Table 2.
Treatment-related adverse events, all grades (occurring in ≥5% of patients) and grade 3–5
| TRAEs | Any grade | Grade 3–5 |
|---|---|---|
| All | 93 (71.5) | 14 (10.8) |
| Serious TRAEs | 8 (6.2) | |
| Treatment interruption due to TRAEs | 21 (16.2) | |
| Permanent treatment discontinuation due to TRAEs | 4 (3.1) | |
| Death due to TRAEs | 0 (0.0%) | |
| TRAEs (≥5%) | ||
| Hypothyroidism | 39 (30.0) | 0 (0.0) |
| Anemia | 20 (15.4) | 1 (0.8) |
| Aspartate aminotransferase increased | 19 (14.6) | 1 (0.8) |
| Blood thyroid stimulating hormone increased | 18 (13.8) | 0 (0.0) |
| Alanine aminotransferase increased | 16 (12.3) | 0 (0.0) |
| Pyrexia | 9 (6.9) | 0 (0.0) |
| Rash | 9 (6.9) | 2 (1.5) |
| Proteinuria | 8 (6.2) | 0 (0.0) |
| Hyponatraemia | 7 (5.4) | 0 (0.0) |
| Gamma-glutamyl transferase increased | 4 (3.1) | 1 (0.8) |
| Hepatic function abnormal | 4 (3.1) | 2 (1.5) |
| Platelet count decreased | 4 (3.1) | 1 (0.8) |
| Ascites | 1 (0.8) | 1 (0.8) |
| Death | 1 (0.8) | 1 (0.8) |
| Herpes zoster disseminated | 1 (0.8) | 1 (0.8) |
| Immune-mediated enterocolitis | 1 (0.8) | 1 (0.8) |
| Malnutrition | 1 (0.8) | 1 (0.8) |
| Pemphigoid | 1 (0.8) | 1 (0.8) |
| Pleural effusion | 1 (0.8) | 1 (0.8) |
| Transaminases increased | 1 (0.8) | 1 (0.8) |