Post Marketing Surveillance on Long Term Drug Use of GIOTRIF Tablets in Patients With Epidermal Growth Factor Receptor Mutation-positive Inoperable or Recurrent Non-small Cell Lung Cancer.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,605
- 试验地点
- 432
- 主要终点
- Incidence of Adverse Drug Reactions (ADRs)
研究概览
简要总结
In Japan, post-approval execution of post marketing surveillance (PMS) is requested by the Japanese Pharmaceutical Affairs Law (J-PAL) in order to accumulate safety and efficacy data for reexamination. Reexamination period is defined by J-PAL. Eight years after approval of a new substance, results of PMS need to be submitted as a part of reexamination dossier to the Japanese regulatory authority, the Ministry of Health, Labour and Welfare (MHLW).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Afatinib
干预措施: Afatinib dimaleate (Drug)
结局指标
主要结局
Incidence of Adverse Drug Reactions (ADRs)
时间窗: From first drug administration until 28 days after the last drug administration, up to 52 weeks.
This outcome measure presents incidence of adverse drug reactions (ADRs). An ADR was defined as an AE if either the investigator or the sponsor (or both) assessed the causal relationship to GIOTRIF® Tablets either as "Yes", "Probably yes" or "Can't be denied". The number of patients with Adverse Drug Reactions (ADRs): "Malignant progression" reported as ADRs were included.
次要结局
- Objective Overall Response Based on Physician's Assessment [According to RECIST Version 1.1](52 weeks.)