SAEs n (%) | OAEs n (%) | Deaths n (%) | |
---|---|---|---|
Reporting rate | |||
ClinicalTrials.gov | 45 (100.0) | 45 (100.0) | 14 (100.0)a |
Publications | 34 (75.6) | 44 (97.8) | 6 (42.9) |
P value b | < 0.001 | 0.317 | 0.001 |
AEs reported as zero | |||
ClinicalTrials.gov | 24 (53.3) | 12 (26.7) | 12 (85.7) |
Publications | 18 (40.0) | 5 (11.1) | 5 (35.7) |
P value c | 0.001 | < 0.001 | 0.014 |
Number of reported AEs per trial (range) | |||
ClinicalTrials.gov | 0–28 | 0–10,648 | 0–1 |
Publications | 0–15 | 0–2,769 | 0–1 |
P value b | 0.003 | < 0.001 | 0.127 |
Number of patients with AEs per trial (range) | |||
ClinicalTrials.gov | 0–23 | 0–1,031 | 0–1 |
Publications | 0–11 | 0–1,215 | 0–1 |
P value b | 0.006 | < 0.001 | 0.127 |
Reported AEs per trial (median, 95% CI) | |||
ClinicalTrials.gov | 0 (95% CI 0.87–4.51) | 21 (95% CI -60.86–1000.59) | 0 (95% CI -0.07–0.35) |
Publications | 0 (95% CI 0.30–2.01) | 77.5 (95% CI 57.78–338.31) | 0 (95% CI -0.05–0.14) |
Number of patients with AEs per trial (median, 95% CI) | |||
ClinicalTrials.gov | 0 (95% CI 0.78–3.88) | 18 (95% CI 26.39–150.59) | 0 (95% CI -0.07–0.35) |
Publications | 0 (95% CI 0.28–1.72) | 59 (95% CI 54.75–188.73) | 0 (95% CI -0.05–0.14) |