Table 3 Adverse events in the integrated safety analysis and CANTAM
Adverse event | Integrated safety analysis | CANTAM PA (N = 2599) | ||||||
|---|---|---|---|---|---|---|---|---|
PA (N = 667) | AL (N = 358) | Relative risk % (95% CI) | P valuea | |||||
N | % (95% CI) | N | % (95% CI) | N | % (95% CI) | |||
Any | 426 | 63.9 (60.2, 67.4) | 222 | 62.0 (56.9, 66.9) | 1.0 (0.93, 1.1) | 0.59 | 460 | 17.7 (16.3, 19.2) |
Drug-related | 200 | 30.0 (26.6, 33.6) | 134 | 37.4 (32.6, 42.6) | 0.80 (0.67, 0.96) | 0.017 | 218 | 8.4 (7.4, 9.5) |
Serious | 8 | 1.2 (0.6, 2.3) | 1 | 0.3 (0.01, 1.6) | 4.3 (0.70, 26.4) | 0.17 | 11 | 0.4 (0.2, 0.8) |
Serious drug-related | 4 | 0.6 (0.2, 1.5) | 1 | 0.3 (0.01, 1.6) | 2.1 (0.32, 14.3) | 0.66 | 3 | 0.1 (0.03, 0.3) |
Severe or life-threatening | 11 | 1.6 (0.9, 2.9) | 4 | 1.1 (0.4, 2.8) | 1.5 (0.50, 4.4) | 0.59 | 8 | 0.3 (0.2, 0.6) |
Leading to death | 1 | 0.1 (0.008, 0.8) | 0 | 0 (0, 1.1) | NA | 1.0 | 0 | 0 (0, 0.1) |