TABLE 3.
TRAEs of Any Grade Reported by ≥15% of Patients or Grade ≥3 TRAEs Reported by ≥5% of Patients
| Category | Event | All Grades, No. (%) | Grade 3, No. (%) | Grade 4, No. (%) |
|---|---|---|---|---|
| GI disorders | Diarrhea | 29 (71) | 8 (20) | 0 |
| Nausea | 23 (56) | 3 (7) | 0 | |
| Vomiting | 12 (29) | 0 | 0 | |
| Stomatitis | 7 (17) | 0 | 0 | |
| General disorders and administration site conditions | Fatigue | 13 (32) | 3 (7) | 0 |
| Asthenia | 17 (41) | 3 (7) | 0 | |
| Skin and subcutaneous tissue disorders | Alopecia | 16 (39) | 0 | 0 |
| Pruritus | 10 (24) | 0 | 0 | |
| Blood and lymphatic system disorders | Anemia | 20 (49) | 7 (17) | 0 |
| Neutropenia | 21 (51) | 8 (20) | 7 (17) | |
| Febrile neutropenia | 4 (10) | 4 (10) | 0 | |
| Leukopenia | 11 (27) | 4 (10) | 4 (10) | |
| Metabolism and nutrition disorders | Decreased appetite | 12 (29) | 2 (5) | 0 |
| Hypomagnesemia | 7 (17) | 0 | 0 | |
| Respiratory, thoracic, and mediastinal disorders | Pneumonitis | 2 (5) | 0 | 2 (5) |
Abbreviation: TRAEs, treatment-related adverse events.