Clinical trial · Observational
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
NCT03644498CI-TRIAL-00073076completedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
A retrospective, observational study conducted on cancer patients receiving a drug that blocks certain proteins made by some types of immune system cells
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Non-Interventional | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Adults treated with a CPI therapy for cancer
- interventionNames
- Other: Non-Interventional
Primary outcomes (3)
- measure
- Incidence of myocarditis
- timeFrame
- Approximately 7 years
- measure
- Incidence of myositis
- timeFrame
- Approximately 7 years
- measure
- Incidence of rhabdomyolysis
- timeFrame
- Approximately 7 years
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.