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. 2014 Oct 6;9(10):e108694. doi: 10.1371/journal.pone.0108694

Table 3. Summary of dose-limiting toxicities and serious adverse events.

Phase I Phase II
30 mg/d (n = 3) 20 mg/d (n = 3) 3-h infusion (20 mg/d) (n = 7) 24-h infusion (60 mg/d) (n = 5)
Dose-limiting toxicity Grade 3 somnolence/confusion (1); grade 3 ataxia (1) 0 0 0
Serious TEAE, n (grade, attribution)
Febrile neutropenia 1 (gr 3, NR) 1 (gr 3, NR)
Atrial fibrillation 2 (gr 3, NR; gr 3, NR)
Acute myocardial infarction 1 (gr 3, NR) 1 (gr 4, PS)
Cough 2 (gr 1, NR; gr 2, PS)
Catheter site infection 1 (gr 3, NR) 1 (gr 3, NR)
Cytokine release syndrome 1 (gr 2, PR)
Pneumonia 1 (gr 3, NR) 1 (gr 3, NR)
Acute sinusitis 1 (gr 1, NR)
Dyspnea 1 (gr 2, NR)
Fatigue 1 (gr 5, NR)
Dizziness 1 (gr 3, PR)

AE, adverse event; DLT, dose-limiting toxicity (DLTs were defined as grade ≥3 infusion-related neurologic AEs and nonhematologic AEs not responsive to symptom-directed therapy); PR, probably related; PS, possibly related; NR, not related; TEAE, treatment-emergent adverse event.