with a microscope, are yet the basic units of living organisms, being the building block of tissue as well as being key components in blood and other fluids. Chromosomes contain the “blueprint” for the functioning and reproduction of the cells and characteristics of the organism as a whole. They are located in a central portion of the cell called a nucleus. There are normally 23 pairs of chromosomes in humans. The general term for an abnormal number of chromosomes in a cell is defined as an aneuploidy, an increase is a hyperploidy.)

Ibr:

Abbreviation used on the bottle and capsules for ibrutinib, the active ingredient in IMBRUVICA.

ibr 140 mg:

IMBTUVICA capsules with “ibr 140 mg” designates that the capsule contains 140 mg of the active ingredient, ibrutinib.

Ibrutinib:

The active ingredient in IMBRUVICA. It blocks the growth and activation of targeted cells which have become cancerous. Certain types of cancer affect some specific cells that are an important part of the immune system called B cells which are a type of white blood cell, that, under normal conditions, helps the body fight infections and combat foreign substances that may pose a threat to the body. B cells become activated in response to the stimulus of such threats. A key component in B cells is an enzyme named Bruton’s Tyrosine Kinase (BTK), named after Dr. Bruton who discovered it. If systems are functioning normally, BTK, in response to stimuli, signals the activation and growth of B Cells Without BTK, B-cells cannot grow and do not function. It functions as an "on" or "off" switch in many cellular functions. But BTK can become mutated, stuck in the "on" position, and cause unregulated growth of the cell, in which the B cells proliferate and respond in excess, sometimes creating tumors or growths and spreading to other areas of the body. Ibrutinib inhibits BTK thereby inhibiting the growth and spread of the malignant B cells.
(Additional Notes/Definitions: An enzyme is a protein which lowers the energy level required to activate or initiate chemical reactions and increases the rates of these reactions inside and outside cells without itself being changed in the process. Almost all chemical reactions in living organisms need enzymes in order to occur at and rates sufficient for life. Cells are the basic units of a living organism which can only be seen under a microscope. They make up tissue, and have vital functions in blood and other fluids. A Kinase is an enzyme that activates other enzymes. Enzymes are responsible for selectively accelerating the rate of chemical reactions that sustain life, called metabolic processes. A Tyrosine Kinase is a type of enzyme involved primarily in signaling across a cell membrane or within a cell. Bruton’s Tyrosine Kinase (BTK), named after Dr. Bruton who discovered it, is an enzyme found specifically inside B Cells, which are one of the types of white blood cells in the immune system that defend against foreign substances such as a chemical, bacteria or virus, and help fight infection. They do this by recognizing these foreign substances through the use of receptors on the surface of their cell membranes, and then making and releasing anti-bodies which defend against these foreign substances called antigens (short for anti-body generator.)

I/Ki<0.07 using mean Cmax at 560 mg:

A formula showing the amount or concentration of a substance, such as a drug, in the blood at an indicated dosage. Specifically in the FDA Label for IMBRUVICA it indicates that the amount of ibrutinib in the blood (the active ingredient in IMBRUVICA), per the 560 mg dose, does not have a meaningful effect on the activity of major CYP enzymes (enzymes that are key in metabolizing, or breaking down and eliminating ibrutinib) in vitro (outside of the body, in a test tube, or sample/culture of some sort).

Imaging Scans:

An MRI (or magnetic resonance imaging) scan is a radiology technique that uses magnetism, radio waves, and a computer to produce images of body structures. The image and resolution produced by MRI is quite detailed and can detect tiny changes of structures within the body and can be used as an extremely accurate method of disease detection throughout the body including finding tumors. (Additional Notes/Definitions: Radiology is the science dealing with X-rays and other high-energy radiation, especially the use of such radiation for the diagnosis and treatment of disease. A tumor is a swelling of a part of the body, generally without inflammation, caused by an abnormal growth of tissue, whether benign/non-cancerous or malignant/cancerous and able to spread to other tissue or parts of the body.)

Imatinib:

A medication used alone or together with other medicines to treat different types of cancer or bone marrow conditions.

IMBRUVICA:

Brand name of drug/medication with the active ingredient, ibrutinib, indicated for the treatment of patients with mantle cell lymphoma (MCL) who have received at least one prior therapy, chronic lymphocytic leukemia (CLL) who have received at least one prior therapy, chronic lymphocytic leukemia (CLL) with 17p deletion, and Waldenström’s Macroglobulinemia (at the time of this writing). IMBRUVICA® is the trade name, manufactured and distributed by Pharmacyclics, Inc.

IMBRUVICA Toxicity:

Unwanted side effects at the time of administration of IMBRUVICA that could indicate that it could be harmful due to the dosage or some other factor.

Impaired Hepatic Function:

Any abnormality of, partial or complete loss of, or loss of the function of the liver. The liver plays important roles: It stores energy from food, makes proteins, and aids in digestion. The liver also helps remove toxins. In relation to drugs, this includes a key function of helping to metabolize (break down and excrete) drugs or medications. (Additional Notes/Definitions: Proteins not only make up much of the structure of the body but also are key to many of the chemical reactions that are vital to life.)

Impairment:

Any abnormality of, partial or complete loss of, or loss of the function of, a body part, organ, or system.

Impairment of Fertility:

Lessoning of the capability to produce offspring.

IgM (Immunoglobulin M):

Immunoglobulin M is a basic antibody that is produced by a type of white blood cell called B cells. Some of the B cells turn into specialized cells called plasma cells whose role it is to produce antibodies which help fight infections and harmful substances that get into the body. Antibodies are made up of a protein called an immunoglobulin, abbreviated Ig. One class of these is called Immunoglobulin M (IgM). The M stands for macroglobulin because it is, by far, physically the largest antibody in the human circulatory system. It is the first antibody produced in response to infection or initial exposure to foreign substances that are perceived as threats, called antigens. Immunoglobulin M antibodies appear early in the course of an infection and usually reappear, to a lesser extent, after further exposure. This biological property of immunoglobulin M makes it useful in the diagnosis of infectious diseases. Demonstrating immunoglobulin M antibodies in a patient's serum, the liquid part of the blood, indicates recent infection. (Additional Notes/Definitions: An excess of immunoglobulin M is a characteristic of Waldenström's macroglobulinemia (WM) because WM causes the B Cells and plasma cells to become abnormal and reproduce in an excessive and uncontrolled manner and also to produce an excess of Immunoglobulin M which can cause a thickening of the blood called hyperviscosity. This can cause many symptoms including excess bleeding, problems with vision, poor blood circulation in the extremities, and nervous system problems. Further complications can arise. An antibody is a protein produced by the body's immune system in response to foreign substances that are perceived as threats called antigens, which is short for antibody generator. They act as a critical part of the immune response by specifically recognizing and binding to particular antigens, such as bacteria or viruses and neutralizing and aiding in their destruction. Note that proteins are the true workhorses of the body, not only making up the majority of cellular structures but carrying out most of the chemical processes as well.)

IgM Value (3.5 g/dL):

A high level of Igm (immuniglobin M) in the blood serum, the liquid part of the blood (3.5 grams per deciliter - a tenth of a liter). Normal serum contains 0.7 – 1.6 g/dL of Ig, At serum IgM concentrations of 3 – 5 g/dL symptoms of a thickening of the blood called hyperviscosity often are present. However some individuals remain asymptomatic (without symptoms) with IgM levels as high as 9 g/dL. (Additional Notes/Definitions: IgM (Immunoglobulin M) is a basic antibody that is produced by a type of white blood cell called B cells. Some of the B cells turn into specialized cells called plasma cells whose role it is to produce antibodies which help fight infections and harmful substances that get into the body. Antibodies are made up of a protein called an immunoglobulin, abbreviated Ig. Proteins are the true workhorses of the body, not only making up the majority of cellular structures but carrying out most of the chemical processes as well.)One class of these is called Immunoglobulin M (IgM). The M stands for macroglobulin because it is, by far, physically the largest antibody in the human circulatory system. It is the first antibody produced in response to infection or initial exposure to foreign substances that are perceived as threats, called antigens. Immunoglobulin M antibodies appear early in the course of an infection and usually reappear, to a lesser extent, after further exposure. This biological property of immunoglobulin M makes it useful in the diagnosis of infectious diseases. Demonstrating immunoglobulin M antibodies in a patient's serum, the liquid part of the blood, indicates recent infection. An excess of immunoglobulin M is a characteristic of Waldenström's macroglobulinemia (WM) because WM causes the B Cells and plasma cells to become abnormal and reproduce in an excessive and uncontrolled manner and also to produce an excess of Immunoglobulin M which can cause a thickening of the blood called hyperviscosity. This can cause many symptoms including excess bleeding, problems with vision, poor blood circulation in the extremities, and nervous system problems.

Immunofixation:

A lab test to identify proteins called immunoglobulins in the serum, the liquid part of the blood. Immunoglobulins are antibodies that help your body fight infection. Too much of the same immunoglobulin is usually due to different types of blood cancer. This test is most often used to check the levels of certain antibodies associated with multiple myeloma and Waldenström’s Macroglobulinemia. A characteristic of WM is that an excess of identical immunoglobulins are created. The term for this is monoclonal. A normal test result means no monoclonal immunglobulins are seen in the blood sample.

Immunoglobulins (Igs):

Any of the structurally related molecules which are called antibodies. An antibody is a protein produced by the body's immune system in response to foreign substances that are perceived as threats called antigens, which is short for antibody generator. They act as a critical part of the immune response by specifically recognizing and binding to particular antigens, such as bacteria or viruses and neutralizing and aiding in their destruction. As a note, proteins are the true workhorses of the body, not only making up the majority of cellular structures but carrying out most of the chemical processes as well. Immunoglobulins are divided into five basic classes or isotypes (immunoglobulin M, immunoglobulin G, immunoglobulin A, immunoglobulin E, and immunoglobulin D with their related subclasses) on the basis of structure and biologic activity. These are each discussed below:

Immunoglobulin A (IgA):

Immunoglobulin A is an antibody that plays a critical role in mucosal immunity. More immunoglobulin A is produced in mucosal linings than all other types of antibody combined; between three and five grams are secreted into the intestinal lumen each day. This accumulates to 75% of the total immunoglobulin produced in the entire body. Immunoglobulin A has two subclasses (IgA1 and IgA2) and can exist in a dimeric form called secretory immunoglobulin A (sIgA). In its secretory form, immunoglobulin A is the main immunoglobulin found in mucous secretions, including tears, saliva, colostrum, and secretions from the genitourinary tract, gastrointestinal tract, prostate and respiratory epithelium.

Immunoglobulin D (IgD):

Immunoglobulin D is an antibody isotype that makes up about 1% of proteins in the plasma membranes of immature B-lymphocytes where it is usually co-expressed with another cell surface antibody called immunoglobulin M. Immunoglobulin D is also produced in a secreted form that is found in very small amounts in blood serum. Immunoglobulin D's function has always been a puzzle in immunology since its discovery in 1964. Immunoglobulin D was recently found to be present in species from cartilaginous fish to humans (probably with the exception of birds). This nearly ubiquitous appearance in species with an adaptive immune system demonstrates that immunoglobulin D is as ancient as immunoglobulin M and suggests the notion that immunoglobulin D has important immunological functions. In B-cells, immunoglobulin D's function is to signal the B-cells to be activated. By being activated, they are ready to take part in the defense of the body in the immune system.

Immunoglobulin E (IgE):

Immunoglobulin E is a class of antibody that has been found only in mammals. Its main function is immunity to parasites, including parasitic worms such as Schistosoma mansoni (schistosomiasis), Trichinella spiralis (trichinosis), and Fasciola hepatica (fascioliasis), and may be important during immune defense against certain protozoan parasites such as Plasmodium falciparum (malaria). It also plays an essential role in type I hyper-sensitivity (allergy disorder). Although immunoglobulin E is typically the least abundant isotype (blood serum immunoglobulin E levels in a normal individual are only 0.05% of the immunoglobulin concentration, compared to 10 mg/ml for the immunoglobulin Gs, the isotypes responsible for most of the classical adaptive immune response).

Immunoglobulin G (IgG):

Immunoglobulin G is an antibody molecule composed of four peptide chains - two heavy chains and two light chains. Each immunoglobulin G has two antigen binding sites. Other immunoglobulins may be described in terms of polymers with the immunoglobulin G structure considered a monomer. Immunoglobulin G constitutes 75% of serum immunoglobulins in humans. Immunoglobulin G antibodies are involved in predominantly the secondary immune response (responses of the lymph nodes). The presence of specific immunoglobulin G, in general, corresponds to maturation of the antibody response.

Immunoglobulin M (IgM):

Immunoglobulin M is a basic antibody that is produced by a type of white blood cell called B cells. Some of the B cells turn into specialized cells called plasma cells whose role it is to produce antibodies which help fight infections and harmful substances that get into the body. Antibodies are made up of a protein called an immunoglobulin, abbreviated Ig. One class of these is called Immunoglobulin M (IgM). The M stands for macroglobulin because it is, by far, physically the largest antibody in the human circulatory system. It is the first antibody produced in response to infection or initial exposure to foreign substances that are perceived as threats, called antigens. Immunoglobulin M antibodies appear early in the course of an infection and usually reappear, to a lesser extent, after further exposure. This biological property of immunoglobulin M makes it useful in the diagnosis of infectious diseases. Demonstrating immunoglobulin M antibodies in a patient's serum, the liquid part of the blood, indicates recent infection. (Additional Notes/Definitions: An excess of immunoglobulin M is a characteristic of Waldenström's macroglobulinemia (WM) because WM causes the B Cells and plasma cells to become abnormal and reproduce in an excessive and uncontrolled manner and also to produce an excess of Immunoglobulin M which can cause a thickening of the blood called hyperviscosity. This can cause many symptoms including excess bleeding, problems with vision, poor blood circulation in the extremities, and nervous system problems. Further complications can arise. An antibody is a protein produced by the body's immune system in response to foreign substances that are perceived as threats called antigens, which is short for antibody generator. They act as a critical part of the immune response by specifically recognizing and binding to particular antigens, such as bacteria or viruses and neutralizing and aiding in their destruction. Note that proteins are the true workhorses of the body, not only making up the majority of cellular structures but carrying out most of the chemical processes as well.)

Inactive Ingredients:

All the substances in a drug that are not the active ingredients. Many inactive ingredients are used to take the active ingredient to a site in the body where it will be most effective, such as those used for tablets and capsules to control how, where, and when the medicine is released in the body to achieve maximum benefit (also called Non-Active Ingredients).

Independent Reading and Interpretation of Imaging Scans:

This is done by an Independent Review Committee (IRC) - see Imaging Scans above and Independent Review Committee below.

Independent Review Committee (IRC):

A committee that is established to independently review the data and results of specific trials. The review is generally blinded (i.e. the Independent Review Committee does not know what treatment the patient received, or how the tests that were done to determine the patient’s response to the treatment were interpreted by other MDs).

Indicated:

1. When a particular remedy, treatment, etc., is pointed out as suitable or necessary; a specific approved use of a medicinal product received from a regulatory agency, such as the FDA. 2. Pointed out; shown, as by measuring or recording; make known: The thermometer indicated air temperature.

Indicated Dose:

Dose that is indicated, suitable, specified or prescribed for a given usage.

Indication:

1. The specific approved use of a medicinal product received from a regulatory agency, such as the FDA. 2. A sign or piece of information that indicates something. 3. A symptom that suggests certain medical treatment is necessary.

Indications:

(Of symptoms) to point out a particular remedy, treatment, etc., as suitable or necessary.

Indinavir:

A drug used for treating HIV (Human Immunodeficiency Virus). Trade name: Crixivan®.

Infection:

Disease caused by an agent (such as microorganisms like bacteria or virus) which have invaded and are living, reproducing and proliferating in the body. (Microorganisms are extremely small, only visible with a microscope)

Infestation:

Inhabited by parasites. Having parasites in or on the body.
(Additional Notes/Definitions: A parasite is an organism that lives off or in another organism, obtaining nourishment and protection while offering no benefit in return. Human parasites are often harmful to the body and can cause diseases.)

Inflammation:

A localized physical condition in which part of the body becomes reddened, swollen, hot, and often painful, especially as a reaction to injury or infection.

Inflammatory Diseases/Disorders:

Inflammation is a localized physical condition in which part of the body becomes reddened, swollen, hot, and often painful, especially as a reaction to injury or infection. After injury or in certain conditions inflammation is a normal, healthy response. But inflammatory disorders that result in the immune system attacking the body's own cells or tissues may cause abnormal inflammation, which results in chronic pain, redness, swelling, stiffness, and damage to normal tissues.

Inhibitor:

A substance that slows or halts a physiological process, e.g. by preventing the activity of an enzyme. (Additional Notes/Definitions: An enzyme is a type of protein that increases the rates of chemical reactions inside and outside cells without itself being changed in the process. It does this by lowering the energy level required to activate or initiate these reactions. Almost all chemical reactions in a biological cell need enzymes in order to occur at rates sufficient for life. Proteins not only make up the majority of cellular structures but carry out most of the chemical processes as well. Cells are the basic units of living organisms which can only be seen under a microscope.)

Inhibitor of BTK:

See Bruton’s Tyrosine Kinase (BTK) Inhibitor.

Inhibitory Activity:

Actions that prevent or decrease the rate of (a reaction) or decrease, limit, or block the action or function of (an enzyme or organ, for example). (Additional Notes/Definitions: An enzyme is a type of protein that increases the rates of chemical reactions inside and outside cells without itself being changed in the process. It does this by lowering the energy level required to activate or initiate these reactions. Almost all chemical reactions in a biological cell need enzymes in order to occur at rates sufficient for life. Proteins not only make up the majority of cellular structures but carry out most of the chemical processes as well. Cells are the basic units of living organisms which can only be seen under a microscope.)

Initiation:

Beginning a particular treatment.

Injury:

An instance of being injured; harm or damage; an act or event that causes someone or something to no longer be fully healthy or in good condition.

In Line With:

In alignment or accordance with.

Insoluble:

Not dissolvable; incapable of being dissolved in a liquid or solution. (Note: For specific data on levels of solubility if something is not completely insoluble, see Solubility Definitions.)

Insomnia:

Habitual sleeplessness; inability to sleep.

Integrins:

A receptor is a structure which is made of a complex protein that selectively receives and binds to a specific substance. Integrins are receptors that cross the cell membrane (transmembrane receptors) that are bridges for interactions with other cells and with substances in the cell’s environment. (Additional Notes/Definitions: Proteins not only make up structures of the body but help carry out most of the chemical reactions that are vital for living organisms to survive.)

Intent to Treat (ITT) Population:

A statistical analysis method in which none of the patients are excluded and the patients are analyzed according to the randomization scheme. In other words, for the purposes of ITT analysis, everyone who begins the treatment is considered to be part of the trial, whether he or she finishes it or not. The intent is to avoid overoptimistic estimates of the effectiveness of the treatment.

International Working Group (IWG):

A group of experts formed to work together to achieve specified goals. The term sometimes refers more specifically to an interdisciplinary collaboration of researchers working on new research activities that would be difficult to develop under traditional funding mechanisms (e.g., federal agencies).

International Working Group (IWG) for Non-Hodgkin’s Lymphoma (NHL) Criteria:

Standardized guidelines and a uniform set of criteria established by an interdisciplinary group of US and international lymphoma experts to ensure comparability among clinical trials for assessing response (how well a patient responds) to treatment for non-Hodgkin's lymphomas (NHL).
(Additional Notes/Definitions: Lymphomas are cancers that begin in the cells of the immune system. Non-Hodgkin’s lymphomas are all kinds of lymphomas except Hodgkin’s disease, which is a malignant form of lymphoma marked by progressive enlargement of the lymph nodes and spleen and sometimes of the liver.)

International Working Group (IWG) on CLL Criteria:

Standardized guidelines and a uniform set of criteria established by an interdisciplinary group of US and international leukemia experts to ensure comparability among clinical trials for assessing response (how well a patient responds) to treatment for chronic lymphocytic leukemia (CLL). (Additional Notes/Definitions: Leukemia is a cancer that starts in blood-forming tissue such as the bone marrow and causes large numbers of abnormal blood cells to be produced and enter the blood. Chronic lymphocytic leukemia tends to progress slowly and affect a group of white blood cells, called lymphocytes, which help your body fight infection. It leads to increased numbers of these which suppress the production of normal blood cells. The progression of symptoms can include anemia, fatigue, appetite loss, an abnormally low level of various blood cells can cause symptoms such as reduced resistance to infections, clotting of blood, etc., and there can be enlargements of certain organs such as liver and spleen. Chronic lymphocytic leukemia most commonly affects older adults.)

International Workshop on CLL (Chronic Lymphocytic Leukemia) Criteria:

Criteria (principles or standards by which something may be judged or decided) established or specified in an international workshop dedicated to the promotion and advancement of the treatment of CCL.

International Workshop of Waldenström’s Macroglobulinemia:

An international workshop dedicated to the promotion and advancement of the treatment of Waldenström’s Macroglobulinemia.

Intravenous Clearance:

When a drug is administered by rapid IV (intravenous) injection, the maximum concentration in the blood is reached almost at once and immediately begins to fall. The profile of this decline can be determined by monitoring blood levels at periodic intervals and then plotting these concentrations against time. Once a drug is absorbed and distributed among the tissues and body fluids, it is then eliminated, or cleared, mainly by the liver and kidneys. Consequently, the plasma concentration of a drug decreases steadily, although at different rates for various drugs in different species. Drug clearance (Cl) is defined as the volume of plasma, the liquid part of the blood, that would contain the amount of drug excreted per minute or, alternatively, the volume of plasma that would have to lose all of the drug that it contains within a unit of time (usually 1 min) to account for an observed rate of drug elimination.

Interrupting Therapy:

Discontinuation or stopping treatment, for a certain period of time or fully.

Intestines:

The long, tube-like organ(s) in the abdomen from the end of the stomach to the anus that completes the process of digestion, absorption of food and elimination of residual waste. It consists of the small and large intestines.

Intima:

Intima (or tunica intima – “inner coat”) is the innermost layer of an artery or vein and is in direct contact with the blood flow. (Additional Notes/Definitions: Arteries are the blood vessels (elastic tubular structures) that carry oxygen-rich blood from the heart to the body. And veins are the blood vessels that carry blood to the heart after the cells have extracted the oxygen from the blood.)

Investigator-Assessed:

As determined by the principal investigator on the study (as opposed to an independent review committee).

Intracranial Hemorrhage:

Bleeding inside the skull.

In Vitro:

Outside of the body, in a test tube, or sample/culture of some sort.

In Vivo:

Within the body of a human or animal. Vivo: Latin for “live”.

Ion:

An atom or molecule with a net electric charge due to the loss or gain of one or more electrons. The smallest basic unit of matter is called an atom. Two or more like or different atoms held together by chemical forces make a molecule. An electron: is a very small particle of matter that has a negative charge, the basic charge of electricity, and travels around the nucleus of an atom. The nucleus of an atom is the positively charged central core of an atom, consisting of protons and neutrons and containing nearly all its mass. An electron has a small mass, less than 0.1% the mass of an atom. Under normal circumstances, electrons move about the nucleus of an atom in orbitals that form an electron cloud bound in varying strengths to the positively charged nucleus. Electrons play a key role in creating chemical bonds to create different chemical substances. Due to attractive force of positive and negative charges many chemical substances become more stable when bonded with another substance. To forms compounds atoms will lose, gain, or share electrons.

IRC (Independent Review Committee):

A committee that is established to independently review the data and results of specific trials. The review is generally blinded (i.e. the Independent Review Committee does not know what treatment the patient received, or how the tests that were done to determine the patient’s response to the treatment were interpreted by other MDs).

Isoenzymes:

Any of the various forms of enzymes that are chemically different but perform the same function.

Isolated Lymphocytosis:

A singular (non-chronic and non-recurring) instance of abnormal increase in the number of lymphocytes in the bloodstream. Lymphocytes are certain types of white blood cells which are part of the immune system and fight infection and disease.

Isotope:

Each of two or more forms of the same element that contain equal numbers of protons but different numbers of neutrons in their nuclei, and hence differ in relative atomic mass but not in chemical properties; in particular, a radioactive form of an element. (Additional Notes/Definitions: Atoms are the smallest basic unit and building block of matter. Protons and neutrons are subatomic particles in the nucleus or center of an atom. Protons have a positive charge of +1, and neutrons have no charge, or are considered neutral.)

Itraconazole:

A drug used for the treatment of fungal infections which are isolated to a small area of the body. Brand Name: Sporanox®. (Additional Notes/Definitions: A fungal infection is any inflammatory condition caused by a fungus. Most fungal infections are superficial and mild, though persistent and difficult to eradicate. Some, particularly in older, debilitated, or immunosuppressed or immunodeficient people, may become systemic and life threatening. Examples of fungal infections are athlete’s foot, yeast and candida.)

ITT (Intent to Treat) Population:

A statistical analysis method in which none of the patients are excluded and the patients are analyzed according to the randomization scheme. In other words, for the purposes of ITT analysis, everyone who begins the treatment is considered to be part of the trial, whether he or she finishes it or not. The intent is to avoid overoptimistic estimates of the effectiveness of the treatment.

IWCLL:

International Workshop on Chronic Lymphocytic Leukemia, a National Cancer Institute (NCI)-sponsored group for the purpose of setting standardized criteria and adverse reactions to be used in clinical trials.

IWG (International Working Group):

A group of experts formed to work together to achieve specified goals. The term sometimes refers more specifically to an interdisciplinary collaboration of researchers working on new research activities that would be difficult to develop under traditional funding mechanisms (e.g., federal agencies).

Kaplan-Meier Curve of Overall Survival:

A graph showing the probability of surviving a given length of time, broken into time intervals. The calculation is based on the percentage of people in a study or treatment group who are alive for a certain period of time after they were diagnosed with or treated for a disease, such as cancer. It can be used to compare the effectiveness of two or more drugs/treatments.

Kaplan-Meier Curve of Progression-Free Survival:

A graph showing the probability the length of time during and after the treatment of a disease, such as cancer, that a patient might live with the disease, but without it getting worse. The calculation is based on actual data in a trial/study. In a clinical trial, measuring the progression-free survival is one way to see how well a new treatment works or to compare its effectiveness with another.

Ketoconazole:

A substance that is effective on a wide variety of infections caused by fungus or yeast administered either orally or topically (on the skin). Brand Name: Nizoral®.
(Additional Notes/Definitions: Most fungal infections are superficial and mild, though persistent and difficult to eradicate. Some, particularly in older, debilitated, or immunosuppressed or immunodeficient people, may become systemic and life threatening. Examples of fungal infections are athlete’s foot, yeast and candida.

