Table 5. Most frequent investigator-reported treatment-emergent drug-related adverse events reported in the ITT (safety) population (≥2% of patients in either treatment group).
Preferred term, n (%) | CDA (N = 914) | AL (N = 458) |
Reticulocyte count decreased | 79 (9) | 44 (10) |
Anemia | 24 (3) | 9 (2) |
Hemoglobin decreased | 24 (3) | 7 (2) |
Vomiting | 14 (2) | 4 (<1) |
Thrombocytopenia | 15 (2) | 3 (<1) |
Patients with at least one drug-related adverse event | 184 (20) | 86 (19) |