Table 1.
Demographic and Clinical Characteristics of Study Participants, Stratified by Geographic Region
| Variable | Overall | North America* | Australia | Western Europe | Eastern Europe | ROW** |
|---|---|---|---|---|---|---|
| N | 674 | 95 | 127 | 367 | 43 | 42 |
| Age Mean ± SD | 55.03 ± 13.88 | 55.29 ± 14.26 | 55.31 ± 13.73 | 54.72 ± 13.73 | 51.77 ± 15.17 | 58.9 ± 12.68 |
| Gender | ||||||
| Female | 277 (41.1%) | 40 (42.1%) | 44 (34.6%) | 160 (43.6%) | 19 (44.2%) | 14 (33.3%) |
| Male | 397 (58.9%) | 55 (57.9%) | 83 (65.4%) | 207 (56.4%) | 24 (55.8%) | 28 (66.7%) |
| Race | ||||||
| White | 667 (99.0) | 91 (95.8%) | 126 (99.2%) | 366 (99.7%) | 43 (100%) | 41 (97.6%) |
| Other | 7 (1.0%) | 4 (4.2%) | 1 (0.8%) | 1 (0.3%) | 0 (0%) | 1 (2.4%) |
| Recurrence | ||||||
| Yes | 252 (37.4%) | 32 (33.7%) | 49 (38.6%) | 137 (37.3%) | 24 (55.8%) | 10 (23.8%) |
| No | 422 (67.6%) | 63 (66.3%) | 78 (61.4%) | 230 (62.7%) | 19 (44.2%) | 32 (76.2%) |
| Median Follow-up Time (months) ± IQR | 24.9 ± 19.8 | 23.4 ± 17.5 | 24.9 ± 22.1 | 24.8 ± 19.7 | 15.0 ± 25.7 | 27.6 ± 3.0 |
| Trial Arm | ||||||
| Nivo240mg+Ipi1mg/kg | 346 (51.3%) | 45 (47.4%) | 62 (48.8%) | 190 (51.8%) | 25 (58.1%) | 24 (57.1%) |
| Nivolumab 480mg | 328 (48.7%) | 50 (52.6%) | 65 (51.2%) | 177 (48.2%) | 18 (41.9%) | 18 (42.9%) |
| Stage | ||||||
| IIIB | 201 (29.8%) | 29 (30.5%) | 39 (30.7%) | 113 (30.8%) | 11 (25.6%) | 9 (21.4%) |
| IIIC | 366 (54.3%) | 57 (60%) | 62 (48.8%) | 199 (54.2%) | 26 (60.5%) | 22 (52.4%) |
| IIID | 15 (2.2%) | 4 (4.2%) | 1 (0.8%) | 9 (2.5%) | 0 (0%) | 1 (2.4%) |
| IV | 92 (13.7%) | 5 (5.3%) | 25 (19.7%) | 46 (12.5%) | 6 (14%) | 10 (23.8%) |
| BRAF Mutation | ||||||
| Wildtype | 325 (48.2%) | 47 (49.5%) | 67 (52.8%) | 182 (49.6%) | 19 (44.2%) | 10 (23.8%) |
| Mutant | 188 (27.9%) | 20 (21.1%) | 35 (27.6%) | 111 (30.2%) | 19 (44.2%) | 3 (7.1%) |
| Missing | 161 (23.9%) | 28 (29.5%) | 25 (19.7%) | 74 (20.2%) | 5 (11.6%) | 29 (69%) |
| LD*** (L/U, mean ± SD) | 216.6 ± 86.5 | 186.8 ± 84.3 | 189.7 ± 3 | 230.5 ± 93.3 | 187.4 ± 52.3 | 276.8 ± 109.5 |
| Missing (N) | 12 | 0 | 1 | 9 | 1 | 1 |
*
North America (NA: U.S. and Canada);
**
ROW stands for “rest of world”, patients from Brazil (n = 28) and New Zealand (n = 14).
***
LD refers lactate dehydrogenase (LDH) level and L/U represent the Lower/Upper of the test result