Table 4.
Treatment-related adverse events reported during the study
| Patients experiencing any grade TRAEs*, n (%) | 496 (34.9) |
|---|---|
| Any grade TRAEs reported in ≥1% of patients*, n (%) | |
| Asthenia | 79 (5.6) |
| Diarrhea | 61 (4.3) |
| Pruritus | 55 (3.9) |
| Hypothyroidism | 42 (3.0) |
| Hyperthyroidism | 39 (2.7) |
| Arthralgia | 36 (2.5) |
| Fatigue | 25 (1.8) |
| Decreased appetite | 22 (1.5) |
| Anemia | 20 (1.4) |
| Interstitial lung disease | 17 (1.2) |
| Dry skin | 17 (1.2) |
| Rash | 14 (1.0) |
| Patients experiencing grade 3–4 TRAEs*, n (%) | 117 (8.2) |
| Grade 3–4 TRAEs reported in ≥0.3% of patients*, n (%) | |
| Diarrhea | 11 (0.8) |
| Asthenia | 9 (0.6) |
| General physical health deterioration | 7 (0.5) |
| Colitis | 6 (0.4) |
| Anemia | 5 (0.4) |
| Lung disorder | 5 (0.4) |
| Interstitial lung disease | 5 (0.4) |
| Decreased appetite | 4 (0.3) |
| Dyspnea | 4 (0.3) |
TRAE, treatment-related adverse event
*Malignant neoplasm progression classified as TRAE was reported in 44 patients, including 10 with grade 3–4.