Table 1.
Baseline clinical characteristics of the patients
| Placebo (N = 476) | Ipilimumab (N = 475) | |
|---|---|---|
| Gender – no. (%) | ||
| Male | 293 (61.6) | 296 (62.3) |
| Female | 183 (38.4) | 179 (37.7) |
| Age | ||
| Median (range), yr | 52 (18 – 78) | 51 (20 – 84) |
| Stage provided at randomization – no. (%)† | ||
| Stage IIIA | 98 (20.6) | 98 (20.6) |
| Stage IIIB | 182 (38.2) | 182 (38.3) |
| Stage IIIC (1–3 LN+) | 121 (25.4) | 122 (25.7) |
| Stage IIIC (≥4 LN+) | 75 (15.8) | 73 (15.4) |
| AJCC 2002 (CRF) – no. (%)‡ | ||
| Stage IIIA | 88 (18.5) | 98 (20.6) |
| Stage IIIB | 207 (43.5) | 213 (44.8) |
| Stage IIIC (1–3 LN+) | 83 (17.4) | 69 (14.5) |
| Stage IIIC (≥4 LN+) | 98 (20.6) | 95 (20.0) |
| Type of lymph node involvement – no. (%)‡ | ||
| Microscopic | 193 (40.5) | 210 (44.2) |
| Macroscopic | 283 (59.5) | 265 (55.8) |
| Nb of LN+ (pathological) – no. (%)‡ | ||
| 1 | 220 (46.2) | 217 (45.7) |
| 2–3 | 158 (33.2) | 163 (34.3) |
| ≥4 | 98 (20.6) | 95 (20.0) |
| Ulceration – no. (%)‡ | ||
| No | 244 (51.3) | 257 (54.1) |
| Yes | 203 (42.6) | 197 (41.5) |
| Unknown | 29 (6.1) | 21 (4.4) |
| Geographical region – no. (%)† | ||
| North-America | 119 (25.1) | 117 (24.6) |
| Australia | 19 (4.0) | 18 (3.8) |
| Europe | 337 (70.9) | 341 (71.6) |
†
as provided at randomization
‡
as indicated on case report forms
LN+: positive lymph nodes