Table 1.
Patient Demographic and Clinical Characteristics at Baseline (Intention-to-Treat Population).*
| Characteristic | A+AVD (N = 664) |
ABVD (N = 670) |
Total (N = 1334) |
|---|---|---|---|
| Male sex — no. (%) | 378 (57) | 398 (59) | 776 (58) |
| Age — yr | |||
| Median | 35 | 37 | 36 |
| Range | 18–82 | 18–83 | 18–83 |
| Age categories — no. (%) | |||
| <45 yr | 451 (68) | 423 (63) | 874 (66) |
| 45–59 yr | 129 (19) | 145 (22) | 274 (21) |
| 60–64 yr | 24 (4) | 40 (6) | 64 (5) |
| ≥65 yr | 60 (9) | 62 (9) | 122 (9) |
| Regions — no. (%) | |||
| Americas | 261 (39) | 262 (39) | 523 (39) |
| Europe | 333 (50) | 336 (50) | 669 (50) |
| Asia | 70 (11) | 72 (11) | 142 (11) |
| Ann Arbor stage at initial diagnosis — no. (%)† | |||
| Stage II‡ | 1 (<1) | 0 | 1 (<1) |
| Stage III | 237 (36) | 246 (37) | 483 (36) |
| Stage IV | 425 (64) | 421 (63) | 846 (64) |
| Not applicable, unknown, or missing | 1 (<1) | 3 (<1) | 4 (<1) |
| International Prognostic Score — no. (%)§ | |||
| 0 or 1 | 141 (21) | 141 (21) | 282 (21) |
| 2 or 3 | 354 (53) | 351 (52) | 705 (53) |
| 4 to 7 | 169 (25) | 178 (27) | 347 (26) |
| ECOG performance status — no. (%)¶ | |||
| 0 | 376 (57) | 378 (57) | 754 (57) |
| 1 | 259 (39) | 262 (39) | 521 (39) |
| 2 | 28 (4) | 26 (4) | 54 (4) |
| Not obtained or missing | 1 (<1) | 4 (<1) | 5 (<1) |
| Extranodal involvement at diagnosis — no. (%) | |||
| Yes | 411 (62) | 416 (62) | 827 (62) |
| 1 extranodal site | 217 (33) | 223 (33) | 440 (33) |
| >1 extranodal sites | 194 (29) | 193 (29) | 387 (29) |
| No | 217 (33) | 228 (34) | 445 (33) |
| Unknown or missing | 36 (5) | 26 (4) | 62 (5) |
| Patients with any B symptom — no. (%)‖ | 399 (60) | 381 (57) | 780 (58) |
A full description of patient demographics and clinical characteristics at baseline can be found in Table S3 in the Supplementary Appendix. Percentages may not total 100 because of rounding. A+AVD denotes brentuximab vedotin plus doxorubicin, vinblastine, dacarbazine, and ABVD doxorubicin, bleomycin, vinblastine, and dacarbazine.
The Ann Arbor staging system ranges from I to IV, with higher stages indicating more widespread disease.
Patients in this category had a major protocol violation.
The International Prognostic Score ranges from 0 to 7, with higher scores indicating increased risk of treatment failure. Scores of 0 to 1 denote low risk, scores of 2 to 3 intermediate risk, and scores of 4 to 7 high risk.
Values for Eastern Cooperative Oncology Group (ECOG) performance status range from 0 to 5, with higher scores indicating greater disability.
B symptoms consist of night sweats, unexplained fever (temperature >38°C), or loss of more than 10% of body weight.