Table 3.
Overview of treatment-emergent adverse events
| n, % | Veliparib + FOLFIRI ± Bevacizumab (N = 65) | Placebo + FOLFIRI ± Bevacizumab (N = 65) | P-valuea |
|---|---|---|---|
| All grade AE | 62 (95%) | 61 (94%) | – |
| All grade AE related to veliparib | 43 (66%) | 44 (68%) | – |
| Grade 3 or 4 AE | 53 (82%) | 51 (79%) | – |
| Grade 3 or 4 AE related to veliparib | 23 (35%) | 21 (32%) | – |
| SAE | 30 (46%) | 33 (51%) | – |
| SAE related to veliparib | 8 (12%) | 8 (12%) | – |
| AE leading to veliparib discontinuationb | 12 (19%) | 14 (22%) | – |
| AE leading to veliparib reduction or interruption | 44 (68%) | 45 (69%) | – |
| All grade haematopoietic cytopenias | 51 (79%) | 34 (52%) | 0.003 |
| Haematopoietic erythropenias | 25 (39%) | 12 (19%) | 0.019 |
| Haematopoietic leukopenias | 47 (72%) | 28 (43%) | 0.001 |
| Any neutropenia and lymphopenia | 46 (71%) | 28 (43%) | 0.002 |
| Fatal AE | 2 (3%) | 2 (3%) | – |
| Deathsc | 27 (42%) | 27 (42%) | – |
AE adverse event
a P-value for difference between treatment groups from Fisher’s Exact Test. Only P-values <0.05 are presented
b Includes adverse events related to progression and not related to progression
c Includes all treatment-emergent deaths and deaths that occurred >30 days after last dose