Table 3.
Frequency of AEs (N = 64)
| Any grade | Grade 3 | Grade 4 | |
|---|---|---|---|
| TRAEs | |||
| Any TRAEs | 61 (95.3) | 14 (21.9) | 3 (4.7) |
| Proteinuria | 30 (46.9) | 0 (0.0) | 0 (0.0) |
| Hypertension | 23 (35.9) | 2 (3.1) | 0 (0.0) |
| Hypothyroidism | 20 (31.3) | 0 (0.0) | 0 (0.0) |
| Aspartate aminotransferase increased | 17 (26.6) | 0 (0.0) | 0 (0.0) |
| Platelet count decreased | 15 (23.4) | 4 (6.3) | 0 (0.0) |
| Weight decreased | 15 (23.4) | 0 (0.0) | 0 (0.0) |
| Palmar-plantar erythrodysaesthesia syndrome | 13 (20.3) | 4 (6.3) | 0 (0.0) |
| Lipase increased | 12 (18.8) | 2 (3.1) | 1 (1.6) |
| Amylase increased | 10 (15.6) | 1 (1.6) | 0 (0.0) |
| Blood creatine phosphokinase MB increased | 10 (15.6) | 0 (0.0) | 0 (0.0) |
| Blood lactate dehydrogenase increased | 10 (15.6) | 0 (0.0) | 0 (0.0) |
| Blood bilirubin increased | 9 (14.1) | 0 (0.0) | 0 (0.0) |
| Rash | 8 (12.5) | 0 (0.0) | 0 (0.0) |
| White blood cell count decreased | 7 (10.9) | 1 (1.6) | 0 (0.0) |
| Haematuria | 7 (10.9) | 0 (0.0) | 0 (0.0) |
| Diarrhoea | 7 (10.9) | 0 (0.0) | 0 (0.0) |
| Dysphonia | 7 (10.9) | 0 (0.0) | 0 (0.0) |
| imAEs | |||
| Any imAEs | 30 (46.9) | 3 (4.7) | 0 (0.0) |
| Hypothyroidism | 20 (31.3) | 0 (0.0) | 0 (0.0) |
| Rash | 8 (12.5) | 0 (0.0) | 0 (0.0) |
| Hyperthyroidism | 3 (4.7) | 0 (0.0) | 0 (0.0) |
| Myositis | 2 (3.1) | 0 (0.0) | 0 (0.0) |
| Pancreatitis | 2 (3.1) | 2 (3.1) | 0 (0.0) |
| Thyroiditis | 2 (3.1) | 0 (0.0) | 0 (0.0) |
| Adrenal insufficiency | 1 (1.6) | 0 (0.0) | 0 (0.0) |
| Enterocolitis | 1 (1.6) | 1 (1.6) | 0 (0.0) |
Data are presented as n (%). TRAEs at any grade occurring in ≥ 10% of patients are listed. No grade 5 adverse events occurred among TRAEs reported at an overall frequency of ≥ 10%. imAEs occurring in ≥ 1 patient. Data are listed in order of decreased frequency of any grade TRAE. AEs Adverse events, TRAEs Treatment-related adverse events, imAEs Immune-mediated adverse events