Table 3.
Summary of TEAEs during the PK phase after administration of a single 300 mg dose of niraparib
| TEAEa, n | Normal hepatic function (n = 9) |
Moderate hepatic impairment (n = 8) |
|---|---|---|
| Any grade TEAE | 5 | 3 |
| Nausea | 1 | 1 |
| ALT increased | 1 | 1 |
| AST increased | 1 | 1 |
| Hyperbilirubinemia | 0 | 2 |
| Abdominal distension | 1 | 0 |
| Increased amylase | 1 | 0 |
| Increased lipase | 1 | 0 |
| Vomiting | 1 | 0 |
| Taste disorder | 1 | 0 |
| Acute respiratory failure | 1 | 0 |
| Pulmonary hypertension | 1 | 0 |
| Influenza | 1 | 0 |
| Pneumonia | 1 | 0 |
| Back pain | 1 | 0 |
| Peripheral neuropathy | 0 | 1 |
| Fatigue | 0 | 1 |
| Decreased appetite | 0 | 1 |
| Hyponatremia | 0 | 1 |
| Lymphopenia | 0 | 1 |
| Any grade drug-related TEAE | 3 | 0 |
| Abdominal distension | 2 | 0 |
| Nausea | 1 | 0 |
| Vomiting | 1 | 0 |
| ALT increased | 1 | 0 |
| Amylase increased | 1 | 0 |
| AST increased | 1 | 0 |
| Lipase increased | 1 | 0 |
| Taste disorder | 1 | 0 |
| Any drug-related Grade ≥ 3 TEAE | 1 | 0 |
| AST increased | 1 | 0 |
| Amylase increased | 1 | 0 |
| Lipase increased | 1 | 0 |
ALT alanine aminotransferase, AST aspartate aminotransferase, TEAE treatment-emergent adverse event
aPatients may have had more than 1 TEAE by preferred term