跳至主要内容
临床试验/NCT02546791
NCT02546791已完成不适用

Frequency and Severity of Pleural Effusion Associated With the Use of Dasatinib in Patients With Chronic Myeloid Leukemia. A Descriptive, Mexican Multicenter Study

Bristol-Myers Squibb0 个研究点目标入组 101 人开始时间: 2015年7月22日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
101
主要终点
Detect the absence and presence of pleural effusion in Mexican patients measured from the medical records and databases of each of the participating medical centers

研究概览

简要总结

This is a retrospective, multicenter, descriptive analysis of patients with a diagnosis of chronic myeloid leukemia, treated with dasatinib for at least 45 days. The study will include 100 patients treated in different public centers in the Mexican Republic.

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
15 Years 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Men and women ≥15 years of age
  • Diagnosis of chronic myeloid leukemia in any phase that used dasatinib at any time between January 2008 and November 2014
  • Have received dasatinib as part of their first-line or second-line treatment for at least 45 days

排除标准

  • Patients who received dasatinib as part of any clinical trial
  • Patients who do not have complete data on the data collection sheet
  • Patients who do not have medical records available at the moment of the data verification

研究组 & 干预措施

Chronic myeloid leukemia patients treated with Dasatinib

patients with a diagnosis of chronic myeloid leukemia treated with Dasatinib for at least 45 days

干预措施: Dasatinib (Drug)

结局指标

主要结局

Detect the absence and presence of pleural effusion in Mexican patients measured from the medical records and databases of each of the participating medical centers

时间窗: 1 year and 4 month of data collection

次要结局

  • Main characteristics of the patients who develop pleural effusion(1 year and 4 month of data collection)
  • Establish the factors associated with response of the patients who develop pleural effusion(1 year and 4 month of data collection)

研究者

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

相似试验

Frequency and Severity of Pleural Effusion... | 临床试验