NCT01103089已完成不适用
Observations From Long Term Responders in the Gefitinib (Iressa) Expanded Access Program (EAP)
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
- 否
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
研究点 (1)
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