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

NCT ID: NCT03644498

Last Updated: 2024-01-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

1056 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-05-02

Study Completion Date

2018-10-17

Brief Summary

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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

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Conditions

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Cancer

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

RETROSPECTIVE

Study Groups

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Adults treated with a CPI therapy for cancer

Non-Interventional

Intervention Type OTHER

Non-Interventional

Interventions

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Non-Interventional

Non-Interventional

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bristol-Myers Squibb

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Bristol-Myers Squibb

Role: STUDY_DIRECTOR

Bristol-Myers Squibb

Locations

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Local Institution

Princeton, New Jersey, United States

Site Status

Countries

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United States

Related Links

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Other Identifiers

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CA209-99J

Identifier Type: -

Identifier Source: org_study_id

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