An Open Label, Non-interventional Study Of The Safety Of Temsirolimus Injection (Torisel) In The Treatment Of Advanced Renal Cell Carcinoma In Filipino Adult Patients: A Post Marketing Surveillance Study
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- Pfizer
- 主要终点
- Number of participants with Adverse Events [AEs] and Serious Adverse Events [SAEs]
研究概览
简要总结
This is a post marketing surveillance which determines the safety profile of the product to Filipinos. This is a FDA requirement for registration.
详细描述
The Philippine Food and Drug Administration requires that a post marketing surveillance study be conducted nationwide and enroll approximately 3,000 study patients. In cases where the 3,000 patients will not be met, the total sample size can be reduced to 10% of the volume of drug use during the first year of it being marketed. Final sample size will be determined after one year of marketing authorization. The decision to use Torisel must be a joint decision made by the subject and the investigator.
The investigator must discuss product information with the subject as per usual practice.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects that will be included in this post marketing surveillance study must be consistent with the approved label indication of Torisel in the Philippines.
- •As per approved label indication, patients diagnosed with advanced renal cell carcinoma will be the ones eligible to participate in the study.
- •The decision to prescribe Torisel will necessarily precede and will be independent of the decision to enroll the patient into the study.
- •Evidence of a personally signed and dated informed consent document indicating that the subject (or a legally acceptable representative) has been informed of all pertinent aspects of the study.
排除标准
- •Subjects with conditions that are contraindicated with Torisel based on the approved local product document in the Philippines will be excluded in this study. This condition includes: Patients with bilirubin >1.5 x ULN.
研究组 & 干预措施
Patient Arm- temsirolimus
干预措施: Temsirolimus (Drug)
结局指标
主要结局
Number of participants with Adverse Events [AEs] and Serious Adverse Events [SAEs]
时间窗: 2 years
次要结局
未报告次要终点