Table 3.
Overall and most frequent AE (≥5% of patients) during the complete study period (safety population)
| Parameter | % of Patients with AEs
|
|
|---|---|---|
| C.E.R.A. (n = 161) | Darbepoetin alfa(n = 162) | |
| Hypertension | 16 | 15 |
| Peripheral edema | 9 | 18 |
| Diarrhea | 9 | 15 |
| Nasopharyngitis | 12 | 12 |
| Constipation | 7 | 11 |
| Upper respiratory tract infection | 8 | 10 |
| Headache | 6 | 9 |
| Urinary tract infection | 7 | 8 |
| Dizziness | 9 | 6 |
| Hyperkalemia | 7 | 7 |
| Renal impairment | 9 | 4 |
| Back pain | 7 | 6 |
| Pain in extremity | 4 | 9 |
| Vomiting | 4 | 8 |
| Gout | 6 | 5 |
| Influenza | 5 | 6 |
| Hypotension | 3 | 7 |
| Nausea | 2 | 9 |
| Cough | 6 | 3 |
| Any AE | 90.1 | 91.4 |
| Serious AE | 30.4 | 35.8 |
| AE leading to withdrawal | 3.1 | 6.2 |
| Arteriovenous thromboembolic events | ||
| Limb venothrombosis | 0 | <1 |
| Pulmonary embolism | 0 | 0 |
| Myocardial infarction | 2 | 0 |
| Stroke | <1 | 0 |
| Deaths | 5 | 6 |