Table 2:
Grades 3 and 4 Treatment-Related Toxicities
| Toxicity | Veliparib + mFOLFIRI (n=56) |
FOLFIRI (n=50) |
p | ||
|---|---|---|---|---|---|
| Grade 3 n (%) |
Grade 4 n (%) |
Grade 3 n (%) |
Grade 4 n (%) |
||
| Alkaline phosphatase increased | 2 (4%) | 0 | 3 (6%) | 0 | 0.66 |
| Anemia | 4 (7%) | 0 | 5 (10%) | 0 | 0.73 |
| Hyperbilirubinemia | 2 (4%) | 2 (4%) | 4 (8%) | 1 (2%) | 0.73 |
| Dehydration | 6 (11%) | 0 | 1 (2%) | 0 | 0.12 |
| Diarrhea | 6 (11%) | 0 | 3 (6%) | 0 | 0.50 |
| Fatigue | 10 (18%) | 0 | 3 (6%) | 0 | 0.08 |
| Hyponatremia | 2 (4%) | 0 | 3 (6%) | 0 | 0.66 |
| Lymphopenia | 3 (5%) | 0 | 6 (12%) | 0 | 0.30 |
| Nausea | 7 (12%) | 0 | 2 (4%) | 0 | 0.17 |
| Neutropenia | 10 (18%) | 9 (16%) | 9 (18%) | 2 (4%) | 0.20 |
| Vomiting | 5 (9%) | 0 | 2 (4%) | 0 | 0.44 |
| Leukopenia | 5 (9%) | 1 (2%) | 3 (6%) | 0 | 0.50 |
| Maximum grade any event | 26 (46%) | 13 (23%) | 25 (50%) | 4 (8%) | 0.23 |