Benefit-risk assessment in a post-market setting: A case study integrating real-life experience into benefit-risk methodology

Pharmacoepidemiology and Drug Safety

Volumn 23, Issue 9, 2014, Pages 974-983

  Hallgreen, Christine E ^a   van den Ham, Hendrika A ^b   Mt Isa, Shahrul ^a   Ashworth, Simon ^c   Hermann, Richard ^d   Hobbiger, Steve ^e   Luciani, Davide ^f   Micaleff, Alain ^g   Thomson, Andrew ^h   Wang, Nan ^a   van Staa, Tjeerd P ^b,i   Downey, Gerald ^j   Hirsch, Ian ^d   Hockley, Kimberley ^a   Juhaeri, Juhaeri ^k   Metcalf, Marilyn ^l   Mwangi, Jeremiah ^m   Nixon, Richard ⁿ   Peters, Ruth ^a   Stoeckert, Isabelle ^o   Waddingham, Ed ^a   Tzoulaki, Ioanna ^a   Ashby, Deborah ^a   Wise, Lesley ^c   more..

^a IMPERIAL COLLEGE LONDON   (United Kingdom)

^b UTRECHT UNIVERSITY   (Netherlands)

^c Takeda Global Research and Development Centre (Europe) Ltd   (United Kingdom)

^d ASTRAZENECA   (United Kingdom)

^e GLAXOSMITHKLINE   (United Kingdom)

^f MARIO NEGRI INSTITUTE FOR PHARMACOLOGICAL RESEARCH   (Italy)

^g MerckSerono International SA   (Switzerland)

^h MEDICINES AND HEALTHCARE PRODUCTS REGULATORY AGENCY   (United Kingdom)

ⁱ LONDON SCHOOL OF HYGIENE AND TROPICAL MEDICINE   (United Kingdom)

^j AMGEN LTD   (United Kingdom)

^k SANOFI   (France)

^l GLAXOSMITHKLINE   (United States)

^m AMERICAN HEART ASSOCIATION   (United States)

ⁿ NOVARTIS PHARMA AG   (Switzerland)

^o BAYER PHARMA AG   (Germany)

more..

Author keywords

Benefit risk; Decision making; Medicines; Pharmacoepidemiology; Qualitative; Quantitative; Warfarin

Indexed keywords

PLACEBO; WARFARIN; ANTICOAGULANT AGENT;

ADULT; AGED; ARTICLE; BRAIN HEMORRHAGE; BRAIN ISCHEMIA; BRAT FRAMEWORK; CEREBROVASCULAR ACCIDENT; CONCEPTUAL FRAMEWORK; CONTROLLED STUDY; DRUG EFFICACY; DRUG SAFETY; EVIDENCE BASED MEDICINE; FEMALE; HEART ATRIUM FIBRILLATION; HUMAN; INCIDENCE; MAJOR CLINICAL STUDY; MALE; MIDDLE AGED; MORTALITY; OUTCOME ASSESSMENT; PERSONAL EXPERIENCE; PHARMACOEPIDEMIOLOGY; POSTMARKETING SURVEILLANCE; PRIMARY PREVENTION; PRIORITY JOURNAL; PROBABILITY; QUALITATIVE ANALYSIS; RANDOMIZED CONTROLLED TRIAL; RISK ASSESSMENT; RISK BENEFIT ANALYSIS; STROKE PATIENT; UNCERTAINTY; VERY ELDERLY; ATRIAL FIBRILLATION; COMPLICATION; PROCEDURES; RANDOMIZED CONTROLLED TRIAL (TOPIC); STATISTICAL MODEL; STROKE;

AGED; AGED, 80 AND OVER; ANTICOAGULANTS; ATRIAL FIBRILLATION; FEMALE; HUMANS; MALE; MODELS, STATISTICAL; PRIMARY PREVENTION; PROBABILITY; RANDOMIZED CONTROLLED TRIALS AS TOPIC; RISK ASSESSMENT; STROKE; WARFARIN;

EID: 84940253289     PISSN: 10538569     EISSN: 10991557     Source Type: Journal    
DOI: 10.1002/pds.3676     Document Type: Article

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