Table 2.
Completeness of Reporting of Key Safety Outcomes in ClinicalTrials.gov and Publications
| Safety outcome | Trials with safety outcomes reported in ClinicalTrials.gov (n = 91), N (%) | Trials with safety outcomes reported in publication (n = 106), N (%) | Risk Difference (95% CI) |
|---|---|---|---|
| All-cause mortality | |||
| All participants in all trial arms | 68 (74.7%) | 83 (78.3%) | −3.6% (−15.5 – 8.3) |
| Participants in a subset of trial arms | 0 (0%) | 3 (2.8%) | |
| No results for any trial arms | 23 (25.3%) | 20 (18.9%) | |
| Serious adverse events | |||
| All participants in all trial arms | 91 (100%) | 84 (79.2%) | 20.8% (13.0 – 28.5) |
| Participants in a subset of trial arms | 0 (0%) | 1 (0.9%) | |
| No results for any trial arms | 0 (0%) | 21 (19.8%) | |
| Adverse event reporting | |||
| All participants in all trial arms | 91 (100%) | 92 (86.8%) | 13.2% (6.8 – 19.7) |
| Participants in a subset of trial arms | 0 (0%) | 1 (0.9%) | |
| No results for any trial arms | 0 (0%) | 13 (12.3%) | |
| Reporting threshold for adverse events a | |||
| No threshold applied | 9/91 (9.9%) | 3/93 (3.2%) | 6.7% (−0.4 – 13.8) |
| Threshold applied | 82/91 (90.1%) | 70/93 (75.3%) | |
| Not specified | 0/91 (0%) | 20/93 (21.5%) | |
| Withdrawals due to adverse events | |||
| All participants in all trial arms | 57 (62.6%) | 98 (92.5%) | −29.8% (−40.1 – −18.7) |
| Participants in a subset of trial arms | 1 (1.1%) | 2 (1.9%) | |
| No results for any trial arms | 33 (36.3%) | 6 (5.7%) | |
a
Analysis of reporting threshold limited to trials with adverse events reported for all participants or for participants in a subset of trial arms