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Table 3 Proportion of trials for which data, including harms data, could be obtained from the sources examined (n = 42)

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 ClincalTrials.gov EU Clinical Trials Register Publications
Source of data identified 37 (88%) 36 (86%) 20 (48%) 32 (76%)
Reporting of
 Included participants
  Number of participants randomised 37 (100%) 36 (100%) 19 (95%) 32 (100%)
  Number of participants in safety population 37 (100%) 36 (100%) 19 (95%) 32 (100%)
 Serious adverse events (SAEs)
  Number of patients with at least one SAE 37 (100%) 36 (100%) 19 (95%) 16 (50%)
  Total number of SAEs 9 (24%) 10 (28%) 17 (85%) 1 (3%)
Any adverse events (AEs)
  Number of patients with at least one AE 37 (100%) 0 (0%) 0 (0%) 13 (41%)
  Total number of AEs 12 (32%) 10 (28%) 17 (85%) 0 (0%)
 CTCAE grade 3–5 AEs
  Number of patients with at least one Grade 3–5 AE 36 (97%) 0 (0%) 0 (0%) 14 (44%)
  Total number of Grade 3–5 AEs 6 (16%) 0 (0%) 0 (0%) 0 (0%)
 Deaths due to AEs
  Number of deaths due to AEs 34 (92%) 0 (0%) 15 (75%) 12 (38%)
  Information on how it was decided whether a death was considered due to an AE 10 (27%) 0 (0%) 0 (0%) 0 (0%)
 Discontinuations due to AEs
  Number of patients who discontinued trial due to AEs 32 (86%) 28 (78%) 17 (85%) 25 (78%)
  1. CSR clinical study report, CTCAE Common Terminology Criteria for Adverse Events