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NCT03644498 Clinical Trial

Study to Determine if the Flu Vaccine Increases the Risk of Muscle Damage in Participants Taking Drugs That Block Certain Proteins Made by Some Types of Immune System Cells

Cancer Clinical Trial

Official title:
Risk of Muscle Damage in Cancer Patients Exposed to the Influenza Vaccine While Receiving Checkpoint Inhibitor Therapies: A Nested Case Control Study Using Claims Data

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03644498
Other study ID # CA209-99J
Secondary ID
Status Completed
Phase
First received
Last updated
Start date May 2, 2018
Est. completion date October 17, 2018

Study information
Verified date January 2024
Source Bristol-Myers Squibb
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

A retrospective, observational study conducted on cancer patients receiving a drug that blocks certain proteins made by some types of immune system cells

Recruitment information / eligibility
Status Completed
Enrollment 1056
Est. completion date October 17, 2018
Est. primary completion date October 16, 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Treatment with a checkpoint inhibitor (CPI) - Age greater than or equal to 18 years on date of first claim for a CPI - ICD-9 or ICD-10 code for a malignancy within 180 days prior to the first claim for any CPI, and - Greater than or equal to 180 days of continuous pharmaceutical and medical benefit enrollment in the database prior to the first claim for any CPI Exclusion Criteria: - Less than 18 years of age Other protocol defined inclusion/exclusion criteria could apply

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• Non-Interventional
Non-Interventional

Locations
Country Name City State
United States Local Institution Princeton New Jersey

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 Incidence of myocarditis Approximately 7 years
Primary Incidence of myositis Approximately 7 years
Primary Incidence of rhabdomyolysis Approximately 7 years
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