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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02363868
Other study ID # CA180-568
Secondary ID
Status Completed
Phase N/A
First received February 10, 2015
Last updated July 3, 2015
Start date February 2014
Est. completion date November 2014

Study information

Verified date July 2015
Source Bristol-Myers Squibb
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Observational

Clinical Trial Summary

The purpose of this study is to examine the healthcare costs among patients with CML receiving dasatinib or nilotinib as first line therapy in a commercially or Medicare insured population.


Recruitment information / eligibility

Status Completed
Enrollment 186
Est. completion date November 2014
Est. primary completion date November 2014
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

- Age >18 years

- International Classification of Diseases, Ninth Revision, Clinical Modification (ICD-9 CM) code for CML (205.1x)

- At least 2 prescriptions for dasatinib or nilotinib from July 1, 2008 to June 31, 2013

- Continuous eligibility for the 6 months pre- and post-index date (defined as the date of first fill for dasatinib or nilotinib)

Exclusion Criteria:

- History of bone marrow or stem cell transplant as identified in the 6 month pre-period

Study Design

Observational Model: Cohort, Time Perspective: Retrospective


Related Conditions & MeSH terms


Locations

Country Name City State
United States Franklin Pharmaceutical Consulting, Llc Clinton South Carolina

Sponsors (1)

Lead Sponsor Collaborator
Bristol-Myers Squibb

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Healthcare costs Average (mean) costs for patients receiving dasatinib or nilotinib as first line therapy Intent-to-treat (ITT) at 6 months No
Secondary Healthcare costs by line of therapy Intent-to-treat (ITT) at 6 months No
Secondary Resource utilization by line of therapy Captured per number of hospitalizations, Emergency room (ER) visits, physician office visits, and medications / number of prescriptions Intent-to-treat (ITT) at 6 months No
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