Table 2.
Treatment-emergent adverse events (safety population)
| Standard Cilengitide Arm (n = 89a) | Intensive Cilengitide Arm (n = 81) | Control Arm (n = 85) | |
|---|---|---|---|
| TEAEs, n (%) | |||
| All | 88 (98.9) | 80 (98.8) | 82 (96.5) |
| Study treatmentb–related | 70 (78.7) | 64 (79.0) | 56 (65.9) |
| Serious TEAEs, n (%) | |||
| All | 47 (52.8) | 36 (44.4) | 30 (35.3) |
| Study treatment*–related | 13 (14.6) | 4 (4.9) | 5 (5.9) |
| NCI-CTCAE grade 3 or 4 TEAEs, n (%) | |||
| All | 57 (64.0) | 47 (58.0) | 45 (52.9) |
| Study treatmentb–related | 25 (28.1) | 19 (23.5) | 17 (20.0) |
| TEAEs leading to death, n (%) | |||
| All | 8 (9.0) | 8 (9.9) | 5 (5.9) |
| Study treatmentb–related | 2 (2.2) | 2 (2.5) | 1 (1.2) |
Abbreviation: NCI-CTCAE, National Cancer Institute's Common Terminology Criteria for Adverse Events.
aIncludes 3 patients who were randomized to cilengitide intensive treatment but actually received cilengitide standard treatment; they were therefore allocated to the cilengitide standard treatment group for the safety population.
bCilengitide, radiotherapy, or temozolomide.