Post-Authorisation Safety Study of Samsca (Tolvaptan) 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.
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|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|
- Drug utilisation of Samsca stratified by prescribing medical specialty, indication for use, patient gender and patient age. [ Time Frame: 3 years ] [ Designated as safety issue: No ]
- Samsca sodium correction rates and adverse events in patients treated with Samsca [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
|Study Start Date:||October 2010|
|Estimated Study Completion Date:||April 2014|
|Estimated Primary Completion Date:||October 2013 (Final data collection date for primary outcome measure)|
|Patients who are treated with Samsca.||
Samsca 15mg tablet; Samsca 30mg tablet Administration as per Samsca SmPC and medical judgement of treating physician.
Other Name: Samsca
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
- Non-SIADH 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01228682
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