Table 3:
Summary of adverse events*
| A+CHP (N=223) |
CHOP (N=226) |
|||
|---|---|---|---|---|
| Adverse events | ||||
| Any adverse events | 221 (99%) | 221 (98%) | ||
| Grade ≥3 adverse events | 147 (66%) | 146 (65%) | ||
| Serious adverse event | 87 (39%) | 87 (38%) | ||
| Discontinued treatment due to adverse event | 14 (6%) | 15 (7%) | ||
| Death due to adverse events | 7 (3%) | 9 (4%) | ||
| Any Grade | Grade ≥3 | Any Grade | Grade ≥3 | |
| Common adverse events | ||||
| Nausea | 103 (46%) | 5 (2%) | 87 (38%) | 4 (2%) |
| Peripheral sensory neuropathy | 100 (45%) | 8 (4%) | 92 (41%) | 6 (3%) |
| Neutropenia | 85 (38%) | 77 (35%) | 85 (38%) | 76 (34%) |
| Diarrhoea | 85 (38%) | 13 (6%) | 46 (20%) | 2 (1%) |
| Constipation | 64 (29%) | 2 (1%) | 67 (30%) | 3 (1%) |
| Alopecia | 58 (26%) | 0 | 56 (25%) | 3 (1%) |
| Pyrexia | 58 (26%) | 4 (2%) | 42 (19%) | 0 |
| Vomiting | 57 (26%) | 2 (1%) | 39 (17%) | 4 (2%) |
| Fatigue | 54 (24%) | 2 (1%) | 46 (20%) | 4 (2%) |
| Anaemia | 46 (21%) | 30 (13%) | 36 (16%) | 23 (10%) |
Data are n (%). Common adverse events are shown for those occurring in ≥20% of subjects in the safety population. A+CHP=brentuximab vedotin, cyclophosphamide, doxorubicin, and prednisone; CHOP=cyclophosphamide, doxorubicin, vincristine, and prednisone.
*
Adverse events are presented and defined as newly occurring (not present at baseline) or worsening after first dose of any component of A+CHP and CHOP.