Table 2. Hepatic, Renal, and Skin Toxicity (Day 7 until Day 30) CTC v. 3.0.
Clo mg/m2. er Day × 5 |
Mel mg/m2 |
Enrolled | Hepatic | Renal | Sk | n | Other | ||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Phase 1 | Gr 1-2 | Gr3-4 | Gr 1-2 | Gr 3-4 | Gr 5 | Gr 1-2 | Gr 3-4 | Gr 1-2 | Gr 3-4 | Gr 5 | |||
10 | 100 | 1 | 1 | ||||||||||
20 | 100 | 2 | 0 | 1 seizure | |||||||||
30 | 100 | 2 | 2 | 3 | 1 cardiovascular | ||||||||
40 | 100 | 1 | 1 | ||||||||||
40 | 120 | 3 | 1 | 1 | 1 | 1 | |||||||
Phase 2 | 40 | 140 | 24 | 14(58%) | 10(42%) | 9 (37%) | 4(17%) | 1 (4%) | 3(12%) | 6 (25%) | 1 confusion | 1 a.fib, | 1 cardiovascular |
1 a. flutter, | 1 mucositis | ||||||||||||
1 mucositis, | 1 mental status changes | ||||||||||||
1 pancreatitis | |||||||||||||
30 | 140 | 27 | 16 (59%) | 10(37%) | 9 (33%) | 7 (26%) | 2 (7%) | 1 (4%) | 1 pancreatitis, | 1 confusion, agitation | 1 irreversible mental status changes | ||
1 mucositis, | 2 severe mental status changes | 1 pulmonary hemorrhage, | |||||||||||
1 seizure, | 1 shock | ||||||||||||
1 anxiety, | |||||||||||||
1 pseudotumor cerebri | |||||||||||||
30 (3h) | 140 | 23 | 13 (56%) | 9 (39%) | 4(18%) | 2(10%) | 2(10%) | 1 (4%) | 1 mucositis, | 1 pulmonary embolism | 1 A fib with RVRand CHF | ||
1 diarrhea | 1 anaphylactic reaction |
Clo indicates clofarabine.