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Table 4 Adverse Events Related to Ezatiostat in Combination with Lenalidomide for Both Dose Groups Combined

From: Phase 1 dose-ranging study of ezatiostat hydrochloride in combination with lenalidomide in patients with non-deletion (5q) low to intermediate-1 risk myelodysplastic syndrome (MDS)

NCI-CTCAE v3.0 Maximum Toxicity Grade (N = 19)
Adverse Event (Preferred Term) Grade 1 Grade 2 Grade 3 Grade 4 Total
  n (%) n (%) n (%) n (%) n (%)
Hematologic (All Patients)
Thrombocytopenia 1 (5) 1 (5) 4 (21) 3 (16) 9 (47)
Neutropenia 0 2 (11) 2 (11) 2 (11) 6 (32)
Anemia 0 0 3 (16) 1 (5) 4 (21)
Febrile Neutropenia 0 0 2 (11) 0 2 (11)
Non-Hematologic (≥ 5% of Patients)
Diarrhoea 5 (26) 3 (16) 3 (16) 0 11 (58)
Nausea 7 (37) 3 (16) 1 (5) 0 11 (58)
Vomiting 6 (32) 4 (21) 1 (5) 0 11 (58)
Fatigue 1 (5) 5 (26) 0 0 6 (32)
Skin Odour Abnormal 3 (16) 1 (5) 0 0 4 (21)
Abdominal Pain Upper 2 (11) 1 (5) 0 0 3 (16)
Anorexia 2 (11) 1 (5) 0 0 3 (16)
Rash 0 1 (5) 2 (11) 0 3 (16)
Constipation 2 (11) 0 0 0 2 (11)
Flatulence 1 (5) 1 (5) 0 0 2 (11)
Muscle Spasms 1 (5) 0 1 (5) 0 2 (11)
Muscular Weakness 0 1 (5) 1 (5) 0 2 (11)
Oedema Peripheral 1 (5) 1 (5) 0 0 2 (11)
  1. Abbreviations: NCI-CTCAE v3.0 National Cancer Institute − Common Toxicity Criteria for Adverse Events, Version 3.0.