Basis Plan For Postmarketing Survelillances, Etc. Of New Ethical Drugs For Torisel
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 1,022
- 试验地点
- 1
- 主要终点
- Number of Participants With Adverse Drug Reactions
研究概览
简要总结
The objective of this investigation is to determine the following items in all patients receiving Torisel for a certain period after marketing:
- Confirmation of efficacy and safety for medical practice use.
- Investigation of factors that may influence the incidence of adverse events (Particularly priority investigation items).
- Investigation of the incidence status and the risk factors for interstitial lung diseases.
详细描述
Implemented as a Drug Use Investigation by Central Registration System
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- — 至 99 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients treated with Torisel (patients with metastatic and/or radically unresectable or advanced renal cell carcinoma).
排除标准
- •Patients not administered Torisel.
- •Patients with a history of severe hypersensitivity to temsirolimus, sirolimus derivative, or any of their components and/or derivatives.
研究组 & 干预措施
Temsirolimus
Patients treated with Torisel (patients with metastatic and/or radically unresectable or advanced renal cell carcinoma)
干预措施: Temsirolimus (Drug)
结局指标
主要结局
Number of Participants With Adverse Drug Reactions
时间窗: 96 weeks at maximum
An adverse drug reaction (ADR) was any untoward medical occurrence attributed to TORISEL Injection in a participant who received TORISEL Injection. A serious ADR was an ADR resulting in any of the following outcomes or deemed significant for any other reason: death, life-threatening experience (immediate risk of dying), initial or prolonged inpatient hospitalization, persistent or significant disability/incapacity, congenital anomaly. Relatedness to TORISEL Injection was assessed by the physician.
Number of Participants With Adverse Drug Reactions of Major Investigation Items
时间窗: 96 weeks at maximum
An adverse drug reaction (ADR) was any untoward medical occurrence attributed to TORISEL Injection in a participant who received TORISEL Injection. Sixteen events were evaluated as major investigation items, and the result is presented in the table.
次要结局
- Overall Response Rate(96 weeks maximum)
- Response Rate Excluding Participants Evaluated as "Unassessable"(96 weeks maximum)