Table 3 Treatment-emergent adverse events ≥10% (all grades, either arm) in patients with leiomyosarcoma
TEAE category, n (%) | Eribulin (n = 156) | Dacarbazine (n = 152) | ||||
|---|---|---|---|---|---|---|
All grades | Grade 3 | Grade 4 | All grades | Grade 3 | Grade 4 | |
Neutropenia | 72 (46) | 36 (23) | 25 (16) | 40 (26) | 16 (11) | 8 (5) |
Fatigue | 71 (46) | 6 (4) | 0 | 63 (41) | 3 (2) | 0 |
Nausea | 64 (41) | 1 (1) | 0 | 74 (49) | 1 (1) | 0 |
Alopecia | 51 (33) | 1 (1) | 0 | 5 (3) | 0 | 0 |
Constipation | 51 (33) | 2 (1) | 0 | 41 (27) | 1 (1) | 0 |
Anaemia | 49 (31) | 10 (6) | 2 (1) | 44 (29) | 15 (10) | 4 (3) |
Pyrexia | 46 (30) | 2 (1) | 0 | 20 (13) | 0 | 0 |
Asthenia | 35 (22) | 2 (1) | 0 | 34 (22) | 4 (3) | 0 |
Cough | 34 (22) | 0 | 0 | 24 (16) | 0 | 0 |
Headache | 32 (21) | 0 | 0 | 17 (11) | 0 | 0 |
Peripheral sensory neuropathy | 30 (19) | 2 (1) | 0 | 6 (4) | 0 | 0 |
Vomiting | 30 (19) | 2 (1) | 0 | 34 (22) | 0 | 0 |
Abdominal pain | 28 (18) | 3 (2) | 1 (1) | 21 (14) | 6 (4) | 0 |
Decreased appetite | 27 (17) | 1 (1) | 0 | 21 (14) | 0 | 0 |
Dyspnoea | 27 (17) | 3 (2) | 1 (1) | 25 (16) | 3 (2) | 2 (1) |
Back pain | 26 (17) | 2 (1) | 0 | 23 (15) | 3 (2) | 0 |
Diarrhoea | 25 (16) | 0 | 0 | 22 (15) | 0 | 0 |
Leukopenia | 25 (16) | 12 (8) | 4 (3) | 20 (13) | 5 (3) | 3 (2) |
Stomatitis | 22 (14) | 2 (1) | 0 | 4 (3) | 1 (1) | 0 |
Oedema peripheral | 21 (14) | 0 | 0 | 11 (7) | 1 (1) | 0 |
Abdominal pain, upper | 17 (11) | 0 | 0 | 8 (5) | 1 (1) | 0 |
Hypokalemia | 17 (11) | 4 (3) | 0 | 7 (5) | 2 (1) | 0 |
Aspartate aminotransferase increased | 16 (10) | 1 (1) | 0 | 5 (3) | 2 (1) | 0 |
Myalgia | 16 (10) | 0 | 0 | 16 (11) | 0 | 0 |
Urinary tract infection | 16 (10) | 2 (1) | 0 | 10 (7) | 0 | 0 |
Thrombocytopenia | 10 (6) | 1 (1) | 0 | 47 (31) | 13 (9) | 13 (9) |
