Hematologic and nonhematologic adverse events related to ezatiostat tablets in 5% or more of patients: by dose level
Adverse event (preferred term) . | Dose level, mg, n (%) . | |||||||||
---|---|---|---|---|---|---|---|---|---|---|
N = 3 . | N = 4 . | N = 5 . | N = 6 . | N = 12 . | ||||||
200 . | 400 . | 1000 . | 1400 . | 2000 . | 2400 . | 3000 . | 4000 . | 5000 . | 6000 . | |
Hematologic | ||||||||||
Neutropenia | 0 | 0 | 0 | 0 | 0 | 0 | 1 (25) | 1 (20) | 0 | 1 (8) |
Nonhematologic | ||||||||||
Nausea | 1 (33) | 0 | 0 | 3 (100) | 2 (67) | 2 (67) | 2 (50) | 3 (60) | 5 (83) | 11 (92) |
Diarrhea | 0 | 0 | 1 (33) | 1 (33) | 1 (33) | 0 | 2 (50) | 3 (60) | 3 (50) | 8 (67) |
Vomiting | 0 | 0 | 1 (33) | 0 | 0 | 1 (33) | 1 (25) | 3 (60) | 2 (33) | 6 (50) |
Anorexia | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 2 (33) | 3 (25) |
Abdominal pain | 0 | 0 | 0 | 0 | 1 (33) | 0 | 1 (25) | 1 (20) | 0 | 1 (8) |
Constipation | 1 (33) | 0 | 1 (33) | 0 | 0 | 0 | 0 | 1 (20) | 0 | 1 (8) |
Dyspepsia | 0 | 0 | 0 | 1 (33) | 0 | 0 | 1 (25) | 0 | 1 (17) | 1 (8) |
Skin odor abnormal | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 4 (33) |
Adverse event (preferred term) . | Dose level, mg, n (%) . | |||||||||
---|---|---|---|---|---|---|---|---|---|---|
N = 3 . | N = 4 . | N = 5 . | N = 6 . | N = 12 . | ||||||
200 . | 400 . | 1000 . | 1400 . | 2000 . | 2400 . | 3000 . | 4000 . | 5000 . | 6000 . | |
Hematologic | ||||||||||
Neutropenia | 0 | 0 | 0 | 0 | 0 | 0 | 1 (25) | 1 (20) | 0 | 1 (8) |
Nonhematologic | ||||||||||
Nausea | 1 (33) | 0 | 0 | 3 (100) | 2 (67) | 2 (67) | 2 (50) | 3 (60) | 5 (83) | 11 (92) |
Diarrhea | 0 | 0 | 1 (33) | 1 (33) | 1 (33) | 0 | 2 (50) | 3 (60) | 3 (50) | 8 (67) |
Vomiting | 0 | 0 | 1 (33) | 0 | 0 | 1 (33) | 1 (25) | 3 (60) | 2 (33) | 6 (50) |
Anorexia | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 2 (33) | 3 (25) |
Abdominal pain | 0 | 0 | 0 | 0 | 1 (33) | 0 | 1 (25) | 1 (20) | 0 | 1 (8) |
Constipation | 1 (33) | 0 | 1 (33) | 0 | 0 | 0 | 0 | 1 (20) | 0 | 1 (8) |
Dyspepsia | 0 | 0 | 0 | 1 (33) | 0 | 0 | 1 (25) | 0 | 1 (17) | 1 (8) |
Skin odor abnormal | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 4 (33) |