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Adverse events
| Patients | 1 mg/kg/day | 2 mg/kg/day | Alternating | All n = 24 |
|---|---|---|---|---|
| Cohort 1/Schedule A n = 10 | Cohort 2 n = 8 | Schedule B n = 6 | ||
| Completed 1st cycle | 7/10 (70 %) | 5/8 (63 %) | 5/6 (83 %) | 17/24 (71 %) |
| Toxicities grade (%) | 2 | 3 | 4 | 2 | 3 | 4 | 2 | 3 | 4 | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Rash | 1 | 4 | 2 | 29.2 | ||||||||
| Diarrhea | 3 | 1 | 1 | 20.8 | ||||||||
| Anorexia | 5 | 2 | 4 | 4 | 62.5 | |||||||
| Weight loss | 1 | 1 | 2 | 16.7 | ||||||||
| Anxiety | 1 | 4.2 | ||||||||||
| Nausia | 3 | 1 | 16.7 | |||||||||
| Vomiting | 4 | 16.7 | ||||||||||
| Fatigue | 4 | 4 | 5 | 1 | 2 | 2 | 75.0 | |||||
| Muscle weakness | 1 | 1 | 6 | 1 | 1 | 41.7 | ||||||
| Myalgia | 2 | 3 | 1 | 1 | 29.2 | |||||||
| Rhabdomyolysis | 1 | 4.2a |
aStudy related death
