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Table 5 Adverse Events Related to Ezatiostat in Combination with Lenalidomide by Dose Level

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)

Adverse Event (Preferred Term) Total Daily Starting Doses
Dose Group 1 Dose Group 2
2000/10 mg/day 2500/10 mg/day
(N = 13) (N = 6)
n (%) n (%)
Hematologic (All Patients)
Thrombocytopenia 7 (54) 2 (33)
Neutropenia 4 (31) 2 (33)
Anaemia 3 (23) 1 (17)
Febrile Neutropenia 2 (15) 0
Non-Hematologic (≥ 10% of Patients)
Vomiting 9 (69) 2 (33)
Diarrhea 8 (62) 3 (50)
Nausea 7 (54) 4 (67)
Fatigue 4 (31) 2 (33)
Abdominal Pain Upper 2 (15) 1 (17)
Constipation 2 (15) 0
Flatulence 2 (15) 0
Anorexia 2 (15) 1 (17)
Muscle Spasms 2 (15) 0
Muscle Weakness 2 (15) 0
Skin Odour Abnormal 3 (23) 1 (17)
Gastritis Erosive 0 1 (17)
Chills 0 1 (17)
Oedema Peripheral 1 (8) 1 (17)
Hypersensitivity 0 1 (17)
Occult Blood Positive 0 1 (17)
Gout 0 1 (17)
Flank Pain 0 1 (17)
Dysgeusia 0 1 (17)
Renal Failure Acute 0 1 (17)
Epitaxis 0 1 (17)
Rash 1 (8) 2 (33)
Night Sweats 0 1 (17)
Swelling Face 0 1 (17)