Table 3 Treatment-emergent AEs that occurred in the first 24 weeks in ≥5% of patients (safety analysis—treatment phase only)
Placebo n = 45 | Epoetin-α n = 85 | |
|---|---|---|
General disorders | 17 (37.8%) | 31 (36.5%) |
Asthenia | 5 (11.1%) | 12 (14.1%) |
Fatigue | 3 (6.7%) | 8 (9.4%) |
Pyrexia | 5 (11.1%) | 7 (8.2%) |
Edema peripheral | 5 (11.1%) | 3 (3.5%) |
Infections and infestations | 11 (24.4%) | 24 (28.2%) |
Nasopharyngitis | 2 (4.4%) | 6 (7.1%) |
Gastrointestinal disorders | 8 (17.8%) | 24 (28.2%) |
Diarrhea | 1 (2.2%) | 8 (9.4%) |
Constipation | 0 | 6 (7.1%) |
Metabolism and nutrition disorders | 4 (8.9%) | 15 (17.6%) |
Respiratory, thoracic and mediastinal disorders | 4 (8.9%) | 13 (15.3%) |
Dyspnea | 1 (2.2%) | 8 (9.4%) |
Skin and subcutaneous tissue disorders | 4 (8.9%) | 12 (14.1%) |
Pruritus | 0 | 5 (5.9%) |
Musculoskeletal and connective tissue disorders | 11 (24.4%) | 11 (12.9%) |
Back pain | 3 (6.7%) | 1 (1.2%) |
Investigations | 7 (15.6%) | 10 (11.8%) |
Vascular disorders | 4 (8.9%) | 10 (11.8%) |
Blood and lymphatic system disorders | 7 (15.6%) | 9 (10.6%) |
Anemia | 5 (11.1%) | 5 (5.9%) |
Injury, poisoning and procedural complications | 5 (11.1%) | 8 (9.4%) |
Neoplasms benign, malignant and unspecified (including cysts and polyps) | 7 (15.6%) | 6 (7.1%) |
Cardiac disorders | 3 (6.7%) | 6 (7.1%) |
