Table 3 Pre- vs post‑registry publication timing: discrepancies & omissions.
Outcome | Pre-publication before CT.gov results | Post-publication after CT.gov results | OR (95% CI) | RR (95% CI) | p-value |
|---|---|---|---|---|---|
SAEs | |||||
Different # of participant | 8/17 (47.1%) | 10/40 (25.0%) | 2.62 (0.68–10.25) | 1.88 (0.90–3.93) | 0.1262 |
Different # of total events | 8/17 (47.1%) | 18/40 (45.0%) | 1.08 (0.30–3.93) | 1.05 (0.57–1.92) | 1.0000 |
Omitted in publication (no mention) | 7/17 (41.2%) | 2/40 (5.0%) | 12.53 (1.99–141.97) | 8.24 (1.90–35.66) | 0.0018 |
OAEs | |||||
Different # of participant | 12/17 (70.6%) | 32/40 (80.0%) | 0.61 (0.14–2.84) | 0.88 (0.63–1.24) | 0.4988 |
Different # of total events | 14/17 (82.4%) | 37/40 (92.5%) | 0.39 (0.05–3.23) | 0.89 (0.70–1.13) | 0.3492 |
Omitted in publication (no mention) | 2/17 (11.8%) | 3/40 (7.5%) | 1.63 (0.12–15.77) | 1.57 (0.29–8.56) | 0.6289 |
Mortality | |||||
Different # reported | 10/17 (58.8%) | 19/40 (47.5%) | 1.57 (0.43–5.92) | 1.24 (0.74–2.07) | 0.5648 |
Discontinuations due to AEs | |||||
Different # reported | 2/17 (11.8%) | 17/40 (42.5%) | 0.19 (0.02–0.97) | 0.28 (0.07–1.07) | 0.0322 |
