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. Author manuscript; available in PMC: 2013 Jun 1.
Published in final edited form as: Biol Blood Marrow Transplant. 2011 Nov 9;18(6):913–921. doi: 10.1016/j.bbmt.2011.10.041

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.