Table 3 Treatment-related adverse events
All patients (N=171) | |||||
|---|---|---|---|---|---|
Any grade | Grade 1 | Grade 2 | Grade 3 | Grade 4 | |
Any | 120 (70%) | 34 (20%) | 49 (29%) | 27 (16%) | 7 (4%) |
Aspartate aminotransferase increased | 40 (23%) | 30 (18%) | 5 (3%) | 4 (2%) | 1 (<1%) |
Alanine aminotransferase increased | 29 (17%) | 22 (13%) | 5 (3%) | 1 (<1%) | 1 (<1%) |
Anemia | 26 (15%) | 9 (5%) | 12 (7%) | 5 (3%) | 0 |
Hypothyroidism | 19 (11%) | 9 (5%) | 10 (6%) | 0 | 0 |
Rash | 18 (11%) | 10 (6%) | 4 (2%) | 4 (2%) | 0 |
Blood bilirubin increased | 18 (11%) | 13 (8%) | 4 (2%) | 1 (<1%) | 0 |
Protein urine present | 15 (9%) | 6 (4%) | 9 (5%) | 0 | 0 |
Bilirubin conjugated increased | 14 (8%) | 9 (5%) | 3 (2%) | 2 (1%) | 0 |
Asthenia | 13 (8%) | 8 (5%) | 4 (2%) | 1 (<1%) | 0 |
Gamma-glutamyltransferase increased | 12 (7%) | 3 (2%) | 3 (2%) | 5 (3%) | 1 (<1%) |
Decreased appetite | 12 (7%) | 9 (5%) | 3 (2%) | 0 | 0 |
Pyrexia | 11 (6%) | 7 (4%) | 4 (2%) | 0 | 0 |
Pruritus | 10 (6%) | 7 (4%) | 2 (1%) | 1 (<1%) | 0 |
Hyponatremia | 9 (5%) | 4 (2%) | 0 | 4 (2%) | 1 (<1%) |
Blood alkaline phosphatase increased | 9 (5%) | 5 (3%) | 3 (2%) | 1 (<1%) | 0 |
Platelet count decreased | 9 (5%) | 5 (3%) | 4 (2%) | 0 | 0 |
Gingival bleeding | 9 (5%) | 5 (3%) | 4 (2%) | 0 | 0 |
Proteinuria | 9 (5%) | 7 (4%) | 2 (1%) | 0 | 0 |