Table 4

Reporting of adverse events and harm-related endpoints

Trial characteristicN totalN (%)
Plans to collect data on adverse events or side effects (in methods)
 Reported300134 (45)
 Not reported166 (55)
Method for collecting adverse events data
 Specified300109 (36)
 Not specified191 (64)
Adverse events*
 Reported data on harms300143 (48)
 Reported severe harms52/143 (36)
 Reported any harm (not individually described)16/143 (11)
 Reported organ-system level harms13/143 (9)
 Reported specific harms106/143 (74)
 Reported that no harms occurred22/143 (15)
 Did not report data on harms157 (52)
Harm-related endpoints†
 Reported data on harm-related endpoints300215 (72)
 Reported discontinuations due to adverse events54/215 (25)
 Reported unexplained withdrawals114/215 (53)
 Reported mortality47/215 (22)
 Reported no discontinuations due to adverse events57/215 (27)
 Did not report data on harm-related endpoints85 (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.