Reporting of adverse events and harm-related endpoints
| Trial characteristic | N total | N (%) |
| Plans to collect data on adverse events or side effects (in methods) | ||
| Reported | 300 | 134 (45) |
| Not reported | 166 (55) | |
| Method for collecting adverse events data | ||
| Specified | 300 | 109 (36) |
| Not specified | 191 (64) | |
| Adverse events* | ||
| Reported data on harms | 300 | 143 (48) |
| Reported severe harms | 52/143 (36) | |
| Reported any harm (not individually described) | 16/143 (11) | |
| Reported organ-system level harms | 13/143 (9) | |
| Reported specific harms | 106/143 (74) | |
| Reported that no harms occurred | 22/143 (15) | |
| Did not report data on harms | 157 (52) | |
| Harm-related endpoints† | ||
| Reported data on harm-related endpoints | 300 | 215 (72) |
| Reported discontinuations due to adverse events | 54/215 (25) | |
| Reported unexplained withdrawals | 114/215 (53) | |
| Reported mortality | 47/215 (22) | |
| Reported no discontinuations due to adverse events | 57/215 (27) | |
| Did not report data on harm-related endpoints | 85 (28) | |
*52 of the 121 trials (43%) that reported harms reported more than one type of harm.
†51 of the 158 trials (32%) that reported the occurrence of harm-related endpoints reported more than one type of harm-related endpoint.