Table 2.
Treatment-emergent adverse events (TEAEs) occurring in ≥2 patients in either cohort and all grade 3/4 TEAEs, by preferred term
| Patients with events, n (%) | Niraparib 200 mg/day (n = 3) | Niraparib 300 mg/day (n = 6) | ||
|---|---|---|---|---|
| Any | Grade 3/4 | Any | Grade 3/4 | |
| Any TEAE | 3 (100.0) | 1 (33.3) | 6 (100.0) | 4 (66.7) |
| Platelet count decreaseda | 1 (33.3) | 0 | 5 (83.3) | 1 (16.7) |
| AST increased | 0 | 0 | 5 (83.3) | 0 |
| Blood ALP increased | 1 (33.3) | 1 (33.3) | 4 (66.7) | 1 (16.7) |
| Nausea | 1 (33.3) | 0 | 4 (66.7) | 0 |
| Decreased appetite | 2 (66.7) | 0 | 2 (33.3) | 0 |
| Vomiting | 2 (66.7) | 0 | 2 (33.3) | 0 |
| ALT increased | 0 | 0 | 3 (50.0) | 1 (16.7) |
| Anaemia | 0 | 0 | 3 (50.0) | 1 (16.7) |
| Constipation | 1 (33.3) | 0 | 2 (33.3) | 0 |
| Fatigue | 2 (66.7) | 0 | 1 (16.7) | 0 |
| GGT increased | 0 | 0 | 3 (50.0) | 2 (33.3) |
| Malaise | 1 (33.3) | 0 | 2 (33.3) | 0 |
| Blood creatinine increased | 1 (33.3) | 0 | 1 (16.7) | 0 |
| Chest pain | 0 | 0 | 2 (33.3) | 0 |
| Diarrhoea | 0 | 0 | 2 (33.3) | 0 |
| Hypertension | 0 | 0 | 2 (33.3) | 0 |
| White blood cell count decreased | 1 (33.3) | 1 (33.3) | 1 (16.7) | 0 |
| Febrile neutropenia | 0 | 0 | 1 (16.7) | 1 (16.7) |
| Thrombocytopeniaa | 0 | 0 | 1 (16.7) | 1 (16.7) |
| Pyelonephritis | 0 | 0 | 1 (16.7) | 1 (16.7) |
| Diabetes mellitus | 0 | 0 | 1 (16.7) | 1 (16.7) |
aTEAEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) version 22.0, in which independent codes were used for thrombocytopenia and platelet count decreased. It was up to each investigator to decide which code to use when reporting a decrease in platelet levels.
ALP, alkaline phosphatase; ALT, alanine aminotransferase; AST, aspartate aminotransferase; GGT, gamma-glutamyl transferase; TEAE, treatment-emergent adverse event.