A single-arm, multicentre, Post-marketing observational follow up on patients who have been given Gadolinium for clinical scans to detect all prospective adverse events immediately post dose and 6 (±2) weeks after administration of Omniscan
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- 1. To detect all prospective adverse events immediately post dose and 6 (±2) weeks after administration of Omniscan.
研究概览
简要总结
| This is a single-arm, multi-center post-marketing surveillance study to evaluate the safety of gadodiamide in Gadolinium Based Contrast Agent (GBCA)-naïve male/female patients of at least 18 years of age. |
Three sites in India that frequently use Omniscan (i.e., Omniscan is on the formulary at the sentinel site and available for routine clinical use) and that have access to eligible patients will be selected. Up to 150 patients will be enrolled. Recruitment of patients will be open at a site for approximately 6 months or until 50 patients are included, whichever is shorter.
Healthcare professionals (HCPs) at each site will be trained on gadodiamide safety and applicable pharmacovigilance requirements. Patients will be informed about the active surveillance by site HCPs, consent will be documented. A questionnaire will be used for the collection of safety information.
All patients scheduled for contrast-enhanced MR imaging will be asked for permission to be contacted 6 (±2) weeks after the gadodiamide-enhanced imaging. Patients will be asked by an HCP (site personnel) about adverse experiences after gadodiamide administration.
Patients will be invited to participate only after the decision to gadodiamide-enhanced MRI has been made.
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.GBCA-naïve male/female patients of at least 18 years of age.
- •2.Patients willing to participate in the active surveillance and agree to be contacted by phone after 6 (±2) weeks after the MR scan for brief interviews.
排除标准
- •1.Patients known to have hypersensitivity to Omniscan or its constituents.
- •2.Patients with chronic, severe kidney disease (GFR<30ml/min/1.73m2), or acute kidney injury.
结局指标
主要结局
1. To detect all prospective adverse events immediately post dose and 6 (±2) weeks after administration of Omniscan.
时间窗: Immediately post dose and 6 (±2) weeks after injection of Omniscan.
2. To estimate the reporting rate of adverse events after use of Omniscan.
时间窗: Immediately post dose and 6 (±2) weeks after injection of Omniscan.
The parameters will be AEs segregation by MedDRA system organ classes and MedDRA preferred terms, by case and event seriousness, by causal relationship by latency (i.e., interval between injection of Omniscan and onset of AE), by duration and by outcome. Descriptive statistics will be done.
时间窗: Immediately post dose and 6 (±2) weeks after injection of Omniscan.
次要结局
未报告次要终点