Table 2.
Management and outcome of the most commonly reported hematologic and non-hematologic adverse events.
| Hematologic adverse events | Anemiaa |
Neutropeniaa |
Thrombocytopeniaa |
|||
|---|---|---|---|---|---|---|
| Olaparib (N = 260) |
Placebo (N = 130) |
Olaparib (N = 260) |
Placebo (N = 130) |
Olaparib (N = 260) |
Placebo (N = 130) |
|
| Patients with event (all grades), n (%) | 101 (38.8) | 13 (10.0) | 60 (23.1) | 15 (11.5) | 29 (11.2) | 5 (3.8) |
| Median (range) number of adverse events per patient | 1.00 (1–9) | 1.00 (1–5) | 1.00 (1–7) | 1.00 (1–8) | 2.00 (1–9) | 1.00 (1–3) |
| Management, n (%) | ||||||
| Supportive treatment | 72 (27.7) | 4 (3.1) | 11 (4.2) | 2 (1.5) | 2 (0.8) | 1 (0.8) |
| Dose interruption | 58 (22.3) | 1 (0.8) | 30 (11.5) | 5 (3.8) | 6 (2.3) | 0 |
| Dose reduction | 44 (16.9) | 1 (0.8) | 10 (3.8) | 1 (0.8) | 4 (1.5) | 0 |
| Discontinuation | 6 (2.3) | 0 | 1 (0.4) | 0 | 1 (0.4) | 0 |
| Outcome, n (%)b | ||||||
| Recovered/resolved | 84 (83.2) | 11 (84.6) | 53 (88.3) | 14 (93.3) | 21 (72.4) | 4 (80.0) |
| Recovered/resolved with sequelae | 2 (2.0) | 0 | 0 | 0 | 2 (6.9) | 0 |
| Recovering/resolving | 5 (5.0) | 0 | 1 (1.7) | 0 | 0 | 0 |
| Not recovered/resolved | 10 (9.9) | 2 (15.4) | 6 (10.0) | 1 (6.7) | 6 (20.7) | 1 (20.0) |
| Patients with grade ≥3 events, n (%) | 56 (21.5) | 2 (1.5) | 22 (8.5) | 6 (4.6) | 2 (0.8) | 2 (1.5) |
| Patients with serious events, n (%) | 18 (6.9) | 0 | 4 (1.5) | 0 | 1 (0.4) | 1 (0.8) |
| Non-hematologic adverse events | Nausea |
Fatigue/astheniaa |
Vomiting |
|||
| Olaparib (N = 260) |
Placebo (N = 130) |
Olaparib (N = 260) |
Placebo (N = 130) |
Olaparib (N = 260) |
Placebo (N = 130) |
|
| Patients with event (all grades), n (%) | 201 (77.3) | 49 (37.7) | 165 (63.5) | 54 (41.5) | 104 (40.0) | 19 (14.6) |
| Median (range) number of adverse events per patient | 1.00 (1–14) | 1.00 (1–6) | 1.00 (1–8) | 1.00 (1–3) | 1.00 (1–12) | 1.00 (1–5) |
| Management, n (%) | ||||||
| Supportive treatment | 117 (45.0) | 15 (11.5) | 11 (4.2) | 0 | 28 (10.8) | 3 (2.3) |
| Dose interruption | 35 (13.5) | 0 | 20 (7.7) | 1 (0.8) | 25 (9.6) | 3 (2.3) |
| Dose reduction | 10 (3.8) | 0 | 15 (5.8) | 1 (0.8) | 0 | 0 |
| Discontinuation | 6 (2.3) | 1 (0.8) | 6 (2.3) | 1 (0.8) | 2 (0.8) | 0 |
| Outcome, n (%)b | ||||||
| Recovered/resolved | 183 (91.0) | 46 (93.9) | 103 (62.4) | 41 (75.9) | 100 (96.2) | 19 (100.0) |
| Recovered/resolved with sequelae | 1 (0.5) | 0 | 1 (0.6) | 1 (1.9) | 1 (1.0) | 0 |
| Recovering/resolving | 2 (1.0) | 1 (2.0) | 13 (7.9) | 3 (5.6) | 1 (1.0) | 0 |
| Not recovered/resolved | 15 (7.5) | 2 (4.1) | 48 (29.1) | 9 (16.7) | 2 (1.9) | 0 |
| Patients with grade ≥3 events, n (%) | 2 (0.8) | 0 | 10 (3.8) | 2 (1.5) | 1 (0.4) | 1 (0.8) |
| Patients with serious events, n (%) | 0 | 0 | 0 | 0 | 0 | 1 (0.8) |
Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events, version 4.0. Adverse events were monitored throughout study treatment and for 30 days after discontinuation of study treatment.
a
Grouped-term events.
b
Percentages were calculated from the number of patients with that event.