Abbreviations used in clinical trials: Difference between revisions

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ABI Ankle-brachial index
ABI Ankle-brachial index
ACC American College of Cardiology
ACC American College of Cardiology
ACCORD Action to Control Cardiovascular Risk in Diabetes
 
ACS Acute coronary syndrome
ACS Acute coronary syndrome
AE Adverse event
AE Adverse event
AHA American Heart Association
AHA American Heart Association
AIDS Acquired immune deficiency syndrome
AIDS Acquired immune deficiency syndrome
AIM-HIGH Atherothrombosis  Intervention  in  Metabolic  Syndrome  with  Low HDL/High Triglycerides: Impact on Global Health Outcomes
 
ALT Alanine aminotransferase
ALT Alanine aminotransferase
AMR101 Ethyl-EPA; ethyl eicosapentaenoic acid; icosapent ethyl
 
ANCHOR Effect of AMR101 (Ethyl Icosapentate) on Triglyceride (Tg) Levels in Patients on Statins with High TG Levels (≥ 200 and < 500 mg/dL)
AP Angina pectoris
AP Angina pectoris
apo B Apolipoprotein B
 
apo B Apolipoprotein B
 
APOC3 Apolipoprotein C3
APOC3 Apolipoprotein C3
AST Aspartate aminotransferase
AST Aspartate aminotransferase
ATP Adult Treatment Panel
ATP Adult Treatment Panel
BMI Body mass index
BMI Body mass index
BUN Blood urea nitrogen
BUN Blood urea nitrogen
CABG Coronary artery bypass graft
CABG Coronary artery bypass graft
CAD Coronary artery disease
CAD Coronary artery disease
CBC Complete blood count
CBC Complete blood count
CEC Clinical Endpoint Committee
CEC Clinical Endpoint Committee
CHD Coronary heart disease
CHD Coronary heart disease
CHF Congestive heart failure
CHF Congestive heart failure
CI Confidence interval
CI Confidence interval
CK-MB Creatine kinase-MB fraction
CK-MB Creatine kinase-MB fraction
CrCL Creatinine clearance
CrCL Creatinine clearance
CRF Case report form
CRF Case report form
CV Cardiovascular
CV Cardiovascular
CVD Cardiovascular disease
CVD Cardiovascular disease
DART Diet and Reinfarction Trial
 
DCCT Diabetes Control and Complications Trial DHA Docosahexaenoic acid
DHA Docosahexaenoic acid
 
DMC Data Monitoring Committee
DMC Data Monitoring Committee
DYSIS The DYSlipidemia International Study
 
EC Independent Ethics Committee
EC Independent Ethics Committee
ECG Electrocardiogram
ECG Electrocardiogram
EDC Electronic data capture
EDC Electronic data capture
eGRF Estimated glomerular filtration rate
eGRF Estimated glomerular filtration rate
EPA Eicosapentaenoic acid
EPA Eicosapentaenoic acid
Ethyl-EPA AMR101; ethyl eicosapentaenoic acid; icosapent ethyl EU European Union
 
Ethyl-EPA ethyl eicosapentaenoic acid
 
EU European Union
 
FBG Fasting blood glucose
FBG Fasting blood glucose
FDA United States Food and Drug Administration
FDA United States Food and Drug Administration
FSH Follicle-stimulating hormone
FSH Follicle-stimulating hormone
GCP Good Clinical Practice
GCP Good Clinical Practice
GGT Gamma-glutamyl transferase
GGT Gamma-glutamyl transferase
GISSI Gruppo  Italiano  per  lo  Studio  della  Sopravvivenza  nell’Infarto Miocardico
 
GMP Good Manufacturing Practice
GMP Good Manufacturing Practice
GWAS Genome-wide association study
GWAS Genome-wide association study
HbA1c Hemoglobin A1c
HbA1c Hemoglobin A1c
Hct Hematocrit
Hct Hematocrit
HDL-C High-density lipoprotein cholesterol
HDL-C High-density lipoprotein cholesterol
HF Heart failure
HF Heart failure
Hgb Hemoglobin
 
