RADAR assessment of quality of reporting of serious adverse drug reactions (sADRs) to an Institutional Review Board (IRB) for 14 clinical trials with imatinib mesylate

摘要: 6588 Background: Although sADR reporting to IRBs is intended be an important part of safety efforts, the quality these reports has not been adequately studied. We evaluated completeness standard IRB versus information for same sADRs abstracted from primary data sources on structured case report forms at a comprehensive cancer center (CCC). Methods: Subjects participated in 14 phase I- III clinical trials with imatinib 1 3 NCI-designated CCCs. Completeness (using CTCAE-3 criteria), causality assessments Naranjo instrument) 2 known drug-associated (edema/pulmonary edema) and (bone fractures/infections), incidence, prevalence rates were measured. Results: Of 115 177 subjects, overall was 2.4-fold greater (95.0% 40.3%, p<0.05). Information supporting recorded 3...