TRAEs of any grade in ≥2 patients or any grade 3 events in any patient (N=32)
| Any grade | Grade 3 | |
| Patients with any TRAE | 22 (69) | 11 (34) |
| Asthenia | 5 (16) | 0 |
| Hypothyroidism | 5 (16) | 0 |
| Pruritus | 5 (16) | 0 |
| Rash maculopapular | 5 (16) | 2 (6) |
| ALT increased | 4 (13) | 1 (3) |
| AST increased | 4 (13) | 1 (3) |
| Stomatitis | 3 (9) | 0 |
| Anemia | 2 (6) | 1 (3) |
| Decreased appetite | 2 (6) | 0 |
| Diarrhea | 2 (6) | 0 |
| Fatigue | 2 (6) | 0 |
| Musculoskeletal pain | 2 (6) | 0 |
| Hyperthyroidism | 2 (6) | 1 (3) |
| Colitis | 1 (3) | 1 (3) |
| Diabetic ketoacidosis | 1 (3) | 1 (3) |
| Hyperglycemia | 1 (3) | 1 (3) |
| Hyperkeratosis follicularis and parafollicularis | 1 (3) | 1 (3) |
| GGT increased | 1 (3) | 1 (3) |
| Lipase increased | 1 (3) | 1 (3) |
| Skin lesions* | 4 (13) | 2 (6) |
| Keratoacanthoma | 3 (9) | 1 (3) |
| SCC of skin | 2 (6) | 1 (3) |
Data are number (%) unless otherwise stated.
*Includes MedDRA V.21.0 preferred terms ‘SCC of skin’, ‘basal cell carcinoma’, ‘keratoacanthoma’, ‘hyperkeratosis’ and ‘actinic keratosis’. In addition to those shown, 1 patient who reported keratoacanthoma and SCC of skin (as above) also reported grade 2 actinic keratosis and grade 2 basal cell carcinoma.
ALT, alanine aminotransferase; AST, aspartate aminotransferase; GGT, gamma-glutamyltransferase; SCC, squamous cell carcinoma; TRAE, treatment-related adverse event.