Table 2. Toxicities observed in 5% or more patients in Phase II studies with cilengitide.
| Toxicity | Grade | Recurrent GBM (in %): n = 81 (EMD 009 Study) [40] | Newly diagnosed GBM (in %): n = 52 (EMD 010 Study) [42] |
|---|---|---|---|
| Hematologic events | |||
| Anemia | 1 or 2 | 60 | NR |
| 3 or 4 | 0 | 0 | |
| Neutropenia | 1 or 2 | 1 | NR |
| 3 or 4 | 0 | 10 | |
| Thrombocytopenia | 1 or 2 | 0 | NR |
| 3 or 4 | 0 | 13 | |
| Non-hematologic events | |||
| Anorexia | 1 or 2 | <5 | 10 |
| 3 or 4 | 0 | 0 | |
| Diarrhea | 1 or 2 | 6 | <5 |
| 3 or 4 | 0 | 0 | |
| Fatigue | 1 or 2 | 11 | 14 |
| 3 or 4 | 0 | 0 | |
| Headache | 1 or 2 | 5 | < 5 |
| 3 or 4 | 0 | 0 | |
| Nausea | 1 or 2 | 5 | 17 |
| 3 or 4 | 0 | 0 |
EMD: EMD Serono, Inc. (US affiliate of MerckKGaA, Darmstadt, Germany); GBM: Glioblastoma multiforme; NR: Not reported.