Health Condition 1: R90-R94- Abnormal findings on diagnostic imaging and in function studies, without diagnosis
Conditions
Interventions
Intervention1: Gadolinium-based contrast Agent (Dotarem): Dotarem is formulated at a gadolinium concentration of 0.5M. The recommended dose of Dotarem® is 0.1 mmol/kg body weight (BW), with higher do
Sponsors
GUERBET
Ms Rutuja Bhonsle
Eligibility
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: There are no exclusion criteria.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Collection of any AEs immediately post-dose and 6 (±2) weeks after Dotarem® administration.Timepoint: 1.Immediately post-dose 2.6 (±2) weeks post administration | — |
Secondary
| Measure | Time frame |
|---|---|
| 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.Timepoint: 1.Immediately post-dose 2.6 (±2) weeks post administration | — |
Countries
India
Contacts
Public ContactDr Somesh Bolegave
Siro Clintech Private Limited
Outcome results
None listed