All n = 21 | 6 to < 12 years n = 4 | 12 to 17 years n = 17 | |
---|---|---|---|
Mean duration of follow-up (days) | 176.7 | 169 | 179 |
Mean number of infusions | 4.3 | ||
AEs, n (%) | 20 (95.2) | 4 (100.0) | 16 (94.1) |
ADRs, n (%) | 15 (71.4) | 3 (75.0) | 12 (70.6) |
AEs leading to discontinuation of IFX, n (%) | 1 (4.8) | 0 (0.0) | 1 (5.9) |
SAEs, n (%) | 3 (14.3) | 0 (0.0) | 3 (17.6) |
Serious ADRs, n (%) | 1 (4.8) | 0 (0.0) | 1 (5.9) |
Infections, n (%) | 13 (61.9) | 4 (100) | 9 (52.9) |
Serious infections, n (%) | 1 (4.8) | 0 (0.0) | 1 (5.9) |
Infusion reactions, n (%) | 2 (9.5) | 0 (0.0) | 2 (11.8) |
Serious infusion reactions, n (%) | 0 (0.0) | 0 (0.0) | 0 (0.0) |