Kidney:

Either of a pair of organs that are found on either side of the spine, just below the rib cage in the back. The kidneys perform the essential function of removing waste products from the blood and produce urine for excretion.

Kidney Failure:

The kidneys perform the essential function of removing waste products from the blood. Partial or complete loss of the function of a kidney or kidneys can create a critical situation where these waste products are not being sufficiently removed which is toxic for the body.

Kidney Problems:

The kidneys perform the essential function of removing waste products from the blood. Partial or complete loss of the function of a kidney or kidneys can create a critical situation where these waste products are not being sufficiently removed which is toxic for the body.

Kinase:

An enzyme that activates other enzymes. (Additional Notes/Definitions: An enzyme is a type of protein that increases the rates of chemical reactions that are critical to life, called metabolic reactions, by lowering the energy level required to activate or initiate these reactions. Proteins not only make up the majority of cellular structures but carry out most of the chemical processes as well. Metabolic reactions or metabolism includes all the physical and chemical changes that occur in organisms to allow growth and maintain body functions. These include processes that break down substances to yield energy and processes that build up other substances necessary for life.)

Kinase Inhibitor:

A kinase is an enzyme that activates other enzymes by bringing about specific chemical reactions. An agent that inhibits or prevents a kinase from being involved in these chemical reactions, therefor inhibiting the activation of other enzymes, is a kinase inhibitor. (Additional Notes/Definitions: An enzyme is a type of protein that increases the rates of chemical reactions that are critical to life, called metabolic reactions, by lowering the energy level required to activate or initiate these reactions. Proteins not only make up the majority of cellular structures but carry out most of the chemical processes as well. Metabolic reactions or metabolism includes all the physical and chemical changes that occur in organisms to allow growth and maintain body functions. These include processes that break down substances to yield energy and processes that build up other substances necessary for life.)

L:

Liters, a metric unit of capacity, formerly defined as the volume of 1 kilogram of water under standard conditions, now equal to 1,000 cubic centimeters.

Laboratory Abnormality:

Laboratory test results that are out of the range considered normal parameters.

Laceration:

A deep cut or tear of the skin and/or flesh.

Large Intestine:

The long, tube-like organ in the abdomen from the end of the small intestine to the anus. The large intestine is about 5 feet long and about 3 inches in diameter. It absorbs water from wastes, creating stool. As stool enters the rectum, nerves there create the urge to defecate. In actual fact the small and large intestines are a continuous tube.

Leaflet:

A printed sheet of paper, sometimes folded, containing information.

Lethargy:

A lack of energy and enthusiasm, fatigue, abnormal drowsiness.

Leukemia:

A broad term covering a type of cancer that starts in blood-forming tissue, such as the bone marrow (the spongy tissue inside the bones), and causes large numbers of abnormal blood cells to be produced and enter the bloodstream (as distinguished from lymphoma which is a cancer that arises in the lymph system, the system responsible for fighting infections and draining excess fluid from body). (Additional Notes/Definitions: Cancer is a term used for diseases in which abnormal cells divide without control and are able to spread and invade other parts of the body.)

Leukocytes:

White (colorless) blood cells that defend the body against disease and infection. (Additional Notes/Definitions: Cells are the basic units of a living organism which can only be seen under a microscope. In addition to some cells being the building block of tissue, there are cells with specialized functions in various other places in the body, such as the blood and other fluids.)

L/h:

Liters per hour. A Liter is a metric unit of capacity, formerly defined as the volume of 1 kilogram of water under standard conditions, now equal to 1,000 cubic centimeters.

Light Chains:

Antibodies, which are part of the immune system and help fight infections and disease, consist of complex protein molecules that are made of 2 pairs of different amino acid chains. The smaller of these two types of amino acid chains are called light chains, or Bence-Jones proteins. In the case of some Waldenström’s Macroglobulinemia patients these partial antibodies are created and secreted and may be deposited in the kidneys which can lead to kidney damage and kidney failure. (Additional Notes/Defintitions: Waldenström’s Macroglobulinemia (WM) is a cancer of cells that are part of our immune system which are white blood cells called B cells that normally help the body to fight infections. Normally, some of our B cells turn into specialized cells called plasma cells whose role it is to produce antibodies which help fight infections and harmful substances that get into the body. Antibodies are made up of a protein called immunoglobulin (abbreviated Ig). Proteins not only make up structures of the body but assist in bringing about most of the chemical reactions that are vital to living organisms. Amino acids are the building blocks of proteins. One of the characteristics of WM is that the malignant (cancerous) plasma cells create an overabundance of one particular immunoglobulin. The malignant plasma cells of some WM patients also produce and secrete partial immunoglobulins called light chains, or Bence-Jones proteins. These light chains that go into circulation may be deposited in the kidneys. There they can plug up the tiny tubules that form the filtering system of the kidneys. This can lead to kidney damage and kidney failure.)

Liver:

A large organ in the abdomen. It is an important organ that has many functions including detoxification, the creation of certain blood proteins, and many processes having to do with digestion and metabolism. Specific to drug therapy, this includes a key function of helping to metabolize (break down and excrete) drugs or medications. (Additional Notes/Definitions: Proteins not only make up the majority of cellular structures but carry out most of the chemical processes as well. Metabolic reactions or metabolism includes all the physical and chemical changes that occur in organisms to allow growth and maintain body functions. These include processes that break down substances to yield energy and processes that build up other substances necessary for life.)

Loose Stools:

Bowel movements that has excess fluids and is freer than would be ideal.

Low Blood Pressure:

Blood pressure is the measure of the force of blood pushing against the blood vessel walls. The heart pumps blood into the arteries (blood vessels), which carry the blood throughout the body. Low blood pressure occurs when blood pressure is much lower than normal. This means the heart, brain, and other parts of the body do not get enough blood which can cause symptoms of dizziness and fainting. (Note: Normal blood pressure is usually between 90/60 mmHg (Read as "90 over 60 millimeters of mercury") and 130/80 mmHg. In each set of numbers the top number, which is also the higher of the two numbers, measures the peak pressure in the arteries when the heart beats (when the heart muscle contracts). It is called systolic pressure. The bottom number, which is also the lower of the two numbers, measures the minimum pressure in the arteries between heartbeats (when the heart muscle is resting between beats and refilling with blood). It is called diastolic. The term millimeter of mercury (mmHg) was derived as a term from the extra pressure generated in a tube by a column of mercury one millimeter high. The medical name for low blood pressure is hypotension.)

Low Blood Platelet Count:

Platelets help the blood clot and stop bleeding. A low count puts you at risk for serious and/or abnormal bleeding. (Additional Notes/Definitions: Platelets are a type of blood cell that is disc-shaped which allows it to get caught on openings in veins, such as from a cut, causing or allowing a blood clot to form in order to control or stop bleeding. They are formed in the bone marrow and then circulate in the blood. They are often called cell fragments because they do not have a definite nucleus. A cell’s nucleus is a membrane-bound structure that contains the cell’s hereditary information and controls the cell’s growth and reproduction. Veins are the blood vessels that carry blood to the heart after the cells have extracted the oxygen from the blood.)

Lymph:

Thin clear fluid that circulates through the lymphatic vessels and carries certain types of white blood cells called lymphocytes that fight infection and disease. (Additional Notes/Definitions: Lymphatic vessels are thin-walled, valved structures that carry lymph. Cells are the basic units of a living organism which can only be seen under a microscope. In addition to some cells being the building block of tissue, there are cells with specialized functions in various other places in the body, such as the blood and other fluids.)

Lymph nodes:

Bean-shaped organs found in the underarms, groin, neck, and abdomen that act as filters for the lymph fluid as it passes through them. Lymph nodes are part of the lymphatic system, a key part of the immune system which carries a fluid containing types of white blood cells called lymphocytes that fight infection and disease. (Additional Notes/Definitions: Cells are the basic units of a living organism which can only be seen under a microscope. In addition to some cells being the building block of tissue, there are cells with specialized functions in various other places in the body, such as the blood and other fluids.)

Lymphocyte:

Certain types of white blood cells which are part of the immune system and fight infection and disease. (Additional Notes/Definitions: Cells are the basic units of a living organism which can only be seen under a microscope. In addition to some cells being the building block of tissue, there are cells with specialized functions in various other places in the body, such as the blood and other fluids.)

Lymphocyte Counts:

Tests which count the numbers of lymphocytes in a given volume of blood. Lymphocytes are part of the immune system. They are certain types of white blood cells which fight infection and disease. Abnormally high counts can indicate an infection. Low numbers of lymphocytes can raise a person’s risk of infection. (Additional Notes/Definitions: Cells are the basic units of a living organism which can only be seen under a microscope. In addition to some cells being the building block of tissue, there are cells with specialized functions in various other places in the body, such as the blood and other fluids.)

Lymphocytic Leukemia:

A type of cancer that starts in blood-forming tissue in the bone marrow (the spongy tissue inside the bones) with a group of white blood cells called lymphocytes, which normally help your body fight infection. It causes large numbers of these blood cells which have become abnormal to be produced and enter the bloodstream. In time, it can also invade other parts of the body, including the lymph nodes, liver and spleen. (Additional Notes/Definitions: Cells are the basic units of a living organism which can only be seen under a microscope. In addition to some cells being the building block of tissue, there are cells with specialized functions in various other places in the body, such as the blood and other fluids. Lymph nodes are bean-shaped organs found in the underarms, groin, neck, and abdomen that act as filters for the lymph fluid as it passes through them. Lymph nodes are part of the lymphatic system, a key part of the immune system which carries a fluid containing types of white blood cells called lymphocytes that fight infection and disease. The liver is a large, important organ in the abdomen that has many functions including detoxification, the creation of certain blood proteins, and many processes having to do with digestion and metabolism. Metabolism includes all the physical and chemical changes that occur in cells and the organism to allow growth and maintain body functions. These include processes that break down substances to yield energy and processes that build up other substances necessary for life. Specific to drug therapy, this includes a key function of helping to metabolize (break down and excrete) drugs or medications. The spleen is an abdominal organ involved in the production and removal of blood cells and forming part of the immune system. It usually lies in the left upper quadrant of the human abdomen, below the heart and diaphragm. The spleen filters out harmful substances from the blood, produces white blood cells (which help fight infections), removes worn-out red blood cells (which transport oxygen to the tissues and cells) from circulation, and maintains a reserve blood supply for the body.)

Lymphocytosis:

Lymphocytes are certain types of white blood cells which are part of the immune system and fight infection and disease. Lymphocytosis is a condition marked by an abnormal increase in the number of lymphocytes in the bloodstream, usually resulting from infection or inflammation. (Additional Notes/Definitions: Cells are the basic units of a living organism which can only be seen under a microscope. In addition to some cells being the building block of tissue, there are cells with specialized functions in various other places in the body, such as the blood and other fluids.)

Lymphoid Tissue:

Tissue that is made up several types of immune system cells that work together to help the body resist infections. Lymphoid tissue is found in many places in the body:
Lymph nodes, which are pea-sized collections of immune system cells throughout the body, including in the underarm area, in the groin, on the sides of the neck, and inside the chest and abdomen
Bone marrow, the soft inner part of certain bones where new blood cells are made
The thymus, a small organ behind the chest bone and in front of the heart
The spleen, an organ on the left side of the abdomen next to the stomach
The tonsils and adenoids in the throat
Throughout body systems like the digestive system and respiratory system
Lymphocytes (lymph cells) are the main cells of lymphoid tissue. There are 2 main types of lymphocytes:
B lymphocytes (B cells) respond to an infection by changing into a different type of cell called a plasma cell. Plasma cells make proteins called antibodies (also called immunoglobulins) that help the body attack and kill disease-causing germs like bacteria.
T lymphocytes (T cells) help direct immune responses, but they also can kill invading germs directly.

Lymphokine:

A substance produced by lymphocytes that can act upon and activate other cells of the immune system. (Additional Notes/Definitions: Lymphocytes are certain types of white blood cells which are part of the immune system and fight infection and disease. Cells are the basic units of a living organism which can only be seen under a microscope. In addition to some cells being the building block of tissue, there are cells with specialized functions in various other places in the body, such as the blood and other fluids.)

Lymphoma:

A cancer of the lymphatic system, the system responsible for fighting infections and draining excess fluid from body. Lymphoma occurs when certain types of white blood cells (lymphocytes) reproduce in an excessive and uncontrolled manner. It can be detected in the lymph nodes and sometimes in the lymph ducts as well as in the blood. (Additional Notes/Definitions: Cells are the basic units of a living organism which can only be seen under a microscope. In addition to some cells being the building block of tissue, there are cells with specialized functions in various other places in the body, such as the blood and other fluids. The lymphatic system is a key part of the immune system which carries a thin clear fluid called lymph containing types of white blood cells called lymphocytes that fight infection and disease. Lymph ducts or lymph vessels, are thin walled, valved structures that carry lymph. Lymph nodes are bean-shaped organs found in the underarms, groin, neck, and abdomen that act as filters for the lymph fluid as it passes through them.)

Lyse:

Undergo or cause disintegration of a cell by rupture of the cell wall or membrane (lysis). (Additional Notes/Definitions: Cells are the basic units of a living organism which can only be seen under a microscope. Cells are the building block of tissue as one brick is part of a brick wall. There are also cells with specialized functions in various other places in the body, such as the blood and other fluids. A membrane is a thin, soft, pliable sheet or layer, especially of animal or vegetable tissue, serving as a covering or lining, as for an organ or cell. The cell membrane is the structure separating the cell from its environment. It is a complex system that allows nutrients to enter the cell and waste products to leave.)

Lysin:

An antibody or other substance able to cause lysis of cells, which is a disintegration of a cell by rupture of the cell wall or membrane (this action being done by an antibody applies especially to bacteria). (Additional Notes/Definitions: An antibody is a protein produced by the body's immune system in response to foreign substances that are perceived as threats. Proteins are the true workhorses of the body, not only making up the majority of cellular structures but carrying out most of the chemical processes as well. Certain white blood cells, called B Cells, and are key components of the immune system. Some of our B cells turn into specialized cells called plasma cells whose role it is to produce specific proteins called antibodies. Cells are the basic units of a living organism which can only be seen under a microscope. Cells are the building block of tissue as one brick is part of a brick wall. There are also cells with specialized functions in various other places in the body, such as the blood and other fluids. A membrane is a thin, soft, pliable sheet or layer, especially of animal or vegetable tissue, serving as a covering or lining, as for an organ or cell. The cell membrane is the structure separating the cell from its environment. It is a complex system that allows nutrients to enter the cell and waste products to leave.)

Lysis:

The disintegration of a cell by rupture of the cell wall or membrane. The dissolution or destruction of cells, such as blood cells or bacteria, as by the action of a specific lysin that disrupts the cell membrane. (Additional Notes/Definitions: Cells are the basic units of a living organism which can only be seen under a microscope. Cells are the building block of tissue as one brick is part of a brick wall. There are also cells with specialized functions in various other places in the body, such as the blood and other fluids. A membrane is a thin, soft, pliable sheet or layer, especially of animal or vegetable tissue, serving as a covering or lining, as for an organ or cell. The cell membrane is the structure separating the cell from its environment. It is a complex system that allows nutrients to enter the cell and waste products to leave.)

Magnesium Stearate:

Magnesium stearate is often used in the manufacture of medical tablets, capsules and powders because it has lubricating properties, preventing ingredients from sticking to manufacturing equipment during the compression of chemical powders into solid tablets.

Major Vessels:

The larger or main blood vessels which are elastic tubular channels, such as an artery or a vein, through which the blood circulates. (Additional Notes/Definitions: An artery is a blood vessel that carries oxygen-rich blood from the heart to the body. A vein is a blood vessel that carries blood to the heart after the cells have extracted the oxygen from the blood.)

Malformation:

The condition of being faulty or abnormal in form, shape, or structure; deformity.

Malignancy:

Where a group of cells display uncontrolled growth, invasion (intrusion on and destruction of adjacent tissues), and sometimes metastasis (spread to other locations in the body). Also known as cancer.

Malignant:

Cancerous; where a group of cells display uncontrolled growth, invasion (intrusion on and destruction of adjacent tissues), and sometimes metastasis (spread to other locations in the body).

Malignant B-cell Proliferation:

B-cells are a type of white blood cell that circulate in the blood and lymph and fights disease and infection. Malignant B-cell Proliferation is when B-cells become cancerous (malignant) and rapidly grow and multiply in an uncontrolled manner.
(Additional Notes/Definitions: Cells are the basic units of a living organism which can only be seen under a microscope. In addition to those that are the building block of tissue there are cells with specialized functions in various other places in the body, such as the blood and other fluids. Lymph is the thin clear fluid that circulates through thin walled, valved structures called lymphatic vessels and carries white blood cells.)

Malignant Tumors:

Tumors that are cancerous. Cells in these tumors can invade nearby tissues and spread to other parts of the body. The spread of cancer from one part of the body to another is called metastasis. (Additional Notes/Definitions: A tumor is a swelling of a part of the body, generally without inflammation, caused by an abnormal growth of tissue, whether benign (non-cancerous) or malignant (cancerous and able to spread to other tissue or parts of the body). Tissue is part of the body of a living thing that is made of similar cells. Cells are the basic units of a living organism which can only be seen under a microscope. Cells are the building block of tissue as one brick is part of a brick wall. There are also cells with specialized functions in various other places in the body, such as the blood and other fluids. Cancer is a term used for diseases in which abnormal cells divide without control and are able to spread and invade other parts of the body.)

Mammalian (CHO) Cells:

Cells from mammals are used as they more closely approximate human cells. CHO stands for Chinese Hamster Ovaries; cells from the ovary of the Chinese Hamster are collected and used in scientific research; very popular for growing cells, especially in molecular biology. (Additional Notes/Definitions: Cells are the basic units of a living organism which can only be seen under a microscope. In addition to those that are the building block of tissue there are cells with specialized functions in various other places in the body, such as the blood and other fluids. Molecular Biology is the branch of biology concerned with the nature and function, at the molecular level, of biological phenomena such as how cells replicate and pass on genetic information, create and handle large molecules called macromolecules that are essential to life, such as proteins, etc. Molecules are the smallest particles of a substance that retains the chemical and physical properties of the substance and is composed of two or more atoms; a group of like or different atoms held together by chemical forces. Atoms are the smallest basic unit and building block of matter. Proteins not only make up the majority of cellular structures but carry out most of the chemical processes as well.)

Manometer:

An instrument for measuring the pressure of a fluid, consisting of a tube filled with a liquid, the level of the liquid being determined by the fluid pressure and the height of the liquid being indicated on a scale. (A liquid previously in common use was mercury. The term millimeters of mercury (mm) remains as a standard for such things as blood pressure. Blood Pressure is the pressure of the blood within the arteries. It is produced primarily by the contraction of the heart muscle, but is also affected by the diameter and elasticity of the walls of the arteries. If either too high or too low it can lead to complications.)

Manometric:

A measurement of pressure, relating to a manometer which is an instrument for measuring the pressure of a fluid, consisting of a tube filled with a liquid, the level of the liquid being determined by the fluid pressure and the height of the liquid being indicated on a scale. (A liquid previously in common use was mercury. The term millimeters of mercury (mm) remains as a standard for such things as blood pressure. Blood Pressure is the pressure of the blood within the arteries. It is produced primarily by the contraction of the heart muscle, but is also affected by the diameter and elasticity of the walls of the arteries. If either too high or too low it can lead to complications.)

Manometric Unit of Pressure:

A standard of measurement of pressure, relating to a manometer which is an instrument for measuring the pressure of a fluid, consisting of a tube filled with a liquid, the level of the liquid being determined by the fluid pressure and the height of the liquid being indicated on a scale. (A liquid previously in common use was mercury. The term millimeters of mercury (mm) remains as a standard for such things as blood pressure. Blood Pressure is the pressure of the blood within the arteries. It is produced primarily by the contraction of the heart muscle, but is also affected by the diameter and elasticity of the walls of the arteries. If either too high or too low it can lead to complications.)

Mantle Cell Lymphoma:

Lymphoma is the general term for a cancer that begins in the cells of the immune system, specifically the lymphatic system, the system responsible for fighting infections and draining excess fluid from body. Lymphoma occurs when one of the types of white blood cells, lymphocytes, become malignant (cancerous) and reproduce in an excessive and uncontrolled manner. Mantle cell lymphoma (MCL) results from cancer of a specific type of white blood cell, called B lymphocyte (or B Cell), and is characterized by expansion (tumors) in the mantle zone area (covering layer of tissue in a lymph node). Hence, the lymph node becomes enlarged. MCL is an aggressive (fast-growing) form of lymphoma. Cells can enter the lymphatic channels and the blood, and can spread to other lymph nodes or tissues, such as the bone marrow, liver, spleen, and gastrointestinal tract. (Additional Notes/Definitions: Lymph nodes are bean-shaped organs found in the underarms, groin, neck, and abdomen that act as filters for the lymph fluid as it passes through them. Lymph nodes are part of the lymphatic system, a key part of the immune system which carries a fluid containing types of white blood called lymphocytes that fight infection and disease. Lymph is the thin clear fluid that circulates through thin walled, valved structures called lymphatic vessels or channels and carries white blood cells. Bone marrow is the spongy tissue occupying the hollow central cavity of bones. There are two types of bone marrow. Red bone marrow contains tissue that is responsible for the formation and development of most of the blood cells – approximately 500 billion per day. The liver is a large important organ in the abdomen that has many functions including detoxification, the creation of certain blood proteins, and many processes having to do with digestion and metabolism. Specific to drug therapy, this includes a key function of helping to metabolize (break down and excrete) drugs or medications. The spleen is an abdominal organ involved in the production and removal of blood cells and forming part of the immune system. It usually lies in the left upper quadrant of the human abdomen, below the heart and diaphragm. The spleen filters out harmful substances from the blood, produces white blood cells (which help fight infections), removes worn-out red blood cells (which transport oxygen to the tissues and cells) from circulation, and maintains a reserve blood supply for the body. Gastrointestinal track refers collectively to the entire digestive system and particularly the stomach and intestines.)

Marmalade:

A clear sweetened jelly in which small pieces of fruit and fruit rind, as of oranges, lemons or grapefruit, are suspended.

Matrix:

An environment or material in which something develops; a surrounding medium or structure.

MCL:

An abbreviation for Mantle Cell Lymphoma (above).

mcL:

Microliter; a unit of liquid volume equal to one millionth of a liter, or approximately a volume of 1 cubic millimeter (1 mm3.).

Mean Metabolite to Parent Ratio:

How many by-products (metabolites) of a drug are present compared to the dose of the drug that was administered (expressed as a ratio). (Additional Notes/Definitions: Mean is an average or intermediate value between other values. Metabolites are the product of metabolism, which is a term used for all the physical and chemical changes that occur in an organism to allow growth and maintain body functions. These include processes that break down substances to yield energy and processes that build up other substances necessary for life. The parent is the initial compound or drug, prior to metabolism.)

Mechanism:

1. The sequence of steps in a chemical reaction. 2. What causes some symptom, injury, illness, etc., or how it comes about. 3. A natural or established process by which something takes place or is brought about.

Mechanism of Action (MOA):

The biologic and chemical explanation for how a drug works and the effect it has on a living organism.

Media:

The media (or tunica media – “middle coat”) is the middle layer of an artery or vein. (Additional Notes/Definitions: Arteries are the blood vessels (elastic tubular structures) that carry oxygen-rich blood from the heart to the body. And veins are the blood vessels that carry blood to the heart after the cells have extracted the oxygen from the blood.)

Median:

Situated in the middle; fifty percent of events or fifty percent of a population or sample on either side. For example, the median score is the middle score in a list of scores; it is the point at which half the scores are above and half the scores are below.

Median Duration:

Median is a statistical term that means the middle value in a series of values. So the median duration means that about half of durations were less than that time and half had a duration that was longer than that time.

Median Time to Response:

Median time is a statistical term that means half of the events occurred before that time, half after that time. So the median time to response means that half of the patients responded by that time.

Median Treatment Duration:

Median is a statistical term that means the middle value in a series of values. So the median treatment duration means that about half of the patients had a treatment duration less than that time and half had a duration that was longer than that time.

Mediastinal Disorders:

Disorders or impaired function in one or more of the organs in the chest region between the lungs (mediastinum). This could involve the heart, some important nerves, tissues or many key organs involved in blood circulation, breathing, digestion, etc.

Mediastinum:

The region in the chest between the lungs, containing the heart, some important nerves and tissues and many key organs involved in blood circulation, breathing, digestion, etc.

Medical Dictionary for Regulatory Activities (MedDRA):

A standardized international medical terminology which can be used for regulatory communication and evaluation of data pertaining to medicinal products for human use.

Medium CYP Inducer:

Substances that initiate or increase the production of the enzymes in the CYP family to a moderate extent. (Additional Notes/Definitions: An enzyme lowers the energy level required to activate or initiate chemical reactions and thereby increases the rates of these reactions, vital for living organisms. Enzymes are key for metabolism which is all of the chemical processes within a living organism that are necessary for the maintenance of life. Drug metabolism, specifically, is when the drug is chemically broken down into simpler substances and any waste is cleared from the body. The CYP family is a class of enzymes, essential for drug metabolism (breakdown and clearance from the body). Mainly found in the liver and also the small intestine, they are known as the cytochrome P450 superfamily of enzymes (officially abbreviated as CYP). Although this class has more than 50 enzymes, six of them metabolize 90 percent of drugs. Increasing the production of these enzymes can lower the amount of a specific drug in the blood. Inhibiting them can increase the amount of the drug in the system.)

Medium CYP Inhibitor:

A substance that slows or stops the activity of the enzymes in the CYP family to a moderate extent. (Additional Notes/Definitions: An enzyme lowers the energy level required to activate or initiate chemical reactions and thereby increases the rates of these reactions, vital for living organisms. Enzymes are key for metabolism which is all of the chemical processes within a living organism that are necessary for the maintenance of life. Drug metabolism, specifically, is when the drug is chemically broken down into simpler substances and any waste is cleared from the body. The CYP family is a class of enzymes, essential for drug metabolism (breakdown and clearance from the body). Mainly found in the liver and also the small intestine, they are known as the cytochrome P450 superfamily of enzymes (officially abbreviated as CYP). Although this class has more than 50 enzymes, six of them metabolize 90 percent of drugs. Increasing the production of these enzymes can lower the amount of a specific drug in the blood. Inhibiting them can increase the amount of the drug in the system.)

