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临床试验/NCT05984615
NCT05984615已完成不适用

Real-world Evaluation of the Impact of Baseline Metastases on Clinical Outcomes Among BRAF Positive Metastatic Melanoma Patients

Novartis Pharmaceuticals1 个研究点 分布在 1 个国家目标入组 1,961 人开始时间: 2022年6月8日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
1,961
试验地点
1
主要终点
Race

研究概览

简要总结

This was a retrospective real-world evidence cohort study.

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

结局指标

主要结局

Race

时间窗: Baseline

Eastern Cooperative Oncology Group performance status (ECOG PS)

时间窗: Baseline

The ECOG scale consists of 4 grades (from 0 to 4) where 0 implies fully active, and 4 implies completely disabled.

Number of metastatic sites

时间窗: Baseline

Mean age

时间窗: Baseline

Number of male patients

时间窗: Baseline

Mean Charlson comorbidity index (CCI) score

时间窗: Baseline

Comorbidity was categorized into three grades: mild, with CCI scores of 1-2; moderate, with CCI scores of 3-4; and severe, with CCI scores ≥5.

Number of patients with study-related biomarkers

时间窗: Baseline

Study-related biomarkers included BRAF and PD1/PDL1 test dates and results.

次要结局

  • Progression-free survival (PFS)(6 months and 1, 1.5, and 2 years)
  • Overall survival (OS)(6 months and 1, 1.5, and 2 years)

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (1)

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