N/A
Completed N=1,167
An Observational Study of Epoetin Beta (NeoRecormon) in Participants With Cancer Receiving Chemotherapy
Source: ClinicalTrials.gov NCT01809314 ↗Enrolled (actual)
1,167
Serious AEs
0.6%
Results posted
Aug 2016
Primary outcomePrimary: Change in Hemoglobin (Hb) Level From Baseline to End of Treatment (EOT) — 14.58 g/L — p=<0.0001
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Hemoglobin (Hb) Level From Baseline to End of Treatment (EOT) |
14.58 | <0.0001 sig |
| SECONDARY Percentage of Participants by Change in Eastern Cooperative Oncology Group (ECOG) Performance Status From Baseline to EOT |
77.5; 19.7; 2.8; 23.8; 67.3; 8.9 | 0.001 sig |
| SECONDARY Percentage of Participants Who Required Blood Transfusions During the Study |
4.1; 4.1; 3.8; 3.9 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT01809314). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.