An Observational Study of Epoetin Beta (NeoRecormon) in Participants With Cancer Receiving Chemotherapy

Roche

Status: Completed

Conditions: Anemia

Treatments: Drug: Epoetin beta

Study type: Observational

Funder types: Industry

Identifiers

NCT01809314

ML21420

Details and patient eligibility

About

This observational study will evaluate the efficacy and safety of epoetin beta (NeoRecormon) in participants with symptomatic anemia and cancer receiving chemotherapy. Participants receiving NeoRecormon once weekly in accordance with the Summary of Product Characteristics will be followed for 4 months.

Enrollment: 1,167 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Adults greater than or equal to (≥) 18 years of age
• Participants with solid tumors or lymphoproliferative disease
• Participants receiving chemotherapy
• Participants for whom erythropoietin is indicated for pre-study Hb level and observed anemic symptoms: Hb less than (<) 11 g/dL or 6.83 millimoles per liter (mmol/L)
• ECOG performance status of 0, 1, or 2

Exclusion criteria

• Resistant hypertension
• Acute chronic bleeding within 3 months prior to study
• Iron deficiency that is unmanageable prior to study
• Hypersensitivity to the active substance or any of the excipients of the product
• Pregnant or breastfeeding women
• Epoetin treatment within 6 months prior to study

Trial design

1,167 participants in 1 patient group

NeoRecormon in Symptomatic Anemia

Description:

Participants with symptomatic anemia who are receiving epoetin beta (NeoRecormon) according to standard of care and the Summary of Product Characteristics will be observed for 4 months. Treatment must be selected at the discretion of the prescriber prior to enrollment and will not be chosen by the Sponsor in this non-interventional study.

Treatment:

Drug: Epoetin beta