Table 2. Most common AEs (any grade and grade ⩾3) with olaparib treatment based on data from 2 large olaparib clinical trials. Shown are any grade AEs reported in at least 15% of patients or grade ⩾3 AEs reported in at least 5% of patients.
|
Kaufman et al (2015) |
Ledermann et al (2012) |
|||||
|---|---|---|---|---|---|---|
|
Olaparib
N=193 |
Olaparib
N=136 |
Placebo
N=128 |
||||
| Any grade number (%) | Grade ⩾3 number (%) | Any grade number (%) | Grade ⩾3 number (%) | Any grade number (%) | Grade ⩾3 number (%) | |
| Fatigue | 116 (60.1) | 12 (6.2) | 66 (48.5) | 9 (6.6) | 48 (37.5) | 4 (3.1)a |
| Nausea | 119 (61.7) | 1 (0.5) | 93 (68.4) | 3 (2.2) | 45 (35.2) | 0 (0) |
| Vomiting | 75 (38.9) | 5 (2.6) | 43 (31.6) | 3 (2.2) | 18 (14.1) | 1 (0.8) |
| Anemia | 62 (32.1) | 36 (18.7) | 23 (16.9) | 7 (5.1) | 6 (4.7) | 1 (0.8) |
| Diarrhea | 56 (29.0) | 3 (1.6) | 31 (22.8) | 3 (2.2) | 29 (22.7) | 3 (2.3) |
| Abdominal pain | 58 (30.1) | 14 (7.3) | 24 (17.6) | 2 (1.5) | 33 (25.8) | 4 (3.1) |
| Decreased appetite | 36 (18.7) | 1 (0.5) | 25 (18.4) | 0 (0) | 17 (13.3) | 0 (0) |
| Dyspepsia | 38 (19.7) | 0 (0) | 22 (16.2) | 0 (0) | 11 (8.6) | 0 (0) |
| Headache | 32 (16.6) | 0 (0) | 25 (18.4) | 0 (0) | 15 (11.7) | 1 (0.8) |
| Dysgeusia | 39 (20.2) | 0 (0) | 19 (14.0) | 0 (0) | 8 (6.3) | 0 (0) |
a
One patient in the placebo group inadvertently received olaparib at a dose of 400 mg twice daily for approximately 2 weeks. The exact dates and duration are unknown. It is not known whether the patient was receiving olaparib or placebo when the adverse event (AE) occurred. This AE was counted in the safety analysis for placebo, but the possibility that it was attributable to olaparib cannot be excluded.