MedDRA (Medical Dictionary for Regulatory Activities):

A standardized international medical terminology which can be used for regulatory communication and evaluation of data pertaining to medicinal products for human use.

Metabolic (Disorders):

Broadly, this covers any difficulty with any of the physical and chemical changes that occur in cells and the organism to allow growth and maintain body functions. But more specifically, this often refers to a disease or disorder that causes or results in ineffective or inadequate digestion/breakdown and absorption of food and nutrients, including the absorption of water or liquids.

Metabolism:

All the physical and chemical changes that occur in cells and the organism to allow growth and maintain body functions. These include processes that break down substances to yield energy and processes that build up other substances necessary for life.

Metabolite:

A substance or compound produced as a result of metabolism or a metabolic reaction; a substance or compound that is involved in metabolism. When a drug undergoes metabolism, it is broken down and changed into various products called metabolites. (Additional Notes/Definitions: Metabolism is a term used for all the physical and chemical changes that occur in an organism to allow growth and maintain body functions. These include processes that break down substances to yield energy and processes that build up other substances necessary for life.)

Metabolize:

To undergo or be transformed by metabolism, the breaking down of various substances such as carbohydrates, proteins, and fats into smaller units; reorganizing of those units as tissue building blocks or as energy sources; and eliminating waste products of the processes. Drugs are also metabolized, broken down and waste products eliminated.

Metastasis:

A cancer or tumor that spreads from its original location to other areas in the body. For example, Brain Metastasis is a cancer or tumor that has spread to the brain from another site in the body, commonly the lung or breast. (Additional Notes/Definitions: Cancer is a term used for diseases in which abnormal cells divide without control and are able to spread and invade other parts of the body. Normally, cells grow and divide in a controlled way to produce more cells as they are needed to replace cells that die because they become old or damaged. However, the genetic material (DNA) of a cell can become damaged or changed, producing mutations that affect normal cell growth and division. When this happens, cells do not die when they should and new cells form when the body does not need them. The extra cells may form a mass of tissue called a tumor.)

Methanol:

A colorless, toxic, flammable liquid, used as an antifreeze, a general solvent, a fuel, and to create denatured alcohol (alcohol used for medicinal purposes that is unfit for consumption).

Mg:

milligram. A unit of mass equal to one thousandth (10-3) of a gram.

Mg/dL:

Milligram (one thousandth of a gram) per deciliter (one tenth of a liter). (Additional Notes/Definitions: A Liter is a metric unit of capacity, formerly defined as the volume of 1 kilogram of water under standard conditions, now equal to 1,000 cubic centimeters.)

Mg/kg:

Milligrams per Kilogram. In this context it refers to the amount of medication (mg) based on body weight (in kg; 1 kg=2.2 pounds) of the subject/patient.

Mg/kg/day:

Milligram per kilogram per day. This refers to the amount of medication (mg) based on body weight (in kg; 1 kg=2.2 pounds) of the subject/patient per day.

Microcrystalline Cellulose:

A natural bulking agent made from refined wood pulp often used when making drugs in tablets or capsules.

Milliliter (ml):

A unit of liquid volume equal to one thousandth of a liter, or approximately a volume of 1 cubic centimeter (1 cm3.).

Mitochondria:

Structures within cells that convert the energy from food into a form that cells can use and create molecules that help assemble protein building blocks (amino acids) into functioning proteins. (Additional Notes/Definitions: Amino acids are the building blocks of protein. Proteins are the true workhorses of the body, not only making up the majority of cellular structures, but carrying out most of the chemical processes as well. Proteins are complex structures built of smaller units. Smallest basic unit of matter is called an atom. Two or more like or different atoms held together by chemical forces make a molecule. Amino acids are molecules that are linked together in various combinations to make up the long molecular chains that are proteins. Additionally, specialized cell structures like mitochondria are called organelles or “little organs”.)

mL/min:

Milliliters per minute. (Additional Notes/Definitions: A milliliter is a unit of liquid volume equal to one thousandth of a liter, or approximately a volume of 1 cubic centimeter (1 cm3.).)

Modified Version:

A particular form of something differing in certain respects from an earlier form or other forms of the same type of thing; a form that has been altered.

Mole:

A chemical mass unit, defined to be 6.022 x 1023 molecules, atoms, or some other unit. (Additional Notes/Definitions: A molecule is the smallest particle of a substance that retains the chemical and physical properties of the substance and is composed of two or more atoms; a group of like or different atoms held together by chemical forces. Atoms are the smallest basic unit and building block of matter.)

Molecular Marker:

A molecule that can be used as an indicator of the physiological state of an organism and any function or process within it, whether normal or abnormal, the presence of a disease, the progress of the disease, response to treatment, etc. This could be a specific substance in the body or a measurable substance that is introduced into the body which can then be monitored at a molecular level. A molecule is the smallest particle of a substance that retains the chemical and physical properties of the substance and is composed of two or more atoms; a group of like or different atoms held together by chemical forces. (Also called biomarker, biological marker and signature molecule.)

Molecular Weight:

The sum of the atomic weights (also known as atomic mass) of all the atoms in a molecule. The mass of an atom of a chemical element expressed in atomic mass units. It is approximately equivalent to the number of protons and neutrons in the atom (the mass number) or to the average number allowing for the relative abundances of different isotopes. Examples: The approximate atomic mass of carbon is 12, and hydrogen 1. More specifically, the atomic mass of carbon is 12.011; the atomic mass of hydrogen is 1.0079. (Additional Notes/Definitions: A molecule is the smallest particle of a substance that retains the chemical and physical properties of the substance and is composed of two or more atoms; a group of like or different atoms held together by chemical forces. Atoms are the smallest basic unit and building block of matter. Protons and neutrons are subatomic particles in the nucleus or center of an atom. Protons have a positive charge of +1, and neutrons have no charge, or are considered neutral. An isotope is each of two or more forms of the same element that contain equal numbers of protons but different numbers of neutrons in their nuclei, and hence differ in relative atomic mass but not in chemical properties; in particular, a radioactive form of an element one that gives off particles in the form of radiation.)

Molecule:

The smallest particle of a substance that retains the chemical and physical properties of the substance and is composed of two or more atoms; a group of like or different atoms held together by chemical forces. (Additional Notes/Definitions: Atoms are the smallest basic unit and building block of matter.)

Monitor:

1.To keep track of systematically with a view to collecting information; to test or sample, especially on a regular or ongoing basis; to keep close watch over; supervise. 2. Term often used as an abbreviation for Medical Monitor or Clinical Study Monitor.

Mononuclear Cells:

A type of white blood cell (leukocytes, which include B Cells) with one (mono) round nucleus (in the center of the cell) that helps defend the body against disease and infection. (Note: Cells are the basic units of a living organism which can only be seen under a microscope. In addition to those that are the building block of tissue there are cells with specialized functions in various other places in the body, such as the blood and other fluids. The nucleus is a membrane-bound structure that contains the cell’s hereditary information and controls the cell’s growth and reproduction.)

MS (Multiple Sclerosis):

A chronic, typically progressive disease in which your immune system attacks the protective sheath (myelin) that covers your nerves, especially affecting the brain and spinal cord. Myelin damage disrupts communication between your brain and the rest of your body. Symptoms may include numbness, impairment of speech and of muscular coordination, blurred vision, and severe fatigue.

Mucous Lining/membrane:

A mucus-secreting membrane lining all bodily passages that are open to the air, as of the digestive and respiratory tracts. Mucus is a slippery and somewhat sticky fluid secreted by the glands in mucous membranes. It lubricates and protects the mucous membranes. (Additional Notes/Definitions: A gland is an organ that secretes particular chemical substances for use in the body or for discharge into the surroundings. A membrane is a thin, soft, pliable sheet or layer, especially of animal or vegetable tissue, serving as a covering or lining, as for an organ or cell. Cells are the basic units of a living organism which can only be seen under a microscope. Cells are the building block of tissue as one brick is part of a brick wall. There are also cells with specialized functions in various other places in the body, such as the blood and other fluids.)

Mucus:

A slippery and somewhat sticky fluid secreted by the glands in mucous membranes. It lubricates and protects the mucous membranes. (Additional Notes/Definitions: A gland is an organ that secretes particular chemical substances for use in the body or for discharge into the surroundings. A mucous lining/membrane is a mucus-secreting membrane lining all bodily passages that are open to the air, as of the digestive and respiratory tracts. A membrane is a thin, soft, pliable sheet or layer, especially of animal or vegetable tissue, serving as a covering or lining, as for an organ or cell. Cells are the basic units of a living organism which can only be seen under a microscope. Cells are the building block of tissue as one brick is part of a brick wall. There are also cells with specialized functions in various other places in the body, such as the blood and other fluids.)

Multicenter:

A multicenter research trial is a clinical trial conducted at more than one medical center or clinic.

Multiple Events:

Events happening more than once, for example the same adverse drug reaction occurring at more than one occasion.

Multiple Sclerosis (MS):

A chronic, typically progressive disease in which your immune system attacks the protective sheath (myelin) that covers your nerves, especially affecting the brain and spinal cord. Myelin damage disrupts communication between your brain and the rest of your body. Symptoms may include numbness, impairment of speech and of muscular coordination, blurred vision, and severe fatigue.

Muscle Spasm:

An involuntary contraction of a muscle that can cause a great deal of pain.

Musculoskeletal:

Relating to or involving the muscles and the skeleton; concerning, involving, or made up of both the muscles and the bones.

Mutagenic:

An agent, such as a chemical, ultraviolet light, or a radioactive element, that can induce or increase the frequency of mutation in an organism. (Additional Notes/Definitions: Mutation is any change in the DNA of a cell or an organism resulting in the creation of a new character or trait not found in the parental type. DNA (Deoxyribonucleic acid) is a molecule that encodes the genetic instructions (blueprint) used in the development and functioning of all known living organisms. Cells are the basic units of a living organism which can only be seen under a microscope. In addition to those that are the building block of tissue there are cells with specialized functions in various other places in the body, such as the blood and other fluids. Molecules are the smallest particles of a substance that retains the chemical and physical properties of the substance and is composed of two or more atoms; a group of like or different atoms held together by chemical forces. Atoms are the smallest basic unit and building block of matter. Ultraviolet (UV) light is a portion of the light spectrum not visible to the eye; electromagnetic radiation with a wavelength shorter than that of visible light but longer than X-rays. Radioactive elements are those that emit or give off radiation (highly energetic particles). Radiation is a type of dangerous and powerful energy that is produced by radioactive substances and nuclear reactions.)

Mutagenesis:

The origin and development of a mutation. (Additional Notes/Defintions: Mutation is any change in the DNA of a cell or an organism resulting in the creation of a new character or trait not found in the parental type. DNA (Deoxyribonucleic acid) is a molecule that encodes the genetic instructions (blueprint) used in the development and functioning of all known living organisms. Cells are the basic units of a living organism which can only be seen under a microscope. In addition to those that are the building block of tissue there are cells with specialized functions in various other places in the body, such as the blood and other fluids. Molecules are the smallest particles of a substance that retains the chemical and physical properties of the substance and is composed of two or more atoms; a group of like or different atoms held together by chemical forces. Atoms are the smallest basic unit and building block of matter.)

Mutation:

Any change in the DNA of a cell or an organism resulting in the creation of a new character or trait not found in the parental type. DNA (Deoxyribonucleic acid) is a molecule that encodes the genetic instructions (blueprint) used in the development and functioning of all known living organisms. (Additional Notes/Defintions: Cells are the basic units of a living organism which can only be seen under a microscope. In addition to those that are the building block of tissue there are cells with specialized functions in various other places in the body, such as the blood and other fluids. Molecules are the smallest particles of a substance that retains the chemical and physical properties of the substance and is composed of two or more atoms; a group of like or different atoms held together by chemical forces. Atoms are the smallest basic unit and building block of matter.)

Myeloma:

A cancer that begin in the cells of the immune system. (Additional Note: Cancer is a term used for diseases in which abnormal cells divide without control and are able to spread and invade other parts of the body.)

Myelosuppression:

A condition, often caused by toxicity, in which bone marrow activity is decreased, such that the blood cells are greatly reduced in number and risk for infection increases. (Additional Notes/Definitions: Cells are the basic units of a living organism which can only be seen under a microscope. In addition to those that are the building block of tissue there are cells with specialized functions in various other places in the body, such as the blood and other fluids. One of these specialized functions is to help the body fight disease and infection. Bone marrow is the spongy tissue occupying the hollow central cavity of bones. There are two types of bone marrow. Red bone marrow contains tissue that is responsible for the formation and development of most of the blood cells – approximately 500 billion per day.)

N or n:

In statistics N refers to population size; and n, to sample size. In the Patient Insert the population referred to is the Intent to Treat Population or total number of cases enrolled in a study, so N = 195 would indicate that there were 195 individuals enrolled in a study or trial. And the sample size would be individuals within a population that exhibited similar symptoms or phenomena; for example if (n = 8) had severe hepatic impairment, 8 individuals in a trial had extensive loss of liver functions.

N at Risk:

The total number of cases/patients that are active in a study/trial. They are considered still at risk of the disease or cancer that is undergoing treatment for statistical purposes. The Number at Risk at the beginning should be the same as the number enrolled/included in the trial. As time goes on the number of people who die are subtracted from the N at Risk. So are individuals who become unavailable because they dropped out of the program, moved, are unreachable, etc. The term used for this is censored. So, for example, if 200 are enrolled, at the start (Month 0) N at Risk = 0. If in the next month 1 patient dies and 2 become unavailable (censored), N at Risk would be
200 – 1 – 2 = 197. If the study/trial is over or there are no longer any patients active in the trial N at Risk becomes 0.

Narrow Therapeutic Index:

If a drug has a narrow therapeutic index/range (i.e. has little difference between toxic and therapeutic doses) the dosage may have to be adjusted according to measurements of the actual blood levels (the levels of the drug in the blood) achieved in the person taking it.

National Cancer Institute (NCI):

Part of the National Institutes of Health, which is one of eleven agencies that are part of the U.S. Department of Health and Human Services. The NCI coordinates the U.S. National Cancer Program and conducts and supports research, training, health information dissemination, and other activities related to the causes, prevention, diagnosis, and treatment of cancer; the supportive care of cancer patients and their families; and cancer survivorship.

Natural Organic Matter (Organic Matter, Organic Material, NOM):

Matter composed of organic compounds that have come from the remains of organisms such as plants and animals and their waste products in the environment. (Additional Notes/Definitions: Organic compounds are chemical compounds that contain a significant amount of carbon. Historically, they were compounds that had been created by living organisms. Many have now been synthesized.)

Nausea:

A feeling of sickness in the stomach characterized by an urge to vomit (to eject part or all of the contents of the stomach through the mouth, usually in a series of involuntary spasmodic movements).

NCI (National Cancer Institute):

Part of the National Institutes of Health, which is one of eleven agencies that are part of the U.S. Department of Health and Human Services. The NCI coordinates the U.S. National Cancer Program and conducts and supports research, training, health information dissemination, and other activities related to the causes, prevention, diagnosis, and treatment of cancer; the supportive care of cancer patients and their families; and cancer survivorship.

NCI Common Terminology Criteria for Adverse Events (CTCAE):

The listing of terms designated by the National Cancer Institute (NCI) which includes Grades for Adverse Events. An adverse event is any unfavorable occurrence (symptom, etc.) happening at or near the time of use of a medicinal product. It becomes associated with the treatment or product whether or not the occurrence is caused by the product or even related to its use. Grade refers to the severity of the adverse event (AE) as follows:
Grade 1: Mild AE
Grade 2: Moderate AE
Grade 3: Severe AE
Grade 4: Life-threatening or disabling AE
Grade 5: Death related to AE
(Additional Notes/Definitions: National Cancer Institute (NCI) is part of the National Institutes of Health, which is one of eleven agencies that are part of the U.S. Department of Health and Human Services. The NCI coordinates the U.S. National Cancer Program and conducts and supports research, training, health information dissemination, and other activities related to the causes, prevention, diagnosis, and treatment of cancer; the supportive care of cancer patients and their families; and cancer survivorship.)

NDC 5796-140-09:

The National Drug Code (NDC) is a unique product identifier used in the United States for drugs intended for human use. See below for details:
NDC = National Drug Code.
5796 = A code for the labeler which is any firm that manufactures, repacks or distributes a drug product (in this case, Pharmacyclics, Inc.).
140 = 140 milligrams of active ingredient(s). (For example in IMBRUVICA, the dosage of the active ingredient, ibrutinib).
09 = 90 capsules per bottle.

NDC 5796-140-12:

The National Drug Code (NDC) is a unique product identifier used in the United States for drugs intended for human use. See below for details:
NDC = National Drug Code.
5796 = A code for the labeler which is any firm that manufactures, repacks or distributes a drug product (in this case, Pharmacyclics, Inc.).
140 = 140 milligrams of active ingredient(s). (For example in IMBRUVICA, the dosage of the active ingredient, ibrutinib).
12 = 120 capsules per bottle.

Nefazodone:

An antidepressant. Its sale has been discontinued in some countries due to incidence of liver damage. Brand Name: Serzone®
(Additional Notes/Definitions: An antidepressant is a substance (drug) that is intended to be used in the treatment of mood disorders, as characterized by various manic or depressive affects. The liver is a large important organ in the abdomen that has many functions including detoxification, the creation of certain blood proteins, and many processes having to do with digestion and metabolism. Specific to drug therapy, this includes a key function of helping to metabolize (break down and excrete) drugs or medications.)

Nelfinavir:

An oral medication that is used for treating infections with the human immunodeficiency virus (HIV). Brand Name: Viracept®.

Neoplasm:

A new and abnormal growth of tissue in some part of the body, especially as a characteristic of cancer. Also called a tumor.

Neoplasm Benign:

A mass of cells (tumor) that lacks the ability to invade neighboring tissue or spread to other parts of the body.

Neoplasm Malignant:

A tumor that is malignant (cancerous) and tends to spread to other parts of the body.

Neoplasm Unspecified:

A new and abnormal growth of tissue in some part of the body which has not been determined or specified as to whether it tends to spread to other parts of the body (and is therefore malignant/cancerous), or not (benign).

Nervous System:

The system of nerves in your body that sends messages for controlling movement and feeling between the brain and other parts of the body; the system of cells, tissues, and organs that regulates the body's responses to internal and external stimuli. (Additional Notes/Definitions: Cells are the basic units of a living organism which can only be seen under a microscope. In addition to those that are the building block of tissue there are cells with specialized functions in various other places in the body, such as the blood and other fluids. Tissues are a large mass of similar cells that make up a part of an organism and perform a specific function.)

Nervous System Disorders:

A physical condition in which there is a disturbance of normal functioning in the system of cells, tissues, and organs that regulates the body's responses to internal and external stimuli. (Additional Notes/Definitions: Cells are the basic units of a living organism which can only be seen under a microscope. In addition to those that are the building block of tissue there are cells with specialized functions in various other places in the body, such as the blood and other fluids. Tissues are a large mass of similar cells that make up a part of an organism and perform a specific function.)

Neuropathy:

Disease, damage or dysfunction of one or more of the nerves outside of the brain and spinal cord. It can cause pain or loss of sensation, weakness, paralysis, loss of reflexes and other symptoms. The term is short for Peripheral Neuropathy because it effects the peripheral nervous system (nerves outside the central nervous system consisting of the brain and spinal cord).

Neutropenia:

A lower-than-normal level of neutrophils, a type of white blood cell normally found circulating in the blood stream. Neutrophils are one of the first to respond to inflammation or bacterial infection. They are the predominant cells in pus, accounting for its whitish/yellowish appearance. Individuals with neutropenia are susceptible to frequent infections and/or disease and can have some of the symptoms that come from that such as fever, diarrhea, etc. (Additional Notes/Definitions: Cells are the basic units of a living organism which can only be seen under a microscope. In addition to those that are the building block of tissue there are cells with specialized functions in various other places in the body, such as the blood and other fluids. White blood cells are part of the immune system and help the body fight infection and disease. Bacteria are microscopic organisms (organisms that are so small as to be visible only with a microscope) some of which may cause illness.)

Neutrophils:

A type of white blood cell normally found circulating in the blood stream. Neutrophils are one of the first to respond to inflammation or bacterial infection. They are the predominant cells in pus, accounting for its whitish/yellowish appearance. (Additional Notes/Definitions: Cells are the basic units of a living organism which can only be seen under a microscope. In addition to those that are the building block of tissue there are cells with specialized functions in various other places in the body, such as the blood and other fluids. Bacteria are microscopic organisms (organisms that are so small as to be visible only with a microscope), some of which may cause illness.)

ng × hr/mL:

nanogram times hour per milliliter. Used for precise monitoring of very small levels of a drug in the body. More information on each abbreviation follows:
ng = nanogram, one billionth (1/1,000,000,000) gram.
hr = abbreviation for hour.
mL = abbreviation for milliliter - a metric unit of volume that is one thousandth (10-3) of a liter. In prescriptions the abbreviations ml and cc (cubic centimeter or cm3) are often used interchangeably because they are so nearly equal.

Ng/mL:

Nanograms per milliliter. A measure (that is very small) for monitoring levels of drug in the blood. A nanogram is one billionth (1/1,000,000,000) gram. A milliliter is a metric unit of volume that is one thousandth (10-3) of a liter. In prescriptions the abbreviations ml and cc (cubic centimeter or cm3) are often used interchangeably because they are so nearly equal.

NHL (Non-Hodgkin’s Lymphoma):

All kinds of lymphomas except Hodgkin’s disease, which is a malignant (cancerous) form of lymphoma marked by progressive enlargement of the lymph nodes and spleen and sometimes of the liver. (Additional Notes/Definitions: Lymphoma is a cancer of the lymphatic system, the system responsible for fighting infections and draining excess fluid from body. Lymphoma occurs when certain types of white blood cells (lymphocytes) reproduce in an excessive and uncontrolled manner. It can be detected in the lymph nodes and sometimes in the lymph ducts as well as in the blood. Lymph nodes are bean-shaped organs found in the underarms, groin, neck, and abdomen that act as filters for the lymph fluid as it passes through them. Lymph nodes are part of the lymphatic system, a key part of the immune system which carries a fluid containing types of white blood called lymphocytes that fight infection and disease. Lymph is the thin clear fluid that circulates through thin walled, valved structures called lymphatic vessels or channels and carries white blood cells. The spleen is an abdominal organ involved in the production and removal of blood cells and forming part of the immune system. It usually lies in the left upper quadrant of the human abdomen, below the heart and diaphragm. The spleen filters out harmful substances from the blood, produces white blood cells (which help fight infections), removes worn-out red blood cells (which transport oxygen to the tissues and cells) from circulation, and maintains a reserve blood supply for the body. The liver is a large important organ in the abdomen that has many functions including detoxification, the creation of certain blood proteins, and many processes having to do with digestion and metabolism. Specific to drug therapy, this includes a key function of helping to metabolize (break down and excrete) drugs or medications. Hodgkin’s disease is named after Thomas Hodgkin, the British pathologist who was the first person to detect it.)

NOM (Organic Matter, Organic Material, Natural Organic Matter):

Matter composed of organic compounds that have come from the remains of organisms such as plants and animals and their waste products in the environment. (Additional Notes/Definitions: Organic compounds are chemical compounds that contain a significant amount of carbon. Historically, they were compounds that had been created by living organisms. Many have now been synthesized.)

Non-Active Ingredients:

All the substances in a drug that are not the active ingredients. Many non-active ingredients are used to take the active ingredient to a site in the body where it will be most effective, such as those used for tablets and capsules to control how, where, and when the medicine is released in the body to achieve maximum benefit (also called Inactive Ingredients).
(Additional Notes/Definitions: An active ingredient is the substance or component in a pharmaceutical drug that is biologically active, that helps directly in achieving its performance objectives.)

Non-Cancer Subjects:

Subjects involved in a clinical trial who have been screened and are not diagnosed with cancer, part of the research process to check effects of a medication. (Additional Notes/Definitions: Cancer is a term used for diseases in which abnormal cells divide without control and are able to spread and invade other parts of the body. Cells are the basic units of living organisms which can only be seen under a microscope. The body is made up of many types of cells, making up structures like tissues and nerves, circulating in the blood & bodily fluids, etc.

Nonclinical:

A stage of research that begins before clinical trials (testing in humans) can begin.

Nonclinical Toxicology:

The study of the nature, effects, and detection of poisons and the treatment of poisoning applied to a stage of research that begins before clinical trials (testing in humans) can begin.

Non-Fatal:

Not resulting in or capable of causing death.

Non-Hematological:

Not dealing with the blood and/or blood-forming tissues.

Non-Hodgkin’s Lymphoma (NHL):

All kinds of lymphomas except Hodgkin’s disease, which is a malignant (cancerous) form of lymphoma marked by progressive enlargement of the lymph nodes and spleen and sometimes of the liver. (Additional Notes/Definitions: Lymphoma is a cancer of the lymphatic system, the system responsible for fighting infections and draining excess fluid from body. Lymphoma occurs when certain types of white blood cells (lymphocytes) reproduce in an excessive and uncontrolled manner. It can be detected in the lymph nodes and sometimes in the lymph ducts as well as in the blood. Lymph nodes are bean-shaped organs found in the underarms, groin, neck, and abdomen that act as filters for the lymph fluid as it passes through them. Lymph nodes are part of the lymphatic system, a key part of the immune system which carries a fluid containing types of white blood called lymphocytes that fight infection and disease. Lymph is the thin clear fluid that circulates through thin walled, valved structures called lymphatic vessels or channels and carries white blood cells. The spleen is an abdominal organ involved in the production and removal of blood cells and forming part of the immune system. It usually lies in the left upper quadrant of the human abdomen, below the heart and diaphragm. The spleen filters out harmful substances from the blood, produces white blood cells (which help fight infections), removes worn-out red blood cells (which transport oxygen to the tissues and cells) from circulation, and maintains a reserve blood supply for the body. The liver is a large important organ in the abdomen that has many functions including detoxification, the creation of certain blood proteins, and many processes having to do with digestion and metabolism. Specific to drug therapy, this includes a key function of helping to metabolize (break down and excrete) drugs or medications. Hodgkin’s disease is named after Thomas Hodgkin, the British pathologist who was the first person to detect it.)

