Table 1.
Adverse events.
| AEs | n (%) | Grades 1-2, n (%) | Grade 3, n (%) |
|---|---|---|---|
| Any TRAE | 9 (100) | – | – |
| Grades 1-2 TRAE | 9 (100) | – | – |
| Grades 3-5 TRAE | 5 (56) | – | – |
| Treatment-related SAE | 4 (44) | – | – |
| Treatment related to discontinuation | 1 (11) | – | – |
| Treatment leading to death | 0 (0) | – | – |
| Most common TRAEs (>10% of patients) | |||
| Rash | 6 (67) | 3 (33) | 3 (33) |
| Diarrhea | 5 (56) | 4 (44) | 1 (11) |
| Pruritus | 3 (33) | 3 (33) | 0 (0) |
| Fatigue | 3 (33) | 3 (33) | 0 (0) |
| Other AEs of interest | |||
| Retinal detachment | 1 (11) | 0 (0) | 1 (11) |
| Increase in AST | 1 (11) | 0 (0) | 1 (11) |
| Increase in ALT | 1 (11) | 1 (11) | 0 (0) |
Abbreviation: AE: adverse events; AST: aspartate aminotransferase; ALT: alanine aminotransferase; SAE: serious adverse event; TRAE: treatment emergent adverse event.