Table 4 Serious treatment-emergent AEs.
Preferred term, n (%) | Safety population (N = 39) | NCI CTCAE | |||
|---|---|---|---|---|---|
Grade 1 | Grade 2 | Grade 3 | Grade 4 | ||
Patients with ≥1 serious AE | 7 (17.9) | 0 | 1 (2.6) | 5 (12.8) | 2 (5.1) |
Gastroenteritis viral | 1 (2.6) | 0 | 0 | 1 (2.6) | 0 |
Parainfluenza virus infection | 1 (2.6) | 0 | 0 | 1 (2.6) | 0 |
Seizure | 4 (10.3) | 0 | 0 | 3 (7.7) | 1 (2.6) |
Headache | 1 (2.6) | 0 | 1 (2.6) | 0 | 0 |
Hydrocephalus | 1 (2.6) | 0 | 0 | 1 (2.6) | 0 |
Hypertension | 1 (2.6) | 0 | 0 | 0 | 1 (2.6) |
