Standardization of definitions and criteria for causality assessment of adverse drug reactions. Drug-induced blood cytopenias: report of an international consensus meeting.
International reporting of adverse drug reactions to pharmaceutical companies or drug regulatory authorities requires internationally accepted standard definitions of reactions and criteria for assessment of causality. Under CIOMS (Council for International Organizations of Medical Sciences) auspices, the Roussel Uclaf pharmaceutical company organized an international meeting concerning drug-induced blood cytopenias. The meeting resulted in proposed standard designations of blood cytopenias and criteria for causality assessment of neutropenia, thrombocytopenia and aplastic anemia.
Benichou
C
C
Roussel Uclaf, Paris, France.
Solal Celigny
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P
D000741:Anemia, Aplastic / Q000097:blood / Q000139:chemically induced* / Q000175:diagnosis; D001772:Blood Cell Count; D001856:Bone Marrow Examination; D002986:Clinical Trials as Topic / Q000592:standards*; D004341:Drug Evaluation / Q000592:standards*; D064420:Drug-Related Side Effects and Adverse Reactions; D006801:Humans; D007390:International Agencies / Q000592:standards*; D007970:Leukopenia / Q000097:blood / Q000139:chemically induced* / Q000145:classification / Q000175:diagnosis; D010198:Pancytopenia / Q000097:blood / Q000139:chemically induced* / Q000175:diagnosis; D011237:Predictive Value of Tests; D013921:Thrombocytopenia / Q000097:blood / Q000139:chemically induced* / Q000175:diagnosis