SIADH Clinical Trial
Official title:
A Multi-Centre, Multi-National, Observational Post-Authorisation Safety Study to Document the Drug Utilisation of Samsca and to Collect Information on the Safety of Samsca When Used in Routine Medical Practice
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.
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.
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Observational Model: Cohort, Time Perspective: Prospective
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