Table 2.
Comparison of select adverse events across single-agent, phase III maintenance drug trials.
| Trial |
Olaparib |
Niraparib |
Rucaparib |
|||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Adverse event |
S0L02 |
SOLOl |
NOVA |
PRIMA |
ARIEL3 |
|||||
| N (treatment group) Grade | 195 |
260 |
367 |
484 |
372 |
|||||
| Grade 3 or 4 | Any Grade | Grade 3 or 4 | Any Grade | Grade 3 or 4 | Any Grade | Grade 3 or 4 | Any Grade | Grade 3 or 4 | Any Grade | |
| Any | 36% | 98% | 39% | 98% | 100% | 65% | 96% | 55% | 100% | |
| Nausea | 3% | 76% | 1% | 77% | 3% | 74% | 1% | 57% | 14% | 75% |
| Neutropenia | 5% | 19% | 9% | 23% | 20% | 30% | 13% | 26% | 7% | 18% |
| Fatigue | 4% | 66% | 4% | 63% | 8% | 59% | 2% | 35% | 7% | 69% |
| Anemia | 19% | 44% | 22% | 39% | 25% | 50% | 31% | 63% | 19% | 37% |
| Thrombocytopenia | 1% | 14% | 1% | 11% | 34% | 61% | 29% | 46% | 5% | 28% |
| Vomiting | 3% | 37% | < 1% | 40% | 2% | 34% | 1% | 22% | 4% | 37% |
| Diarrhea | 1% | 33% | 3% | 34% | <1% | 19% | 1% | 32% | ||
| Constipation | 0% | 21% | 0% | 28% | 1% | 40% | <1% | 39% | 2% | 37% |
| Abdominal pain | 3% | 24% | 2% | 25% | 1% | 23% | 1% | 22% | 2% | 30% |
| Decreased appetite | 0% | 22% | 0% | 20% | <1% | 25% | 1% | 23% | ||
| Insomnia | <1% | 24% | 1% | 25% | 0% | 14% | ||||
| Arthralgia | 0% | 15% | 0% | 25% | <1% | 12% | 1% | 15% | ||
| Dizziness | 1% | 13% | 0% | 20% | 0% | 17% | 0% | 15% | ||
| Headache | 1% | 25% | <1% | 23% | <1% | 26% | <1% | 26% | <1% | 18% |
| Hypomagnesemia | 0% | 14% | <1% | 11% | ||||||
| Dyspnea | 1% | 12% | 0% | 15% | 1% | 19% | 0% | 13% | ||
| Urinary Tract Infection | 1% | 9% | 1% | 10% | ||||||
| Hypertension | 8% | 19% | ||||||||
| Creatinine | 0% | 11% | <1% | 15% | ||||||
| AST ALT elevation | 10% | 34% | ||||||||