Clinical trial · Observational
An Observational Study of NeoRecormon (Epoetin Beta) in Cancer Patients With Anemia (FAST)
Pharmaco-epidemiological Observational Study of the Clinical Benefit of NeoRecormon® in Cancer Patients With Anemia, According to Early Response to Treatment
NCT01168349CI-TRIAL-00019316completedResults 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 clinical benefit of NeoRecormon (epoetin beta) in daily routine practice in cancer patients with anemia. Data will be collected from patients who are receiving chemotherapy for a solid tumor or hematological malignancy. Patients will be followed for 28 weeks.
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, Neoplasms | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| epoetin beta [NeoRecormon] | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Cohort
- interventionNames
- Drug: epoetin beta [NeoRecormon]
Primary outcomes (20)
- measure
- Percentage of Participants With Early Treatment Response: Day 28 to 42
- timeFrame
- Day 28 to 42
- description
- Early treatment response was defined as an increase of Hemoglobin (Hb) concentration of at least 1 gram/deciliter (g/dL), 4 to 6 weeks after treatment initiation.
- measure
- Percentage of Participants With Early Treatment Response: Day 21 to 42
- timeFrame
- Day 21 to 42
- description
- Early treatment response was defined as an increase of Hb concentration of at least 1 g/dL, 3 to 6 weeks after treatment initiation.
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Adult patients, \>/=18 years of age * Patients receiving myelosuppressive chemotherapy for a solid tumor, a hematological malignancy or an autograft for hematological malignancy * Patients for whom treatment with epoetin beta is started at the inclusion visit * Life expectancy \>/=6 months according to the physician * Patients accepting and able to complete a French written questionnaire about his/her professional and social activities at each visit Exclusion Criteria: * Patients who received erythropoiesis-stimulating agents treatment, or red blood cell transfusion within 4 weeks before enrollment * Participation in a clinical trial in onco-hematology * Patients with myelodysplasia * Patients with more than one active malignancy at the time of enrollment
References
Publications (0)
Data not yet available
No reference posted for this study.