AE type reported | 850 mg/m2 | 1000 mg/m2 | Total | |||
---|---|---|---|---|---|---|
N = 57, n(%) | N = 6, n(%) | N = 63, n(%) | ||||
All events | Grade ≥ 3 | All events | Grade ≥ 3 | All events | Grade ≥ 3 | |
Patients with AEs | 46 (81) | 30 (53) | 6 (100) | 2 (33) | 52 (83) | 32 (51) |
AE by term | ||||||
 Palmar-plantar erythrodysesthesia syndrome | 23 (40) | 3 (5) | 3 (50) | 1 (17) | 26 (41) | 4 (6) |
 Hypertension | 20 (35) | 14 (25) | 1 (17) | 0 (0) | 21 (33) | 14 (22) |
 Oral Mucositis | 8 (14) | 2 (4) | 4 (67) | 1 (17) | 12 (19) | 3 (5) |
 Fatigue | 9 (16) | 0 (0) | 1 (17) | 0 (0) | 10 (16) | 0 (0) |
 Proteinuria | 9 (16) | 2 (4) | NA | NA | 9 (14) | 2 (3) |
 Anorexia | 3 (5) | 1 (2) | 2 (33) | 1 (17) | 5 (8) | 2 (3) |
 Nausea | 3 (5) | 2 (4) | NA | NA | 3 (5) | 2 (3) |
 Platelet count decreased | 4 (7) | 2 (4) | NA | NA | 4 (6) | 2 (3) |
 Dehydration | 2 (4) | 2 (4) | NA | NA | 2 (3) | 2 (3) |
 Intracranial Hemorrhage | 1 (2) | 1 (2) | NA | NA | 1 (2) | 1 (2) |
 Death NOS | 1 (2) | 1 (2) | NA | NA | 1 (2) | 1 (2) |