Table 3:
Treatment-Emergent Adverse Reactions in Safety Population
| Preferred Term | Any Grade | Grade ≥3 |
|---|---|---|
| Nausea | 57 (38) | 0 |
| Fatigue/Malaise | 55 (36) | 2 (1) |
| Arthralgia* | 43 (28) | 4 (3) |
| Constipation | 39 (26) | 0 |
| Leukocytosis | 38 (25) | 14 (9) |
| Dyspnea* | 37 (24) | 4 (3) |
| Rash* | 36 (24) | 2 (1) |
| Pyrexia | 36 (24) | 1 (1) |
| Mucositis | 35 (23) | 5 (3) |
| Diarrhea | 31 (20) | 2 (1) |
| Transaminitis* | 31 (20) | 18 (12) |
| Abdominal Pain | 28 (18) | 1 (1) |
| Edema* | 27 (18) | 4 (3) |
| Cough* | 26 (17) | 1 (1) |
| Differentiation Syndrome | 25 (16) | 13 (8) |
| Vomiting | 25 (16) | 1 (1) |
| Headache | 19 (13) | 0 |
| Hypertension* | 16 (10) | 7 (5) |
Source: FDA Data
Includes Grouped Terms. See Supplementary Table S1 for more information.