A Post Marketing Surveillance study of gadodiamide
Not Applicable
- Conditions
- Health Condition 1: B- Imaging
- Registration Number
- CTRI/2023/05/053235
- Lead Sponsor
- GE HealthCare Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Closed to Recruitment of Participants
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
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.
Exclusion Criteria
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.
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. To detect all prospective adverse events immediately post dose and 6 (±2) weeks after administration of Omniscan. <br/ ><br>2. To estimate the reporting rate of adverse events after use of Omniscan. <br/ ><br> <br/ ><br>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.Timepoint: Immediately post dose and 6 (±2) weeks after injection of Omniscan.
- Secondary Outcome Measures
Name Time Method ilTimepoint: Nil