Non-Melanoma Skin Cancer:

Any type of skin cancer that is not classified as melanoma, which is the most serious form of skin cancer forming malignant tumors. (Additional Notes/Definitions: Cancer is a term used for diseases in which abnormal cells divide without control and are able to spread and invade other parts of the body. Cells are the basic units of living organisms which can only be seen under a microscope. The body is made up of many types of cells, making up structures like tissues and nerves, circulating in the blood & bodily fluids, etc. Tissues are part of the body of a living thing that is made of similar cells.)

Non-Skin Carcinomas:

Carcinoma is a general name for cancer of the cells that make up tissues that line the cavities and surfaces of structures throughout the body, in this case excluding cancer of the skin tissue. (Additional Notes/Definitions: Cancer is a term used for diseases in which abnormal cells divide without control and are able to spread and invade other parts of the body. Cells are the basic units of living organisms which can only be seen under a microscope. The body is made up of many types of cells, making up structures like tissues and nerves, circulating in the blood & bodily fluids, etc. Tissues are part of the body of a living thing that is made of similar cells.)

Not Reached (NR):

Usually a study endpoint, such as Duration of Response, Progression Free Survival, etc. has not been reached. (Additional Notes/Definitions: Often in a study it is valuable to know a median time to achieve something. But the endpoint has not been reached then a range is not known and thus the median time cannot be calculated.)

NR (Not Reached):

Usually a study endpoint, such as Duration of Response, Progression Free Survival, etc. has not been reached.

Nuclear Reaction:

A change in the identity or characteristics of an atomic nucleus that results when it is bombarded with an energetic particle, as in fission, fusion, or radioactive decay. A process, such as fission, fusion, or radioactive decay, in which the structure of an atomic nucleus is altered through release of energy or mass or by being broken apart. (Additional Notes/Definitions: An atom is the smallest basic unit and building block of matter. And the nucleus is the positively charged central core of an atom, consisting of protons and neutrons and containing nearly all its mass. Protons are subatomic particles, smaller than an atom, that have a positive charge and neutrons are neutral, giving the nucleus an overall positive charge.)

Nucleus:

An atom is the smallest basic unit and building block of matter. And a nucleus is the positively charged central core of an atom, consisting of protons and neutrons and containing nearly all its mass. Protons are subatomic particles (smaller than an atom) that have a positive charge and neutrons are neutral, giving the nucleus an overall positive charge.

Nucleic Acid:

A complex organic substance present in living cells, especially such as DNA (Deoxyribonucleic Acid) which is a molecule that encodes the genetic instructions (blueprint) used in the development and functioning of all known living organisms. They consist of many a long linked chain of smaller molecules. (Additional Notes/Definitions: Organic compounds/substances are generally considered to be any member of a large class of gaseous, liquid, or solid chemical compounds that contains a significant amount of carbon. Originally confined to compounds produced by living organisms but now extended to include man-made substances based on carbon. Molecules are the smallest particles of a substance that retains the chemical and physical properties of the substance and is composed of two or more atoms; a group of like or different atoms held together by chemical forces. Atoms are the smallest basic unit and building block of matter.)

Number of Death (%):

The percentage of a group of subjects involved in a clinical trial that died.

Number of Events (%):

The percentage of adverse events experienced by a group of subjects involved in a clinical trial.

Nursing (Infants/Mothers):

Breast feeding; the baby ingesting milk from its mother’s breasts.

Nutritional (Disorders):

Nutrition disorders can be caused by an insufficient intake of food or of certain nutrients, by an inability of the body to absorb and use nutrients, or by overconsumption of certain foods.

Occupancy:

The amount or percentage of active sites that has made a chemical bond with a medicine. (In the case of IMBRUVICA it involves the active site of a B cell.)
(Additional Notes/Definitions: Cells are the basic units of a living organism which can only be seen under a microscope. In addition to those that are the building block of tissue there are cells with specialized functions in various other places in the body, such as the blood and other fluids. B Cells help fight infection and disease. An active site is the part of an enzyme where a molecule binds (attaches) and a chemical reaction occurs. An enzyme is a type of protein with specific characteristics. Proteins not only make up the majority of cellular structures of the body, but carry out most of the chemical processes vital to life as well. When molecules bind to an active site they create a complex which lowers the amount of energy required to either combine the molecules into more complex substances or break up the molecule into simpler substances. An enzyme lowers the energy level required to activate or initiate chemical reactions and thereby increases the rates of these reactions inside and outside cells without itself being changed in the process. Almost all chemical reactions in living organisms need enzymes in order to occur at rates sufficient for life. Molecules are the smallest particle of a substance that retains the chemical and physical properties of the substance and is composed of a group of two or more like or different atoms held together by chemical forces. Atoms are the smallest basic units and building blocks of matter.)

Ofatumumab:

A drug that has been approved by the FDA for patients with chronic lymphocytic leukemia (CLL) whose cancer is no longer being controlled by other forms of chemotherapy. Brand name, Arzerra®, made by GlaxoSmithKline.

Off-White:

White mixed with a small amount of gray, yellow, or other light color.

Ongoing Dedicated Drug Interaction Trial:

A dedicated drug interaction trial being conducted at the given time. (See Dedicated Drug Interaction Trial above.)

Ongoing Trial:

A trial that has had one or more patients or participants enrolled and is progressing, but is not yet completed.

Onset:

In medicine, the first appearance of the signs or symptoms of an illness.

Opaque:

Impenetrable by light; neither transparent nor translucent.

Open-Label/Open-label trial:

A type of clinical trial in which both the researchers and participants know which treatment is being administered. This contrasts with single-blind trials where participants are not aware of what treatment they are receiving, and double-blind experimental designs, where neither participants or clinicians are aware of what treatment is being administered.

Ophthalmoscope:

An instrument for examining the interior structures of the eye, especially the retina, consisting essentially of a mirror that reflects light into the eye and a central hole through which the eye is examined. An examination with an ophthalmoscope may show retinal veins that are enlarged or bleeding.

Oral:

Pertaining to the mouth; taken through or applied in the mouth (for example, oral medication).

Oral Administration:

Medications taken by mouth. This often means swallowing the medication, whether it comes in the form of a pill or a liquid.

Orally (Administered):

Medications taken by mouth. This often means swallowing the medication, whether it comes in the form of a pill or a liquid.

Oral Clearance:

Refers to the how fast the drug is removed (or cleared) from the body when it is administered orally. If a drug is administered intravenously, the amount of the original dose of the drug that reaches systemic circulation in an unchanged form (bioavailability) is 100%. But when it is administered orally the bioavailability is not necessarily known. So a method of calculating the clearance is done that does not depend on that, but rather is dependent on the rate of elimination of the drug from the body and the dose administered.

Oral Narrow Therapeutic Index:

When a drug, taken orally, has little difference between the amount that is therapeutic and the amount that becomes toxic, and so must be monitored closely.

Organelle:

A membrane-bound structure that is specialized to perform a distinct process within a cell. (From Latin, organella, literally ‘small organ’.)

Organic (Chemistry Definition):

Generally considered to be any member of a large class of gaseous, liquid, or solid chemical compounds that contains a significant amount of carbon.
(Additional Notes/Definitions: The word organic is historical, dating to the 1st century. For many centuries, Western alchemists believed in “vitalism”. This is the theory that certain compounds could be synthesized only from their classical elements—earth, water, air, and fire—by the action of a "life-force" (Latin: vis vitalis) that only organisms possessed. Vitalism taught that these "organic" compounds were fundamentally different from the "inorganic" compounds that could be obtained from the elements by chemical manipulation. Over the years scientific advance has included the ability to synthesize many of these organic compounds. However, scientific nomenclature retains the distinction between organic and inorganic compounds. The modern meaning of organic compound is any compound that contains a significant amount of carbon. But there is no single "official" definition of an organic compound. Some textbooks define an organic compound as one that contains one or more C-H bonds (Carbon-Hydrogen bonds). Others include C-C bonds (Carbon-Carbon bonds) in the definition. Others state that if a molecule contains carbon?it is organic. Even the broader definition of "carbon-containing molecules" requires the exclusion of carbon-containing alloys, including steel, and some other compounds. In summary, most carbon-containing compounds are organic, and almost all organic compounds contain at least a C-H bond or a C-C bond. Molecules are the smallest particles of a substance that retains the chemical and physical properties of the substance and is composed of two or more atoms; a group of like or different atoms held together by chemical forces. Atoms are the smallest basic unit and building block of matter.)

Organic Chemistry:

A branch of chemistry concerned with compounds of carbon, originally confined to compounds produced by living organisms but now extended to include man-made substances based on carbon. Organic compounds/substances are generally considered to be any member of a large class of gaseous, liquid, or solid chemical compounds that contains a significant amount of carbon. (Additional Notes/Definitions: The word organic is historical, dating to the 1st century. For many centuries, Western alchemists believed in “vitalism”. This is the theory that certain compounds could be synthesized only from their classical elements—earth, water, air, and fire—by the action of a "life-force" (Latin: vis vitalis) that only organisms possessed. Vitalism taught that these "organic" compounds were fundamentally different from the "inorganic" compounds that could be obtained from the elements by chemical manipulation. Over the years scientific advance has included the ability to synthesize many of these organic compounds. However, scientific nomenclature retains the distinction between organic and inorganic compounds. The modern meaning of organic compound is any compound that contains a significant amount of carbon. But there is no single "official" definition of an organic compound. Some textbooks define an organic compound as one that contains one or more C-H bonds (Carbon-Hydrogen bonds). Others include C-C bonds (Carbon-Carbon bonds) in the definition. Others state that if a molecule contains carbon?it is organic. Even the broader definition of "carbon-containing molecules" requires the exclusion of carbon-containing alloys (including steel), and some other compounds. In summary, most carbon-containing compounds are organic, and almost all organic compounds contain at least a C-H bond or a C-C bond. Molecules are the smallest particles of a substance that retains the chemical and physical properties of the substance and is composed of two or more atoms; a group of like or different atoms held together by chemical forces. Atoms are the smallest basic unit and building block of matter.)

Organic Compound:

Generally considered to be any member of a large class of gaseous, liquid, or solid chemical compounds that contains a significant amount of carbon.
(Additional Notes/Definitions: The word organic is historical, dating to the 1st century. For many centuries, Western alchemists believed in “vitalism”. This is the theory that certain compounds could be synthesized only from their classical elements—earth, water, air, and fire—by the action of a "life-force" (Latin: vis vitalis) that only organisms possessed. Vitalism taught that these "organic" compounds were fundamentally different from the "inorganic" compounds that could be obtained from the elements by chemical manipulation. Over the years scientific advance has included the ability to synthesize many of these organic compounds. However, scientific nomenclature retains the distinction between organic and inorganic compounds. The modern meaning of organic compound is any compound that contains a significant amount of carbon. But there is no single "official" definition of an organic compound. Some textbooks define an organic compound as one that contains one or more C-H bonds (Carbon-Hydrogen bonds). Others include C-C bonds (Carbon-Carbon bonds) in the definition. Others state that if a molecule contains carbon?it is organic. Even the broader definition of "carbon-containing molecules" requires the exclusion of carbon-containing alloys (including steel), and some other compounds. In summary, most carbon-containing compounds are organic, and almost all organic compounds contain at least a C-H bond or a C-C bond. Molecules are the smallest particles of a substance that retains the chemical and physical properties of the substance and is composed of two or more atoms; a group of like or different atoms held together by chemical forces. Atoms are the smallest basic unit and building block of matter.)

Organic Material (Organic Matter, Natural Organic Matter, NOM):

Matter composed of organic compounds that have come from the remains of organisms such as plants and animals and their waste products in the environment. (Additional Notes/Definitions: Organic compounds are chemical compounds that contain a significant amount of carbon. Historically, they were compounds that had been created by living organisms. Many have now been synthesized.)

Organic Matter: (Organic Material, Natural Organic Matter, NOM):

Matter composed of organic compounds that have come from the remains of organisms such as plants and animals and their waste products in the environment. (Additional Notes/Definitions: Organic compounds are chemical compounds that contain a significant amount of carbon. Historically, they were compounds that had been created by living organisms. Many have now been synthesized.)

Organogenesis:

The origin and development of organs and organ systems, especially during embryonic development (within the first three months of pregnancy in humans).

Oropharyngeal Pain:

Pain in the mouth and/or pharynx (the part of the airway into which the mouth leads).

ORR (Overall Response Rate):

A term used in clinical trials to specify how effective the therapy is.

OS (Overall Survival):

The percentage of people in a study or treatment group who are alive for a certain period of time after they were diagnosed with or treated for a disease, such as cancer.

OS % (Overall Survival Percentage):

The probability (listed as a percentage) of Overall Survival (OS) at any point in time. The percentage of people in a study or treatment group estimated to be alive at any point in time after they were diagnosed with or treated for a disease, such as cancer.

Overall Response Rate (ORR):

A term used in clinical trials to specify how effective the therapy is.

Overall Survival:

The percentage of people in a study or treatment group who are alive for a certain period of time after they were diagnosed with or treated for a disease, such as cancer.

Over-the-counter Drug/Medicine:

A drug or medicine that is sold without a prescription.

P (as in p<0.0001, p<0.05):

In statistics and probability, the letter "p" refers to probability, or the chance that something will happen randomly. When you flip a coin, you'd expect p = 0.5 for heads and p = 0.5 for tails. The lower the p-value, the more statistically valid are the results. In other words, the less likely that whatever results were obtained in a clinical trial of a drug/treatment would’ve occurred by chance, or to put it another way, the more likely that whatever results were obtained could be attributed to that drug/treatment. (p<0.05 indicates that the results are reliable, and p<0.0001 is even more so.)

Palpitations:

Noticeably rapid, strong, or irregular heartbeat due to agitation, exertion, or illness.

Pancreas:

A spongy, tube-shaped organ that is about 6 inches long and is located in the back of the abdomen, behind the liver and stomach. The pancreas makes pancreatic juices and hormones. The pancreatic juices contain enzymes that help digest food in the small intestine. The hormones include some that activate other organs in the body and insulin which regulates the amount of glucose (sugar) in the blood. The lack of insulin causes a form of diabetes. Both pancreatic enzymes and hormones are needed to keep the body working correctly.

Parasite:

An organism that lives off or in another organism, obtaining nourishment and protection while offering no benefit in return. An organism that lives in or on another organism (its host) and benefits by deriving nutrients at the host's expense.

Partial Response (PR):

The condition in which the decrease in the tumor is at least 50% but less than 100%. (Additional Notes/Definitions: A tumor is a swelling of a part of the body, generally without inflammation, caused by an abnormal growth of tissue, whether benign, non-cancerous, or malignant, cancerous, and able to spread to other tissue or parts of the body).

Pathway (Activation):

When a stimulus initiates a series of chemical reactions occurring within a cell. In each pathway, a principal chemical is modified by a series of chemical reactions. One example is the pathway that transmits a signal to activate B Cells. (Additional Notes/Definitions: Cells are the basic units of a living organism which can only be seen under a microscope. Cells are the building block of tissue as one brick is part of a brick wall. There are also cells with specialized functions in various other places in the body, such as the blood and other fluids. One example of this is B Cells which are one of the types of white blood cells in the immune system that defends against foreign substances and helps fight infection.)

Patient Counseling:

Providing medication information orally or in written form to the patient or their representative, or providing directions of use and storage of medications, advice on side effects, diet and     life-style modifications.

Patient Counseling Information:

Information to assist with providing medication information orally or in written form to the patient or their representative, or providing directions of use and storage of medications, advice on side effects, diet and life-style modifications.

Patient Information Leaflet (PIL):

A small flat or folded sheet of printed matter containing specific information about medical conditions, doses, side effects that are packed with medicines to give the user information about the product. PIL is the European version of the Package insert.

PBPK (Physiologically-Based Pharmacokinetic Models):

Models that approximate how the body metabolizes the drug, where this happens, often in the liver, and how the drug is eliminated from the body, by the kidneys through urine or the gastrointestinal/GI tract in stool or feces.
(Additional Notes/Definitions: To metabolize is to process by metabolism, the physical and chemical changes that occur in an organism to allow growth and maintain bodily functions, including processes that break down substances to yield energy and processes that build up other substances necessary for life. When drugs are metabolized, they are broken down and waste products eliminated. The liver is a large important organ in the abdomen that has many functions which include assisting with detoxification, digestion and metabolism. The kidneys are a pair of organs that are found on either side of the spine, just below the rib cage in the back, that perform the essential function of removing waste products from the blood and produce urine for excretion. The gastrointestinal (GI) tract is the entire digestive system and particularly the stomach and intestines.)

PCI-45227:

Biopharmaceutical companies will assign a number to their proprietary molecules for record keeping. PCI-45227 is an active metabolite of ibrutinib. When a drug undergoes metabolism, it is broken down and changed into various products called metabolites. A metabolite is a substance or compound produced as a result of metabolism or a metabolic reaction; a substance or compound that is involved in metabolism. An active metabolite is a product of the metabolism of a drug that retains therapeutic activity similar to the original drug. (Additional Notes/Definitions: Metabolism is a term used for all the physical and chemical changes that occur in an organism to allow growth and maintain body functions. These include processes that break down substances to yield energy and processes that build up other substances necessary for life. Molecules are the smallest particles of a substance that retains the chemical and physical properties of the substance and is composed of two or more atoms; a group of like or different atoms held together by chemical forces. Atoms are the smallest basic unit and building block of matter.)

Pediatric:

Pertaining to the health of children.

Percent:

The number of parts out of 100 of something. For example, a quarter (25 cents) is 25 percent of a dollar (100 cents). In the case where the total amount is not 100, it is calculated by dividing the number of parts you are referring to by the total number and then multiplying it by 100. For example if there were 111 patients that were part of the trial and 10 of them had a certain effect the percentage would be calculated as 10 ÷ 111 = .09 X 100 = 9%. (The symbol for percent is: %).

Peripheral Blood:

The blood in a person’s veins and arteries. (Additional Notes/Definitions: A vein is a blood vessel of varying size that carries blood to the heart after the cells have extracted the oxygen from the blood. An artery is a blood vessel that carries oxygen-rich blood from the heart to the body. A blood vessel is an elastic tube or passage in the body through which blood circulates.

Peripheral Blood Mononuclear Cells

: Mononuclear cells are a type of white blood cell (leukocytes, which include B Cells) with one (mono) round nucleus (in the center of the cell) that help defend the body against disease and infection. The term “peripheral blood” is used when these cells circulate in the blood. (Additional Notes/Definitions: Cells are the basic units of a living organism which can only be seen under a microscope. Cells are the building block of tissue as one brick is part of a brick wall. There are also cells with specialized functions in various other places in the body, such as the blood and other fluids. One example of this is B Cells which are one of the types of white blood cells in the immune system that defends against foreign substances and helps fight infection. The nucleus is a membrane-bound structure that contains the cell’s hereditary information and controls the cell’s growth and reproduction.)

Peripheral Edema:

Edema is a condition of abnormally large fluid volume in the circulatory system or in tissues between the body's cells. Peripheral edema is edema that is affecting the extremities; seen in heart disease.

Peripheral Neuropathy:

Disease, damage or dysfunction of one or more of the nerves outside of the brain and spinal cord. It can cause pain or loss of sensation, weakness, paralysis, loss of reflexes and other symptoms.

Persist:

Continue to exist; be prolonged.

Persistent:

Continuing to exist or endure over a prolonged period; continuance of a symptom or effect after the cause is removed.

Petechiae:

Unraised, round red spots under the skin caused by bleeding.

PFS (Progression-Free Survival):

The length of time during and after the treatment of a disease, such as cancer, that a patient lives with the disease but without it getting worse. In a clinical trial, measuring the progression-free survival is one way to see how well a new treatment works.

PFS %:

The probability (listed as a percentage) of Progression-Free Survival (PFS) at any point in time. PFS indicates the length of time during and after the treatment of a disease, such as cancer, that a patient lives with the disease but without it getting worse. In a clinical trial, measuring the progression-free survival is one way to see how well a new treatment works.

P-gp (Permeability GlycoProtein, also known as P-Glycoprotein abbreviated as P-gp or Pgp):

A protein found in the GI (gastrointestinal) tract (particularly the liver, pancreas and colon) that transports drugs into and out of cells and may have a role in drug resistance.
(Additional Notes/Definitions: Proteins not only make up the majority of cellular structures but carry out most of the chemical processes as well. The gastrointestinal (GI) tract is the entire digestive system and particularly the stomach and intestines. The liver is a large important organ in the abdomen that has many functions including detoxification, the creation of certain blood proteins, and many processes having to do with digestion and metabolism. The pancreas is a spongy, tube-shaped organ that is about 6 inches long and is located in the back of the abdomen, behind the liver and stomach. The pancreas makes pancreatic juices and hormones. The pancreatic juices contain enzymes that help digest food in the small intestine. An enzyme is a type of protein that increases the rates of chemical reactions inside and outside cells without itself being changed in the process. Almost all chemical reactions in a biological cell need enzymes in order to occur at rates sufficient for life. The hormones include some that activate other organs in the body and insulin which regulates the amount of glucose (sugar) in the blood. The lack of insulin causes a form of diabetes. Both pancreatic enzymes and hormones are needed to keep the body working correctly. The colon is the part of the large intestine that extends to the rectum. The long, coiled, tube-like organ that removes water from digested food. The remaining material, solid waste called stool, moves through the colon to the rectum and leaves the body through the anus. Cells are the basic units of a living organism which can only be seen under a microscope. Cells are the building block of tissue as one brick is part of a brick wall. There are also cells with specialized functions in various other places in the body, such as the blood and other fluids.)

P-gp Substrate:

A substance or chemical acted on and changed by P-gp in a chemical reaction and converted into different molecules, called products.
(Additional Notes/Definitions: P-gp: P-Glycoprotein (Permeability GlycoProtein, abbreviated as P-gp or Pgp) is a protein found in the GI (gastrointestinal) tract (liver, pancreas and colon) that transports drugs into and out of cells and may have a role in drug resistance. Proteins not only make up the majority of cellular structures but carry out most of the chemical processes as well. The gastrointestinal (GI) tract is the entire digestive system and particularly the stomach and intestines. The liver is a large important organ in the abdomen that has many functions including detoxification, the creation of certain blood proteins, and many processes having to do with digestion and metabolism. The pancreas is a spongy, tube-shaped organ that is about 6 inches long and is located in the back of the abdomen, behind the liver and stomach. The pancreas makes pancreatic juices and hormones. The pancreatic juices contain enzymes that help digest food in the small intestine. The hormones include some that activate other organs in the body and insulin which regulates the amount of glucose (sugar) in the blood. The lack of insulin causes a form of diabetes. Both pancreatic enzymes and hormones are needed to keep the body working correctly. The colon is the part of the large intestine that extends to the rectum. The long, coiled, tube-like organ that removes water from digested food. The remaining material, solid waste called stool, moves through the colon to the rectum and leaves the body through the anus. Cells are the basic units of a living organism which can only be seen under a microscope. Cells are the building block of tissue as one brick is part of a brick wall. There are also cells with specialized functions in various other places in the body, such as the blood and other fluids. Molecules are the smallest particles of a substance that retain the chemical and physical properties of the substance and is composed of two or more atoms; a group of like or different atoms held together by chemical forces. Atoms are the smallest basic units and building blocks of matter.)

Pharmacist:

A person who is professionally qualified to prepare and dispense medicinal drugs.

Pharmacodynamics (PD):

The study of how a drug affects the body. This includes determining the best dose and regimen for administering the drug and what the side effects might be at different doses. This information is an important part of the clinical trial process.

Pharmacokinetics (PK):

The study of how the body affects a drug by measuring levels of drug in your blood, urine, and/or stool. This includes determining how the body metabolizes the drug, how it excretes or gets rid of the drug and what the side effects might be at different doses. This information is an important part of the clinical trial process. (Additional Notes/Definitions: To metabolize is to undergo or be transformed by metabolism, which is all the physical and chemical changes that occur in an organism to allow growth and maintain body functions. Metabolism includes processes that break down substances to yield energy and processes that build up other substances necessary for life. Drugs are also metabolized, broken down and waste products eliminated.)

Pharmacology:

1. The science of drugs, including their composition, uses, and effects. 2. The characteristics or properties of a drug, especially those that make it medically effective.

Phase 1 Study:

Phase 1 includes the initial introduction of an investigational new drug into humans. These studies are closely monitored and may be conducted in patients, but are usually conducted in healthy volunteer subjects. These studies are designed to determine the metabolic and pharmacologic actions of the drug in humans, the side effects associated with increasing doses, and, if possible, to gain early evidence on effectiveness. (Additional Notes/Definitions: Metabolism includes all the physical and chemical changes that occur in an organism to allow growth and maintain body functions. These include processes that break down substances to yield energy and processes that build up other substances necessary for life. Drugs are also metabolized, broken down and waste products eliminated. Pharmacology is the science of drugs, including their composition, uses, and effects, and particularly the characteristics or properties of a drug that make it medically effective.)

Phase 2 Study:

Phase 2 includes the early controlled clinical studies conducted to obtain some preliminary data on the effectiveness of the drug for a particular indication or indications in patients with the disease or condition. This phase of testing also helps determine the common short-term side effects and risks associated with the drug. Phase 2 studies are typically well-controlled, closely monitored, and conducted in a relatively small number of patients.

Phase 3 Study:

Phase 3 studies are expanded controlled and uncontrolled trials. They are performed after preliminary evidence suggesting effectiveness of the drug has been obtained in Phase 2 (above), and are intended to gather the additional information about effectiveness and safety that is needed to evaluate the overall benefit-risk relationship of the drug. Phase 3 studies also provide an adequate basis for extrapolating the results to the general population and transmitting that information in the physician labeling. Phase 3 studies usually include more people than Phase 2.

Phase 4 Confirmatory Trials:

Clinical trials using endpoints that demonstrate clinical benefit. This is in relation to drugs that have been conditionally approved under the Accelerated Approval Program which allows faster approval of drugs for serious conditions that fill an unmet medical need. If the drug later proves unable to demonstrate clinical benefit in relation to risk to patients, the FDA may withdraw approval. (Additional Notes/Definitions: An endpoint in clinical trials is an event or outcome that can be measured objectively to determine whether the intervention being studied is beneficial. Endpoints of a clinical trial are usually included in the study objectives.)

Phenytoin:

An anticonvulsant drug used most commonly in the treatment of epilepsy and in the treatment of abnormal heart rhythms (arrhythmia). (Additional Notes/Definitions: Epilepsy is a disorder of the brain or nervous system that can cause people to suddenly become unconscious and to have violent, uncontrolled movements of the body.)