Hgb Hemoglobin
 
HIV Human immunodeficiency virus
HIV Human immunodeficiency virus
HPS2-THRIVE Heart Protection Study 2–Treatment of HDL to Reduce the Incidence of Vascular Events
 
HR Hazard ratio
HR Hazard ratio
hs-CRP High-sensitivity C-reactive protein
hs-CRP High-sensitivity C-reactive protein
hsTnT High-sensitivity troponin T
hsTnT High-sensitivity troponin T
HTG Hypertriglyceridemia
HTG Hypertriglyceridemia
ICF Informed consent form
ICF Informed consent form
ICH International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use
ICH International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use
IFCC International Federation of Clinical Chemistry
IFCC International Federation of Clinical Chemistry
IMP Investigational medicinal product
IMP Investigational medicinal product
IQR Interquartile range
IQR Interquartile range
IRB Institutional Review Board
IRB Institutional Review Board
ITT Intent-to-Treat
ITT Intent-to-Treat
IWRS Interactive Web Response System
IWRS Interactive Web Response System
JAS Japanese Atherosclerosis Society
JAS Japanese Atherosclerosis Society
JELIS Japan Eicosapentaenoic Acid Lipid Intervention Study LBBB Left bundle branch block
 
LBBB Left bundle branch block
 
LDL-C Low-density lipoprotein cholesterol
LDL-C Low-density lipoprotein cholesterol
LOE Lack of efficacy
LOE Lack of efficacy
LpPLA2 Lipoprotein-associated phospholipase A2 LVH Left ventricle hypertrophy
 
LpPLA2 Lipoprotein-associated phospholipase A2  
 
LVH Left ventricle hypertrophy
 
MACE Major adverse coronary event
MACE Major adverse coronary event
MARINE Efficacy and Safety of AMR101 (Ethyl Icosapentate) in Patients With Fasting Triglyceride (TG) Levels ≥ 500 and ≤ 2000 mg/dL
 
MI Myocardial infarction
MI Myocardial infarction or mitral insufficiency
 
mITT Modified Intent-to-Treat
mITT Modified Intent-to-Treat
NCEP National Cholesterol Education Program
NCEP National Cholesterol Education Program
NGSP National Glycohemoglobin Standardization Program NMR Nuclear magnetic resonance
 
NSTE-ACS Non-ST-segment elevation acute coronary syndrome O3FA Omega-3 fatty acid
NGSP National Glycohemoglobin Standardization Program  
ODIS Off drug in study
 
NMR Nuclear magnetic resonance
 
NSTE-ACS Non-ST-segment elevation acute coronary syndrome  
 
O3FA Omega-3 fatty acid
 
ODIS Off drug in stud
y
OGTT Oral glucose tolerance test
OGTT Oral glucose tolerance test
OR Odds ratio
OR Odds ratio
PAD Peripheral arterial disease
PAD Peripheral arterial disease
PCI Percutaneous coronary intervention PCSK9 Proprotein convertase subtilisin kexin 9 PH Proportional hazard
 
PCI Percutaneous coronary intervention  
 
PCSK9 Proprotein convertase subtilisin kexin 9  
 
PH Proportional hazard
 
PI Principal Investigator
PI Principal Investigator
PP Per protocol
PP Per protocol
PROVE-IT Pravastatin or Atorvastatin Evaluation and Infection Therapy PVD Peripheral vascular disease
 
PVD Peripheral vascular disease
 
RBC Red blood cells
RBC Red blood cells
REDUCE-IT Reduction of Cardiovascular Events with EPA – Intervention Trial RLP-C Remnant lipoprotein cholesterol
 
RLP-C Remnant lipoprotein cholesterol
 
RR Relative risk
RR Relative risk
SAE Serious adverse event
SAE Serious adverse event
SAP Statistical Analysis Plan
SAP Statistical Analysis Plan
SC Steering Committee
SC Steering Committee
SPC Summary of Product Characteristics
SPC Summary of Product Characteristics
SUSAR Suspected unexpected serious adverse reaction  
 
