Table 2.
Summary of AEs in the Asian subgroup and the global OlympiAD study population.
| Asian subgroup | Global OlympiAD study population | |||||||
|---|---|---|---|---|---|---|---|---|
| Olaparib (N = 59) | Chemotherapy TPC (N = 27) | Olaparib (N = 205) | Chemotherapy TPC (N = 91) | |||||
| Any grade | Grade ≥3 | Any grade | Grade ≥3 | Any grade | Grade ≥3 | Any grade | Grade ≥3 | |
| Any AE | 59 (100) | 27 (45.8) | 26 (96.3) | 16 (59.3) | 200 (97.6) | 78 (38) | 87 (95.6) | 45 (49.5) |
| Nausea | 32 (54.2) | 0 | 11 (40.7) | 0 | 119 (58.0) | 0 | 32 (35.2) | 1 (1.1) |
| Anaemia† | 26 (44.1) | 12 (20.3) | 9 (33.3) | 4 (14.8) | 82 (40.0) | 33 (16.1) | 24 (26.4) | 4 (4.4) |
| Neutropenia‡ | 5 (8.5) | 1 (1.7) | 7 (25.9) | 4 (14.8) | 56 (27.3) | 19 (9.3) | 45 (49.5) | 24 (26.4) |
| Decreased WBC count | 23 (39.0) | 6 (10.2) | 14 (51.9) | 8 (29.6) | 33 (16.1) | 7 (3.4) | 19 (20.9) | 9 (9.9) |
| Vomiting | 17 (28.8) | 0 | 6 (22.2) | 0 | 66 (32.2) | 0 | 14 (15.4) | 1 (1.1) |
| Increased ALT | 16 (27.1) | 1 (1.7) | 7 (25.9) | 1 (3.7) | 24 (11.7) | 3 (1.5) | 16 (17.6) | 1 (1.1) |
| Increased AST | 13 (22.0) | 2 (3.4) | 8 (29.6) | 0 | 20 (9.8) | 5 (2.4) | 15 (16.5) | 0 |
| Decreased appetite | 11 (18.6) | 0 | 7 (25.9) | 0 | 35 (17.1) | 0 | 11 (12.1) | 0 |
| Upper respiratory tract infection | 10 (16.9) | 1 (1.7) | 6 (22.2) | 0 | 27 (13.2) | 1 (0.5) | 9 (9.9) | 0 |
| Fatigue | 10 (16.9) | 0 | 1 (3.7) | 0 | 61 (29.8) | 7 (3.4) | 22 (24.2) | 1 (1.1) |
| Diarrhoea | 9 (15.3) | 0 | 6 (22.2) | 0 | 42 (20.5) | 1 (0.5) | 20 (22.0) | 0 |
| Pyrexia | 8 (13.6) | 0 | 6 (22.2) | 0 | 30 (14.6) | 0 | 16 (17.6) | 0 |
| Headache | 7 (11.9) | 0 | 4 (14.8) | 1 (3.7) | 42 (20.5) | 2 (1.0) | 14 (15.4) | 2 (2.2) |
| PPE syndrome | 1 (1.7) | 0 | 5 (18.5) | 1 (3.7) | 1 (0.5) | 0 | 19 (20.9) | 2 (2.2) |
| Dose reduction due to AEs, n (%) | 10 (16.9) | — | 8 (29.6) | — | 52 (25.4) | — | 28 (30.8) | — |
| Treatment interruption due to AEs, n (%) | 17 (28.8) | — | 6 (22.2) | — | 74 (36.1) | — | 26 (28.6) | — |
| Treatment discontinuations because of AEs, n (%) | 4 (6.8) | — | 2 (7.4) | — | 10 (4.9) | — | 7 (7.7) | — |
Most common AE of any grade occurring in ≥20% of Asian patients or the global OlympiAD study population in either treatment arm. AEs were graded using the National Cancer Institute’s Common Terminology Criteria for Adverse Events version 4.0, and data were collected for the duration of study and the 30-day post-treatment follow-up period. Data cut-off 25 September 2017; †Anaemia includes anaemia, decreased haemoglobin level, decreased haematocrit, decreased red blood cell count and erythropenia; ‡Neutropenia includes febrile neutropenia, granulocytopenia, decreased granulocyte count, neutropenia, neutropenic sepsis, decreased neutrophil count and neutropenic infection. AE, adverse event; ALT, alanine aminotransferase; AST, aspartate aminotransferase; PPE, palmar–plantar erythrodysesthesia; WBC, white blood cell.