Table 2.
Overall AE profile in overall population and across age groups.
| Overall (N = 179) n (%) | Age at consent, years | |||||
|---|---|---|---|---|---|---|
| ≤2 (N = 7) n (%) | >2 to ≤9 (N = 27) n (%) | >9 to <18 (N = 27) n (%) | ≥18 (N = 118) n (%) | P-value | ||
| Overall, any AEs | 118 (65.9) | 6 (85.7) | 21 (77.8) | 19 (70.4) | 72 (61) | |
| Patients with frequent (>3%) adverse events with CTC grade | ||||||
| Grade 1 | 40 (22.3) | 2 (28.6) | 8 (29.6) | 8 (29.6) | 22 (18.6) | |
| Grade 2 | 27 (15.1) | 1 (14.3) | 2 (7.4) | 4 (14.8) | 20 (16.9) | |
| Grade 3 | 16 (8.9) | 2 (28.6) | 5 (18.5) | 2 (7.4) | 7 (5.9) | |
| Grade 4 | 2 (1.1) | 0 | 0 | 0 | 2 (1.7) | |
| Patients with grade 3/4 AEs | 43 (24.0) | 4 (57.1) | 8 (29.6) | 6 (22.2) | 25 (21.2) | |
| Patients with SAE | 54 (30.2) | 5 (71.4) | 12 (44.4) | 7 (25.9) | 30 (25.4) | 0.0567 |
| AE requiring dose adjustment | 56 (31.3) | 5 (71.4) | 10 (37.0) | 9 (33.3) | 32 (27.1) | 0.1342 |
| AE leading to discontinuation | 9 (5.0) | 1 (14.3) | 1 (3.7) | 1 (3.7) | 6 (5.1) | 0.8357 |
| Treatment-related AE | 76 (42.5) | 6 (85.7) | 15 (55.6) | 16 (59.3) | 39 (33.1) | 0.0023 |
| Deaths | 3 (1.7) | 0 | 0 | 0 | 3 (2.5) | |
AE, adverse event; CTC, Common Terminology Criteria; SAE, serious adverse events.