SUSAR Suspected unexpected serious adverse reaction
TC Total cholesterol
TC Total cholesterol
TEAE Treatment-emergent adverse event
TEAE Treatment-emergent adverse event
TG Triglycerides
TG Triglycerides
TIA Transient Ischemic Attack
TIA Transient Ischemic Attack
TIMI Thrombolysis In Myocardial Infarction
TIMI Thrombolysis In Myocardial Infarction
ULN Upper limit of normal
ULN Upper limit of normal
US United States
US United States
USPI United States Prescribing Information  
USPI United States Prescribing Information  
VLDL-C Very low density lipoprotein cholesterol  
VLDL-C Very low density lipoprotein cholesterol  
WBC White cell blood count
WBC White cell blood count

Latest revision as of 17:43, 27 October 2019

ABI Ankle-brachial index

ACC American College of Cardiology

ACS Acute coronary syndrome

AE Adverse event

AHA American Heart Association

AIDS Acquired immune deficiency syndrome

ALT Alanine aminotransferase

AP Angina pectoris

apo B Apolipoprotein B

APOC3 Apolipoprotein C3

AST Aspartate aminotransferase

ATP Adult Treatment Panel

BMI Body mass index

BUN Blood urea nitrogen

CABG Coronary artery bypass graft

CAD Coronary artery disease

CBC Complete blood count

CEC Clinical Endpoint Committee

CHD Coronary heart disease

CHF Congestive heart failure

CI Confidence interval

CK-MB Creatine kinase-MB fraction

CrCL Creatinine clearance

CRF Case report form

CV Cardiovascular

CVD Cardiovascular disease

DHA Docosahexaenoic acid

DMC Data Monitoring Committee

EC Independent Ethics Committee

ECG Electrocardiogram

EDC Electronic data capture

eGRF Estimated glomerular filtration rate

EPA Eicosapentaenoic acid

Ethyl-EPA ethyl eicosapentaenoic acid

EU European Union

FBG Fasting blood glucose

FDA United States Food and Drug Administration

FSH Follicle-stimulating hormone

GCP Good Clinical Practice

GGT Gamma-glutamyl transferase

GMP Good Manufacturing Practice

GWAS Genome-wide association study

HbA1c Hemoglobin A1c

Hct Hematocrit

HDL-C High-density lipoprotein cholesterol

HF Heart failure

Hgb Hemoglobin

HIV Human immunodeficiency virus

HR Hazard ratio

hs-CRP High-sensitivity C-reactive protein

hsTnT High-sensitivity troponin T

HTG Hypertriglyceridemia

ICF Informed consent form

ICH International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use

IFCC International Federation of Clinical Chemistry

IMP Investigational medicinal product

IQR Interquartile range

IRB Institutional Review Board

ITT Intent-to-Treat

IWRS Interactive Web Response System

JAS Japanese Atherosclerosis Society

LBBB Left bundle branch block

LDL-C Low-density lipoprotein cholesterol

LOE Lack of efficacy

LpPLA2 Lipoprotein-associated phospholipase A2

LVH Left ventricle hypertrophy

MACE Major adverse coronary event

MI Myocardial infarction or mitral insufficiency

mITT Modified Intent-to-Treat

NCEP National Cholesterol Education Program

NGSP National Glycohemoglobin Standardization Program

NMR Nuclear magnetic resonance

NSTE-ACS Non-ST-segment elevation acute coronary syndrome

O3FA Omega-3 fatty acid

ODIS Off drug in stud y OGTT Oral glucose tolerance test

OR Odds ratio

PAD Peripheral arterial disease

PCI Percutaneous coronary intervention

PCSK9 Proprotein convertase subtilisin kexin 9

PH Proportional hazard

PI Principal Investigator

PP Per protocol

PVD Peripheral vascular disease

RBC Red blood cells

RLP-C Remnant lipoprotein cholesterol

RR Relative risk

SAE Serious adverse event

SAP Statistical Analysis Plan

SC Steering Committee

SPC Summary of Product Characteristics

SUSAR Suspected unexpected serious adverse reaction

TC Total cholesterol

TEAE Treatment-emergent adverse event

TG Triglycerides

TIA Transient Ischemic Attack

TIMI Thrombolysis In Myocardial Infarction

ULN Upper limit of normal

US United States

USPI United States Prescribing Information

VLDL-C Very low density lipoprotein cholesterol

WBC White cell blood count

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