ENA-related serious adverse event
| ENA-related SAE, n (%)∗ . | Phase 2 and Exp (n = 60) . | Phase 1b (n = 17) . | ||||
|---|---|---|---|---|---|---|
| Grade . | 1/2 . | 3+ . | All . | 1/2 . | 3+ . | All . |
| Differentiation syndrome | 0 (0) | 12 (20) | 12 (20) | 0 (0) | 2 (11.8) | 2 (11.8) |
| Acute respiratory failure | 0 (0) | 1 (1.7) | 1 (1.7) | 0 (0) | 0 (0) | 0 (0) |
| Blood bilirubin increased | 0 (0) | 0 (0) | 0 (0) | 0 (0) | 1 (5.9) | 1 (5.9) |
| Cardiomyopathy | 1 (1.7) | 0 (0) | 1 (1.7) | 0 (0) | 0 (0) | 0 (0) |
| Dehydration | 0 (0) | 1 (1.7) | 1 (1.7) | 0 (0) | 0 (0) | 0 (0) |
| Diarrhea | 1 (1.7) | 0 (0) | 1 (1.7) | 0 (0) | 0 (0) | 0 (0) |
| Hypoxia | 0 (0) | 1 (1.7) | 1 (1.7) | 0 (0) | 0 (0) | 0 (0) |
| Nausea | 0 (0) | 0 (0) | 0 (0) | 0 (0) | 1 (5.9) | 1 (5.9) |
| Peripheral embolism | 0 (0) | 1 (1.7) | 1 (1.7) | 0 (0) | 0 (0) | 0 (0) |
| Renal failure | 0 (0) | 1 (1.7) | 1 (1.7) | 0 (0) | 0 (0) | 0 (0) |
| Tumor lysis syndrome | 0 (0) | 1 (1.7) | 1 (1.7) | 0 (0) | 0 (0) | 0 (0) |
| ENA-related SAE, n (%)∗ . | Phase 2 and Exp (n = 60) . | Phase 1b (n = 17) . | ||||
|---|---|---|---|---|---|---|
| Grade . | 1/2 . | 3+ . | All . | 1/2 . | 3+ . | All . |
| Differentiation syndrome | 0 (0) | 12 (20) | 12 (20) | 0 (0) | 2 (11.8) | 2 (11.8) |
| Acute respiratory failure | 0 (0) | 1 (1.7) | 1 (1.7) | 0 (0) | 0 (0) | 0 (0) |
| Blood bilirubin increased | 0 (0) | 0 (0) | 0 (0) | 0 (0) | 1 (5.9) | 1 (5.9) |
| Cardiomyopathy | 1 (1.7) | 0 (0) | 1 (1.7) | 0 (0) | 0 (0) | 0 (0) |
| Dehydration | 0 (0) | 1 (1.7) | 1 (1.7) | 0 (0) | 0 (0) | 0 (0) |
| Diarrhea | 1 (1.7) | 0 (0) | 1 (1.7) | 0 (0) | 0 (0) | 0 (0) |
| Hypoxia | 0 (0) | 1 (1.7) | 1 (1.7) | 0 (0) | 0 (0) | 0 (0) |
| Nausea | 0 (0) | 0 (0) | 0 (0) | 0 (0) | 1 (5.9) | 1 (5.9) |
| Peripheral embolism | 0 (0) | 1 (1.7) | 1 (1.7) | 0 (0) | 0 (0) | 0 (0) |
| Renal failure | 0 (0) | 1 (1.7) | 1 (1.7) | 0 (0) | 0 (0) | 0 (0) |
| Tumor lysis syndrome | 0 (0) | 1 (1.7) | 1 (1.7) | 0 (0) | 0 (0) | 0 (0) |
Only the worst grade of the same adverse event was counted for the same patient. Overall, ENA-related serious adverse events occurred in 15 patients during phase 2 and 3 patients during phase 1b.