N/A N=160

An Observational Study of NeoRecormon (Epoetin Beta) in Anemic Patients With Non-myeloid Malignancy

Anemia

Bottom Line

View on ClinicalTrials.gov: NCT01716559 ↗

Enrolled (actual)

160

Serious AEs

15.6%

Results posted

Feb 2016

Primary outcome: Primary: Percentage of Participants With an Increase of Greater Than or Equal to 1 Gram Per Decilitre in Hemoglobin Level at Week 8 — 67.96 percentage of participants

Study Design & Population

Study type: Observational
Phase: N/A
Interventions: —
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Hoffmann-La Roche
Primary completion: Mar 2012

Outcome Measures

Outcome	Result	p-value
PRIMARY Percentage of Participants With an Increase of Greater Than or Equal to 1 Gram Per Decilitre in Hemoglobin Level at Week 8	67.96	—
SECONDARY Mean Change From Baseline in Hemoglobin Level up to Week 16	1.194; 1.641; 1.970; 1.789	—
SECONDARY Percentage of Red Blood Cell Transfusion-free Participants	76.25	—
SECONDARY Number of Participants With or With no Response on Efficacy of Treatment With or Without Iron Replacement Therapy	19; 44; 9; 31	—
SECONDARY Number of Participants With Adverse Events and Serious Adverse Events	43; 25	—

Summary

This observational, prospective, multicenter study will evaluate the treatment response rate and the safety of NeoRecormon (epoetin beta) in anemic patients with non-myeloid malignancy. In addition to NeoRecormon, patients receive chemotherapy for their malignancy. Data will be collected for 16 weeks.

Eligibility Criteria

Inclusion Criteria

Adult patients, >/=18 years of age
Presence of solid-tumor or non-myeloid malignancy
Patients receiving chemotherapy
Eastern Cooperative Oncology Group (ECOG) Performance status 0-2
Patients require NeoRecormon

Exclusion Criteria

Hypersensitivity to the drug
Uncontrolled hypertension
Female patients if pregnant and/or lactating

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01716559). 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.