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
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
1 other identifier
observational
1,056
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started May 2018
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 2, 2018
CompletedFirst Submitted
Initial submission to the registry
August 22, 2018
CompletedFirst Posted
Study publicly available on registry
August 23, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 16, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
October 17, 2018
CompletedJanuary 18, 2024
January 1, 2024
6 months
August 22, 2018
January 16, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Incidence of myocarditis
Approximately 7 years
Incidence of myositis
Approximately 7 years
Incidence of rhabdomyolysis
Approximately 7 years
Study Arms (1)
Adults treated with a CPI therapy for cancer
Interventions
Eligibility Criteria
All participants in this study will be enrolled in the PharMetrics or MarketScan database and will have exposure to at least one checkpoint inhibitor
You may qualify if:
- 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
You may not qualify if:
- Less than 18 years of age
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Local Institution
Princeton, New Jersey, 08540, United States
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Bristol-Myers Squibb
Bristol-Myers Squibb
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 22, 2018
First Posted
August 23, 2018
Study Start
May 2, 2018
Primary Completion
October 16, 2018
Study Completion
October 17, 2018
Last Updated
January 18, 2024
Record last verified: 2024-01