Table 2:
Most Frequent Adverse Events by Arm (> 10%, any grade) in modified intent-to-treat analysis set (70% information fraction).
| Adverse Events | N-AVD | BV-AVD |
|---|---|---|
| n = 482 | n = 476 | |
| Any Grade | Any Grade | |
| No (%) | No (%) | |
| Nausea | 312 (65%) | 331 (70%) |
| Fatigue | 228 (47%) | 242 (51%) |
| Neutrophil count decreased | 272 (56%) | 160 (34%) |
| Anemia | 190 (39%) | 217 (46%) |
| Peripheral sensory neuropathy | 139 (29%) | 266 (56%) |
| Constipation | 193 (40%) | 204 (43%) |
| ALT increased | 160 (33%) | 201 (42%) |
| White blood cell decreased | 197 (41%) | 128 (27%) |
| Vomiting | 134 (28%) | 157 (33%) |
| AST increased | 125 (26%) | 160 (34%) |
| Diarrhea | 100 (21%) | 129 (27%) |
| Alopecia | 103 (21%) | 124 (26%) |
| Lymphocyte count decreased | 103 (21%) | 109 (23%) |
| Mucositis oral | 107 (22%) | 100 (21%) |
| Anorexia | 61 (13%) | 106 (22%) |
| Abdominal pain | 58 (12%) | 107 (22%) |
| Headache | 69 (14%) | 75 (16%) |
| Platelet count decreased | 52 (11%) | 86 (18%) |
| Bone pain | 40 (8%) | 96 (20%) |
| Alkaline phosphatase increased | 54 (11%) | 81 (17%) |
| Fever | 62 (13%) | 61 (13%) |
| Arthralgia | 64 (13%) | 58 (12%) |
| Hyperglycemia | 57 (12%) | 63 (13%) |
| Rash maculo-papular | 54 (11%) | 58 (12%) |
| Myalgia | 52 (11%) | 57 (12%) |
| Dyspnea | 42 (9%) | 58 (12%) |
| Weight loss | 25 (5%) | 71 (15%) |
| Dysgeusia | 35 (7%) | 59 (12%) |
N-AVD = nivolumab, doxorubicin, vinblastine, dacarbazine; BV-AVD = brentuximab vedotin, doxorubicin, vinblastine, dacarbazine; ALT = alanine aminotransferase; AST = aspartate aminotransferase