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%) |