Adverse event | Total (N = 62) | OV Group (N = 30) | Placebo Group (N = 32) |
Patients with adverse events* | 50 (80.6) | 21 (70.0) | 29 (90.6) |
Anaemia | 20 (32.3) | 10 (33.3) | 10 (31.3) |
Vomiting | 11 (17.7) | 5 (16.7) | 6 (18.8) |
Cystitis | 11 (17.7) | 5 (16.7) | 6 (18.8) |
Nausea | 10 (16.1) | 4 (13.3) | 6 (18.8) |
Neutropenia | 8 (12.9) | 6 (20.0) | 2 (6.3) |
Thrombocytopenia | 6 (9.7) | 4 (13.3) | 2 (6.3) |
Vaginal bleeding | 6 (9.7) | 2 (6.7) | 4 (12.5) |
Rectal bleeding | 4 (6.4) | 1 (3.3) | 3 (9.4) |
Vaginal dryness | 3 (4.8) | 0 | 3 (9.4) |
Asthenia | 2 (4.8) | 1 (3.3) | 1 (3.1) |
Degree of severity as per CTCAE |
|
|
|
No adverse event | 12 (19.4) | 9 (30.0) | 3 (9.4) |
Mild | 4 (6.5) | - | 4 (12.5) |
Moderate | 24 (38.7) | 11 (36.7) | 13 (40.6) |
Severe | 20 (32.2) | 9 (29.9) | 11 (34.4) |
Very severe | 2 (3.2) | 1 (3.4) | 1 (3.1) |