Table 3.
Number of patients with clinical adverse events occurring in 15% or more of patients
| Adverse event | Dose level, mg/m2 |
Total N = 32 | |||||||
|---|---|---|---|---|---|---|---|---|---|
| 3.5 N = 2 | 5 N = 1 | 7 N = 2 | 10 N = 5 | 14 N = 7 | 20 N = 3 | 28 N = 7 | 40 N = 5 | ||
| Somnolence | |||||||||
| Grade 1 | 1/2 | 2/2 | 5/5 | 5/7 | 1/3 | 14/32 | |||
| Grade 2 | 1/3 | 3/7 | 2/5 | 6/32 | |||||
| Grade 3 | 2/7 | 1/5 | 3/32 | ||||||
| Euphoric mood | |||||||||
| Grade 1 | 2/2 | 1/1 | 4/5 | 4/7 | 3/3 | 1/7 | 1/5 | 16/32 | |
| Grade 2 | 1/5 | 1/7 | 1/7 | 3/32 | |||||
| Fatigue | |||||||||
| Grade 1 | 1/2 | 1/1 | 2/7 | 1/3 | 1/7 | 2/5 | 8/32 | ||
| Grade 2 | 1/2 | 1/32 | |||||||
| Grade 3 | 2/7 | 2/32 | |||||||
| Cough | |||||||||
| Grade 1 | 1/2 | 3/7 | 1/3 | 2/5 | 7/32 | ||||
| Grade 2 | 1/2 | 1/32 | |||||||
| Fever | |||||||||
| Grade 1 | 1/1 | 3/7 | 1/7 | 1/5 | 6/32 | ||||
| Grade 3 | 1/5 | 1/32 | |||||||
| Diploplia | |||||||||
| Grade 1 | 1/2 | 1/5 | 1/3 | 2/7 | 2/5 | 7/32 | |||
| Dizziness | |||||||||
| Grade 1 | 1/2 | 2/5 | 1/3 | 1/7 | 5/32 | ||||
| Grade 3 | 1/5 | 1/32 | |||||||
| Headache | |||||||||
| Grade 1 | 1/2 | 1/5 | 1/7 | 1/7 | 1/5 | 5/32 | |||
| Grade 3 | 1/1 | 1/32 | |||||||
| Ataxia | |||||||||
| Grade 1 | 1/2 | 1/5 | 2/32 | ||||||
| Grade 2 | 1/7 | 1/32 | |||||||
| Grade 3 | 1/7 | 1/5 | 2/32 | ||||||
| Confusional state | |||||||||
| Grade 1 | 1/5 | 1/7 | 1/5 | 3/32 | |||||
| Grade 2 | 1/7 | 1/32 | |||||||
| Grade 3 | 1/5 | 1/32 | |||||||
| Hangover | |||||||||
| Grade 1 | 2/5 | 1/3 | 1/7 | 1/5 | 5/32 | ||||
| Nausea | |||||||||
| Grade 1 | 1/5 | 2/7 | 1/5 | 4/32 | |||||
| Grade 2 | 1/7 | 1/32 | |||||||