Special Investigation For Long-term Use Of Macugen (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
- 3,538
- 主要终点
- Factors considered to affect the safety and/or efficacy of this drug.
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 Macugen® should be registered consecutively until the number of subjects reaches target number in order to extract patients enrolled into the investigation at random.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients need to be administered Macugen® in order to be enrolled in the surveillance.
排除标准
- •Patients not administered Macugen®.
研究组 & 干预措施
Pegaptanib sodium
Patients administered Pegaptanib sodium.
干预措施: Pegaptanib sodium (Drug)
结局指标
主要结局
Factors considered to affect the safety and/or efficacy of this drug.
时间窗: 2 years
The incidence of adverse drug reactions in this surveillance.
时间窗: 2 years
Adverse drug reaction not expected from the LPD (unknown adverse drug reaction).
时间窗: 2 years
次要结局
未报告次要终点