跳至主要内容
临床试验/NCT03644498
NCT03644498已完成不适用

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

Bristol-Myers Squibb1 个研究点 分布在 1 个国家目标入组 1,056 人开始时间: 2018年5月2日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
1,056
试验地点
1
主要终点
Incidence of myositis

研究概览

简要总结

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

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Retrospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • Less than 18 years of age
  • Other protocol defined inclusion/exclusion criteria could apply

结局指标

主要结局

Incidence of myositis

时间窗: Approximately 7 years

Incidence of myocarditis

时间窗: Approximately 7 years

Incidence of rhabdomyolysis

时间窗: Approximately 7 years

次要结局

未报告次要终点

研究者

发起方
Bristol-Myers Squibb
申办方类型
Industry
责任方
Sponsor

研究点 (1)

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