Table 2 Treatment-related adverse events (all-patients-as-treated population; N = 192)
Treatment-related adverse event | Any grade occurring in ≥2% of patients (No. (%)) |
|---|---|
Any | 123 (64) |
Fatigue | 42 (22) |
Hypothyroidism | 19 (10) |
Rash | 18 (9) |
Pruritus | 16 (8) |
Appetite decrease | 16 (8) |
Pyrexia | 12 (6) |
Nausea | 11 (6) |
Arthralgia | 10 (5) |
Dry skin | 9 (5) |
Weight decrease | 9 (5) |
AST level increase | 6 (3) |
Facial swelling | 6 (3) |
Anaemia | 8 (4) |
ALT level increase | 5 (3) |
Myalgia | 5 (3) |
Diarrhoea | 5 (3) |
Pneumonitis | 5 (3) |
Stomatitis | 4 (2) |
Vomiting | 4 (2) |
Chills | 4 (2) |
Blood TSH level increase | 4 (2) |
Hyponatremia | 4 (2) |
Maculopapular rash | 4 (2) |
Grade 3/4 occurring in ≥2 patients (No. (%)) | |
Any | 24 (13) |
ALT level increase | 3 (2) |
AST level increase | 3 (2) |
Hypothyroidism | 2 (1) |
Fatigue | 2 (1) |
Appetite decrease | 2 (1) |
Hyponatremia | 2 (1) |
Pneumonitis | 2 (1) |
Facial swelling | 2(1) |
Rare events of interest (No. (%) [grade]) | |
Immune-mediated | |
Adrenal insufficiency | 2 (1) [1, 2] |
Colitis | 1 (1) [3] |
Diabetic ketoacidosis | 1 (1) [4] |
Type 1 diabetes mellitus | 1 (1) [3] |
Cardiac | |
Atrial fibrillation | 1 (1) [3] |
Congestive heart failure | 1 (1) [3] |
