Table 1. . Toxicities reported with rucaparib in the ARIEL 3 trial.
| Toxicities, percentage of patients | Grade | Rucaparib (n = 372) | Placebo (n = 189) |
|---|---|---|---|
| Hematologic toxicities | |||
| Anemia | All | 39 | 5 |
| Grade 3/4 | 21 | 0.5 | |
| Thrombocytopenia | All | 29 | 3 |
| Grade 3/4 | 5 | 0 | |
| Neutropenia | All | 20 | 5 |
| Grade 3/4 | 8 | 1 | |
| Gastrointestinal toxicities | |||
| Nausea | All | 76 | 36 |
| Grade 3/4 | 4 | 0.5 | |
| Constipation | All | 37 | 24 |
| Grade 3/4 | 2 | 1 | |
| Vomiting | All | 37 | 15 |
| Grade 3/4 | 4 | 1 | |
| Abdominal pain | All | 46 | 39 |
| Grade 3/4 | 3 | 0.5 | |
| Diarrhea | All | 32 | 22 |
| Grade 3/4 | 0.5 | 1 | |
| Dyspepsia | All | 15 | 5 |
| Grade 3/4 | <1 | 0 | |
| Dysgeusia | All | 40 | 7 |
| Grade 3/4 | 0 | 0 | |
| Respiratory toxicities | |||
| Nasopharyngitis/upper respiratory tract infection | All | 29 | 18 |
| Grade 3/4 | 0.3 | 1 | |
| Cough | All | 15 | 13 |
| Grade 3/4 | 0 | 0 | |
| General toxicities | |||
| Fatigue | All | 73 | 46 |
| Grade 3/4 | 7 | 3 | |
| Decreased appetite | All | 23 | 14 |
| Grade 3/4 | 1 | 0 | |
| Neurologic toxicities | |||
| Headache | All | 18 | 16 |
| Grade 3/4 | 1 | 1 | |
| Insomnia | All | 14 | 8 |
| Grade 3/4 | 0 | 0 | |
| Dermatologic toxicities | |||
| Photosensitivity reaction | All | 17 | 1 |
| Grade 3/4 | 1 | 1 | |
| Pruritus | All | 13 | 10 |
| Grade 3/4 | 0 | 0 | |
| Rash | All | 43 | 23 |
| Grade 3/4 | 1 | 0 | |
| Other nonhematologic toxicities | |||
| Increase in alanine aminotransferase or aspartate aminotransferase | All | 38 | 4 |
| Grade 3/4 | 11 | 0 | |