Table 2. Summary of TEAEs.
| Adverse events | Niraparib 300 mg (n=20) | ||
|---|---|---|---|
| Any TEAEs | 20 (100.0) | ||
| Related to study drug | 20 (100.0) | ||
| Leading to study drug dose reduction | 16 (80.0) | ||
| Leading to study drug interruption | 15 (75.0) | ||
| Leading to study drug discontinuation | 2 (10.0) | ||
| Serious TEAEs | 8 (40.0) | ||
| Related to study drug | 4 (20.0) | ||
| TEAEs observed in ≥20% of patients | |||
| Blood and lymphatic system disorders | 15 (75.0) | ||
| Anemia | 15 (75.0) | ||
| Cardiac disorders | 4 (20.0) | ||
| Palpitations | 4 (20.0) | ||
| Gastrointestinal disorders | 20 (100.0) | ||
| Nausea | 12 (60.0) | ||
| Constipation | 9 (45.0) | ||
| Vomiting | 8 (40.0) | ||
| Stomatitis | 5 (25.0) | ||
| General disorders and administration site conditions | 7 (35.0) | ||
| Malaise | 6 (30.0) | ||
| Infections and infestations | 9 (45.0) | ||
| Investigations | 17 (85.0) | ||
| Platelet count decreased | 11 (55.0) | ||
| Neutrophil count decreased | 6 (30.0) | ||
| White blood cell count decreased | 6 (30.0) | ||
| Blood creatinine increased | 4 (20.0) | ||
| Weight decreased | 4 (20.0) | ||
| Metabolism and nutrition disorders | 5 (25.0) | ||
| Decreased appetite | 5 (25.0) | ||
| Musculoskeletal and connective tissue disorders | 8 (40.0) | ||
| Nervous system disorders | 14 (70.0) | ||
| Headache | 7 (35.0) | ||
| Dysgeusia | 4 (20.0) | ||
| Respiratory, thoracic, and mediastinal disorders | 9 (45.0) | ||
| Skin and subcutaneous tissue disorders | 8 (40.0) | ||
| Vascular disorders | 8 (40.0) | ||
| Hypertension | 6 (30.0) | ||
Values are presented as number (%) of patients. TEAEs were defined as adverse events that occurred after administration of the first dose of study drug and are shown by MedDRA System Organ Class and Preferred Term.
MedDRA, Medical Dictionary for Regulatory Activities; TEAE, treatment-emergent adverse event.