Table 2.
Treatment-emergent AEs occurring in ≥ 5 patients (15%), regardless of attribution
| AEs | All patients (N = 27) | |
|---|---|---|
| All grades | Grade ≥ 3* | |
| Any AE | 27 (100) | 10 (37) |
| Nausea | 25 (93) | 3 (11) |
| Diarrhea | 21 (78) | 0 |
| Vomiting | 11 (41) | 1 (4) |
| Fatigue | 10 (37) | 2 (7) |
| Constipation | 9 (33) | 0 |
| Headache | 8 (30) | 0 |
| Dizziness | 7 (26) | 0 |
| Abdominal pain | 6 (22) | 0 |
| Taste disorder | 6 (22) | 0 |
| Decreased appetite | 6 (22) | 0 |
| Insomnia | 6 (22) | 1 (4) |
| Anemia | 5 (19) | 0 |
| Thrombocytopenia† | 5 (19) | 0 |
All data are n (%).
*
One grade 4 event (atrial fibrillation; n = 1), but no grade 5 events, occurred during the study.
†
Includes the terms “thrombocytopenia” and “platelet count decreased,” as defined by the Medical Dictionary for Regulatory Activities.