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