Table 5.
Most common treatment-emergent AEs of any grade (≥15% of patients in either arm) and grade ≥3 (≥5% in either arm; safety population)
| Treatment-emergent AEs | VR-CAP, n = 82 | R-CHOP, n = 79 | ||
|---|---|---|---|---|
| n | % | n | % | |
| Any grade | ||||
| Any AE | 81 | 99 | 79 | 100 |
| Neutropenia | 65 | 79 | 66 | 84 |
| Thrombocytopenia | 40 | 49 | 7 | 9 |
| Diarrhea | 26 | 32 | 11 | 14 |
| PN NEC | 26 | 32 | 17 | 22 |
| Vomiting | 25 | 31 | 11 | 14 |
| Constipation | 24 | 29 | 25 | 32 |
| Nausea | 22 | 27 | 20 | 25 |
| Pyrexia | 22 | 27 | 18 | 23 |
| Fatigue | 21 | 26 | 11 | 14 |
| Anemia | 19 | 23 | 17 | 22 |
| Leukopenia | 19 | 23 | 24 | 30 |
| Cough | 14 | 17 | 11 | 14 |
| Peripheral edema | 14 | 17 | 5 | 6 |
| Decreased appetite | 13 | 16 | 5 | 6 |
| Paresthesia | 12 | 15 | 10 | 13 |
| Asthenia | 10 | 12 | 14 | 18 |
| Febrile neutropenia | 7 | 9 | 16 | 20 |
| Grade ≥3 | ||||
| Any AE | 72 | 88 | 70 | 89 |
| Neutropenia | 64 | 78 | 64 | 81 |
| Thrombocytopenia | 30 | 37 | 2 | 3 |
| Leukopenia | 18 | 22 | 18 | 23 |
| Febrile neutropenia | 7 | 9 | 16 | 20 |
| Hyperglycemia | 5 | 6 | 0 | 0 |
| PN NEC | 5 | 6 | 2 | 3 |
| Anemia | 4 | 5 | 7 | 9 |
| Diarrhea | 4 | 5 | 1 | 1 |
| Pneumonia | 4 | 5 | 4 | 5 |
| Vomiting | 4 | 5 | 1 | 1 |
PN NEC, peripheral neuropathy not elsewhere classified, including peripheral sensory neuropathy, neuropathy peripheral, peripheral sensorimotor neuropathy, and peripheral motor neuropathy.