Table 3.
Cycle 1 Drug-Related Toxicities (possible, probable, or definite) in Patients With HGG by Category
| Category | No. of Events (%) |
|||
|---|---|---|---|---|
| Toxicity Grade |
Related SAE | |||
| 1-2 | 3-4 | 5 | ||
| All toxicities (n = 565) | 512 (90.6) | 52 (9.2) | 1 (< 1) | 33 (5.8) |
| Constitutional | 89 (15.7) | 8 (1.4) | 8 (1.4) | |
| Cardiovascular | 22 (3.8) | 1 (< 0.5) | 1 (< 0.5) | |
| GI | 84 (14.8) | 2 (< 0.5) | 2 (< 0.5) | |
| Respiratory | 4 (< 1) | 2 (< 0.5) | 2 (< 0.5) | |
| Metabolic | 34 (6) | 3 (< 0.5) | 3 (< 0.5) | |
| Dermatologic | 35 (6) | 6 (1) | 6 (1) | |
| Neurologic | 35 (6) | 5 (< 1) | 5 (< 1) | |
| Hematologic | ||||
| WBC | 42 (7) | 12 (2) | 5 (< 1) | |
| Hemoglobin | 73 (13) | 1 (0.8) | ||
| Platelets | 61 (11) | 12 (2) | ||
| Others | 29 (5) | 1 (< 1) | 1 | |
| Subcategories of all related neurologic toxicities during cycle 1 | ||||
| Encephalopathy | 4 | 0 | 0 | |
| Headache | 18 | 1 | 0 | |
| Neuropathy | 18 | 2 | 0 | |
| Other | 35 | 3 | 0 | |
| Total | 75 | 6 | 0 | |
NOTE. Toxicities within each category are listed on a per-patient basis. The sum of neurologic subcategories is greater than listed under neurology category.
Abbreviations: HGG, high-grade glioma; SAE, serious adverse event.