Active Surveillance Study of the Safety of MultiHance®in India.
试验速览
- 阶段
- Unknown
- 状态
- 已完成
- 入组人数
- 150
- 试验地点
- 5
- 主要终点
- Prospective Assessment of adverse events (AEs)
研究概览
简要总结
This Active Surveillance Study Protocol is aimed at supporting the National Coordination Centre-Pharmacovigilance Programme of India in monitoring the safety of MultiHance® through a better characterization of the associated ADRs and the identification of specific risk factors.
The objective of the current study is to actively survey patients for longer than it is typically done during the development studies of GBCAs for 6 (±2) weeks after the administration of MultiHance® and determine the occurrence of late AEs that could be possibly associated with its administration.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Is the subject ≥ 18 years of age?
- •Is the subject scheduled to undergo MRI with MultiHance® as standard of care?
- •Is the subject willing to provide written informed consent and comply with protocol requirements?
排除标准
- •Did the subject receive prior GBCA?
- •Was the subject already included in the study?
结局指标
主要结局
Prospective Assessment of adverse events (AEs)
时间窗: From the time the ICF is signed are collected during the post-MR examination observation period, up to 30 minutes, and during a telephone contact to the subject performed 6 weeks (± 2 weeks) post-MultiHance® administration
次要结局
未报告次要终点