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

Bristol-Myers Squibb (BMS)

Status: Completed

Conditions: Cancer

Treatments: Other: Non-Interventional

Study type: Observational

Funder types: Industry

Identifiers

NCT03644498

CA209-99J

Details and patient eligibility

About

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

Enrollment: 1,056 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

1,056 participants in 1 patient group

Adults treated with a CPI therapy for cancer

Treatment:

Other: Non-Interventional