Adverse effects (AE) related to continuous erythropoietin receptor activator (C.E.R.A.)
| Patients not on dialysis (N=524) | Kidney transplant patients (N=92) | |||||
|---|---|---|---|---|---|---|
| Initial ESA treatment | Initial ESA treatment | |||||
| Naïve (N=253) | ESA-treated (N=271) | Total (N=524) | Naïve (N=22) | ESA-treated (N=70) | Total (N=92) | |
| At least 1 AE* | 15 (5.9%) | 10 (3.7%) | 25 (4.8%) | 1 (4.5%) | 3 (4.3%) | 4 (4.3%) |
| Blood and lymphatic system disorders | 9 (3.6%) | 4 (1.5%) | 13 (2.5%) | – | 2 (2.9%) | 2 (2.2%) |
| Thrombocytopenia | 9 (3.6%) | 3 (1.1%) | 12 (2.3%) | – | 2 (2.9%) | 2 (2.2%) |
| Thrombocythemia | – | 1 (0.4%) | 1 (1.02%) | – | – | |
| General disorders and administration site conditions | 1 (0.4%) | 2 (0.7%) | 3 (0.6%) | – | 1 (1.4%) | 1 (1.1%) |
| Treatment ineffective | 1 (0.4%) | 2 (0.7%) | 3 (0.6%) | – | 1 (1.4%) | 1 (1.1%) |
| Vascular disorders | 1 (0.4%) | 3 (1.1%) | 4 (0.8%) | – | – | |
| Arterial thrombosis | – | 1 (0.4%) | 1 (0.2%) | – | – | |
| Venous thrombosis | 1 (0.4%) | – | 1 (0.2%) | – | – | |
| Hypertension | 1 (0.4%) | 1 (0.2%) | – | – | ||
| Hypotension | – | 1 (0.4%) | 1 (0.2%) | – | – | |
| Gastrointestinal disorders | 2 (0.8%) | – | 2 (0.4%) | 1 (4.5%) | – | 1 (1.1%) |
| Gastrointestinal disorder | 1 (0.4%) | – | 1 (0.2%) | – | – | – |
| Gastrointestinal bleeding | 1 (0.4%) | – | 1 (0.2%) | – | – | – |
| Oedema, tongue | – | – | – | 1 (4.5%) | – | 1 (1.1%) |
| Infections and infestations | – | 2 (0.7%) | 2 (0.4%) | – | – | – |
| Flu | – | 1 (0.4%) | 1 (0.2%) | – | – | – |
| Urinary tract infections | – | 1 (0.4%) | 1 (0.2%) | – | – | – |
| Nervous system disorders | 1 (0.4%) | 1 (0.4%) | 2 (0.4%) | – | – | – |
| Headache | – | 1 (0.4%) | 1 (0.2%) | – | – | – |
| Ischaemic stroke | 1 (0.4%) | – | 1 (0.2%) | – | – | – |
| Skin and subcutaneous tissue disorders | 1 (0.4%) | 1 (0.4%) | 2 (0.4%) | – | – | – |
| Dry skin | – | 1 (0.4%) | 1 (0.2%) | – | – | – |
| Pruritus | 1 (0.4%) | – | 1 (0.2%) | – | – | – |
| Metabolism and nutrition disorders | – | 1 (0.4%) | 1 (0.2%) | – | – | – |
| Diabetes poorly controlled | – | 1 (0.4%) | 1 (0.2%) | – | – | – |
| Neoplasms, benign, malignant and unspecified (including cysts and polyps) | 1 (0.4%) | – | 1 (0.2%) | – | – | – |
| Lymphoma | 1 (0.4%) | – | 1 (0.2%) | – | – | – |
| Psychiatric disorders | 1 (0.4%) | – | 1 (0.2%) | – | – | – |
| Confusional state | 1 (0.4%) | – | 1 (0.2%) | – | – | – |
| Respiratory, thoracic and mediastinal disorders | 1 (0.4%) | – | 1 (0.2%) | – | – | – |
| Pulmonary embolism | 1 (0.4%) | – | 1 (0.2%) | – | – | – |
One patient could have had more than one AE.
*Eleven led to modification or discontinuation of treatment (non-dialysis n=9; transplant n=2).
Italics represent targeted AEs.
ESA, erythropoiesis-stimulating agent.