Physiologically-Based Pharmacokinetic (PBPK) Models:

Models that approximate how the body metabolizes the drug, where this happens, often in the liver, and how the drug is eliminated from the body, by the kidneys through urine or the gastrointestinal/GI tract in stool or feces.
(Additional Notes/Definitions: To metabolize is to undergo or be transformed by metabolism, which includes all the physical and chemical changes that occur in an organism to allow growth and maintain bodily functions, including processes that break down substances to yield energy and processes that build up other substances necessary for life. When drugs are metabolized, they are broken down and waste products eliminated. The liver is a large important organ in the abdomen that has many functions that assist with detoxification, digestion and metabolism, and the creation of certain blood proteins which help with transporting nourishment and blood clotting to help with healing in the case of injury. The kidneys are a pair of organs that are found on either side of the spine, just below the rib cage in the back, that perform the essential function of removing waste products from the blood and produce urine for excretion. The gastrointestinal (GI) tract is the entire digestive system and particularly the stomach and intestines.)

PIL (Patient Information Leaflet):

A small flat or folded sheet of printed matter containing specific information about medical conditions, doses, side effects that are packed with medicines to give the user information about the product. PIL is the European version of the Package Insert.

Pink or Brown Urine:

Indicates blood in the urine, and that there is very likely internal bleeding.

PK Data (Pharmacokinetic Data):

How the body affects a drug by measuring levels of drug in your blood, urine, and/or stool. This includes determining how the body metabolizes the drug, how it excretes or gets rid of the drug and what the side effects might be at different doses. This information is an important part of the clinical trial process.

Placebo:

A substance that has no therapeutic effect, used as a control in testing new drugs. For instance, some people in a study might be given a new drug. Others would get a placebo. None of the people in the study will be informed if they got the real treatment or the placebo. Researchers then compare the effects of the drug and the placebo on the people in the study. That way, they can determine the effectiveness of the new drug and check for side effects.

Plasma:

The clear, protein-rich fluid which is left behind when the blood cells are removed from the blood. (Additional Notes/Definitions: Proteins not only make up the majority of cellular structures but carry out most of the chemical processes as well. Cells are the basic units of a living organism which can only be seen under a microscope. Cells are the building block of tissue as one brick is part of a brick wall. There are also cells with specialized functions in various other places in the body, such as the blood and other fluids.)

Plasma Cell:

A key part of the immune system whose role it is to produce antibodies which help fight infections and harmful substances that get into the body. Plasma cells stem from a type of white blood cell called B cells, which are generated in the bone marrow, the spongy material inside our larger bones. Some of the B cells become activated and develop into plasma cells which then circulate in the blood and create and antibodies which are proteins specifically designed to fight infectious or harmful substances such as bacteria. As with most cell types, plasma cells can mutate to give rise to cancer. One of these is Waldenstrom macroglobulinemia, Plasma cells are also known as plasmacytes. (Additional Notes/Definitions: Plasma is the clear, protein-rich fluid which is left behind when the blood cells are removed from the blood. Proteins not only make up the majority of cellular structures but carry out most of the chemical processes as well. Cells are the basic units of a living organism which can only be seen under a microscope. Cells are the building block of tissue as one brick is part of a brick wall. There are also cells with specialized functions in various other places in the body, such as the blood and other fluids.)

Plasma Concentrations:

This defines how much of the drug is in your blood. (Additional Notes/Definitions: Plasma is the clear, protein-rich fluid which is left behind when the blood cells are removed from the blood. Proteins not only make up the majority of cellular structures but carry out most of the chemical processes as well. Cells are the basic units of a living organism which can only be seen under a microscope. Cells are the building block of tissue as one brick is part of a brick wall. There are also cells with specialized functions in various other places in the body, such as the blood and other fluids.)

Plasmapheresis:

A procedure in which whole blood is taken from a person and separated into plasma and blood cells with a centrifuge; the plasma is removed and replaced with another solution, such as saline solution, albumin, or specially prepared donor plasma; and the reconstituted solution is then returned to the patient. Plasmapheresis is used in the treatment of many different conditions, including autoimmune disorders. When the plasma is removed, it takes with it the antibodies that have been developed against self-tissue in an attempt to reduce the attack on the patient's own body. This procedure can also be utilized with Waldenström’s Macroglobulinemia because one of the characteristics is a thickening of the blood caused by excess production of a specific antibody. Plasmapheresis carries with it the same risks as any intravenous procedure but is otherwise generally safe. (Additional Noted/Definitions: Plasma is the clear, protein-rich fluid which is left behind when the blood cells are removed from the blood. Proteins not only make up the majority of cellular structures but carry out most of the chemical processes as well. Cells are the basic units of a living organism which can only be seen under a microscope. Cells are the building block of tissue as one brick is part of a brick wall. There are also cells with specialized functions in various other places in the body, such as the blood and other fluids. An antibody is a protein produced by the body's immune system in response to foreign substances that are perceived as threats. Certain white blood cells, called B Cells, and are key components of the immune system. Some of our B cells turn into specialized cells called plasma cells whose role it is to produce specific proteins called antibodies which help the body fight infections and harmful foreign substances.)

Plasma Protein:

Plasma proteins are proteins found in the blood plasma, the clear, protein-rich fluid which is left behind when the blood cells are remove from the blood. . (Additional Notes/Definitions: Proteins not only make up the majority of cellular structures but carry out most of the chemical processes as well. Cells are the basic units of a living organism which can only be seen under a microscope. Cells are the building block of tissue as one brick is part of a brick wall. There are also cells with specialized functions in various other places in the body, such as the blood and other fluids.)

Platelets:

A type of blood cell that is disc-shaped which allows it to get caught on openings in veins, such as from a cut, causing or allowing a blood clot to form in order to control or stop bleeding. They are formed in the bone marrow and then circulate in the blood. They are often called cell fragments because they do not have a definite nucleus. (Additional Notes/Definitions: Cells are the basic units of a living organism which can only be seen under a microscope. Cells are the building block of tissue as one brick is part of a brick wall. There are also cells with specialized functions in various other places in the body, such as the blood and other fluids. A vein is a blood vessel of varying size that carries blood to the heart after the cells have extracted the oxygen from the blood. A blood vessel is an elastic tube or passage in the body through which blood circulates. Bone marrow is the spongy tissue occupying the hollow central cavity of bones. It contains immature blood-forming stem cells which develop into the different types of blood cells. The nucleus is a membrane-bound structure that contains the cell’s hereditary information and controls the cell’s growth and reproduction.)

Pneumonia:

An acute or chronic disease marked by inflammation of the lungs and caused by viruses, bacteria, or other microorganisms and sometimes by physical and chemical irritants.
(Additional Notes/Definitions: Bacteria are microscopic organisms or microorganisms (organisms that are so small as to be visible only with a microscope), some of which may cause illness. A virus is a small infectious agent that replicates only inside the living cells of other organisms. Viruses can infect all types of life forms and are even smaller than bacteria and cannot be seen with a normal light microscope.)

Poisoning:

The condition produced by a poison or by a toxic substance which tends to destroy life or impair health.

Polyps:

An abnormal growth of tissue projecting from a mucous membrane. They are typically benign (non-cancerous) and generally small and often attached to the surface by a narrow elongated stalk. Polyps are commonly found in the colon (or large intestine), stomach, nose, sinuses, urinary bladder and uterus. They may also occur elsewhere in the body where mucous membranes exist, such as the vocal cords or small intestine. (Additional Notes/Definitions: Tissue is a part of the body of a living thing that is made of similar cells. Cells are the basic units of a living organism which can only be seen under a microscope. Cells are the building block of tissue as one brick is part of a brick wall. There are also cells with specialized functions in various other places in the body, such as the blood and other fluids. A mucous lining/membrane is a mucus-secreting membrane lining all bodily passages that are open to the air, as of the digestive and respiratory tracts. A membrane is a thin, soft, pliable sheet or layer, especially of animal or vegetable tissue, serving as a covering or lining, as for an organ or cell. Cancer is a term used for diseases in which abnormal cells divide without control and are able to spread and invade other parts of the body. Benign, non-cancerous, means not having the tendency or ability to invade neighboring tissues, create new tumors or spread to other parts of the body. The colon is the long, coiled, tube-like organ that removes water from digested food. The remaining material, solid waste called stool, moves through the colon to the rectum and leaves the body through the anus. Also known as large bowel and large intestine. The uterus is the organ in the lower body of a woman or female mammal where offspring are conceived and in which they gestate before birth; the womb.)

Populations (Specific):

In clinical trials this usually refers to the patients with specific conditions that can only be allowed to participate in a study.

Posaconazole:

A medication used to prevent serious fungal infections in people with a weakened ability to fight infection. Trade name: Noxafil®
(Additional Notes/Definitions: A fungus is an organism that feeds on organic matter. Some fungi can cause infections. Athlete’s foot is an example of a fungus. Yeast is a microscopic fungus (one that is so small it can only be viewed using a microscope) consisting of single oval cells that reproduce by budding or fission (splitting), and are capable of converting sugar into alcohol and carbon dioxide. Yeasts include forms such as candida that can cause disease.)

Post-Implantation Loss:

A loss of the embryo after the point in which a fertilized egg had been implanted in the uterine lining (i.e. a miscarriage). (Additional Notes/Definitions: An embryo is a human or animal in the early stages of development before it is born, hatched, etc. In humans, it is from the point of conception through the eighth week of development.)

Post-Approval Use:

The period after a drug has been approved for specific uses or indications, and in particular, the data collected through various channels after a drug has been licensed for public use, designed to provide information on use and on occurrence of side effects, adverse effects, etc.

Post-Marketing Experience:

Data collected through various channels after a drug has been licensed for public use, designed to provide information on use and on occurrence of side effects, adverse effects, etc.

Post-Marketing (PM) Surveillance:

Procedure implemented after a drug has been licensed for public use, designed to provide information on use and on occurrence of side effects, adverse effects, etc.

Post-Procedural Hemorrhage:

Bleeding in a fast and uncontrolled way following a medical procedure, such as an operation. The bleeding may be internal (inside the body) or external (outside the body).

Potential:

Having or showing the capacity to become or develop into something in the future.

PR (Partial Response):

The condition in which the decrease in the tumor is at least 50% but less than 100%. (Additional Notes/Definitions: A tumor is a swelling of a part of the body, generally without inflammation, caused by an abnormal growth of tissue, whether benign (non-cancerous) or malignant (cancerous and able to spread to other tissue or parts of the body).

Practically Insoluble:

Not dissolving easily in a liquid; not able to be dissolved well in another substance. More specifically, practically insoluble refers to needing greater than 10,000ml of a specific liquid to dissolve 1g of a particular substance (e.g., ibrutinib is practically insoluble in water).

Practice/In Practice:

The actual application or use of an idea, belief, or method especially in the carrying out or exercise of a profession, such as that of a doctor.

Pre and Post-Surgery:

Before and after surgery, often referring to the amount of time before and after surgery.

Pregnancy Category D:

There is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience or studies in humans, but the potential benefits from the use of the drug in pregnant women may be acceptable despite its potential risks (for example, if the drug is needed in a life-threatening situation or serious disease for which safer drugs cannot be used or are ineffective).

Pregnancy Categories (per FDA, US Food and Drug Administration):

Category A: Adequate and well-controlled (AWC) studies in pregnant women have failed to demonstrate a risk to the fetus in the first trimester of pregnancy (and there is no evidence of a risk in later trimesters).
Category B: Animal reproduction studies have failed to demonstrate a risk to the fetus and there are no AWC studies in humans, AND the benefits from the use of the drug in pregnant women may be acceptable despite its potential risks. OR animal studies have not been conducted and there are no AWC studies in humans.
Category C: Animal reproduction studies have shown an adverse effect on the fetus, there are no AWC studies in humans, AND the benefits from the use of the drug in pregnant women may be acceptable despite its potential risks. OR animal studies have not been conducted and there are no AWC in humans.
Category D: There is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience or studies in humans, BUT the potential benefits from the use of the drug in pregnant women may be acceptable despite its potential risks (for example, if the drug is needed in a life-threatening situation or serious disease for which safer drugs cannot be used or are ineffective).
Category X: Studies in animals or humans have demonstrated fetal abnormalities OR there is positive evidence of fetal risk based on adverse reaction reports from investigational or marketing experience, or both, AND the risk of the use of the drug in a pregnant woman clearly outweighs any possible benefit (for example, safer drugs or other forms of therapy are available).

Preliminary PK Data:

Preliminary or initial data on what the body does to the drug. “PK” stands for Pharmacokinetics, a study of what the body does to the drug.

Prescribing Information:

A package insert or prescribing information is a document provided along with a prescription medication to provide additional information about that drug.

Prescription Medicines:

Medicines that are allowed to be taken with a specific direction, prescription, from a doctor, usually written.

Primary Endpoint:

The main objective of a clinical study. (Additional Notes/Definitions: A clinical trial/clinical study is a type of research study that tests how well new medical approaches work in human beings. These studies follow a defined plan to determine the risks and benefits of a given therapy and test new methods of screening, prevention, diagnosis, or treatment of a disease.)

Prior Therapy:

Any therapy that has been used previously for the same illness. With cancer this could often include chemotherapy or radiation therapy. (Additional Notes/Definitions: Chemotherapy is the treatment of diseases, infections or other disorders by the use of chemical substances, especially the treatment of cancer by use of powerful drugs that kill cells (cytotoxic), especially intended to kill fast-growing cells. Radiation Therapy is a cancer therapy that uses high-energy radiation to kill cancer cells by damaging their ability to reproduce by damaging their DNA (Deoxyribonucleic Acid), DNA contains the genetic instructions (blueprint) used in the development and functioning of all known living organisms. Controlled amounts of radiation are also used for the treatment of diseases such as cancer, but radiation is a type of dangerous and powerful energy that is produced by radioactive substances and nuclear reactions, Radiation therapy can damage normal cells as well as cancer cells. The radiation used for cancer treatment may come from a machine outside the body, or it may come from radioactive material placed in the body near tumor cells or injected into the bloodstream.

Procedural Complications:

In medicine, an unanticipated problem that arises following, and is a result of, a medical procedure, treatment, or illness.

Progression:

In the context of disease progression, in relation to cancer, when it continues to grow, spread or become more severe.

Progression-Free Survival (PFS):

The length of time during and after the treatment of a disease, such as cancer, that a patient lives with the disease but without it getting worse. In a clinical trial, measuring the progression-free survival is one way to see how well a new treatment works.

Progressive Multifocal Leukoencephalopathy (PML):

A rare and usually fatal viral disease characterized by progressive damage (-pathy) or inflammation of the white matter (leuko-) of the brain (-encephalo-) at multiple locations (multifocal). PML is sometimes associated with AIDS and certain cancers. (Additional Notes/Definitions: Cancer is a term used for diseases in which abnormal cells divide without control and are able to spread and invade other parts of the body. Cells are the basic units of living organisms which can only be seen under a microscope. The body is made up of many types of cells, making up structures like tissues and nerves, circulating in the blood & bodily fluids, etc. Tissues are part of the body of a living thing that is made of similar cells.)

Proliferation:

The growth and reproduction of similar cells, which could be cancerous cells or tumors.

Prolonged (Bleeding):

(Bleeding) that is continuing for a long time or longer than usual; lengthy.

Protein:

Proteins are the true workhorses of the body. In addition to making up the majority of cellular structures, they carry out most of the chemical processes that are vital to living organisms as well. Proteins are complex structures built of amino acids which are molecules that are linked together in various combinations to make up the long molecular chains that are proteins. (Additional Notes/Definitions: A molecule is the smallest particle of a substance that retains the chemical and physical properties of the substance and is composed of two or more atoms; a group of like or different atoms held together by chemical forces. Atoms are the smallest basic unit and building block of matter.)

Pruritus:

Severe itching of the skin, as a symptom of various ailments. It can result from drug reaction, food allergy, kidney or liver disease, cancers, parasites, aging or dry skin, contact skin reaction, such as poison ivy, and for unknown reasons.

Psychiatric Disorders:

Any pattern of psychological or behavioral symptoms that causes an individual significant distress, impairs their ability to function in life, and/or significantly increases their risk of death, pain, disability, or loss of freedom. In addition, to be considered a psychiatric disorder, the symptoms must be more than an expected response to a particular event (e.g., normal grief after the loss of a loved one would not be considered a psychiatric disorder).

Purpura:

Refers to purple spots on the skin, resulting from the frequent bleeding and bruising that can be a symptom of Waldenstroem's Macroglobulinemia (WM). Because of this WM is sometimes called Waldenstrom's purpura.

Pyrexia:

A fever; An abnormally high body temperature, usually accompanied by shivering, headache, and in severe instances, delirium. Normal body temperatures vary depending on many factors, including age, sex, time of day, ambient temperature, activity level, and more. But a body temperature reading over 37.5 °C (99.5°F) would often be considered a fever or pyrexia.

Radiation:

A type of dangerous and powerful energy that is produced by radioactive substances and nuclear reactions. Additionally, there is a use of controlled amounts of radiation for the treatment of diseases (such as cancer).

Radiation Therapy:

The treatment of disease, especially cancer, using X-rays or similar forms of radiation. Radiation therapy uses high-energy radiation to kill cancer cells by damaging their DNA (the molecules inside cells that carry genetic information and pass it from one generation to the next). Cancer cells whose DNA is damaged beyond repair stop dividing or die. When the damaged cells die, they are broken down and eliminated by the body’s natural processes. Radiation therapy can damage normal cells as well as cancer cells. Therefore, treatment must be carefully planned to minimize side effects. The radiation used for cancer treatment may come from a machine outside the body, or it may come from radioactive material placed in the body near tumor cells or injected into the bloodstream. A patient may receive radiation therapy before, during, or after surgery, depending on the type of cancer being treated. Some patients receive radiation therapy alone, and some receive radiation therapy in combination with chemotherapy. (Additional Notes/Definitions: Radiation is a type of dangerous and powerful energy that is produced by radioactive substances and nuclear reactions. This must be considered even when controlled amounts of radiation for the treatment of diseases (such as cancer).

Radioactivity:

Emission of radiation (highly energetic particles), or the amount of radiation emitted. (Additional Notes/Definitions: Radiation is a type of dangerous and powerful energy that is produced by radioactive substances and nuclear reactions. However, there is a use of controlled amounts of radiation for the treatment of diseases (such as cancer). And there is a use of low levels to mark and track certain substances in drug research and discovery in order to determine the pathway that a drug follows and the major changes it goes through as it metabolizes in the body. The technique is called carbon labeling: carbon 14 atoms (which are radioactive) can be used to replace nonradioactive carbon in a compound or drug (for example, ibrutinib) in order to trace reactions and pathways. One way to trace it or view it is with x-rays. The doses of carbon 14 utilized are very small with reportedly little or no radiation risks

Radiolabel:

To incorporate an element that is radioactive into a compound to tag or mark it so it can be traced. A common choice is to replace a carbon atom with a form of carbon known as Carbon 14. Often it is able to be viewed with x-rays. (Additional Notes/Definitions: Radioactive means that the substance emits radiation, which are highly energetic particles. Radiation can be a type of dangerous and powerful energy that is produced by radioactive substances and nuclear reactions. Radiation can also be used for the treatment of diseases, such as cancer. And there is also the use of controlled amounts of radiation such as in the use of tagging substances including drugs so as to be able to trace them. In this last case the level of radiation is considered safe.)

Radiologist:

A radiologist is a doctor who specializes in the interpretation of x-rays and other medical images. (Additional Notes/Definitions: X Ray: noun 1. An electromagnetic wave of high energy and very short wavelength, which is able to pass through many materials that visible light will not penetrate. X-rays can produce images of the structures inside your body — particularly your bones. X-ray beams can pass through your body, but they are absorbed in different amounts depending on the density of the material they pass through. Dense materials, such as bone and metal, show up as white on X-rays. The air in your lungs shows up as black. Fat and muscle appear as varying shades of gray. For some types of X-ray tests, a contrast medium — such as iodine or barium — is introduced into your body to provide greater detail on the X-ray images. 2. A photographic or digital image of the internal composition of something, especially a part of the body, produced by X-rays being passed through it and being absorbed to different degrees by the different materials. verb 1. Photograph or examine with X-rays. Electromagnetic waves are waves that contain an electric field and a magnetic field and carry energy resulting from the acceleration of an electric charge. They travel at the speed of light and exhibit a wide range of frequencies. A frequency range of electromagnetic waves includes visible light but it is only one small portion of the full spectrum.)

Randomized:

Selected at random for some purpose.

Randomized Control Trial:

A study in which the participants are assigned by chance to separate groups that compare the treatment in question with a control group receiving placebo or another previously tested treatment. Neither the researchers nor the participants can choose which group. The demonstration of efficacy of a new treatment is based on comparing the response in the treated group with that of a control group. (Additional Notes/Definitions: A placebo is a substance that has no therapeutic effect, used as a control in testing new drugs. For instance, some people in a study might be given a new drug. Others would get a placebo. None of the people in the study will be informed if they got the real treatment or the placebo. Researchers then compare the effects of the drug and the placebo on the people in the study. That way, they can determine the effectiveness of the new drug and check for side effects.)

Randomized Clinical Trial:

A study in which the participants are assigned by chance to separate groups that compare different treatments; neither the researchers nor the participants can choose which group. Using chance to assign people to a particular group means, that the groups will not be preselected or the assignments influenced, and that the treatments they receive can be compared objectively. At the time of the trial, it is not known which treatment is best. It is the patient’s choice whether or not they will participate in a randomized trial.

Range:

The area of variation between upper and lower limits on a particular scale.

Rash:

An eruption or outbreak on the skin’s surface that is often red and itchy. A simple rash is called dermatitis, meaning inflammation of the skin.

Receptor

: A structure on the surface of a cell (or inside a cell) that selectively receives and binds to a specific substance. There are many receptors. (Additional Notes/Definitions: More specific to IMBRUVICA, the receptors are on B cells which are one of the types of white blood cells in the immune system that defend against foreign substances such as a chemical, bacteria or virus, and help fight infection. They do this by recognizing these foreign substances through the use of receptors (BCRs) on the surface of their cell membranes, and then making and releasing anti-bodies which defend against to these foreign substances called antigens (short for anti-body generator). A receptor is a complex protein with a structure that matches the shape of the antigen to which it is specific, much like a lock and key. Proteins not only make up the majority of cellular structures but carry out most of the chemical processes as well. When an antigen engages (binds to) the BCR it causes the B cell to grow and develop, and create and release antibodies. Engaging the BCR is also known as “activating” the BCR.)

Recur:

Occur again, periodically, or repeatedly.

Recurrent:

Returning after remission, a disease symptom that returns periodically. (Additional Notes/Definitions: A remission is a disappearance of signs and symptoms of disease. A remission is a temporary end to the medical signs and symptoms of a disease that has not been cured.)

Red Blood Cell:

Specialized cells normally found circulating in the blood. Red blood cells transport oxygen from the lungs to the cells and tissues of the body and carbon dioxide back to the lungs so it can be exhaled. Red blood cells contain a special protein called hemoglobin which binds with oxygen. In addition to transporting oxygen, the large number of red blood cells give blood its characteristic red color due to the hemoglobin which contains iron which turns red when combined with oxygen. Red blood cells begin their life as stem cells, which are the immature cells created in the bone marrow that can develop, differentiate, and mature into three main types of cells—one of these being red blood cells (see blood cells if data on the other two types of blood cells is needed). (Additional Notes/Definitions: Cells are the basic units of a living organism which can only be seen under a microscope. In addition to those that are the building block of tissue there are cells with specialized functions in various other places in the body, such as the blood and other fluids. Bone marrow is the spongy tissue occupying the hollow central cavity of bones. There are two types of bone marrow. Red bone marrow contains tissue that is responsible for the formation and development of most of the blood cells – approximately 500 billion per day. Red blood cells contain a special protein called hemoglobin, which helps carry oxygen from the lungs to the rest of the body and then returns carbon dioxide from the body to the lungs so it can be exhaled. Blood appears red because of the large number of red blood cells, which get their color from the hemoglobin which contains iron which turns red when combined with oxygen. Proteins not only make up most of the cellular structures of the body but also help carry out most of the chemical reactions that are vital to a living organism.

Red Blood Cell Count:

A blood test that can provide information about how many red blood cells are in a person's blood. One main function of red blood cells is to transport oxygen to the cells and tissues. (Additional Notes/Definitions: Cells are the basic units of a living organism which can only be seen under a microscope. Cells are the building block of tissue as one brick is part of a brick wall. There are also cells with specialized functions in various other places in the body, such as the blood and other fluids.)

Reflect:

1. Represent something in a faithful or appropriate way; reproduce; show; be the same or correspond to. 2. (Of a surface or body) cast or throw back (heat, light, or sound) without absorbing it.

Regimen:

A treatment plan that specifies the dosage, the schedule, and the duration of treatment.

Remission:

Disappearance of signs and symptoms of disease. A remission is a temporary end to the medical signs and symptoms of a disease that has not been cured.

Renal:

Pertaining to the kidney, of or in the region of the kidneys. (Additional Notes/Definitions: The kidneys are a pair of organs that are found on either side of the spine, just below the rib cage in the back. The kidneys perform the essential function of removing waste products from the blood and produce urine for excretion.) 

Renal Failure:

Partial or complete loss of the function of a kidney or kidneys. (Additional Notes/Definitions: The kidneys are a pair of organs that are found on either side of the spine, just below the rib cage in the back. The kidneys perform the essential function of removing waste products from the blood and produce urine for excretion. Partial or complete loss of the function of a kidney or kidneys can create a critical situation where these waste products are not being sufficiently removed which is toxic for the body.)

Renal Impairment:

Partial or complete loss of the function of a kidney or kidneys. Partial or complete loss of the function of a kidney or kidneys. (Additional Notes/Definitions: The kidneys are a pair of organs that are found on either side of the spine, just below the rib cage in the back. The kidneys perform the essential function of removing waste products from the blood and produce urine for excretion. Partial or complete loss of the function of a kidney or kidneys can create a critical situation where these waste products are not being sufficiently removed which is toxic for the body.)

Renal Toxicity:

The term renal pertains to the kidney, of or in the region of the kidneys.
(Additional Notes/Definitions: The kidneys are a pair of organs that are found on either side of the spine, just below the rib cage in the back. The kidneys perform the essential function of removing waste products from the blood. Partial or complete loss of the function of a kidney or kidneys can create a critical situation where these waste products are not being sufficiently removed which is toxic for the body.)

