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临床试验/NCT05714371
NCT05714371已完成不适用

Retrospective Assessment of Adverse Events-related Healthcare Resource Utilization and Costs of Immune Checkpoint Inhibitor and Targeted Therapy for Adjuvant Treatment of Melanoma

Novartis Pharmaceuticals1 个研究点 分布在 1 个国家目标入组 618 人开始时间: 2021年10月2日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
618
试验地点
1
主要终点
Number of patients on first systemic adjuvant therapy with adverse avents (AEs)

研究概览

简要总结

This was a retrospective cohort study using the PharMetrics database. The analysis was conducted using the most recent 5 years of data from the database, January 1, 2015, to October 30, 2020. Included patients were followed for outcome evaluation from the index date (first prescription of treatment, immunotherapy [IO], or targeted therapy [TT] following diagnosis of non-metastatic malignant melanoma and evidence of first lymph node resection), until the first occurrence or end of continuous eligibility or end of the study period.

研究设计

研究类型
Observational
观察模型
Cohort
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

  • 未提供

排除标准

  • 未提供

研究组 & 干预措施

Immunotherapy (IO)

Patients receiving IO

干预措施: Nivolumab (Drug)

Immunotherapy (IO)

Patients receiving IO

干预措施: Ipilimumab + nivolumab (Drug)

Immunotherapy (IO)

Patients receiving IO

干预措施: Pembrolizumab (Drug)

Targeted therapy (TT)

Patients receiving TT

干预措施: Dabrafenib + trametinib (Drug)

结局指标

主要结局

Number of patients on first systemic adjuvant therapy with adverse avents (AEs)

时间窗: Up to approximately 5 years

次要结局

  • Number of patients with AEs following first systemic adjuvant therapy completion/discontinuation.(Up to approximately 5 years)
  • Healthcare resource utilization (HCRU) associated with AEs on first systemic adjuvant therapy(Up to approximately 5 years)
  • Healthcare costs associated with AEs on first systemic adjuvant therapy(Up to approximately 5 years)
  • HCRU associated with AEs following first systemic adjuvant therapy completion/discontinuation(Up to approximately 5 years)
  • Healthcare costs associated with AEs following first systemic adjuvant therapy completion/discontinuation(Up to approximately 5 years)

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (1)

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