Table 2 Baseline demographic and clinical characteristics for the integrated safety analysis and CANTAM

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]