Reproductive Organs:

The group of organs, including the testes, ovaries, and uterus, whose purpose is to produce a new individual and continue the species. (Additional Notes/Definitions: The testes are the male sex glands, located behind the penis in a pouch of skin called the scrotum. The testes produce and store sperm and are also the body's main source of male hormones, such as testosterone. These hormones control the development of the reproductive organs and other male characteristics, such as body and facial hair, low voice, and wide shoulders. The singular form is testis, also known as testicle. Ovaries are a pair of female reproductive organs located in the pelvis, one on each side of the uterus. Each ovary is about the size and shape of an almond. The ovaries produce eggs (ova) and female hormones. The singular form is ovary. The uterus is the organ in the lower body of a woman or female mammal where offspring are conceived and in which they gestate before birth; the womb.)

Reproductive Potential:

Physically capable of producing new life or offspring; able to have babies.

Respectively:

Separately or individually and in the order already mentioned (used when enumerating two or more items or facts that refer back to a previous statement).

Respiratory:

Of or relating to respiration, which is the act or process of breathing and includes various processes that lead to and include the exchange of oxygen and carbon dioxide between the atmosphere and the body cells.

Respiratory Tract:

The passage formed by the mouth, nose, throat, and lungs, through which air passes during breathing.

Response:

1. A description of how cancer has responded to treatment. 2. Any behavior of a living organism that results from an external or internal stimulus.

Response Criteria in Waldenström’s Macroglobulinemia (WM):

Complete Response (CR):
Absence of serum monoclonal IgM protein by immunofixation
Normal serum IgM level
Complete resolution of lymphadenopathy and splenomegaly if present at baseline
Morphologically normal bone marrow aspirate and trephine biopsy
Very Good Partial Response (VGPR):
Monoclonal IgM protein is detectable
≥ 90% reduction in serum IgM level from baseline
Decreased lymphadenopathy/splenomegaly if present at baseline
No new signs or symptoms of active disease
Partial Response (PR):
Monoclonal IgM protein is detectable
≥ 50% but <90% reduction in serum IgM level from baseline
Decreased lymphadenopathy/splenomegaly if present at baseline
No new signs or symptoms of active disease
Minor Response (MR): Monoclonal IgM protein is detectable
≥ 25% but <50% reduction in serum IgM level from baseline
No new signs or symptoms of active disease
Stable Disease (SD): Monoclonal IgM protein is detectable
< 25% reduction and < 25% increase in serum IgM level from baseline
No progression in lymphadenopathy/splenomegaly
No new signs or symptoms of active disease
Progressive Disease (PD):
≥ 25% increase in serum IgM level from lowest nadir and/or
Progression in clinical features attributable to the disease

Response rate:

The percentage of patients whose cancer shrinks or disappears after treatment.

Response rate (CR+VGPR+PR), (%):

The percentage of patients whose cancer shrinks or disappears after treatment. (CR = Complete Response, VGPR = Very Good Partial Response, PR = Partial Response.)

Retinal Eye Examination:

An examination with an ophthalmoscope may show retinal veins that are enlarged or bleeding. An ophthalmoscope is an instrument for examining the interior structures of the eye, especially the retina, consisting essentially of a mirror that reflects light into the eye and a central hole through which the eye is examined.

Reversible Binding:

A reversible combination, one that can be undone, of various drugs with body components such as proteins. (Additional Notes/Definitions: Proteins not only make up the majority of cellular structures but carry out most of the chemical processes as well. Binding is when a chemical bond is created. It is critical for many of the chemical processes that are vital for life. Generally, the ability to bind is dependent on the shape and chemical nature of the two substances.)

Rifampin:

A reddish-brown antibiotic used chiefly to treat tuberculosis and leprosy. Brand Name: Rifadin® IV. (Additional Notes/Definitions: Antibiotics are medications that are used to treat infections caused by bacteria and are typically natural products or modified versions of natural products that either kill or slow the growth of bacteria. Bacteria are microscopic organisms (organisms that are so small as to be visible only with a microscope), some of which may cause illness. Tuberculosis, commonly known as TB, is a contagious and an often severe airborne disease caused by a bacterial infection. It is characterized by the growth of nodules (tubercles) in the tissues. TB typically affects the lungs, but it also may affect any other organ of the body. Leprosy is a contagious disease that has been known since biblical times. It affects the skin, mucous membranes, and nerves, causing discoloration and lumps on the skin and, in severe cases, disfigurement and deformities. If not treated it will get worse over time. Leprosy is now mainly confined to tropical Africa and Asia, with about 60% of new cases occurring in India.)

Ritonavir:

An oral medication that is used for treating infections with the human immunodeficiency virus (HIV). Brand Name: Norvir®, Norvir® Soft Gelatin.

Saquinavir:

An oral medication that is used for treating infections with the human immunodeficiency virus (HIV). Brand Name: Invirase®, Fortovase®.

Sarcoma:

Cancer that begins in bone, cartilage, fat, muscle, blood vessels, or other connective or supportive tissue. (Additional Notes/Definitions: Cancer is a term used for diseases in which abnormal cells divide without control and are able to spread and invade other parts of the body.)

Screening:

Examination of a group to separate physically well persons from those who have an undiagnosed condition or who are at high risk.

Second Malignancy:

A new cancer or tumor that is different from the original cancer that was being treated. (Additional Notes/Definitions: Cancer is a term used for diseases in which abnormal cells divide without control and are able to spread and invade other parts of the body. Cells are the basic units of living organisms which can only be seen under a microscope. The body is made up of many types of cells, making up structures like tissues and nerves, circulating in the blood & bodily fluids, etc. Tissues are part of the body of a living thing that is made of similar cells. A tumor is a swelling of a part of the body, generally without inflammation, caused by an abnormal growth of tissue, whether benign, non-cancerous, or malignant, cancerous and able to spread to other tissue or parts of the body.)

Second Primary Cancer/Malignancy:

A new cancer or tumor that is different from the original cancer that was being treated. (Additional Notes/Definitions: Cancer is a term used for diseases in which abnormal cells divide without control and are able to spread and invade other parts of the body. Cells are the basic units of living organisms which can only be seen under a microscope. The body is made up of many types of cells, making up structures like tissues and nerves, circulating in the blood & bodily fluids, etc. Tissues are part of the body of a living thing that is made of similar cells. A tumor is a swelling of a part of the body, generally without inflammation, caused by an abnormal growth of tissue, whether benign, non-cancerous, or malignant, cancerous and able to spread to other tissue or parts of the body.)

Second Primary Malignancy/Cancer:

A new cancer or tumor that is different from the original cancer that was being treated. (Additional Notes/Definitions: Cancer is a term used for diseases in which abnormal cells divide without control and are able to spread and invade other parts of the body. Cells are the basic units of living organisms which can only be seen under a microscope. The body is made up of many types of cells, making up structures like tissues and nerves, circulating in the blood & bodily fluids, etc. Tissues are part of the body of a living thing that is made of similar cells. A tumor is a swelling of a part of the body, generally without inflammation, caused by an abnormal growth of tissue, whether benign, non-cancerous, or malignant, cancerous and able to spread to other tissue or parts of the body.)

Sequential Design Trial:

Clinical Trials where there are multiple trials in one; if the first part of a trial is successful, it meets the primary endpoint or objective, i.e., safety, then the second part of the trial is done. This type of trial design means fewer patients are needed to get information. (Additional Notes/Definitions: A Clinical Trial/Clinical Study is a type of research study that tests how well new medical approaches work in human beings. These studies follow a defined plan to determine the risks and benefits of a given therapy and test new methods of screening, prevention, diagnosis, or treatment of a disease. An endpoint in clinical trials refers to an event or outcome that can be measured objectively to determine whether the intervention being studied is beneficial. Endpoints of a clinical trial are usually included in the study objectives.)

Serum:

Used to describe substances that are in the liquid part of the blood. Serum is the clear yellowish fluid obtained upon separating whole blood into its solid and liquid components after it has been allowed to clot (which facilitates the removal of these clotting factors). It is blood plasma with the clotting factors removed. Also called blood serum. (Additional Notes/Definitions: Plasma is the clear, protein-rich fluid which is left behind when the blood cells are removed from the blood. Proteins not only make up the majority of cellular structures but carry out most of the chemical processes as well. Cells are the basic units of a living organism which can only be seen under a microscope. Cells are the building block of tissue as one brick is part of a brick wall. There are also cells with specialized functions in various other places in the body, such as the blood and other fluids. Clotting factors are any of a number of substances in blood plasma that are involved in the clotting process.)

Serum Aspartate Transaminase (AST/ASAT):

An enzyme found in the blood or serum (liquid part of the blood) that can be used to test for heart or liver damage. AST is normally present in body tissues, especially in the heart and liver, but is released into the blood as the result of tissue injury. Hence an increase of levels in the blood may indicate a heart attack or liver damage. (Also known as AspAT/AAT or an earlier name for the same enzyme, SGOT, which stands for serum glutamic oxaloacetic transaminase.) (Additional Notes/Definitions: An enzyme lowers the energy level required to activate or initiate chemical reactions and thereby increases the rates of these reactions, vital for living organisms. Enzymes are key for metabolism which is all of the chemical processes within a living organism that are necessary for the maintenance of life. The liver is a large important organ in the abdomen that has many functions including detoxification, the creation of certain blood proteins, and many processes having to do with digestion and metabolism. Specific to drug therapy, this includes a key function of helping to metabolize (break down and excrete) drugs or medications.)

Serum Globulin Electrophoresis:

A lab test that measures the levels of proteins called globulins in the fluid (serum) part of a blood sample. The technician places the blood sample on special paper and applies an electric current. The proteins are separated in the electrical field based on the size and electrical charge of the proteins, move on the paper and form bands that show the amount of each protein. Abnormal results may mean: acute infection, chronic inflammatory disease, overactive immune system, or bone marrow cancer, including Waldenström’s Macroglobulinemia.
(Additional Notes/Definitions: Proteins not only make up the cellular structures of the body, they carry out many of the vital functions necessary for life. Globulins are a group of proteins that make up a large portion of the proteins in blood serum, the liquid part of the blood. Some are produced by the liver, while others by the immune system. Globulins can play many key roles including enzymes which help speed up chemical reactions vital to life, carrier proteins such as hemoglobin that transports oxygen from the lungs to muscle tissue and other cells, and antibodies which help the immune system of the body fight infections and other substances that may pose threats to the body. This last group are called immunoglobulins. Globulins are a family of a larger class called globular proteins, one of the three main classes of proteins. Globular proteins are formed by compacted amino acid chains, which are folded into intricate shapes that often roughly resemble spheres or “globes”.

Serum IgM Value was 3.5 g/dL:

A high level of Igm (immuniglobin M) in the blood serum, the liquid part of the blood (3.5 grams per deciliter - a tenth of a liter). Normal serum contains 0.7 – 1.6 g/dL of Ig, At serum IgM concentrations of 3 – 5 g/dL symptoms of a thickening of the blood called hyperviscosity often are present. However some individuals remain asymptomatic (without symptoms) with IgM levels as high as 9 g/dL. (Additional Notes/Definitions: IgM (Immunoglobulin M) is a basic antibody that is produced by a type of white blood cell called B cells. Some of the B cells turn into specialized cells called plasma cells whose role it is to produce antibodies which help fight infections and harmful substances that get into the body. Antibodies are made up of a protein called an immunoglobulin, abbreviated Ig. Proteins are the true workhorses of the body, not only making up the majority of cellular structures but carrying out most of the chemical processes as well.)One class of these is called Immunoglobulin M (IgM). The M stands for macroglobulin because it is, by far, physically the largest antibody in the human circulatory system. It is the first antibody produced in response to infection or initial exposure to foreign substances that are perceived as threats, called antigens. Immunoglobulin M antibodies appear early in the course of an infection and usually reappear, to a lesser extent, after further exposure. This biological property of immunoglobulin M makes it useful in the diagnosis of infectious diseases. Demonstrating immunoglobulin M antibodies in a patient's serum, the liquid part of the blood, indicates recent infection. An excess of immunoglobulin M is a characteristic of Waldenström's macroglobulinemia (WM) because WM causes the B Cells and plasma cells to become abnormal and reproduce in an excessive and uncontrolled manner and also to produce an excess of Immunoglobulin M which can cause a thickening of the blood called hyperviscosity. This can cause many symptoms including excess bleeding, problems with vision, poor blood circulation in the extremities, and nervous system problems.

Serum Immunofixation:

A lab test to identify proteins called immunoglobulins in the serum, the liquid part of the blood. Immunoglobulins are antibodies that help your body fight infection. Too much of the same immunoglobulin is usually due to different types of blood cancer. This test is most often used to check the levels of certain antibodies associated with multiple myeloma and Waldenström’s Macroglobulinemia. A characteristic of WM is that an excess of identical immunoglobulins are created. The term for this is monoclonal. A normal test result means no monoclonal immunglobulins are seen in the blood sample.

Setting (In the Setting of):

The place and conditions in which something happens or exists.

Seville Orange:

A bitter orange which is used to make marmalade. (Additional Notes/Definitions: Marmalade is a clear sweetened jelly in which small pieces of fruit and fruit rind, as of oranges, lemons or grapefruit, are suspended.)

Shock:

Medically, shock is defined as a condition where the tissues in the body don't receive enough blood flow, oxygen and nutrients to allow the cells to function properly. This ultimately leads to cellular death, progressing to organ failure, multiple organ damage, and finally, if untreated, whole body failure and death.

Shortness of Breath:

A feeling of difficult or labored breathing that is out of proportion to the patient's level of physical activity.

Short-Term:

Occurring over or involving a relatively short period of time.

Side Effects:

Any unwanted nontherapeutic effect caused by a drug.

Signaling Molecule:

A molecule involved in transmitting information between cells or within a cell.
(Additional Notes/Definitions: A molecule is the smallest particle of a substance that retains the chemical and physical properties of the substance and is composed of two or more atoms; a group of like or different atoms held together by chemical forces. Atoms are the smallest basic units and building blocks of matter. Cells are the basic units of a living organism which can only be seen under a microscope. Cells are the building block of tissue as one brick is part of a brick wall. There are also cells with specialized functions in various other places in the body, such as the blood and other fluids.)

Signature Molecule:

A molecule that can be used as an indicator of the physiological state of an organism and any function or process within it, whether normal or abnormal, the presence of a disease, the progress of the disease, response to treatment, etc. This could be a specific substance in the body or a measurable substance that is introduced into the body which can then be monitored at a molecular level. (Additional Notes/Definitions: A molecule is the smallest particle of a substance that retains the chemical and physical properties of the substance and is composed of two or more atoms; a group of like or different atoms held together by chemical forces. Atoms are the smallest basic units and building blocks of matter. Also called biomarker, biological marker and molecular marker.)

Simulations Using Fasted Conditions:

In order to predict how a drug would dissolve (dissolution) and be absorbed in a live subject and how it would react to certain foods tests are done in the lab, in vitro (in a test tube), using specifically designed media to simulate fasted and fed states. (Additional Notes/Definitions: Fasted state or condition usually refers to not eating food for a defined period (often “overnight”, or approximately 4-6 hours so the stomach is empty) but may allow consumption of water.)

Simulations Using PBPK (Physiologically-Based Pharmacokinetic) Models:

Simulations using models that approximate how the body metabolizes the drug, where this happens, often in the liver, and how the drug is eliminated from the body, by the kidneys through urine or the gastrointestinal/GI tract in stool or feces. (Additional Notes/Definitions: To metabolize is to undergo or be transformed by metabolism, which is all the physical and chemical changes that occur in an organism to allow growth and maintain body functions. Metabolism includes processes that break down substances to yield energy and processes that build up other substances necessary for life. Drugs are also metabolized, broken down and waste products eliminated. The liver is a large important organ in the abdomen that has many functions including detoxification, the creation of certain blood proteins, and many processes having to do with digestion and metabolism. The kidneys are a pair of organs that are found on either side of the spine, just below the rib cage in the back. The kidneys perform the essential function of removing waste products from the blood and produce urine for excretion. The gastrointestinal (GI) tract is the entire digestive system and particularly the stomach and intestines.)

Single Agent:

A trial where only one drug is used versus trials with several drugs in combination. (Additional Notes/Definitions: A Clinical Trial/Clinical Study is a type of research study that tests how well new medical approaches work in human beings. These studies follow a defined plan to determine the risks and benefits of a given therapy and test new methods of screening, prevention, diagnosis, or treatment of a disease.)

Single-Arm/Single-Arm Trial:

A trial where everyone enrolled in the trial receives the same experimental drug. And it does not include several drugs in combination.
(Additional Notes/Definitions: A Clinical Trial/Clinical Study is a type of research study that tests how well new medical approaches work in human beings. These studies follow a defined plan to determine the risks and benefits of a given therapy and test new methods of screening, prevention, diagnosis, or treatment of a disease.)

Single Dose AUC Values:

Refers the amount of drug the body is exposed to from a single dose. AUC is an abbreviation for Area Under the Curve; reflects the amount of drug the body is exposed to; depends on the dose of medication given and how fast it is metabolized and cleared from the body. (Additional Notes/Definitions: To metabolize is to undergo or be transformed by metabolism, which is all the physical and chemical changes that occur in an organism to allow growth and maintain body functions. Metabolism includes processes that break down substances to yield energy and processes that build up other substances necessary for life. Drugs are also metabolized, broken down and waste products eliminated.)

Sinusitis:

Inflammation of the sinuses or a sinus, which are the air-filled cavities in the bones of the skull, especially in the nasal region.

Skin Cancer:

The uncontrolled growth of abnormal skin cells. It occurs when unrepaired DNA damage to skin cells, most often caused by ultraviolet (UV) radiation from sunshine or tanning beds, triggers mutations, or genetic defects, that lead the skin cells to multiply rapidly and form malignant (cancerous) tumors. (Additional Notes/Definitions: A mutation is any change in the DNA of a cell or an organism resulting in the creation of a new character or trait not found in the parental type. DNA, Deoxyribonucleic acid, is a molecule that encodes the genetic instructions (blueprint) used in the development and functioning of all known living organisms. Cells are the basic units of a living organism which can only be seen under a microscope. In addition to those that are the building block of tissue there are cells with specialized functions in various other places in the body, such as the blood and other fluids. Molecules are the smallest particles of a substance that retains the chemical and physical properties of the substance and is composed of two or more atoms; a group of like or different atoms held together by chemical forces. Atoms are the smallest basic unit and building block of matter.)

Skin Disorder:

A disease or condition affecting the skin.

Skin Infection:

An infection of the skin which involves the invasion and multiplication of microorganisms such as bacteria or viruses. (Additional Notes/Definitions: Microorganisms are microscopic organisms, organisms that are so small as to be visible only with a microscope. Bacteria are microorganisms, some of which may cause illness. A virus is a small infectious agent that replicates or reproduces itself only inside the living cells of other organisms. Viruses can infect all types of life forms and are even smaller than bacteria and cannot be seen with a normal light microscope.)

SLL (Small Lymphocytic Lymphoma):

An indolent (slow-growing) cancer in which immature lymphocytes (white blood cells) are found in the blood and bone marrow and/or in the lymph nodes. CLL (chronic lymphocytic leukemia) and SLL (small lymphocytic lymphoma) are essentially the same disease, but in CLL cancer cells are found mostly in the blood and bone marrow. In SLL cancer cells are found mostly in the lymph nodes. (Additional Notes/Definitions: Lymphomas are cancers that begin in the cells of the immune system. Leukemia is a cancer that starts in blood-forming tissue such as the bone marrow and causes large numbers of abnormal blood cells to be produced and enter the blood. Cancer is a term used for diseases in which abnormal cells divide without control and are able to spread and invade other parts of the body. Cells are the basic units of a living organism which can only be seen under a microscope. Cells are the building blocks of tissue as one brick is part of a brick wall. There are also cells with specialized functions in various other places in the body, such as the blood and other fluids. White blood cells (lymphocytes) are specialized, nearly colorless cells in the blood stream that defend the body against disease and infection. There are several specific types that are essential for a properly functioning immune system. White blood cells are formed in the bone marrow. Bone marrow is the spongy tissue occupying the hollow central cavity of bones. There are two types of bone marrow. Red bone marrow contains tissue that is responsible for the formation and development of most of the blood cells – approximately 500 billion per day. Lymph nodes are bean-shaped organs found in the underarms, groin, neck, and abdomen that act as filters for the lymph fluid as it passes through them. Lymph nodes are part of the lymphatic system, a key part of the immune system which carries a fluid containing types of white blood called lymphocytes that fight infection and disease. Lymph is the thin clear fluid that circulates through thin walled, valved structures called lymphatic vessels or channels and carries white blood cells.)

Small Intestine:

The long, tube-like organ in the abdomen from the end of the stomach to the large intestine. The small intestine is about 20 feet long and about an inch in diameter. It is where much of the digestion of food and absorption of nutrients takes place. In actual fact the small and large intestines are a continuous tube.

Small Lymphocytic Lymphoma (SLL):

An indolent (slow-growing) cancer in which immature lymphocytes (white blood cells) are found in the blood and bone marrow and/or in the lymph nodes. CLL (chronic lymphocytic leukemia) and SLL (small lymphocytic lymphoma) are essentially the same disease, but in CLL cancer cells are found mostly in the blood and bone marrow. In SLL cancer cells are found mostly in the lymph nodes. (Additional Notes/Definitions: Lymphomas are cancers that begin in the cells of the immune system. Leukemia is a cancer that starts in blood-forming tissue such as the bone marrow and causes large numbers of abnormal blood cells to be produced and enter the blood. Cancer is a term used for diseases in which abnormal cells divide without control and are able to spread and invade other parts of the body. Cells are the basic units of a living organism which can only be seen under a microscope. Cells are the building blocks of tissue as one brick is part of a brick wall. There are also cells with specialized functions in various other places in the body, such as the blood and other fluids. White blood cells (lymphocytes) are specialized, nearly colorless cells in the blood stream that defend the body against disease and infection. There are several specific types that are essential for a properly functioning immune system. White blood cells are formed in the bone marrow. Bone marrow is the spongy tissue occupying the hollow central cavity of bones. There are two types of bone marrow. Red bone marrow contains tissue that is responsible for the formation and development of most of the blood cells – approximately 500 billion per day. Lymph nodes are bean-shaped organs found in the underarms, groin, neck, and abdomen that act as filters for the lymph fluid as it passes through them. Lymph nodes are part of the lymphatic system, a key part of the immune system which carries a fluid containing types of white blood called lymphocytes that fight infection and disease. Lymph is the thin clear fluid that circulates through thin walled, valved structures called lymphatic vessels or channels and carries white blood cells.)

Small-Molecule:

A molecule with a low molecular weight. Small molecules have the advantage that they can be taken orally, dissolve in the gastrointestinal tract, go into the bloodstream and reach almost any part of the body. A small molecule is generally considered any molecule under 500 mg per mole (a chemical mass unit, defined to be 6.022 x 1023 molecules or atoms).
(Additional Notes/Definitions: A molecule is the smallest particle of a substance that retains the chemical and physical properties of the substance and is composed of two or more atoms; a group of like or different atoms held together by chemical forces. Atoms are the smallest basic units and building blocks of matter. The gastrointestinal (GI) tract is the entire digestive system and particularly the stomach and intestines. A mass unit is a quantity of mass chosen as a standard in terms of which other quantities of mass may be expressed. In the biopharmaceutical industry, the discovery and development of small molecule drugs and peptides are referred to as New Chemical Entities or NCEs by regulatory agencies such as the US Food and Drug Administration, or FDA. A peptide is a molecule consisting of 2 or more amino acids. Peptides are smaller than proteins, which are also chains of amino acids. Amino acids are the building blocks of proteins or peptides. Molecules small enough to be synthesized from the constituent amino acids are, by convention, called peptides rather than proteins.)

Sodium:

Sodium (Na+) is an essential element for all human cells to function; it has a positive charge.

Sodium Lauryl Sulfate:

An emulsifying or wetting agent, sometimes used in personal care (toothpastes, ointments and shampoos) and cleaning products. (Additional Notes/Definitions: Emulsifying/wetting agents are chemical substances that increase the spreading and penetrating properties of a liquid by lowering its surface tension - that is, the tendency of its molecules to adhere to each other at the surface. The surface tension of a liquid is the tendency of the molecules to bond together, and is determined by the strength of the bonds or attraction between the liquid molecules. A wetting agent stretches these bonds and decreases the tendency of molecules to bond together, which allows the liquid to spread more easily across any solid surface. Molecules are the smallest particles of a substance that retain the chemical and physical properties of the substance and is composed of two or more atoms; a group of like or different atoms held together by chemical forces. Atoms are the smallest basic units and building blocks of matter.)

Solid:

A state of matter characterized by particles arranged such that their shape and volume are relatively stable, not liquid or gaseous.

Soluble:

Dissolving in liquid; able to be dissolved in another substance. The level of solubility often varies with temperature, often used in combination such as water-soluble. More specifically, soluble indicates that 10 to 30 ml of a specific liquid are required to dissolve a particular substance (e.g., ibrutinib is soluble in methanol).
Levels of solubility (approximate. volume (ml) of solvent needed to dissolve 1g of solute):
Very Soluble:                        Less than 1
Freely Soluble:                     1 to 10
Soluble:                     10 to 30
Sparingly Soluble:   30 to 100
Slightly Soluble:       100 to 1000
Very Slightly Soluble:          1000 to 10,000
Practically Insoluble:          Greater than 10,000
(Note: It is important to distinguish between three closely related terms solute, solvent, and solution defined below.)

Solute

– The substance that dissolves to form a solution.

Solution

– A mixture of one or more solutes dissolved in a solvent.

Solvent

– The substance in which a solute dissolves.

Specific Populations:

In clinical trials this usually refers to the patients with specific conditions that can be allowed to participate in a study also known as the per-protocol population.
(Additional Notes/Definitions: A Clinical Trial/Clinical Study is a type of research study that tests how well new medical approaches work in human beings. These studies follow a defined plan to determine the risks and benefits of a given therapy and test new methods of screening, prevention, diagnosis, or treatment of a disease.)

Spleen:

An abdominal organ involved in the production and removal of blood cells and forming part of the immune system. It usually lies in the left upper quadrant of the human abdomen, below the heart and diaphragm. The spleen filters out harmful substances from the blood, produces white blood cells (which help fight infections), removes worn-out red blood cells (which transport oxygen to the tissues and cells) from circulation, and maintains a reserve blood supply for the body. (Additional Notes/Definitions: Cells are the basic units of a living organism which can only be seen under a microscope. Cells are the building block of tissue as one brick is part of a brick wall. There are also cells with specialized functions in various other places in the body, such as the blood and other fluids.)

