EPO and Venous thrombosis: Two treatment-emergent SAEs in the epoetin-α group were considered related to study drug by the investigator: thromboembolism (distal deep venous thrombosis, during the first 24 weeks of treatment) and in one patient the anti-erythropoietin antibody testing (after 24 weeks of treatment) was positive during the routine study safety assessment, which led to permanent discontinuation of the study drug.