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)