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. Here, EPO is linked to Thromboembolism.