Special Investigation For RCC Of Sutent (Regulatory Post Marketing Commitment Plan).
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 1,674
- 主要终点
- Number of Participants With Treatment-Related Adverse Events
研究概览
简要总结
The objective of this surveillance is to collect information about 1) adverse drug reaction not expected from the LPD (unknown adverse drug reaction), 2) the incidence of adverse drug reactions in this surveillance, and 3)factors considered to affect the safety and/or efficacy of this drug.
详细描述
All the patients whom an investigator prescribes the first sunitinib malate(Sutent) should be registered.
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
- 0 Days 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients need to be administered sunitinib malate (Sutent) in order to be enrolled in the surveillance.
排除标准
- •Patients not administered sunitinib malate (Sutent).
研究组 & 干预措施
sunitinib malate
Patients taking sunitinib malate
干预措施: sunitinib malate (Drug)
结局指标
主要结局
Number of Participants With Treatment-Related Adverse Events
时间窗: MAX 2 Years
A treatment-related adverse event was any untoward medical occurrence attributed to sunitinib malate in a participant who received sunitinib malate. Relatedness to sunitinib malate was assessed by the investigator and sponsor (Pfizer Japan Inc.).
Objective Response Rate
时间窗: MAX 2 Years
Percentage of participants with objective response per Response Evaluation Criteria In Solid Tumors Criteria (RECIST V1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR),\>=30% decrease in the sum of the longest diameter of target lesion; Overall Response(OR) = CR + PR. The result was presented along with the corresponding exact 2-sided 95% confidence interval (CI).
次要结局
- Number of Participants With Treatment-Related Adverse Events in Pediatric Population(MAX 2 Years)
- Number of Participants With Treatment-Related Adverse Events Who Had Renal Impairment(MAX 2 Years)
- Number of Participants With Treatment-Related Adverse Events Who Used Concomitant Cytochrome P450 3A4 (CYP3A4) Inhibitors(MAX 2 Years)
- Number of Participants With Treatment-Related Adverse Events Who Were Under Long-Term Treatment(MAX 2 Years)
- Number of Participants With Treatment-Related Adverse Events in Elderly Population(MAX 2 Years)
- Number of Participants With Treatment-Related Adverse Events Who Had Hepatic Impairment(MAX 2 Years)
- Numbers of Participants With Treatment-Related Adverse Events Corresponded to Items for Priority Investigation(MAX 2 Years)