Table 1.
Availability of Trial-Level Safety Data for 156 Clinical Drug Trials
| Trials with safety results reported | Median time to reporting,a months | ||||
|---|---|---|---|---|---|
| ClinicalTrials.gov N (%) | Publications N (%) | Risk Difference (95% CI) | ClinicalTrials.gov, median (IQR) | Publications, median (IQR) | |
| All-cause mortality | 68 (43.6%) | 86 (55.1%) | −11.5% (−22.6 – −0.5) | 2.7 (1.2 – 5.6) | 0 (0 – 4.2) |
| Serious adverse events | 91 (58.3%) | 85 (54.5%) | 3.8 % (−7.2 – 14.8) | 1.9 (0 – 3.9) | 0 (0 – 2.4) |
| Adverse events | 91 (58.3%) | 93 (59.6%) | −1.3 % (−12.2 – 9.6) | 1.9 (0 – 3.9) | 0 (0 – 3.4) |
| Withdrawals due to adverse event | 58 (37.2%) | 100 (64.1%) | −27.0 % (−37.6 – −16.2) | 2.1 (0 – 5.1) | 0 (0 – 3.4) |
a
Represents time from FDA drug approval to availability of trial safety data