Splenomegaly:

An abnormal enlargement of the spleen. (Additional Notes/Definitions: The spleen is an abdominal organ involved in the production and removal of blood cells and forming part of the immune system. It usually lies in the left upper quadrant of the human abdomen, below the heart and diaphragm. The spleen filters out harmful substances from the blood, produces white blood cells (which help fight infections), removes worn-out red blood cells (which transport oxygen to the tissues and cells) from circulation, and maintains a reserve blood supply for the body. Cells are the basic units of a living organism which can only be seen under a microscope. Cells are the building block of tissue as one brick is part of a brick wall. There are also cells with specialized functions in various other places in the body, such as the blood and other fluids.)

St. John’s Wort:

St. John’s wort is an herb. Its flowers and leaves are used to make medicine. St. John’s wort is most commonly used for depression and conditions that sometimes go along with depression such as anxiety, tiredness, loss of appetite and trouble sleeping. It is also used for cancer, HIV/AIDS, and hepatitis C. (Additional Notes/Definitions: An herb is any plant with leaves, seeds, or flowers used for flavoring, food, medicine, or perfume. Herbal supplements/products are medications prepared from plants, including most of the world's traditional herbal remedies for disease. Some of these should be used as carefully as prescription medicines, taking care to avoid overdose, interactions with other medications, and misuse.)

Standard Deviation:

A statistical measure of the amount that a set of values differs from the average.

Statistically Significant:

When a statistic is significant, it simply means that you are very sure that the statistic is reliable. A result that is not likely to occur randomly, but rather is likely to be attributable to a specific cause.

Steady-State:

In drug therapy, this refers to the situation where the amount of the drug taken is approximately equal to the amount of the drug being eliminated (removed) so there is a steady amount of drug in the body.

Steady-State AUC:

A steady amount of a drug that the body is exposed to. AUC is an abbreviation for Area Under the Curve which reflects the amount of drug the body is exposed to. It depends on the dose of medication given and how fast it is metabolized and cleared from the body.
(Additional Notes/Definitions: To metabolize is to undergo or be transformed by metabolism, which is all the physical and chemical changes that occur in an organism to allow growth and maintain body functions. Metabolism includes processes that break down substances to yield energy and processes that build up other substances necessary for life. Drugs are also metabolized, broken down and waste products eliminated.)

Steady-State Exposures:

The amount of the drug that a person needs to take to get to a steady state, which is where the amount of the drug taken is approximately equal to the amount of the drug being eliminated, so there is a steady amount of drug in the body.

Stem Cell:

Stem cells are the immature cells that are created in the bone marrow and can develop into various specific cells in the blood. (Additional Notes/Definitions: Cells are the basic units of a living organism which can only be seen under a microscope. Cells are the building block of tissue as one brick is part of a brick wall. There are also cells with specialized functions in various other places in the body, such as the blood and other fluids. Bone marrow is the spongy tissue occupying the hollow central cavity of bones. There are two types of bone marrow. Red bone marrow contains tissue that is responsible for the formation and development of most of the blood cells – approximately 500 billion per day.)

Stem Cell Transplant:

The infusion of healthy stem cells into the body. Stem cells are the immature cells that are created in the bone marrow and can develop into various specific cells in the blood. A stem cell transplant may be necessary if the bone marrow stops working and doesn't produce enough healthy stem cells. (Additional Notes/Definitions: Cells are the basic units of a living organism which can only be seen under a microscope. Cells are the building block of tissue as one brick is part of a brick wall. There are also cells with specialized functions in various other places in the body, such as the blood and other fluids. Bone marrow is the spongy tissue occupying the hollow central cavity of bones. There are two types of bone marrow. Red bone marrow contains tissue that is responsible for the formation and development of most of the blood cells – approximately 500 billion per day.)

Stomatitis:

An inflammation of the mucous lining of any of the structures in the mouth, which may involve the cheeks, gums, tongue, lips, throat, and roof or floor of the mouth. (Additional Notes/Definitions: A mucous lining/membrane is a mucus-secreting membrane lining all bodily passages that are open to the air, as of the digestive and respiratory tracts. Mucus is a slippery and somewhat sticky fluid secreted by the glands in mucous membranes. A gland is an organ that secretes particular chemical substances for use in the body or for discharge into the surroundings. Mucus lubricates and protects the mucous membranes. A membrane is a thin, soft, pliable sheet or layer, especially of animal or vegetable tissue, serving as a covering or lining, as for an organ or cell. Cells are the basic units of a living organism which can only be seen under a microscope. Cells are the building block of tissue as one brick is part of a brick wall. There are also cells with specialized functions in various other places in the body, such as the blood and other fluids.)

Stool:

A common term normally used in reference to human feces.

Strong CYP Inducer:

Substances that initiate or increase the production of the enzymes in the CYP family to a great extent. (Additional Notes/Definitions: An enzyme lowers the energy level required to activate or initiate chemical reactions and thereby increases the rates of these reactions, vital for living organisms. Enzymes are key for metabolism which is all of the chemical processes within a living organism that are necessary for the maintenance of life. Drug metabolism, specifically, is when the drug is chemically broken down into simpler substances and any waste is cleared from the body. The CYP family is a class of enzymes, essential for drug metabolism (breakdown and clearance from the body). Mainly found in the liver and also the small intestine, they are known as the cytochrome P450 superfamily of enzymes (officially abbreviated as CYP). Although this class has more than 50 enzymes, six of them metabolize 90 percent of drugs. Increasing the production of these enzymes can lower the amount of a specific drug in the blood. Inhibiting them can increase the amount of the drug in the system.)

Strong CYP Inhibitor:

A substance that slows or stops the activity of the enzymes in the CYP family to a great extent.
(Additional Notes/Definitions: An enzyme lowers the energy level required to activate or initiate chemical reactions and thereby increases the rates of these reactions, vital for living organisms. Enzymes are key for metabolism which is all of the chemical processes within a living organism that are necessary for the maintenance of life. Drug metabolism, specifically, is when the drug is chemically broken down into simpler substances and any waste is cleared from the body. The CYP family is a class of enzymes, essential for drug metabolism (breakdown and clearance from the body). Mainly found in the liver and also the small intestine, they are known as the cytochrome P450 superfamily of enzymes (officially abbreviated as CYP). Although this class has more than 50 enzymes, six of them metabolize 90 percent of drugs. Increasing the production of these enzymes can lower the amount of a specific drug in the blood. Inhibiting them can increase the amount of the drug in the system.)

Subcutaneous:

Under the skin.

Subcutaneous Tissue Disorders:

Disease or an abnormal condition affecting the tissue under the skin. (Additional Notes/Definitions: Tissue is part of the body of a living thing that is made of similar cells. Cells are the basic units of a living organism which can only be seen under a microscope. Cells are the building block of tissue as one brick is part of a brick wall. There are also cells with specialized functions in various other places in the body, such as the blood and other fluids.)

Subdural Hematoma:

Bleeding and spreading of blood in the skull, more specifically between the membrane attached to the skull and the membrane surrounding the brain. This is usually associated with traumatic brain injury and can put pressure on the brain. Slurred speech, dizziness and difficulty walking can result, and it can progress to coma and even death. (Additional Notes/Definitions: A membrane is a thin, soft, pliable sheet or layer, especially of animal or vegetable tissue, serving as a covering or lining, as for an organ or cell. Cells are the basic units of a living organism which can only be seen under a microscope. Cells are the building block of tissue as one brick is part of a brick wall. There are also cells with specialized functions in various other places in the body, such as the blood and other fluids.)

Subsection:

A division of a section; a subdivision or a subordinate division of a section; a sub-portion of a document.

Substrate:

A substance or chemical acted on and changed by an enzyme in a chemical reaction. The substrates are converted into different molecules, called products. (Additional Notes/Definitions: An enzyme lowers the energy level required to activate or initiate chemical reactions and thereby increases the rates of these reactions, vital for living organisms. Enzymes are key for metabolism which is all of the chemical processes within a living organism that are necessary for the maintenance of life. A molecule is the smallest particle of a substance that retains the chemical and physical properties of the substance and is composed of two or more atoms; a group of like or different atoms held together by chemical forces. Atoms are the smallest basic units and building blocks of matter.)

Substrate Adhesion/Cell Substrate Adhesion:

Cell substrate adhesion is the attachment of one cell to another, or the attachment of a cell to some substance or chemical. This can cause cells to congregate or collect (which can result in enlargement of glands and organs, and tumors). (Additional Notes/Definitions: For example, IMBRUVICA has been shown to inhibit B-Cell substrate adhesion would inhibit the congregation of B Cells. This has been measured in, in vitro, in a lab using a test tube. Cells are the basic units of a living organism which can only be seen under a microscope. Cells are the building block of tissue as one brick is part of a brick wall. There are also cells with specialized functions in various other places in the body, such as the blood and other fluids. One example of this is B Cells which are one of the types of white blood cells in the immune system that defends against foreign substances and helps fight infection.)

Substrate Adhesion Molecules (SAMs):

Proteins that attach cells to specific substances or compounds in the environment of the cell called the extracellular matrix. This is a process known as cell adhesion. Proteins are complex chains of building blocks called amino acids. Some of the amino acids in the SAM bind to components of the extracellular matrix, while others bind to receptors on the surface of the cell called integrins. (Additional Notes/Definitions: Proteins not only make up structures of the body but help carry out most of the chemical reactions that are vital for living organisms to survive. Cells are the basic units of a living organism which can only be seen under a microscope. Cells are the building block of tissue as one brick is part of a brick wall. There are also cells with specialized functions in various other places in the body, such as the blood and other fluids. A receptor is a structure which is made of a complex protein that selectively receives and binds to a specific substance. Integrins are receptors that cross the cell membrane (transmembrane receptors) that are bridges for interactions with other cells and with substances in the cell’s environment. A membrane is a thin, soft, pliable sheet or layer, especially of animal or vegetable tissue, serving as a covering or lining, as for an organ or cell. The cell membrane is the structure separating the cell from its environment. It is a complex system that allows nutrients to enter the cell and waste products to leave.)

Substrate of P-Glycoprotein:

A substance or chemical acted on, changed and moved across a membrane by P-Glycoprotein. A P-gp substrate is substance or chemical acted on and changed by P-gp in a chemical reaction and converted into different molecules, called products.
(Additional Notes/Definitions: P-gp: P-Glycoprotein (Permeability GlycoProtein, abbreviated as P-gp or Pgp) is a protein found in the GI (gastrointestinal) tract (liver, pancreas and colon) that transports drugs into and out of a cells and may have a role in drug resistance. The gastrointestinal (GI) tract is the entire digestive system and particularly the stomach and intestines. The liver is a large important organ in the abdomen that has many functions including detoxification, the creation of certain blood proteins, and many processes having to do with digestion and metabolism. The pancreas is a spongy, tube-shaped organ that is about 6 inches long and is located in the back of the abdomen, behind the liver and stomach. The pancreas makes pancreatic juices and hormones. The pancreatic juices contain enzymes that help digest food in the small intestine. The hormones include some that activate other organs in the body and insulin which regulates the amount of glucose (sugar) in the blood. The lack of insulin causes a form of diabetes. Both pancreatic enzymes and hormones are needed to keep the body working correctly. The colon is the part of the large intestine that extends to the rectum. The long, coiled, tube-like organ that removes water from digested food. The remaining material, solid waste called stool, moves through the colon to the rectum and leaves the body through the anus. Cells are the basic units of a living organism which can only be seen under a microscope. Cells are the building block of tissue as one brick is part of a brick wall. There are also cells with specialized functions in various other places in the body, such as the blood and other fluids. Molecules are the smallest particles of a substance that retain the chemical and physical properties of the substance and is composed of two or more atoms; a group of like or different atoms held together by chemical forces. Atoms are the smallest basic units and building blocks of matter. A membrane is a thin, soft, pliable sheet or layer, especially of animal or vegetable tissue, serving as a covering or lining, as for an organ or cell. The cell membrane is the structure separating the cell from its environment. It is a complex system that allows nutrients to enter the cell and waste products to leave.)

Substrates of Transporters:

Substances that get moved across a membrane by a protein. The protein that is involved in the movement of these substances is called a transporter. (Additional Notes/Definitions: A membrane is a thin, soft, pliable sheet or layer, especially of animal or vegetable tissue, serving as a covering or lining, as for an organ or cell. The cell membrane is the structure separating the cell from its environment. It is a complex system that allows nutrients to enter the cell and waste products to leave. Proteins not only make up the majority of cellular structures but carry out most of the chemical processes as well.)

Supplements:

A dietary supplement is a product intended for ingestion that contains a "dietary ingredient" intended to add further nutritional value to (supplement) the diet. Some can help ensure that you get an adequate dietary intake of essential nutrients; others may help you reduce your risk of disease.

Surgery/Surgical:

The treatment of injuries or disorders of the body by incision or manipulation, especially with instruments.

Survival:

Staying alive, continuation in life or existence; the state or fact of continuing to live or exist in spite of an accident, illness, ordeal, or difficult circumstances.

Systemic:

Affecting the body as a whole. When the word systemic is used in reference to drugs, it indicates that the drugs travel through the bloodstream and reach and affect cells all over the body (e.g., systemic ibrutinib).

Systemic Chemotherapy:

Chemotherapy that employs drugs that travel through the bloodstream and reach and affect cells all over the body. (Additional Notes/Definitions: Chemotherapy is the treatment of diseases, infections or other disorders by the use of chemical substances, especially the treatment of cancer by use of powerful drugs that kill cells (cytotoxic), especially intended to kill fast-growing cells.)

Systemic Clearance:

Clearance of toxins from the body. A toxin is something that is poison or harmful to the body. Toxic substances usually cause unwanted side effects.

Systemic Inflammatory Response Syndrome (SIRS) is an inflammatory state affecting the whole body, frequently a response of the immune system to infection, but not necessarily so. (Additional Notes/Definitions: Generally inflammation is a localized physical condition in which part of the body becomes reddened, swollen, hot, and often painful, especially as a reaction to injury or infection. After injury or in certain conditions inflammation is a normal, healthy response. But inflammatory disorders that result in the immune system attacking the body's own cells or tissues may cause abnormal inflammation, which results in chronic pain, redness, swelling, stiffness, and damage to normal tissues.)

System Organ Class:

Agreed upon classifications of areas of physiological functions, disease origin or purpose as designated in the MedDRA or Medical Dictionary for Regulatory Activities, which is a clinically validated international medical terminology dictionary used by regulatory authorities in the pharmaceutical industry during the regulatory process. The dictionary contains the 26 MedDRA system organ classes (e.g. blood and lymphatic system disorders, cardiac disorders, surgical and medical procedures).

Systolic Pressure:

The peak pressure in the arteries, which occurs when the heart beats (when the heart muscle contracts). (Additional Notes/Definition: The heart pumps blood into the arteries which are blood vessels that transport blood rich in oxygen from the heart to the rest of the body. A vessel is an elastic tube or passage in the body through which blood circulates. Blood pressure is the measure of the force of blood pushing against blood vessel walls.)

T Cell (T Lymphocyte):

A type of white blood cell or lymphocyte that help direct immune responses, but they also can kill invading germs directly.

Telomere:

Inside the nucleus of a cell, our genes are arranged along twisted, double-stranded molecules of DNA called chromosomes. At the ends of the chromosomes are stretches of DNA called telomeres, which protect our genetic data, make it possible for cells to divide, and hold some secrets to how we age and get cancer. Telomeres have been compared with the plastic tips on shoelaces, because they keep chromosome ends from fraying and sticking to each other, which would destroy or scramble an organism's genetic information. Yet, each time a cell divides, the telomeres get shorter. When they get too short, the cell can no longer divide; it becomes inactive or "senescent" or it dies. This shortening process is associated with aging, cancer, and a higher risk of death. So telomeres also have been compared with a bomb fuse. (Additional Notes/Definitions: Cells are the basic units of a living organism which can only be seen under a microscope. Cells are the building block of tissue as one brick is part of a brick wall. There are also cells with specialized functions in various other places in the body, such as the blood and other fluids. A chromosome is a threadlike structure that contains the “blueprint” for the functioning and reproduction of the cells and characteristics of the organism as a whole. Chromosomes are located in a central portion of the cell called a nucleus. DNA molecules are among the largest molecules now known. The DNA is encoded with genes. A gene is the basic physical and functional unit of heredity. Genes, which are sections of the DNA, act as instructions to make molecules called proteins. Proteins not only make up the cellular structures but carry out most of the chemical reactions necessary for life. Hence the chromosomes contain the genetic information necessary for the production of other cell components and for the reproduction of life.

Telaprevir:

A medication that is used to treat hepatitis C virus (HCV).

Telithromycin:

A drug used to treat pneumonia (a lung infection) that is caused by bacteria. Brand Name: Ketek®, Ketek® Pak. (Additional Notes/Definitions: Pneumonia is an acute or chronic disease marked by inflammation of the lungs and caused by viruses, bacteria, or other microorganisms and sometimes by physical and chemical irritants. Bacteria are microscopic organisms or microorganisms (organisms that are so small as to be visible only with a microscope), some of which may cause illness.)

Therapeutic Index:

A comparison of the amount of a therapeutic agent or drug that causes the therapeutic effect to the amount that causes death (in animal studies) or toxicity (in human studies). If a drug has a narrow therapeutic range (i.e. has little difference between toxic and therapeutic doses) the dosage may have to be adjusted. (Additional Notes/Definitions: Something is toxic if it is poison or harmful to the body. Toxic substances usually cause unwanted side effects.)

Thoracic:

Pertaining to the thorax (chest).

Thrombocyte:

A type of blood cell that is disc-shaped which allows it to get caught on openings in veins (such as from a cut), causing or allowing a blood clot to form in order to control or stop bleeding. They are formed in the bone marrow and then circulate in the blood. They are often called cell fragments because they do not have a definite nucleus (also called platelets).
(Additional Notes/Definitions: Cells are the basic units of a living organism which can only be seen under a microscope. Cells are the building block of tissue as one brick is part of a brick wall. There are also cells with specialized functions in various other places in the body, such as the blood and other fluids. A vein is a blood vessel of varying size that carries blood to the heart after the cells have extracted the oxygen from the blood. Bone marrow is the spongy tissue occupying the hollow central cavity of bones. There are two types of bone marrow. Red bone marrow contains tissue that is responsible for the formation and development of most of the blood cells – approximately 500 billion per day. A cell’s nucleus is a membrane-bound structure that contains the cell’s hereditary information and controls the cell’s growth and reproduction.)

Thrombocytopenia:

An abnormally low number of thrombocytes (also called platelets) in the blood which are key to the forming of blood clots. So a low number of these would hamper the ability to control or stop bleeding. This can occur in people who have leukemia, an immune system malfunction, or as a medication side effect. (Additional Notes/Definitions: A thrombocyte is a type of blood cell that is disc-shaped which allows it to get caught on openings in veins (such as from a cut), causing or allowing a blood clot to form in order to control or stop bleeding. They are formed in the bone marrow and then circulate in the blood. They are often called cell fragments because they do not have a definite nucleus. Cells are the basic units of a living organism which can only be seen under a microscope. Cells are the building block of tissue as one brick is part of a brick wall. There are also cells with specialized functions in various other places in the body, such as the blood and other fluids. A vein is a blood vessel of varying size that carries blood to the heart after the cells have extracted the oxygen from the blood. Bone marrow is the spongy tissue occupying the hollow central cavity of bones. There are two types of bone marrow. Red bone marrow contains tissue that is responsible for the formation and development of most of the blood cells – approximately 500 billion per day. A cell’s nucleus is a membrane-bound structure that contains the cell’s hereditary information and controls the cell’s growth and reproduction. Leukemia is a cancer that starts in blood-forming tissue such as the bone marrow and causes large numbers of abnormal blood cells to be produced and enter the blood. Cancer is a term used for diseases in which abnormal cells divide without control and are able to spread and invade other parts of the body.)

Time to Response:

The time it took for patients to respond to treatment.

__Times the Exposure AUC:

The amount that the exposure to a drug of one subject or group of subjects is considered to be multiplied in relation to another subject or group. This can be affected by body weight. As an example, if one subject with similar body weight takes twice the dosage it could be two times (2X) the exposure. If two subjects take the same dosage but one subject is ½ the weight of the other, the subject with ½ the weight would also be receiving a two times (2X) exposure. AUC is an abbreviation for Area Under the Curve; reflects the amount of drug the body is exposed to; depends on the dose of medication given and how fast it is metabolized and cleared from the body. (Additional Notes/Definitions: To metabolize is to undergo or be transformed by metabolism, which is all the physical and chemical changes that occur in an organism to allow growth and maintain body functions. Metabolism includes processes that break down substances to yield energy and processes that build up other substances necessary for life. Drugs are also metabolized, broken down and waste products eliminated.)

Tissue:

A part of the body of a living thing that is made of similar cells. (Additional Notes/Definitions: Cells are the basic units of a living organism which can only be seen under a microscope. Cells are the building block of tissue as one brick is part of a brick wall. There are also cells with specialized functions in various other places in the body, such as the blood and other fluids.)

Titanium Dioxide:

A naturally occurring mineral commonly used as a white pigment for gelatin capsules utilized in pharmaceutical products.

T Lymphocyte (T Cell):

A type of white blood cell or lymphocyte that help direct immune responses, but they also can kill invading germs directly.

Tmax:

The time after administration of a drug when the maximum concentration of a drug in the body (the maximum plasma concentration) is reached; when the rate of absorption equals the rate of elimination.

Toxicity:

Having to do with poison or something harmful to the body. Toxic substances usually cause unwanted side effects.

Toxicity Occurrence:

An incident of a reaction from a toxic or poisonous substance causing an unwanted side effect, or the frequency or number of times such a reaction has occurred (i.e., first time, second, etc.)

Toxicology:

The study of the nature, effects, and detection of poisons and the treatment of poisoning.

Transporter:

A protein that is involved in the movement of another substance across a membrane.   (Additional Notes/Definitions: Proteins not only make up the majority of cellular structures but carry out most of the chemical processes as well. A membrane is a thin, soft, pliable sheet or layer, especially of animal or vegetable tissue, serving as a covering or lining, as for an organ or cell. The cell membrane is the structure separating the cell from its environment. It is a complex system that allows nutrients to enter the cell and waste products to leave. Cells are the basic units of a living organism which can only be seen under a microscope. Cells are the building block of tissue as one brick is part of a brick wall. There are also cells with specialized functions in various other places in the body, such as the blood and other fluids.)

Treatment-Emergent:

Any occurrence (symptom, etc.) happening at or near the time of use of a medicinal product. The term is particularly used with unfavorable occurrences. The unexpected side effect is therefore considered associated, whether or not the occurrence is caused by the product or even related to its use.

Treatment-Emergent Grade 3 or 4 Cytopenia:

Severe to life threatening condition in which there is a lower-than-normal numbers of blood cells that emerges during treatment.
(Additional Notes/Definitions: Cytopenia is a general term and could refer to a deficiency in all blood cells or to a deficient number of one or more specific types of blood cell in circulation. Cells are the basic units of a living organism which can only be seen under a microscope. In addition to cells that make up the tissues and physical structure of the body, there are cells with specialized functions in various other places in the body, such as the blood and other fluids.)

Tumor:

A swelling of a part of the body, generally without inflammation, caused by an abnormal growth of tissue, whether benign (non-cancerous) or malignant (cancerous and able to spread to other tissue or parts of the body). (Additional Notes/Definitions: Tissue is part of the body of a living thing that is made of similar cells. Cells are the basic units of a living organism which can only be seen under a microscope. Cells are the building block of tissue as one brick is part of a brick wall. There are also cells with specialized functions in various other places in the body, such as the blood and other fluids.)

Tumor Burden:

Refers to the number of cancer cells, the size of a tumor, or the amount of cancer in the body. Also called tumor load. This can be differentiated from bulky tumor, which is when individual masses are about 10 cm in diameter or larger. (Additional Notes/Definitions: A tumor is a swelling of a part of the body, generally without inflammation, caused by an abnormal growth of tissue, whether benign (non-cancerous) or malignant (cancerous and able to spread to other tissue or parts of the body). Tissue is part of the body of a living thing that is made of similar cells. Cells are the basic units of a living organism which can only be seen under a microscope. Cells are the building block of tissue as one brick is part of a brick wall. There are also cells with specialized functions in various other places in the body, such as the blood and other fluids.)

Tumor Lysis Syndrome (TLS):

Lysis is the disintegration of a cell by rupture of the cell wall or membrane. Tumor Lysis Syndrome (TLS) is a group of complications caused by the fast breakdown of a large number of tumor/cancer cells, which release their contents into the bloodstream, putting a strain on the body's systems, with the kidneys and liver having the job of filtering this out. TLS can occur either spontaneously or in response to therapy. In a person with high tumor burden (large tumors or many tumors) large amounts of potassium, phosphate, and uric acid can wind up in systemic circulation. The excess phosphate can combine with calcium which can cause a deficient amount of calcium to be in circulation creating further complications. These disturbances can progress to clinical toxic effects. One possible reaction is where the immune system responds in such a way as to create an inflammatory state affecting the whole body known as a Systemic Inflammatory Response Syndrome. This can result in chronic pain, redness, swelling, stiffness, and damage to normal tissues. Additionally, TLS can cause kidney failure and the need for dialysis treatment, abnormal heart rhythm, seizure, multiple organ failure, and sometimes death.

Tyrosine Kinase:

A Kinase is an enzyme that activates other enzymes. A Tyrosine Kinase is a type of enzyme involved primarily in signaling across a cell membrane or within a cell. It serves as an “on” or “off” switch in many cellular functions. (Additional Notes/Definitions: An enzyme lowers the energy level required to activate or initiate chemical reactions and thereby increases the rates of these reactions, vital for living organisms. Enzymes are key for metabolism which is all of the chemical processes within a living organism that are necessary for the maintenance of life. Drug metabolism, specifically, is when the drug is chemically broken down into simpler substances and any waste is cleared from the body. Cells are the basic units of a living organism which can only be seen under a microscope. Cells are the building block of tissue as one brick is part of a brick wall. There are also cells with specialized functions in various other places in the body, such as the blood and other fluids. A membrane is a thin, soft, pliable sheet or layer, especially of animal or vegetable tissue, serving as a covering or lining, as for an organ or cell. The cell membrane is the structure separating the cell from its environment. It is a complex system that allows nutrients to enter the cell and waste products to leave.)

