Table 1.
Patient baseline characteristics and demographics (intention-to-treat population)
| Standard Cilengitide Arm (n = 88) | Intensive Cilengitide Arm (n = 88) | Control Arm (n = 89) | |
|---|---|---|---|
| Age, y | |||
| Median (range) | 55.6 (26–77) | 56.0 (21–76) | 57.7 (21–74) |
| Gender, n (%) | |||
| Male | 50 (56.8) | 50 (56.8) | 55 (61.8) |
| ECOG performance status, n (%) | |||
| 0 | 45 (51.1) | 46 (52.3) | 40 (44.9) |
| 1 | 42 (47.7) | 41 (46.6) | 49 (55.1) |
| Missing | 1 (1.1) | 1 (1.1) | 0 (0.0) |
| RPA class, n (%) | |||
| III | 13 (14.8) | 15 (17.0) | 15 (16.9) |
| IV | 48 (54.5) | 49 (55.7) | 57 (64.0) |
| V | 26 (29.5) | 22 (25.0) | 17 (19.1) |
| Missing | 1 (1.1) | 2 (2.3) | 0 (0.0) |
| Extent of surgery, n (%) | |||
| Total resection | 44 (50.0) | 46 (52.3) | 46 (51.7) |
| Partial resection | 37 (42.0) | 37 (42.0) | 37 (41.6) |
| Biopsy | 7 (8.0) | 4 (4.5) | 6 (6.7) |
| Missing | 0 (0.0) | 1 (1.1) | 0 (0.0) |
| Time, wk, from diagnosis to randomization, n (%) | |||
| Median (range) | 4.3 (2.1–6.6) | 4.0 (2.1–7.1) | 3.7 (1.6–6.7) |