Table 5 Incidence of vomiting and prolonged QT interval by body weight in the integrated safety analysis and CANTAM
Adverse event by body weight | Integrated safety analysis | CANTAMb PA (N = 2599) | ||||||
|---|---|---|---|---|---|---|---|---|
PA (N = 667) | AL (N = 358) | Relative risk % (95% CI) | P valuea | |||||
n/N | % (95% CI) | n/N | % (95% CI) | n/N | % (95% CI) | |||
Vomiting | ||||||||
≥ 5 to < 8 kg | 2/7 | 28.6 (5.1, 64.1) | 1/3 | 33.3 (1.7, 88.2) | 0.86 (0.16, 5.7) | 1.00 | 4/70 | 5.7 (2.2, 13.8) |
≥ 8 to < 15 kg | 40/319 | 12.5 (9.3, 16.6) | 7/165 | 4.2 (2.1, 8.5) | 3.0 (1.4, 6.4) | 0.003 | 100/1268 | 7.9 (6.5, 9.5) |
≥ 15 to < 20 kg | 10/341 | 2.9 (1.6, 5.3) | 4/190 | 2.1 (0.8, 5.3) | 1.4 (0.47, 4.2) | 0.78 | 37/1261 | 2.9 (2.1, 4.0) |
Prolonged QT interval | ||||||||
≥ 5 to < 8 kg | 0/7 | 0 (0, 35.4) | 1/3 | 33.3 (1.7, 88.2) | 0 (0, 1.5) | 0.30 | 0/70 | 0 (0, 5.2) |
≥ 8 to < 15 kg | 13/319 | 4.1 (2.4, 6.8) | 18/165 | 10.9 (7.0, 16.6) | 0.37 (0.19, 0.73) | 0.006 | 0/1268 | 0 (0, 0.30) |
≥ 15 to < 20 kg | 8/341 | 2.3 (1.2, 4.6) | 10/190 | 5.3 (2.9, 9.4) | 0.45 (0.18, 1.1) | 0.084 | 0/1261 | 0 (0, 0.30) |