Assessing the extent and impact of the masking effect of disproportionality analyses on two spontaneous reporting systems databases

Pharmacoepidemiology and Drug Safety

Volumn 23, Issue 2, 2014, Pages 195-207

  Maignen, Francois ^a   Hauben, Manfred ^b,c,d,e   Hung, Eric ^b   Van Holle, Lionel ^f   Dogne, Jean Michel ^g  

^a EUROPEAN MEDICINES AGENCY   (United Kingdom)

^b PFIZER INC   (United States)

^c NEW YORK UNIVERSITY SCHOOL OF MEDICINE   (United States)

^d NEW YORK MEDICAL COLLEGE   (United States)

^e BRUNEL UNIVERSITY   (United Kingdom)

^f GLAXOSMITHKLINE BIOLOGICALS   (Belgium)

^g University of Namur   (Belgium)

Author keywords

Disproportionality analysis; EudraVigilance; Masking; Pharmacoepidemiology; Proportional reporting ratio; Public health; Signal detection

Indexed keywords

ARTICLE; CROSS-SECTIONAL STUDY; DATA BASE; DISPROPORTIONALITY ANALYSIS; DRUG INDUSTRY; DRUG SAFETY; MASKING; MATHEMATICAL ANALYSIS; MEDICAL DICTIONARY FOR REGULATORY ACTIVITIES; PRIORITY JOURNAL; PUBLIC HEALTH;

DISPROPORTIONALITY ANALYSIS; EUDRAVIGILANCE; MASKING; PHARMACOEPIDEMIOLOGY; PROPORTIONAL REPORTING RATIO; PUBLIC HEALTH; SIGNAL DETECTION;

ADVERSE DRUG REACTION REPORTING SYSTEMS; ALGORITHMS; CROSS-SECTIONAL STUDIES; DATA INTERPRETATION, STATISTICAL; DATABASES, FACTUAL; DRUG-RELATED SIDE EFFECTS AND ADVERSE REACTIONS; HUMANS; PHARMACOEPIDEMIOLOGY; PHARMACOVIGILANCE; PUBLIC HEALTH;

EID: 84892897011     PISSN: 10538569     EISSN: 10991557     Source Type: Journal    
DOI: 10.1002/pds.3529     Document Type: Article

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