Clinical trial · Observational
An Observational Study of Epoetin Beta (NeoRecormon) in Participants With Cancer Receiving Chemotherapy
Non-Interventional Study to Evaluate Treatment of Symptomatic Anemia in Patients With Malignancies Receiving Chemo- and NeoRecormon-Therapy
NCT01809314CI-TRIAL-00023566completedResults postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Anemia | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Epoetin beta | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- 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.
- interventionNames
- Drug: Epoetin beta
Primary outcomes (1)
- measure
- Change in Hemoglobin (Hb) Level From Baseline to End of Treatment (EOT)
- timeFrame
- Baseline, Month 4
- description
- The change in Hb level from Baseline to the EOT visit at Month 4 was averaged among all participants and expressed in grams per liter (g/L).
Secondary outcomes (2)
- measure
- Percentage of Participants by Change in Eastern Cooperative Oncology Group (ECOG) Performance Status From Baseline to EOT
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.