Table 4. . Summary of relevant adverse events attributable to eflornithine from the pooled Phase III anaplastic glioma and glioblastoma study data for the eflornithine–procarbazine, lomustine, vincristine versus procarbazine, lomustine, vincristine treatment†.
| AEs | Toxicity grade 1 | Toxicity grade 2 | Toxicity grade 3 | Toxicity grade 4 | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Eflornithine-PCV (%) | PCV (%) | AEs due to eflornithine (%) | Eflornithine–PCV (%) | PCV (%) | AEs due to eflornithine (%) | Eflornithine–PCV (%) | PCV (%) | AEs due to eflornithine (%) | Eflornithine–PCV (%) | PCV (%) | AEs due to eflornithine (%) | |
| Anemia | 36.7 | 24.2 | 12.5 | 31.9 | 16.3 | 15.6 | 7.7 | 3.2 | 4.5 | 2.0 | 0.0 | 2.0 |
| Leukopenia | 58.1 | 61.5 | -3.4 | 53.6 | 52.4 | 1.2 | 27.8 | 27.8 | 0.0 | 4.0 | 3.2 | 0.9 |
| Granulocytopenia | 52.0 | 49.6 | 2.4 | 43.5 | 42.5 | 1.1 | 26.6 | 30.6 | -3.9 | 11.3 | 9.5 | 1.8 |
| Thrombocytopenia | 41.1 | 36.5 | 4.6 | 39.5 | 29.0 | 10.5 | 20.2 | 16.7 | 3.5 | 5.2 | 3.2 | 2.1 |
| Hearing loss | 2.4 | 2.4 | 0.0 | 2.8 | 1.6 | 1.2 | 0.8 | 0.0 | 0.8 | 0.0 | 0.0 | 0.0 |
| Anorexia | 7.7 | 9.1 | -1.5 | 6.0 | 3.6 | 2.5 | 1.2 | 0.0 | 1.2 | 0.0 | 0.0 | 0.0 |
| Diarrhea | 28.2 | 2.8 | 25.4 | 19.0 | 1.6 | 17.4 | 6.0 | 0.0 | 6.0 | 0.8 | 0.0 | 0.8 |
| Nausea only | 36.7 | 35.7 | 1.0 | 23.0 | 23.0 | 0.0 | 7.7 | 6.7 | 0.9 | 0.0 | 0.0 | 0.0 |
| Vomiting | 24.6 | 19.4 | 5.2 | 21.0 | 19.8 | 1.1 | 7.7 | 3.2 | 4.5 | 0.4 | 1.6 | -1.2 |
| Constipation | 4.0 | 6.0 | -1.9 | 4.8 | 5.6 | -0.7 | 0.4 | 0.0 | 0.4 | 0.4 | 0.0 | 0.4 |
| Fatigue | 18.5 | 13.9 | 4.7 | 12.5 | 5.6 | 6.9 | 1.6 | 0.8 | 0.8 | 0.0 | 0.0 | 0.0 |
| Headache | 3.6 | 5.6 | -1.9 | 4.0 | 2.8 | 1.3 | 1.2 | 0.8 | 0.4 | 0.0 | 0.0 | 0.0 |
| Pruritus | 4.4 | 5.2 | -0.7 | 8.1 | 7.1 | 0.9 | 4.0 | 4.4 | -0.3 | 0.0 | 0.0 | 0.0 |