Table 3.
Summary of Adverse Events in the Safety Analysis Set.*
| Adverse Event | Olaparib (N = 911) | Placebo (N = 904) |
|---|---|---|
| no. of patients (%) | ||
| Any adverse event | 835 (91.7) | 753 (83.3) |
| Serious adverse event | 79 (8.7) | 76 (8.4) |
| Adverse event of special interest† | 30 (3.3) | 46 (5.1) |
| MDS or AML | 2 (0.2) | 3 (0.3) |
| Pneumonitis‡ | 9 (1.0) | 11 (1.2) |
| New primary cancer§ | 19 (2.1) | 32 (3.5) |
| Grade ≥3 adverse event | 221 (24.3) | 102 (11.3) |
| Grade 4 adverse event¶ | 17 (1.9) | 4 (0.4) |
| Adverse event leading to permanent discontinuation of olaparib or placebo‖ | 90 (9.9) | 38 (4.2) |
| Adverse event leading to death** | 1 (0.1) | 2 (0.2) |
Included are adverse events with an onset date on or after the date of the first dose and up to and including 30 days after the date of the last dose of olaparib or placebo. AML denotes acute myeloid leukemia, and MDS myelodysplastic syndrome.
Included are adverse events of special interest with an onset at any date after the first dose of olaparib or placebo. One patient in the olaparib group had both pneumonitis and a nonmelanoma skin cancer and is counted in both the pneumonitis and new primary cancer categories.
In the olaparib group, seven patients had pneumonitis, and two patients had radiation pneumonitis. In the placebo group, eight patients had pneumonitis, and three patients had radiation pneumonitis.
Detailed information on the numbers of patients in each group with specific new primary cancers is provided in Table S19.
A total of 18 grade 4 adverse events were reported in 17 patients who received olaparib; one patient had both grade 4 anemia and decreased neutrophil count. In the olaparib group, grade 4 adverse events included decreased neutrophil count (in 5 patients), anemia (in 4 patients), decreased lymphocyte count (in 3 patients), and AML, bipolar disorder, fatigue, febrile neutropenia, abnormal hepatic function, and a suicide attempt (in 1 patient each). In the placebo group, grade 4 adverse events included depression (in 2 patients) and increased aspartate aminotransferase level and acute cholecystitis (in 1 patient each).
The most common adverse events, occurring in at least 1% of the patients, that led to discontinuation of olaparib were nausea (2.0%), anemia (1.8%), fatigue (1.3%), and decreased neutrophil count (1.0%); there were no adverse events that occurred in at least 1% of patients that led to discontinuation of placebo.
In the olaparib group, cardiac arrest led to death in one patient. In the placebo group, AML and ovarian cancer led to death in one patient each.