Table 2.
Serious adverse events (CTCAE grade 3–5)
| Toxicity category | Toxicity | Cohort 1 | Cohort 2 | Cohort 3 |
|---|---|---|---|---|
| General symptoms | Fatigue | 1 (14) | 1 (13) | |
| Angioedema | 1 (14) | |||
| Dehydration | 2 (28) | |||
| Lab abnormalities | ALT Elevation | 1 (13) | ||
| AST Elevation | 1 (25) | 1+ (14) | 2 (25) | |
| Alkaline phosphatase elevation | 2+ (28) | 1 (13) | ||
| Elevated bilirubin | 1+ (14) | |||
| Tumor lysis syndrome | 1* (13) | |||
| Hypophosphatemia | 1 (13) | |||
| Anemia | 2 (28) | 1 (13) | ||
| Neutropenia | 1* (14) | |||
| Thrombocytopenia | 1 (13) | |||
| Gastrointestinal symptoms | Mucositis | 1 (14) | 1 (13) | |
| Diarrhea | 1 (14) | 1 (13) | ||
| Nausea/vomiting | 1 (13) | |||
| Hepatorenal syndrome | 1* (13) | |||
| Infectious complications | Gram positive bacteremia | 2+** (25) | ||
| Pneumonia+ | 1 (25) | |||
| Perforated diverticulitis+ | 1* (13) | |||
| Neurologic symptoms | Gait imbalance+ | 1 (14) | ||
| Hydrocephalus+ | 1* (25) | |||
| Peripheral neuropathy | 1 (13) |
+Due to disease progression rather than study medication. *Grade 4 events included neutropenia, tumor lysis syndrome, hepatorenal syndrome, gram positive sepsis, diverticulitis, and hydrocephalus. **Grade 5 event included an episode of gram positive sepsis. The percentage of adverse events in each cohort is indicated in ().