Table 2 Reporting adverse events for glaucoma trials (n = 79) in the ClinicalTrials.gov and the corresponding publication.
ClinicalTrials.gov | Publication | P-value | |
|---|---|---|---|
Reporting rate (n, %) | |||
SAEs | 79 (100) | 65 (82) | < .001a |
OAEs | 79 (100) | 78 (99) | .32a |
Deaths | 37 (47) | 26 (33) | .07a |
AEs reported as zero (n, %) | |||
SAEs | 20 (25) | 27 (34) | .22a |
OAEs | 16 (20) | 3 (4) | .001a |
Deaths | 26 (33) | 18 (23) | .37a |
Number of different AEs reported per trial (median, IQR/range) | |||
SAEs | 3 (0–8/0–74) | 1 (1–4/0–23) | .22b |
OAEs | 4 (1–9/0–64) | 10.5 (6–15/0–47) | .001b |
Deaths | 0 (0–0/0–4) | 0 (0–1/0–5) | .37b |
Number of patients with AEs per trial (median, IQR/range) | |||
SAEs | 2 (0–7/0–74) | 2 (1–6/0–74) | .93b |
OAEs | 27 (5–95.5/0–507 | 53 (120.3–124.7/0–555) | .02b |
Deaths | 0 (0–0/0–4) | 0 (0–1/0–5) | .53b |