Summary of All AEs with Relatedness by Maximum Toxicity Grade Occurring in ≥25% of Patients (n = 12)
| Grade 1 | Grade 2 | Grade 3 | Grade 4 | Total | ||||||
| AE | Related | All | Related | All | Related | All | Related | All | Related | All |
| Subjects with any event | 5 (42) | 1 (8) | 3 (25) | 4 (33) | 2 (17) | 5 (42) | 0 | 2 (17) | 10 (83) | 12 (100) |
| Nausea | 4 (33) | 7 (58) | 1 (8) | 2 (17) | 0 | 1 (8) | 0 | 0 | 5 (42) | 10 (83) |
| Lethargy | 0 | 6 (50) | 0 | 4 (33) | 0 | 0 | 0 | 0 | 0 | 10 (83) |
| Vomiting | 5 (42) | 7 (58) | 0 | 1 (8) | 0 | 0 | 0 | 1 (8) | 5 (42) | 9 (75) |
| Decreased appetite | 2 (17) | 5 (42) | 0 | 4 (33) | 0 | 0 | 0 | 0 | 2 (17) | 9 (75) |
| Diarrhea | 3 (25) | 5 (42) | 1 (8) | 3 (25) | 0 | 0 | 0 | 0 | 4 (33) | 8 (67) |
| Rash* | 4 (33) | 5 (42) | 0 | 0 | 1 (8) | 1 (8) | 0 | 0 | 5 (42) | 6 (50) |
| Constipation | 0 | 3 (25) | 0 | 2 (17) | 0 | 0 | 0 | 0 | 0 | 5 (42) |
| Dizziness | 0 | 3 (25) | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 3 (25) |
| Insomnia | 0 | 2 (17) | 0 | 1 (8) | 0 | 0 | 0 | 0 | 0 | 3 (25) |
| Fatigue | 0 | 2 (17) | 0 | 1 (8) | 0 | 0 | 0 | 0 | 0 | 3 (25) |
↵* Preferred term for related AE of rash was rash macular-papular.
Data are number, with percentage in parentheses.