Active surveillance in India of the safety of Dotarem®, a gadolinium-based contrast agent. Post-marketing observational, surveillance study
试验速览
- 阶段
- Unknown
- 状态
- 已完成
- 发起方
- GUERBET
- 入组人数
- 150
- 试验地点
- 5
- 主要终点
- Collection of any AEs immediately post-dose and 6 (±2) weeks after Dotarem® administration.
研究概览
简要总结
This is a post-marketing observational, surveillance study of Dotarem® in India.
Patients will be informed about the active surveillance by site personnel. For patients who agree to participate, GBCA administration and follow-up call will be documented by site personnel.
During the follow-up phone call, the patients will be asked by open, non-directing questions about adverse experience after exposure to Dotarem®. Up to two attempts will be made to contact a patient.
The site personnel will complete the eCRF on the day of Dotarem® administration (Day 1) and on the day of the follow-up call.
All patients scheduled for contrast-enhanced MRI with Dotarem® will be invited to participate in the study. The recruitment of patients within each site will be open for approximately 6 months or until 65 patients are included, whichever is shorter.
Healthcare professionals (HCP, such as physician, nurse, radiology technician) at each site will be trained on Dotarem® safety, protocol and applicable pharmacovigilance requirements.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Male or female patients aged at least 18 years or older 2.Patients for whom Dotarem®-enhanced MRI exam is confirmed 3.Patient who did not previously receive any gadolinium-based contrast agent GBCA 4.Patient having agreed to participate in the active surveillance and agree to be contacted by phone after 6 ± 2 weeks after the MR scan for brief interview.
排除标准
- •There are no exclusion criteria.
结局指标
主要结局
Collection of any AEs immediately post-dose and 6 (±2) weeks after Dotarem® administration.
时间窗: 1.Immediately post-dose | 2.6 (±2) weeks post administration
次要结局
- Description of the reported adverse events after use of Dotarem® in terms of seriousness, causal relationship, duration, latency, outcome and additional gadolinium-based contrast agent (GBCA) administration.(1.Immediately post-dose)
研究者
Dr. Amel Antony
Lisie Hospital