Table 2. Summary of AEs in the Japan subset*.
| AE | Olaparib + bevacizumab (n=15) | Placebo + bevacizumab (n=9) | ||
|---|---|---|---|---|
| All grades | Grade ≥3 | All grades | Grade ≥3 | |
| Anemia† | 11 (73) | 5 (33) | 1 (11) | 0 |
| Leukopenia‡ | 11 (73) | 4 (27) | 4 (44) | 1 (11) |
| Neutropenia§ | 11 (73) | 3 (20) | 1 (11) | 0 |
| Lymphopenia¶ | 8 (53) | 2 (13) | 4 (44) | 2 (22) |
| Nausea | 6 (40) | 0 | 1 (11) | 0 |
| Hypertension | 4 (27) | 0 | 8 (89) | 2 (22) |
| Increased weight | 2 (13) | 2 (13) | 4 (44) | 1 (11) |
| Thrombocytopenia¶ | 2 (13) | 0 | 1 (11) | 0 |
| Stomatitis | 2 (13) | 0 | 1 (11) | 0 |
| Gingivitis | 2 (13) | 0 | 0 | 0 |
| Hypersensitivity | 2 (13) | 1 (7) | 0 | 0 |
| Proteinuria | 1 (7) | 0 | 4 (44) | 0 |
| Pelvic infection | 1 (7) | 0 | 2 (22) | 1 (11) |
| URTI | 1 (7) | 0 | 2 (22) | 0 |
| Headache | 1 (7) | 0 | 2 (22) | 0 |
| Constipation | 1 (7) | 0 | 2 (22) | 0 |
| Vomiting | 0 | 0 | 3 (33) | 1 (11) |
| Hyperkalemia | 0 | 0 | 2 (22) | 0 |
Values are presented as number (%).
AE, adverse event; URTI, upper respiratory tract infection.
*Data are shown for all-grade AEs that occurred in at least 10% of patients in either treatment group and the associated incidence of grade ≥3 AEs during study treatment or up to 30 days after discontinuation of the intervention. AEs were graded using National Cancer Institute Common Terminology Criteria for Adverse Events (version 4.03). †Anemia includes anemia, decreased hemoglobin level, decreased hematocrit, decreased red blood cell count, erythropenia, macrocytic anemia, normochromic anemia, normochromic normocytic anemia, and normocytic anemia. ‡Leukopenia includes leukopenia and decreased white blood cell count. §Neutropenia includes neutropenia, febrile neutropenia, neutropenic sepsis, neutropenic infection, decreased neutrophil count, idiopathic neutropenia, granulocytopenia, decreased granulocyte count, and agranulocytosis. ∥Lymphopenia includes decreased lymphocyte count, lymphopenia, decreased B-lymphocyte count, and decreased T-lymphocyte count. ¶Thrombocytopenia includes thrombocytopenia, decreased platelet production, decreased platelet count, and decreased plateletcrit.