Table 3.
Adverse events with an incidence of ≥10% and immune‐related adverse events (safety analysis set, N = 17)
| All Grade | Grade 3–4 | |||
|---|---|---|---|---|
| n | % | n | % | |
| AEs in ≥10% of patients | ||||
| Overall | 17 | 100 | 4 | 23.5 |
| Pyrexia | 7 | 41.2 | 1 | 5.9 |
| Pruritus | 6 | 35.3 | ||
| Rash | 6 | 35.3 | 1 | 5.9 |
| Hypothyroidism | 5 | 29.4 | ||
| Headache | 4 | 23.5 | ||
| Fatigue | 3 | 17.6 | ||
| Nasopharyngitis | 3 | 17.6 | ||
| Back pain | 2 | 11.8 | ||
| Cataract | 2 | 11.8 | ||
| Constipation | 2 | 11.8 | ||
| Dermal cyst | 2 | 11.8 | ||
| Dermatitis acneiform | 2 | 11.8 | ||
| Diarrhea | 2 | 11.8 | ||
| Dizziness | 2 | 11.8 | ||
| Hepatic function abnormal | 2 | 11.8 | 1 | 5.9 |
| Hyponatremia | 2 | 11.8 | 1 | 5.9 |
| Malaise | 2 | 11.8 | ||
| Myalgia | 2 | 11.8 | ||
| Edema | 2 | 11.8 | ||
| Upper respiratory tract inflammation | 2 | 11.8 | ||
| Categories of immune‐related AE | ||||
| Skin disorders | 8 | 47.1 | 1 | 5.9 |
| Endocrine disorders | 6 | 35.3 | 1 | 5.9 |
| Gastrointestinal disorders | 3 | 17.6 | 0 | 0 |
| Hepatic disorders | 2 | 11.8 | 0 | 0 |
| Pulmonary disorders | 1 | 5.9 | 1 | 5.9 |
| Hypersensitivity and infusion reactions | 1 | 5.9 | 0 | 0 |
| Renal disorders | 0 | 0 | 0 | 0 |
AE, adverse event.