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Table 4 Discrepancies in harms data between CSRs, trial registries, and publications for variables that were reported in two sources

From: Reporting of harms in oncological clinical study reports submitted to the European Medicines Agency compared to trial registries and publications—a methodological review

  CSR and trial registries CSR and publications Publications and trial registries
Discrepancies
 Number of patients with at least one SAE 15/32 trials (47%) 5/13 trials (38%) 8/14 trials (57%)
 Total number of SAEs 5/5 trials (100%) 0/1 trial (0%) No trials with data from both sources
 Number of patients with at least one AE No trials with data from both sources 2/11 trials (18%) No trials with data from both sources
 Total number of AEs 5/5 trials (100%) No trials with data from both sources No trials with data from both sources
 Number of patients with at least one Grade 3–5 AE No trials with data from both sources 7/12 trials (58%) No trials with data from both sources
 Total number of Grade 3–5 AEs No trials with data from both sources No trials with data from both sources No trials with data from both sources
 Number of deaths due to AEs 12/13 trials (92%) 4/10 trials (40%) 4/4 trials (100%)
 Number of patients who discontinued trial due to AEs 23/26 trials (88%) 18/20 trials (90%) 11/18 trials (61%)
  1. CSR clinical study report, AE adverse event, SAE serious adverse event
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BMC Medicine

ISSN: 1741-7015

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