Post-Authorisation Safety Study of Samsca (Tolvaptan) Used in Routine Medical Practice

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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

Conditions
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SIADH, Non-SIADH Hyponatremia, Non-Hyponatremia

Intervention / Treatment
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* Drug: Tolvaptan


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients who are treated with Samsca Exclusion Criteria: Patients who have not signed the data consent form
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients who are treated with Samsca.<br> | Drug: Tolvaptan<br>* Samsca 15mg tablet; Samsca 30mg tablet Administration as per Samsca SmPC and medical judgement of treating physician.<br>* Other names: Samsca;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Drug utilisation of Samsca stratified by prescribing medical specialty, indication for use, patient gender and patient age. |  | 3 years | 
| Samsca sodium correction rates and adverse events in patients treated with Samsca |  | 3 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Sodium, SIADH, Hyponatremia, Vasopressin, Salt, Water