Characteristic | Integrated safety analysis | CANTAM PA (N = 2599) | |
---|---|---|---|
PA (N = 667) | AL (N = 358) | ||
Sex, n (%) | |||
Male | 310 (46.5) | 183 (51.1) | 1283 (49.4) |
Female | 357 (53.5) | 175 (48.9) | 1316 (50.6) |
Mean age, years (SD) [range] | 4.1 (2.0) [0–10] | 4.3 (2.0) [0–11] | 3.5 (2.0) [0–17] |
Age category, n (%) | |||
≤ 6 months | 4 (0.6) | 3 (0.8) | 35 (1.3) |
> 6 months to < 1 year | 16 (2.4) | 5 (1.4) | 101 (3.9) |
≥ 1 to < 3 years | 131 (19.6) | 55 (15.4) | 769 (29.6) |
≥ 3 to < 6 years | 370 (55.5) | 206 (57.5) | 1258 (48.4) |
≥ 6 years | 146 (21.9) | 89 (24.9) | 436 (16.8) |
Mean body weight, kg (SD) [range] | 14.6 (3.1) [6.0–19.9] | 14.9 (2.8) [7.2–19.9] | 14.0 (3.3) [5.7–19.9] |
Body weight category, n (%) | |||
≥ 5 to < 8 kg | 7 (1.0) | 3 (0.8) | 70 (2.7) |
≥ 8 to < 15 kg | 319 (47.8) | 165 (46.1) | 1268 (48.8) |
≥ 15 to < 20 kg | 341 (51.1) | 190 (53.1) | 1261 (48.5) |
Body mass index, kg/m2 (SD) [range] | 14.7 (1.7) [6.0–24.5] | 14.5 (1.6) [8.0–21.9] | 14.9 (2.1) [7.9–32.0] |