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

Completed

• Conditions: Cancer
• Interventions: Other: Non-Interventional

• Registration Number: NCT03644498
• Lead Sponsor: Bristol-Myers Squibb

Brief Summary

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

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2018-05-02
• Study First Submitted: 2018-08-22
• Study First Submitted QC: 2018-08-22
• Study First Posted: 2018-08-23
• Primary Completion: 2018-10-16
• Study Completion: 2018-10-17
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-16
• Last Update Posted: 2024-01-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1056

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

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Exclusion Criteria

• Less than 18 years of age

Other protocol defined inclusion/exclusion criteria could apply

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Adults treated with a CPI therapy for cancer	Non-Interventional	-

Primary Outcome Measures

Name	Time	Method
Incidence of myositis	Approximately 7 years
Incidence of myocarditis	Approximately 7 years
Incidence of rhabdomyolysis	Approximately 7 years

Trial Locations

Locations (1)

Local Institution; 🇺🇸 Princeton, New Jersey, United States