Most common treatment-related adverse events (any grade in ≥25% of patients or grade ≥3 in ≥10% of patients in any arm; treatment related according to investigator assessment)
Adverse event, n (%) | Arm A (n=36) | Arm B (n=18) | Arm C (n=30) | ||||||
Any grade | Grade 1/2 | Grade ≥3 | Any grade | Grade 1/2 | Grade ≥3 | Any grade | Grade 1/2 | Grade ≥3 | |
Any | 32 (89) | 10 (28) | 22 (61) | 12 (67) | 11 (61) | 1 (6) | 29 (97) | 10 (34) | 19 (63) |
Diarrhea | 18 (50) | 15 (42) | 3 (8) | 1 (6) | 1 (6) | 0 | 9 (30) | 7 (23) | 2 (7) |
Aspartate aminotransferase increased | 17 (47) | 15 (42) | 2 (6) | 0 | 0 | 0 | 16 (53) | 14 (47) | 2 (7) |
Alanine aminotransferase increased | 15 (42) | 12 (33) | 3 (8) | 0 | 0 | 0 | 14 (47) | 12 (40) | 2 (7) |
Fatigue | 14 (39) | 13 (36) | 1 (3) | 6 (33) | 6 (33) | 0 | 16 (53) | 14 (47) | 2 (7) |
Hypertension | 11 (31) | 5 (14) | 6 (17) | 0 | 0 | 0 | 10 (33) | 7 (23) | 3 (10) |
Anorexia | 11 (31) | 11 (31) | 0 | 1 (6) | 1 (6) | 0 | 6 (20) | 6 (20) | 0 |
Nausea | 11 (31) | 10 (28) | 1 (3) | 2 (11) | 2 (11) | 0 | 11 (37) | 10 (33) | 1 (3) |
Weight loss | 11 (31) | 11 (31) | 0 | 1 (6) | 1 (6) | 0 | 6 (20) | 6 (20) | 0 |
Mucositis oral | 11 (31) | 9 (25) | 2 (6) | 1 (6) | 1 (6) | 0 | 3 (10) | 3 (10) | 0 |
Platelet count decreased | 10 (28) | 9 (25) | 1 (3) | 0 | 0 | 0 | 6 (20) | 6 (20) | 0 |
Hypothyroidism | 8 (22) | 8 (22) | 0 | 1 (6) | 1 (6) | 0 | 9 (30) | 9 (30) | 0 |
Palmar-plantar erythrodysesthesia syndrome | 8 (22) | 6 (17) | 2 (6) | 0 | 0 | 0 | 8 (27) | 8 (27) | 0 |
Anemia | 6 (17) | 4 (11) | 2 (6) | 1 (6) | 1 (6) | 0 | 13 (43) | 11 (37) | 2 (7) |
Thyroid-stimulating hormone increased | 5 (14) | 5 (14) | 0 | 1 (6) | 1 (6) | 0 | 8 (27) | 8 (27) | 0 |
Lymphocyte count decreased | 4 (11) | 3 (8) | 1 (3) | 1 (6) | 0 | 1 (6) | 7 (23) | 1 (3) | 6 (20) |