ULN (Upper Limit of Normal):

At the high end of the normal range.

Unacceptable Toxicity:

Not acceptable; unsatisfactory poison or something harmful to the body. Toxic substances usually cause unwanted side effects.

Uncontrolled Trial:

A study in which the all participants receive the same treatment. In contrast, a Controlled Trial uses a control group receiving placebo or another previously tested treatment which is used to evaluate the effectiveness of the treatment by comparison. (Additional Notes/Definitions: A placebo is a substance that has no therapeutic effect, used as a control in testing new drugs. For instance, some people in a study might be given a new drug. Others would get a placebo. None of the people in the study will be informed if they got the real treatment or the placebo. Researchers then compare the effects of the drug and the placebo on the people in the study. That way, they can determine the effectiveness of the new drug and check for side effects.)

Unit:

A quantity chosen as a standard in terms of which other quantities may be expressed.

Unspecified:

Not stated clearly, exactly or in detail.

Upper Limit of Normal:

At the high end of the normal range.

Upper Respiratory Tract:

Upper part of passage through which air passes during breathing, which includes the nose and nasal passages, sinuses, and throat.

Upper Respiratory Tract Infection:

An acute (brief and severe as opposed to chronic) infection of the upper part of passage through which air passes during breathing, which includes the nose and nasal passages, sinuses, and throat.

Uric acid:

A waste product of metabolism that is carried in the blood, filtered by the kidneys and excreted in urine. (Additional Notes/Definitions: Metabolism is all the physical and chemical changes that occur in an organism to allow growth and maintain body functions. Metabolism includes processes that break down substances to yield energy and processes that build up other substances necessary for life. The kidneys are a pair of organs that are found on either side of the spine, just below the rib cage in the back. The kidneys perform the essential function of removing waste products from the blood and produce urine for excretion. Urine is a yellow to amber-colored, slightly acid fluid discharged from the body through the urethra, the canal through which urine is discharged from the bladder in most mammals.)

Urinalysis:

A test that evaluates a sample of your urine. Urinalysis is used to detect and assess a wide range of disorders, such as urinary tract infection, kidney disease and diabetes. Urinalysis may include checking for protein in the urine which could indicate certain forms of cancer.
(Additional Notes/Definitions: Urine is the waste product secreted by the kidneys that in mammals is a yellow to amber-colored, slightly acid fluid discharged from the body through the urethra, the canal through which urine is discharged from the bladder in most mammals. The kidneys are a pair of organs that are found on either side of the spine, just below the rib cage in the back. The kidneys perform the essential function of removing waste products from the blood and produce urine for excretion. Urinalysis may include checking for protein in the urine. Antibodies, which are part of the immune system and help fight infections and disease, consist of complex protein molecules that are made of 2 pairs of different amino acid chains. Amino acids are the building blocks of proteins. The smaller of these two types of amino acid chains are called light chains, or Bence-Jones proteins. Waldenström’s Macroglobulinemia (WM) is a cancer of cells that are part of our immune system. In the case of some WM patients these partial antibodies are created and secreted and may be deposited in the kidneys which can lead to kidney damage and kidney failure. A urine Bence-Jones protein test may include the presence of these small, partial immunoglogulins (Igs).)

Urinary Tract Infection:

An infection of any part of the body parts involved in the elimination of urine, especially the bladder or urethra (the duct by which urine is conveyed out of the body from the bladder), usually caused by bacteria. (Additional Notes/Definitions: Urine is the waste product secreted by the kidneys that in mammals is a yellow to amber-colored, slightly acid fluid discharged from the body through the urethra, the canal through which urine is discharged from the bladder in most mammals. The kidneys are a pair of organs that are found on either side of the spine, just below the rib cage in the back. The kidneys perform the essential function of removing waste products from the blood and produce urine for excretion. A bladder is a stretchable saclike structure in the body that holds fluids. The term is used most often to refer to the urinary bladder, which is used to collect urine for excretion.)

Urine:

The waste product secreted by the kidneys that in mammals is a yellow to amber-colored, slightly acid fluid discharged from the body through the urethra, the canal through which urine is discharged from the bladder in most mammals. (Additional Notes/Definitions: The kidneys are a pair of organs that are found on either side of the spine, just below the rib cage in the back. The kidneys perform the essential function of removing waste products from the blood and produce urine for excretion.)

U.S. Food and Drug Administration:

A federal agency established in 1906 with the Federal Food and Drugs Act that is responsible for monitoring trading and safety standards in the food and drug industries.

Urticaria:

A rash of round, red welts on the skin that itch intensely, sometimes with dangerous swelling, caused by an allergic reaction, to specific foods, medicine, or other irritants. (Also known as hives.)

Vaccine:

A preparation of killed microorganisms, living attenuated organisms (organisms that are kept alive but altered so that it is less harmful or capable of causing disease), or living fully virulent organisms (organisms that are actively capable of causing rapid onset of disease) that is administered to produce or artificially increase immunity to a particular disease.

Validate:

To authenticate, verify, prove.

Value:

A numerical quantity that is assigned or is determined by calculation or measurement.

Vascular:

Of, relating to, affecting, or consisting of a vessel or vessels, especially those that carry blood. (Note: A blood vessel is an elastic tube or passage in the body through which blood circulates.)

Vascular Disorder:

Any condition that negatively affects your circulatory system, primarily affecting the blood vessels and often affecting circulation. (Additional Notes/Definitions: The circulatory system is the bodily system consisting of the heart, blood, and blood vessels (elastic tubular structures) that circulates blood throughout the body, delivers oxygen, nutrients and other essential materials to cells, and removes waste products. Also called cardiovascular system, from the Latin words meaning ‘heart’ – ‘vessel’. Further Note: The circulatory system is often seen to be composed of both the cardiovascular system, which distributes blood, and the lymphatic system which circulates lymph, which is a thin clear fluid that circulates through the lymphatic vessels (thin walled, valved structures) and carries certain types of white blood cells called lymphocytes that fight infection and disease. The systems are connected. Although blood does not enter the lymphatic system, lymph does enter the blood system and return once filtered. Lymph is essentially like the fluid portion of the blood called blood plasma. Cells are the basic units of a living organism which can only be seen under a microscope. Some cells are the building block of tissue and some have specialized functions, such as in the blood and other fluids.)

Vd,ss/F (Volume of Distribution/Volume of Distribution at Steady State):

The volume of distribution is the volume that a drug or medication occupies or is distributed to in the body. It is calculated at steady state which is when the maximum drug amount is stably distributed in the body as determined by the fact that a steady level of the drug is maintained in the body and where the amount of the drug taken is approximately equal to the amount of the drug being eliminated. The larger the volume the greater the distribution, for example, the drug could be distributed locally or throughout the blood system or in the cells or even into the fat tissues. (The symbol is: Vd,ss/F.)

Vein:

A blood vessel of varying size that carries blood to the heart after the cells have extracted the oxygen from the blood. (Additional Notes/Definitions: A blood vessel is an elastic tube or passage in the body through which blood circulates. Cells are the basic units of a living organism which can only be seen under a microscope. In addition to those that are the building block of tissue there are cells with specialized functions in various other places in the body, such as the blood and other fluids.)

Venule:

A very small blood vessel that allows deoxygenated blood to return from the capillary beds to the larger veins. (Additional Notes/Definitions: A blood vessel is an elastic tube or passage in the body through which blood circulates. Veins are the blood vessels that carry blood to the heart after the cells have extracted the oxygen from the blood. Arteries are the blood vessels that carry oxygen-rich blood from the heart to the body. Capillaries are the fine, branching blood vessels that form a network between artery and vein systems that enables the actual exchange of water, chemicals, and oxygen between the blood and the tissues. Capillaries have an internal diameter of hair-like thickness. Venules are the blood vessels that transport the blood between the capillaries and veins and have a size that is between the capillaries and veins.)

Verapamil:

A medication used in treating and preventing chest pain (angina) resulting from spasm (contraction) of the coronary arteries that reduces the flow of blood to the heart.
Additional Notes/Definitions: Coronary arteries are the vessels that supply the heart muscle with blood rich in oxygen. They are called the coronary arteries because they encircle the heart in the manner of a crown. The word "coronary" comes from the Latin "corona" and Greek "koron" meaning crown. A vessel is an elastic tube or passage in the body through which blood circulates.)

Versus:

As opposed to; in contrast to.

Very Good Partial Response (VGPR):

A new defined category of response to treatment. While monoclonal IgM may still be detectable with a test called immunofixation. But there is a ≥ 90% reduction in serum IgM levels from baseline (the condition of the patient at the start of treatment). In addition there is no involvement of the lymph nodes or spleen if there had been at baseline. And there are no new signs or symptoms of active disease. (Additional Notes/Definitions: Waldenström’s Macroglobulinemia (WM) is a cancer of cells that are part of our immune system that normally produce antibodies which help fight infections and harmful substances that get into the body. Antibodies are made up of a protein called immunoglobulin (abbreviated Ig). The largest of the five general classes of these is immunoglobulin M (for macroglobulin), or IgM. One characteristic of WM that the affected cells produce an excess of exact copies of immunoglobulin M, which is called monoclonal IgM. Immunofixation is a test to determine the levels of specific types of immunoglobulins. Serum IgM is the amount of Immunoglobulin M that is present in the serum, the liquid part of the blood, hence in circulation.)

Vesicle:

An organelle that contains and transports materials within the cytoplasm.
(Additional Notes/Definitions: An organelle is a membrane-bound structure that is specialized to perform a distinct process within a cell. From Latin, organella, literally ‘small organ’. Cells are the basic units of a living organism which can only be seen under a microscope. Cells are the building block of tissue as one brick is part of a brick wall. There are also cells with specialized functions in various other places in the body, such as the blood and other fluids. A membrane is a thin, soft, pliable sheet or layer, especially of animal or vegetable tissue, serving as a covering or lining, as for an organ or cell. The cell membrane is the structure separating the cell from its environment. It is a complex system that allows nutrients to enter the cell and waste products to leave. A cell’s nucleus is a membrane-bound structure that contains the cell’s hereditary information and controls the cell’s growth and reproduction. Cytoplasm is the clear, gel-like substance outside the nucleus of the cell. It is composed mainly of water and also contains enzymes, salts, organelles, and various organic molecules. The cytoplasm helps to move materials around the cell and also dissolves cellular waste. An enzyme lowers the energy level required to activate or initiate chemical reactions and thereby increases the rates of these reactions, vital for living organisms. Enzymes are key for metabolism which is all of the chemical processes within a living organism that are necessary for the maintenance of life. Molecules are the smallest particles of a substance that retains the chemical and physical properties of the substance and is composed of two or more atoms; a group of like or different atoms held together by chemical forces. Atoms are the smallest basic unit and building block of matter. An organic molecule/compound is generally considered to be any member of a large class of gaseous, liquid, or solid chemical compounds that contains a significant amount of carbon. Historically, the theory was that organic compounds could only be synthesized or created by living organisms. Over the years scientific advance has included the ability to synthesize many of these organic compounds. However, scientific nomenclature retains the distinction between organic and inorganic compounds. The general modern meaning of organic compound is any compound that contains a significant amount of carbon. But there is no single "official" definition of an organic compound.)

Vessel:

An elastic tube or passage in the body through which blood circulates; an artery, a vein, or a capillary. (Additional Notes/Definitions: Arteries are the blood vessels that carry oxygen-rich blood from the heart to the body. Veins are the blood vessels that carry blood to the heart after the cells have extracted the oxygen from the blood. Capillaries are the fine, branching blood vessels that form a network between artery and vein systems that enables the actual exchange of water, chemicals, and oxygen between the blood and the tissues. Capillaries have an internal diameter of hair-like thickness.)

VGPR:

Very Good Partial Response.

Virus:

A microorganism that is smaller than bacteria that cannot grow or reproduce apart from a living cell. A virus invades living cells and can infect them and change how the cells function while it uses the cell’s chemical machinery to keep itself alive and to replicate itself. It may reproduce with fidelity (exactly copying itself) or with errors (mutations); this ability to mutate is responsible for the ability of some viruses to change slightly in each infected person, making treatment difficult. Viruses cause many common human infections and are also responsible for a number of rare diseases. Examples of viral illnesses range from the common cold to AIDS. (Additional Notes/Definitions: Microorganisms are organisms that are so small as to be visible only with a microscope. Bacteria are microscopic organisms which may cause illness. Cells are the basic units of a living organism which can only be seen under a microscope. In addition to those that are the building block of tissue there are cells with specialized functions in various other places in the body, such as the blood and other fluids. Fidelity is the degree of exactness with which something is copied or reproduced (such as an organism reproducing itself exactly). Mutation is any change in the DNA of a cell or an organism resulting in the creation of a new character or trait not found in the parental type. DNA (Deoxyribonucleic acid) is a molecule that encodes the genetic instructions (blueprint) used in the development and functioning of all known living organisms. Molecules are the smallest particles of a substance that retains the chemical and physical properties of the substance and is composed of two or more atoms; a group of like or different atoms held together by chemical forces. Atoms are the smallest basic unit and building block of matter.)

Visceral:

Relating to the viscera, which is the soft internal organs of the body, especially those contained within the chest and abdomen. This includes the heart, lungs, stomach, liver, intestines, major blood vessels, etc. (Additional Notes/Definitions: The liver is a large important organ in the abdomen that has many functions including detoxification, the creation of certain blood proteins, and many processes having to do with digestion and metabolism. Specific to drug therapy, this includes a key function of helping to metabolize (break down and excrete) drugs or medications. The intestines consist of the long, tube-like organ in the abdomen from the end of the stomach to the anus that completes the process of digestion, absorption of food and elimination of residual waste. It consists of the small and large intestines. The small intestine is the long, tube-like organ in the abdomen from the end of the stomach to the large intestine. The small intestine is about 20 feet long and about an inch in diameter. It is where much of the digestion of food and absorption of nutrients takes place. The large Intestine is the long, tube-like organ in the abdomen from the end of the small intestine to the anus. The large intestine is about 5 feet long and about 3 inches in diameter. It absorbs water from wastes, creating stool. As stool enters the rectum, nerves there create the urge to defecate. In actual fact the small and large intestines are a continuous tube. The major blood vessels are the larger or main blood vessels which are elastic tubular channels through which the blood circulates. An artery is a blood vessel that carries oxygen-rich blood from the heart to the body. A vein is a blood vessel that carries blood to the heart after the cells have extracted the oxygen from the blood. Cells are the basic units of a living organism which can only be seen under a microscope. In addition to those that are the building block of tissue there are cells with specialized functions in various other places in the body, such as the blood and other fluids.)

Visceral Malformations:

Misshapen or malformed viscera, which is the soft internal organs of the body, especially those contained within the chest and abdomen. This includes the heart, lungs, stomach, liver, intestines, the major blood vessels, etc. (Additional Notes/Definitions: The liver is a large important organ in the abdomen that has many functions including detoxification, the creation of certain blood proteins, and many processes having to do with digestion and metabolism. Specific to drug therapy, this includes a key function of helping to metabolize (break down and excrete) drugs or medications. The intestines consist of the long, tube-like organ in the abdomen from the end of the stomach to the anus that completes the process of digestion, absorption of food and elimination of residual waste. It consists of the small and large intestines. The small intestine is the long, tube-like organ in the abdomen from the end of the stomach to the large intestine. The small intestine is about 20 feet long and about an inch in diameter. It is where much of the digestion of food and absorption of nutrients takes place. The large Intestine is the long, tube-like organ in the abdomen from the end of the small intestine to the anus. The large intestine is about 5 feet long and about 3 inches in diameter. It absorbs water from wastes, creating stool. As stool enters the rectum, nerves there create the urge to defecate. In actual fact the small and large intestines are a continuous tube. A blood vessel is an elastic tube or passage in the body through which blood circulates. The major vessels are the larger or main elastic tubular channels called blood vessels through which the blood circulates. An artery is a blood vessel that carries oxygen-rich blood from the heart to the body. A vein is a blood vessel that carries blood to the heart after the cells have extracted the oxygen from the blood. Cells are the basic units of a living organism which can only be seen under a microscope. In addition to those that are the building block of tissue there are cells with specialized functions in various other places in the body, such as the blood and other fluids.)

Vision, Blurred:

Lack of sharpness of vision with, as a result, the inability to see fine detail.

Vitamin:

Any of a group of organic compounds that are essential for normal growth and nutrition and are required in small quantities in the diet because they cannot be synthesized by the body. (Additional Notes/Definitions: An organic compound is generally considered to be any member of a large class of gaseous, liquid, or solid chemical compounds that contains a significant amount of carbon. Historically, the theory was that organic compounds could only be synthesized or created by living organisms. Over the years scientific advance has included the ability to synthesize many of these organic compounds. However, scientific nomenclature retains the distinction between organic and inorganic compounds. The general modern meaning of organic compound is any compound that contains a significant amount of carbon. But there is no single "official" definition of an organic compound.)

Vitro, In:

Outside of the body, in a test tube, or sample/culture of some sort.

Vivo, In:

Within the body of a human or animal. Vivo: Latin for “live”.

Volume of Distribution/Volume of Distribution at Steady State:

The volume of distribution is the volume that a drug or medication occupies or is distributed to in the body. It is calculated at steady state which is when the maximum drug amount is stably distributed in the body as determined by the fact that a steady level of the drug is maintained in the body and where the amount of the drug taken is approximately equal to the amount of the drug being eliminated. The larger the volume the greater the distribution, for example, distributed locally or throughout the blood system or in the cells or even into the fat tissues. (The symbol is: Vd,ss/F.)

Vomit:

To eject part or all of the contents of the stomach through the mouth, usually in a series of involuntary spasmodic movements.

Vomit Blood:

Refers to significant amounts of blood in your vomit. Blood in vomit may be bright red if the bleeding is very recent, or it may appear black or dark brown like coffee grounds if it has had more contact with the gastric juices.

Vomit Looks Like Coffee Grounds:

Refers to significant amounts of blood in your vomit. Blood in vomit may be bright red if the bleeding is very recent, or it may appear black or dark brown like coffee grounds if it has had more contact with the gastric juices.

Voriconazole:

An antifungal medication that is generally used to treat serious, invasive fungal infections. Brand Name: Vfend®. (Additional Notes/Definitions: A fungal infection is any inflammatory condition caused by a fungus. Most fungal infections are superficial and mild, though persistent and difficult to eradicate. Some, particularly in older, debilitated, or immunosuppressed or immunodeficient people, may become systemic and life threatening. Examples of fungal infections are athlete’s foot, yeast and candida.)

Waldenström’s Macroglobulinemia (WM):

A slow-growing cancer that begins in the immune system. It was named after Jan Gösta Waldenström, the Swedish physician who, in 1944, first described the condition in patients who had a thickening of the serum, or liquid part of the blood It was discovered that their blood contained a great deal of a type of blood protein called a globulin, or more specifically a macroglobulin since it was a very large globulin. Hence, the disorder is named Waldenström’s Macroglobulinemia. WM is classified as a lymphoma which is a cancer of cells that are part of our immune system called lymphocytes, which are white blood cells that normally help the body to fight infections. WM specifically affects a white blood cell called a B lymphocyte or B cell. Normally, some of our B cells turn into specialized cells called plasma cells whose role it is to produce antibodies which help fight infections and harmful substances that get into the body. Antibodies are made up of a protein called immunoglobulin (abbreviated Ig). The largest of the 5 general classes of these is immunoglobulin M (for macroglobulin), or IgM. Part of the early immune response, IgM is the first type of antibody produced in response to infection, forming clusters and covering the foreign entity, such as bacteria. WM, however, causes the B Cells and plasma cells to become abnormal and reproduce in an excessive and uncontrolled manner. In addition the WM affected plasma cells produce an excess of Immunoglobulin M which can cause a thickening of the blood called hyperviscosity. This can cause many symptoms including excess bleeding, problems with vision, poor blood circulation in the extremities, and nervous system problems. Further complications can arise. White blood cells, such as B cells, are made in the bone marrow, which is a spongy tissue found in the middle of some of our bigger bones and the source of all our blood cells. Therefore, the WM cells grow mainly in the bone marrow, where they can crowd out the normal cells that make the different types of blood cells. This can lead to low levels of red blood cells (called anemia), which can make people feel tired and weak. It can also cause low numbers of white blood cells, which makes it hard for the body to fight infection. The numbers of platelets in the blood can also drop, leading to increased bleeding and bruising. However, WM is slow-growing cancer and often there are no symptoms noted until it has advanced, and symptoms. It is estimated that it may affect about five out of every 100,000 people. It usually affects people over the age of 50, and most often develops after age 65. It is more common in men than in women. The disease can run in families.

Waldenström’s Macroglobulinemia (WM) Response Criteria:

Complete Response (CR):
Absence of serum monoclonal IgM protein by immunofixation
Normal serum IgM level
Complete resolution of lymphadenopathy and splenomegaly if present at baseline
Morphologically normal bone marrow aspirate and trephine biopsy
Very Good Partial Response (VGPR):
Monoclonal IgM protein is detectable
≥ 90% reduction in serum IgM level from baseline
Decreased lymphadenopathy/splenomegaly if present at baseline
No new signs or symptoms of active disease
Partial Response (PR):
Monoclonal IgM protein is detectable
≥ 50% but <90% reduction in serum IgM level from baseline
Decreased lymphadenopathy/splenomegaly if present at baseline
No new signs or symptoms of active disease
Minor Response (MR): Monoclonal IgM protein is detectable
≥ 25% but <50% reduction in serum IgM level from baseline
No new signs or symptoms of active disease
Stable Disease (SD): Monoclonal IgM protein is detectable
< 25% reduction and < 25% increase in serum IgM level from baseline
No progression in lymphadenopathy/splenomegaly
No new signs or symptoms of active disease
Progressive Disease (PD):
≥ 25% increase in serum IgM level from lowest nadir and/or
Progression in clinical features attributable to the disease

Wetting Agents:

Chemical substances that increase the spreading and penetrating properties of a liquid by lowering its surface tension - that is, the tendency of its molecules to adhere to each other at the surface. The surface tension of a liquid is the tendency of the molecules to bond together, and is determined by the strength of the bonds or attraction between the liquid molecules. A wetting agent stretches these bonds and decreases the tendency of molecules to bond together, which allows the liquid to spread more easily across any solid surface. Molecules are the smallest particles of a substance that retain the chemical and physical properties of the substance and is composed of two or more atoms; a group of like or different atoms held together by chemical forces. Atoms are the smallest basic units and building blocks of matter.)

White Blood Cells:

Specialized, nearly colorless cells in the blood stream that defend the body against disease and infection. There are several specific types that are essential for a properly functioning immune system. White blood cells are formed in the bone marrow. (Additional Notes/Definitions: Cells are the basic units of a living organism which can only be seen under a microscope. In addition to those that are the building block of tissue there are cells with specialized functions in various other places in the body, such as the blood and other fluids. The immune system is the body's defense against infectious organisms and other invaders. Through a series of steps called the immune response, the immune system attacks organisms and substances that invade body systems and cause disease. Bone marrow is the spongy tissue occupying the hollow central cavity of bones. There are two types of bone marrow. Red bone marrow contains tissue that is responsible for the formation and development of most of the blood cells – approximately 500 billion per day.)

White Blood Cell Count:

A test that gives information about the number of white blood cells in a volume of blood. Abnormally high or low counts may indicate the presence of many forms of disease, infection or conditions. Some treatments, such as radiation and chemotherapy, are also known to affect white blood cells and may be monitored using white blood cell counts. It is also used to monitor bone marrow function since white blood cells originate in the bone marrow.
(Additional Notes/Definitions: White blood cells are specialized, nearly colorless cells in the blood stream that defend the body against disease and infection. There are several specific types that are essential for a properly functioning immune system. Cells are the basic units of a living organism which can only be seen under a microscope. Cells are the building block of tissue as one brick is part of a brick wall. There are also cells with specialized functions in various other places in the body, such as the blood and other fluids. Bone marrow is the spongy tissue occupying the hollow central cavity of bones. There are two types of bone marrow. Red bone marrow contains tissue that is responsible for the formation and development of most of the blood cells – approximately 500 billion per day. Radiation Therapy is a cancer therapy that uses high-energy radiation to kill cancer cells by damaging their ability to reproduce by damaging their DNA (Deoxyribonucleic Acid), DNA contains the genetic instructions (blueprint) used in the development and functioning of all known living organisms. Radiation therapy can damage normal cells as well as cancer cells. The radiation used for cancer treatment may come from a machine outside the body, or it may come from radioactive material placed in the body near tumor cells or injected into the bloodstream. Radiation is a type of dangerous and powerful energy that is produced by radioactive substances and nuclear reactions. Also the use of controlled amounts of radiation for the treatment of diseases such as cancer. Chemotherapy is the treatment of diseases, infections or other disorders by the use of chemical substances, especially the treatment of cancer by use of powerful drugs that kill cells (cytotoxic), especially intended to kill fast-growing cells.)

Widely Variable Conditions:

Conditions or situations that are apt or liable to vary, change or differ, and possibly greatly.

WM:

Waldenström’s Macroglobulinemia. (see above).

X Ray: noun 1. An electromagnetic wave of high energy and very short wavelength, which is able to pass through many materials that visible light will not penetrate. X-rays can produce images of the structures inside your body — particularly your bones. X-ray beams can pass through your body, but they are absorbed in different amounts depending on the density of the material they pass through. Dense materials, such as bone and metal, show up as white on X-rays. The air in your lungs shows up as black. Fat and muscle appear as varying shades of gray. For some types of X-ray tests, a contrast medium — such as iodine or barium — is introduced into your body to provide greater detail on the X-ray images. 2. A photographic or digital image of the internal composition of something, especially a part of the body, produced by X-rays being passed through it and being absorbed to different degrees by the different materials. verb 1. Photograph or examine with X-rays.
(Additional Notes/Definitions: Electromagnetic waves are waves that contain an electric field and a magnetic field and carry energy resulting from the acceleration of an electric charge. They travel at the speed of light and exhibit a wide range of frequencies. A frequency range of electromagnetic waves includes visible light but that is only one small portion of the full spectrum.)
Yeast:

A microscopic fungus consisting of single oval cells that reproduce by budding or fission (splitting), and are capable of converting sugar into alcohol and carbon dioxide. Yeasts include forms such as candida that can cause disease.