跳至主要内容
临床试验/NCT01103089
NCT01103089已完成不适用

Observations From Long Term Responders in the Gefitinib (Iressa) Expanded Access Program (EAP)

AstraZeneca1 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2010年3月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
AstraZeneca
入组人数
10
试验地点
1
主要终点
The following characteristics of the 'long-term responders' from the EAP; gender, ethnicity, smoking history (pack years), EGFR-TK mutation and histology of NSCLC.

研究概览

简要总结

The purpose of the study is to determine patient characteristics from patients that have used Iressa for a period of minimal 3 years.

研究设计

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

入排标准

性别
All
接受健康志愿者

入选标准

  • Participation in the gefitinib Expanded Access Program
  • Patient still uses gefitinib in September 2009

排除标准

  • 未提供

结局指标

主要结局

The following characteristics of the 'long-term responders' from the EAP; gender, ethnicity, smoking history (pack years), EGFR-TK mutation and histology of NSCLC.

时间窗: Characteristics will be recorded once, retrospectively

次要结局

  • To assess the long-term safety in subjects treated with gefitinib by collecting information on: All adverse events that have lead to an interruption/reduction of gefitinib or another intervention(Once, retrospectively for the period the patient has used gefitinib (minimal 3 years))
  • long-term safety in subjects; what real life data measures are being taken by lung physicians to counter side effects caused by long term gefitinib treatment; the number, reason, effect and description of interventions that have been taken(Once, retrospectively for the period the patient has used gefitinib (minimal 3 years))
  • long-term safety: Number, reason and effect of interruptions during gefitinib use to determine side effects typical for the long-term treatment with gefitinib(Once, retrospectively for the period the patient has used gefitinib (minimal 3 years))

研究者

发起方
AstraZeneca
申办方类型
Industry
责任方
Sponsor

研究点 (1)

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