Table:
Patient demographics and baseline characteristics
| Olaparib group (n=1196) | Placebo group (n=99) | |
|---|---|---|
| Median age, years (IQR) | 56 (51–63) | 56 (49–63) |
| ECOG performance status | ||
| 0 | 162 (83%) | 77 (78%) |
| 1 | 32 (16%) | 22 (22%) |
| Missing | 2 (1%) | 0 |
| Primary tumour location | ||
| Ovary | 164 (84%) | 86 (87%) |
| Fallopian tube or primary peritoneal | 31 (16%) | 13 (13%) |
| Missing | 1 (1%) | 0 |
| Response to previous platinum therapy | ||
| Complete response | 91 (46%) | 47 (47%) |
| Partial response | 105 (54%) | 52 (53%) |
| Previous platinum regimens | ||
| 2 | 110 (56%) | 62 (63%) |
| B | 60 (31%) | 20 (20%) |
| 4 | 18 (9%) | 12 (12%) |
| ≥5 | 7 (4%) | 5 (5%) |
| Time to disease progression in the penultimate platinum regimen | ||
| >6–12 months | 79 (40%) | 40 (40%) |
| >12 months | 117 (60%) | 59 (60%) |
| Median time from previous platinum regimen to randomisation, days (IQR) | 41.0 (32.0–48.0) | 38.0 (31.0–49.0) |
| Adverse events of interest at baseline* | ||
| Abdominal pain | 10 (5%) | 3 (3%) |
| Constipation | 21 (11%) | 14 (14%) |
| Nausea | 14 (7%) | 4 (4%) |
| Fatigue | 29 (15%) | 15 (15%) |
| Vomiting | 1 (1%) | 0 |
| Anaemia | 42 (21%) | 20 (20%) |
| Leucopenia | 8 (4%) | 2 (2%) |
| Mean TOI score (SD) | 75.26 (13.78) | 77.12 (11.35) |
| Mean total FACT-O score (SD) | 114.4 (19.31) | 116.6 (17.24) |
| Mean EQ-5D-5L score (SD) | 0.81(0.182) | 0.84 (0.120) |
Data are n (%), unless otherwise specified. ECOG=Eastern Cooperative Oncology Group. TOI=Trial Outcome Index. FACT-O=Functional Assessment of Cancer Therapy—Ovarian Cancer. EQ-5D-5L=EuroQol five-dimensions five-level. MedDRA=Medical Dictionary for Regulatory Activities.
*
Investigator-recorded adverse events at baseline (all grades; MedDRA preferred term).