Status:

COMPLETED

Assessment of Quality of Life in Patients With Symptomatic Chemotherapy-induced Anaemia

Lead Sponsor:

Amgen

Conditions:

Anemia

Breast Cancer

Eligibility:

All Genders

18+ years

Brief Summary

This is a multicenter, international, prospective, observational study of patients who are receiving systemic chemotherapy for solid tumour cancers (breast, colorectal, ovarian, prostate, lung, bladde...

Detailed Description

Before enrolling participants, each country was assigned to either cohort 1 (patients receiving only darbepoetin alfa) or cohort 2 (patients receiving any ESA). Cohort 2 was assigned only to those cou...

Eligibility Criteria

Inclusion

  • Diagnosed with breast, colorectal, ovarian, prostate, lung, bladder, endometrial, renal, pancreatic, esophageal or gastric cancer
  • Expected to receive at least 8 additional weeks of a given regimen of myelosuppressive chemotherapy after enrolment
  • Starting treatment with either darbepoetin alfa (in Cohort 1 countries) or any ESA (in Cohort 2 countries) as per European Summary of Product Characteristics (SPC) for symptomatic anaemia.

Exclusion

  • Received any ESA treatment or Red Blood Cell (RBC) transfusion within 28 days prior to enrolment
  • Known primary benign or malignant haematologic disorder which can cause anaemia
  • Known hypersensitivity to ESAs

Key Trial Info

Start Date :

October 1 2011

Trial Type :

OBSERVATIONAL

Allocation :

ACTUAL

End Date :

Estimated Enrollment :

1262 Patients enrolled

Trial Details

Trial ID

NCT01444456

Start Date

October 1 2011

Last Update

March 20 2017

Active Locations (117)

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Page 1 of 30 (117 locations)

1

Research Site

Graz, Austria, 8042

2

Research Site

Innsbruck, Austria, 6020

3

Research Site

Sankt Pölten, Austria, 3100

4

Research Site

Vienna, Austria, 1090