Total (column %) | Registration | Timeliness of registrationc, d | Primary outcome Comparisong, h | Primary outcome Resultsi | |||||||
---|---|---|---|---|---|---|---|---|---|---|---|
Unregistered (%)b | RR (95% CI); chi-squared p value | Retrospective (%)e | RR (95% CI); chi-squared p value | Retrospective after initial primary outcome ascertainment (%) e, f | RR (95% CI); chi-squared p value | Non-discordant (%)e | RR (95% CI); chi-squared p value | Favorable (%)j | RR (95% CI); chi-squared p value | ||
Total | 486 (100) | 47 (9.7) | 99 (22.6) | 67 (15.3) | 249 (56.7) | 282 (66.4) | |||||
Drug/device/ biological | |||||||||||
Yes | 392 (80.7) | 31 (7.9) | 0.46 (0.27–0.81); 0.0073 | 65 (18.0) | 0.42 (0.30–0.58); < 0.001 | 42 (11.6) | 0.37 (0.24–0.57); < 0.001 | 216 (59.8) | 1.36 (1.05–1.77); 0.009 | 218 (64.7) | 0.89 (0.77–1.03); 0.16 |
No | 94 (19.3) | 16 (17.0) | 34 (43.6) | 25 (32.1) | 33 (42.3) | 64 (72.7) | |||||
Fundinga | |||||||||||
Industry | 216 (44.4) | 11 (5.1) | 0.38 (0.20–0.73); 0.0023 | 25 (12.2) | 0.39 (0.26–0.58); < 0.001 | 18 (8.8) | 0.41 (0.25–0.68); < 0.001 | 131 (63.9) | 1.22 (1.04–1.42); 0.014 | 117 (65.7) | 0.98 (0.86–1.13); 0.82 |
Non-industry | 270 (55.6) | 36 (13.3) | 74 (31.6) | 49 (20.9) | 118 (50.4) | 165 (66.8) | |||||
Location | |||||||||||
≥ 1 US site | 250 (51.4) | 15 (6.0) | 0.44 (0.25–0.80); 0.0048 | 35 (14.9) | 0.47 (0.33–0.68); < 0.001 | 23 (9.8) | 0.44 (0.28–0.71); < 0.001 | 133 (56.6) | 0.94 (0.80–1.10); 0.44 | 148 (65.8) | 0.98 (0.86–1.12); 0.79 |
Non-US | 236 (48.6) | 32 (13.5) | 64 (31.4) | 44 (21.6) | 116 (56.9) | 134 (67.0) | |||||
Randomized | |||||||||||
Yes | 372 (76.5) | 23 (6.2) | 0.29 (0.17–0.50); < 0.001 | 79 (22.6) | 1.02 (0.66–1.58); 0.91 | 56 (16.0) | 1.30 (0.71–2.36); 0.39 | 195 (55.9) | 0.85 (0.72–1.02); 0.10 | 231 (64.0) | 0.80 (0.69–0.93); 0.01 |
No | 114 (23.5) | 24 (21.1) | 20 (22.2) | 11 (12.2) | 54 (60) | 51 (79.7) | |||||
Enrollment | |||||||||||
≥ 100 | 280 (57.6) | 9 (3.2) | 0.17 (0.09–0.35); < 0.001 | 58 (21.4) | 0.88 (0.62–1.25); 0.49 | 43 (15.9) | 1.10 (0.69–1.74); 0.69 | 162 (59.8) | 1.06 (0.90–1.25); 0.47 | 161 (62.7) | 0.87 (0.76–0.99); 0.046 |
< 100 | 206 (42.4) | 38 (18.5) | 41 (24.4) | 24 (14.3) | 87 (51.8) | 121 (72.0) |