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