Table 3.
Summary of adverse events reported in cohorts A–C
| Adverse events | All patients (n = 120) |
Prophylaxis: cohort A (n = 88) |
Treatment: cohort B (n = 7) |
Treatment: cohort C (n = 25) |
|---|---|---|---|---|
| Individual adverse events (CTCAE any grade) | ||||
| Adverse events (any grade) [n (%)] | 95 (79.2) | 69 (78.4) | 6 (85.7) | 20 (80.0) |
| Headache [n (%)] | 83 (69.2) | 61 (69.3) | 6 (85.7) | 16 (64.0) |
| Nausea [n (%)] | 25 (20.8) | 13 (14.8) | 2 (28.6) | 10 (40.0) |
| Fever [n (%)] | 20 (16.7) | 12 (13.6) | 2 (28.6) | 6 (24.0) |
| Neurological deficits [n (%)] | 10 (8.3) | 3 (3.4) | 0 (0.0) | 7 (28.0) |
| Dizziness [n (%)] | 8 (6.7) | 3 (3.4) | 1 (14.3) | 4 (16.0) |
| Vomiting [n (%)] | 8 (6.7) | 5 (5.7) | 1 (14.3) | 2 (8.0) |
| Myelopathy [n (%)] | 2 (1.7) | 1 (1.1) | 0 (0.0) | 1 (4.0) |
| Individual adverse events (CTCAE grade 3) | ||||
| Grade 3 events [n (%)] | 7 (5.8) | 6 (6.8) | 0 (0.0) | 1 (4.0) |
| Headaches [n (%)] | 5 (4.1) | 4 (4.5) | 0 (0.0) | 1 (4.0) |
| Fever | 1 (0.8) | 1 (1.1) | 0 (0.0) | 0 (0.0) |
| Nausea | 1 (0.8) | 1 (1.1) | 0 (0.0) | 0 (0.0) |
Only seven patients developed grade 3 AEs: five headaches, one fever, one nausea: six of them were reported in cohort A (CNS prophylaxis), one in cohort C (CNS lymphoma therapy)