Table 2. Summary of adverse events (all CTCAE grades) reported in ⩾20% of patients in the pivotal Phase II olaparib maintenance study in patients with platinum-sensitive relapsed serous ovarian cancer.
|
Olaparib (
n
=136)
|
Placebo (
n
=128)
|
|||
|---|---|---|---|---|
| Adverse event (AE), n (%) | All grades (%) | Grade ⩾3 | All grades (%) | Grade ⩾3 |
| Patients with any AE | 132 (97) | 55 (40) | 119 (93) | 28 (22) |
| Nausea | 96 (71) | 3 (2) | 46 (36) | 0 |
| Fatigue | 71 (52) | 10 (7) | 50 (39) | 4 (3) |
| Vomiting | 46 (34) | 3 (2) | 18 (14) | 1 (<1) |
| Diarrhoea | 37 (27) | 3 (2) | 31 (24) | 3 (2) |
| Abdominal pain | 34 (25) | 3 (2) | 34 (27) | 4 (3) |
| Anaemia | 29 (21) | 7 (5) | 7 (5) | 1 (<1) |
| Headache | 28 (21) | 0 | 16 (13) | 1 (<1) |
| Constipation | 28 (21) | 0 | 14 (11) | 0 |
| Decreased appetite | 28 (21) | 0 | 17 (13) | 0 |
Abbreviation: CTCAE=Common Terminology Criteria for Adverse Events. From Ledermann et al (2014b).