Table 1.
Characteristics of patients at baseline.
| Patient-reported outcome population | Overall study [4] | ||||
|---|---|---|---|---|---|
|
|
|
||||
| Nivolumab (n = 270) | Nivolumab + ipilimumab (n = 274) | Ipilimumab (n = 259) | Overalla (n = 803) | Total (N = 945) | |
| Age | |||||
| Mean (SD) | 58.9 (13.2) | 59.2 (14.0) | 60.7 (13.2) | 59.6 (13.5) | 60 (13.7) |
| Sex, n (%) | |||||
| Male | 173 (64.1) | 183 (66.8) | 167 (64.5) | 523 (65.1) | 610 (64.6) |
| Female | 97 (35.9) | 91 (33.2) | 92 (35.5) | 280 (34.9) | 335 (35.4) |
| ECOG performance status score, n (%) | |||||
| 0 | 209 (77.4) | 207 (75.5) | 186 (71.8) | 602 (75.0) | 692 (73.2) |
| ≥1 | 61 (22.6) | 67 (24.5) | 73 (28.2) | 201 (25.0) | 252 (26.7) |
| Metastasis stage, n (%) | |||||
| M0/M1a/M1b | 114 (42.2) | 116 (42.3) | 111 (42.9) | 341 (42.5) | 397 (42.0) |
| M1c | 156 (57.8) | 158 (57.7) | 148 (57.1) | 462 (57.5) | 548 (58.0) |
| Lactate dehydrogenase status, n (%) | |||||
| ≤ULN | 172 (63.7) | 181 (66.1) | 167 (64.5) | 520 (64.8) | 589 (62.3) |
| >ULN | 94 (34.8) | 93 (33.9) | 90 (34.7) | 277 (34.5) | 341 (36.1) |
| Missing | 4 (1.5) | 0 | 2 (0.8) | 6 (0.7) | 15 (1.6) |
| Brain metastases, n (%) | |||||
| Yes | 6 (2.2) | 9 (3.3) | 9 (3.5) | 24 (3.0) | 34 (3.6) |
| No | 264 (97.8) | 265 (96.7) | 250 (96.5) | 779 (97.0) | 911 (96.4) |
| BRAF mutation status, n (%) | |||||
| Mutation | 83 (30.7) | 93 (33.9) | 84 (32.4) | 260 (32.4) | 298 (31.5) |
| Wild type | 187 (69.3) | 181 (66.1) | 175 (67.6) | 543 (67.6) | 647 (68.5) |
| PD-L1 status, n (%) | |||||
| Positive | 126 (46.7) | 126 (46.0) | 120 (46.3) | 372 (46.3) | 223 (23.6) |
| Negative | 144 (53.3) | 148 (54.0) | 139 (53.7) | 431 (53.7) | 620 (65.6) |
a
Based on patients who had both baseline and at least one post-baseline HRQoL assessment.
ECOG, Eastern Cooperative Oncology Group; SD, standard deviation; ULN, upper limit of normal.