VIZIMPRO 片剂的特别调查（二次数据收集研究；日本医疗实践中 VIZIMPRO 的安全性和有效性）
威津普片专项调查
研究概览
研究类型
注册 (实际的)
联系人和位置
学习地点
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Tokyo、日本
- Pfizer Japan
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
取样方法
研究人群
描述
纳入标准：
- 未接受 VIZIMPRO（dacomitinib hydrate）治疗的 EGFR 突变阳性不能手术或复发性 NSCLC 患者
排除标准：
- 本研究未提供排除标准
学习计划
研究是如何设计的？
设计细节
- 观测模型：仅案例
- 时间观点：预期
队列和干预
团体/队列 |
干预/治疗 |
|---|---|
|
VIZIMPRO（达克替尼水合物）
未接受 VIZIMPRO（dacomitinib hydrate）治疗的 EGFR 突变阳性不能手术或复发性 NSCLN（非小细胞肺癌）患者
|
通常成人口服起始剂量为每天一次 45mg 达克替尼水合物。
应根据患者病情适当减量。
其他名称：
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
The Number and Percentage of Participants With Interstitial Lung Disease (ILD)
大体时间：52 weeks from the first day of administration. If discontinued, it was until the date of treatment discontinuation (AEs were reported until 28 days after the date of treatment discontinuation).
|
An adverse drug reaction (ADR) was a treatment-related adverse event (AE), and any untoward medical occurrence attributed to VIZIMPRO Tablets 15mg and/or 45mg in a participant who received this drug. A serious ADR was a treatment-related AE resulting in any of the following outcomes or deemed significant for any other reason: death; life-threatening; initial or prolonged inpatient hospitalization; persistent or significant disability/incapacity; or congenital anomaly/birth defect. Relatedness to this drug was assessed. This study focused on ILD, but an ADR other than ILD was also included in the analysis. |
52 weeks from the first day of administration. If discontinued, it was until the date of treatment discontinuation (AEs were reported until 28 days after the date of treatment discontinuation).
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Assessment of Response Rate: Assess the Response Rate According to the "Response Evaluation Criteria in Solid Tumors Guidelines (RECIST) - Revised Version 1.1"
大体时间：52 weeks from the first day of administration. If discontinued, it was until the date of treatment discontinuation.
|
The response rate was calculated based on the best overall response as evaluated by the physician in accordance with the RECIST - Revised Version 1.1. The response rate was defined as the proportion of participants with a best overall response of complete response (CR) or partial response (PR). In addition, the response rate and its two-sided 95% confidence interval (using exact method) were calculated. The participants not reported response were considered to have achieved a best overall response other than CR or PR. |
52 weeks from the first day of administration. If discontinued, it was until the date of treatment discontinuation.
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合作者和调查者
赞助
调查人员
- 研究主任：Pfizer CT.gov Call Center、Pfizer
出版物和有用的链接
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他相关的 MeSH 术语
其他研究编号
- A7471048
- NCT04155541 (注册表标识符：ClinicalTrials.gov)
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
IPD 计划说明
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.