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) |