Post-Authorisation Safety Study of Samsca (Tolvaptan) Used in Routine Medical Practice
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About
A Drug Utilisation Survey is performed to monitor and document the drug utilisation patterns of Samsca in routine medical practice.
A Post-Authorisation Safety Study is performed to collect information on the safety of Samsca when used in a real-life setting.
Full description
Drug Utilisation Survey The drug utilisation analysis will describe the number of prescriptions, their distribution between different medical specialties, and indication for use as compared to the SmPC, patient age and patient gender distributions on a prescription level. In addition, the indication for use will be further categorised as
- SIADH
- Non-SIADH hyponatraemia
- Non-Hyponatraemia
Post-Authorisation Safety Study
Sodium levels at baseline and rate of sodium correction under therapy will be analysed. Safety findings will be described. The number of all non-serious and serious adverse events and the relative frequencies will be analysed in consideration of the risk categories below:
- Renal safety
- Aquaresis-related adverse effects
- Serum sodium correction rate
- Glucose homeostasis
- Cardiovascular safety and hemodynamics
- Respiratory system
- Drug metabolism and drug interactions
- Drug exposure during pregnancy
- Paediatric safety
Subgroup analyses will be performed for all safety findings by indication subgroups (SIADH and other indications), subgroups according to SIADH-underlying diseases, age groups, hepatically impaired patients and renally impaired patients.
Enrollment
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Volunteers
Inclusion criteria
- Patients who are treated with Samsca
Exclusion criteria
- Patients who have not signed the data consent form
Trial design
200 participants in 1 patient group
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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