Table 4.
Summary of Adverse Events in the Safety Population.*
| Events | A+AVD (N = 662) |
ABVD (N = 659) |
|---|---|---|
| no. (%) | ||
| Adverse events | ||
| Any adverse event | 653 (99) | 646 (98) |
| Grade ≥3 adverse event | 549 (83) | 434 (66) |
| Serious adverse event | 284 (43) | 178 (27) |
| Adverse event resulting in drug discontinuation | 88 (13) | 105 (16) |
| Death during treatment† | 9 (1) | 13 (2) |
| Death due to drug-related adverse events | 8 (1) | 7 (1) |
| Hospitalizations | 242 (37) | 186 (28) |
| Common adverse events‡ | ||
| Neutropenia | ||
| Any grade | 382 (58) | 295 (45) |
| Grade ≥3 | 357 (54) | 260 (39) |
| Constipation | ||
| Any grade | 279 (42) | 241 (37) |
| Grade ≥3 | 11 (2) | 4 (<1) |
| Vomiting | ||
| Any grade | 216 (33) | 183 (28) |
| Grade ≥3 | 23 (3) | 9 (1) |
| Fatigue | ||
| Any grade | 211 (32) | 211 (32) |
| Grade ≥3 | 19 (3) | 7 (1) |
| Peripheral sensory neuropathy | ||
| Any grade | 189 (29) | 111 (17) |
| Grade ≥3 | 31 (5) | 3 (<1) |
| Diarrhea | ||
| Any grade | 181 (27) | 121 (18) |
| Grade ≥3 | 19 (3) | 5 (<1) |
| Pyrexia | ||
| Any grade | 179 (27) | 147 (22) |
| Grade ≥3 | 19 (3) | 13 (2) |
| Peripheral neuropathy | ||
| Any grade | 174 (26) | 85 (13) |
| Grade ≥3 | 27 (4) | 6 (<1) |
| Abdominal pain | ||
| Any grade | 142 (21) | 65 (10) |
| Grade ≥3 | 21 (3) | 4 (<1) |
| Stomatitis | ||
| Any grade | 138 (21) | 104 (16) |
| Grade ≥3 | 10 (2) | 3 (<1) |
*
For a full summary of adverse events, including rates of drug-related adverse events and deaths, see Table S7 in the Supplementary Appendix.
†
Death during treatment is a death that occurred within 30 days after the last dose of frontline therapy.
‡
The events listed include the most clinically important common adverse events. Adverse events (those of any grade that occurred in at least 20% of the patients in either group) excluded from the table are nausea, alopecia, weight loss, and anemia.