Abbreviation Description
ADR Adverse drug reactions
AE Adverse Event: Any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment
AF Atrial Fibrillation
AFASAK Placebo-controlled, randomised trial of warfarin and aspirin for prevention of thromboembolic complications in chronic atrial fibrillation: the Copenhagen AFASAK study.
BAATAF Boston Area Anticoagulation Trial for Atrial Fibrillation
BMI Body Mass Index
BRA Benefit-Risk Analysis
BRAT Benefit-Risk Action Team
BRR Benefit Risk Ratio
CAFA Canadian Atrial Fibrillation Anticoagulation
CB1 Cannabinoid type I
CHF Congestive heart failure
CHMP Committee for Medicinal Products for Human Use
CI Confidence Interval
CI Cumulative Incidence (used within the warfarin case study)
CIN Cases Impact Number
CIS Clinically Isolated Syndrome
CMA Comprehensive Meta-Analysis (software)
CMV Cytomegalovirus
CNS Central Nervous System
CPRD Clinical Practice Research Datalink
CV Cardio-vascular
DALY Disability Adjusted Life Year
DCE Discrete Choice Experiment
DIN Disease Impact Number
DLQI The DLQI is a 10-item questionnaire that incorporates patients' assessments of itch, pain, feelings of embarrassment and self-consciousness, problems with their psoriasis treatment, and interference of their psoriasis with daily activities, relationships, and sexual activity. The DLQI scores range from 0 (no impairment) to 30 (maximal impairment).
DMD Disease-Modifying Drug
DSA Deterministic Sensitivity Analysis
EAFT European Atrial Fibrillation Trial
EBV Epstein-Barr virus
ECIN Exposed Cases Impact Number
EDSS Expanded Disability Status Scale
EIN Exposure Impact Number
EMA European Medicines Agency
EBV Epstein-Barr virus
EMSP European Multiple-Sclerosis Platform
EPAR European Public Assessment Report
EU European Union
FDA Food and Drug Administration
GA Glatiramer Acetate
Gd Gadolinium
GSK GkaxoSmithKline
HDL High Density Lipoprotein
HES Hospital Episodes Statistics
HR Hazard Ratio
IFN Interferon
IM Intramuscular
IMI Innovative Medicines Initiative
INHB Incremental Net Health Benefit
ISS Integrated Safety Summary
ITT Intention to Treat
IV Intravenous
LCI Lower Confidence Interval
LDL Low Density Lipoprotein
MACE Major adverse cardiovascular events
MAH Marketing Authorization Holder
MCDA Multi Criteria Decision Analysis
MI Myocardial infarction (heart attack)
MRI Magnetic Resonance Imaging
MS Multiple Sclerosis
MSFC Multiple Sclerosis Functional Composite
MTC Mixed Treatment Comparison
NCB Net Clinical Benefit
NCB* Net Clinical Benefit metric calculated as "benefit-k x risk", where is an arbitrary constant
NCBI National Center for Biotechnology Information
NEJM New England Journal of Medicine
NEPP Number of Events Prevented in the Population
NNH Number Needed to (treat to cause) Harm
NNT Number Needed to Treat
OLS Percentage of patients with Overall Lesion Severity rating of minimal or clear at FT (week 12). OLS is a static global assessment with 6 categories (clear, minimal, mild, moderate, severe and very severe) based on the characteristics of plaque elevation, scaling and erythema.
OR Odds Ratio
PASI50 Percentage of patients achieving 50% reduction in baseline PASI at week 12. The PASI is a measure of the average redness, thickness and scaliness of the lesions (each graded on a 0-4 scale), weighted by the area of involvement. PASI range is from 0 to 72
PASI75 Percentage of patients achieving at least a 75% reduction of PASI at week 12 when compared to baseline. The PASI is a measure of the average redness, thickness and scaliness of the lesions (each graded on a 0-4 scale), weighted by the area of involvement. PASI range is from 0 to 72.
Pbo Placebo
PD Pharmacodynamic
PGA Percentage of patients achieving Physician's Global Assessment clear/almost clear at week12. This is a seven point scale with 7 being clear, 6 almost clear, 5 mild, 4 mild to moderate, 3 moderate, 2 moderately severe and 1 severe psoriasis.
PhRMA Pharmaceutical Research and Manufacturers of America
PIN Population Impact Number
PIN-ER-t Population Impact Number of Eliminating a Risk factor over time T
PK Pharmacokinetic
PML Progressive Multifocal Leucoencephalopathy, is a rare and usually fatal viral disease that is characterized by progressive damage or inflammation of the white matter of the brain at multiple locations. It occurs almost exclusively in people with severe immune deficiency, such as transplant patients on immunosuppressive medications, patients receiving certain kinds of chemotherapy, patients receiving natalizumab (Tysabri) for multiple sclerosis, psoriasis patients on long-term efalizumab (Raptiva) or AIDS patients. It is caused by a virus, the JC virus, which is normally present and kept under control by the immune system. Immunosuppressive drugs prevent the immune system from controlling the virus.
PMS Post-marketing surveillance
PPMS Post-marketing surveillance
PPMS Primary Progressive Multiple Sclerosis
PrOACT-URL An eight-stage process for structuring a decision as an aid to decision makers
PROTECT Pharmacoepidemiological Research on Outcomes of Therapeutics by a European Consortium
PSA Probabilistic Sensitivity Analysis
PSM Probabilistic Simulation Methods
QALY Quality-Adjusted Life-Years
QTc Corrected QT interval, an electrocardiographic measure of both depolarization and repolarization within the heart
Q-TWiST Quality-adjusted Time Without Symptoms and Toxicity
RCT Randomised Controlled Trial
RR Relative Risk
RRMS Relapsing-Remitting Multiple Sclerosis
SC Subcutaneous
SD Standard Deviation
SE Standard Error
SMAA Stochastic Multicriteria Acceptability Analysis
SPIN I Stroke Prevention in Atrial Fibrillation
SPINAF Stroke Prevention in Nonrheumatic Atrial Fibrillation
SPMS Secondary Progressive Multiple Sclerosis
TIA Transient ischaemic attack
Tx Active treatment
UCI Upper Confidence Interval
UK United Kingdom
US United States
VAS Visual Analogue Scale
w-NCB Weighted Net Clinical Benefit
WP5 Work Package 5 of the PROTECT project