Health Condition 1: B- Imaging
Conditions
Interventions
Intervention1: OMNISCAN (Gadodiamide): Gadodiamide is a non-ionic paramagnetic contrast medium for cranial and spinal MRI and for general MRI of the body after intra venous administration. The product
Sponsors
GE HealthCare Ltd
Eligibility
Inclusion criteria
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
Exclusion criteria: 1.Patients known to have hypersensitivity to Omniscan or its constituents. 2.Patients with chronic, severe kidney disease (GFR
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. To detect all prospective adverse events immediately post dose and 6 (±2) weeks after administration of Omniscan. 2. To estimate the reporting rate of adverse events after use 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.Timepoint: Immediately post dose and 6 (±2) weeks after injection of Omniscan. | — |
Secondary
| Measure | Time frame |
|---|---|
| NilTimepoint: Nil | — |
Countries
India
Contacts
Public ContactDr Mugdha Chopra
GE HealthCare Ltd
Outcome results
None listed