An Observational Study on Real-world Use and Outcomes of Patients Treated With Tolvaptan for Hyponatraemia Due to SIADH

Study Overview
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Brief Summary
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This is a retrospective chart review non-interventional study designed to collect real world data on the use and outcomes of tolvaptan for the treatment of patients with hyponatraemia secondary to syndrome of inappropriate antidiuretic hormone (SIADH) secretion.

Official Title
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A Non Interventional, Retrospective Study on Real World Usage and Treatment Outcomes of Patients Treated With Tolvaptan for Hyponatraemia Due to the SIADH.

Conditions
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Hyponatremia, Syndrome of Inappropriate ADH (SIADH) Secretion

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Provision of patient informed consent unless a) not required by local regulations, b) it would take a non reasonable effort or c) if the source patient is deceased or untraceable. Female and/or male patients aged 18 years and over. Patients who received at least 2 doses of tolvaptan, for the treatment of one occurrence of hyponatraemia secondary to SIADH. Exclusion Criteria: A patient cannot take part in this study if participating in any other clinical study in which the medicinal product aims to treat the causes or symptoms of hyponatraemia at the time of the hyponatraemia episode being documented in the current study.

Ages Eligible for Study
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Minimum Age: 18 Years

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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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Sodium Levels From Start of Treatment With Tolvaptan Until Hospital Discharge | The primary variable of the study was the change in sodium levels from baseline to discharge or the final available measurement for patients who were not discharged (up to 6 weeks after treatment initiation). | From Baseline Up to discharge (or a maximum of 6 weeks after start of treatment) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Sodium Levels 24 Hours After Treatment Initiation | Change in sodium level from last value prior to receiving tolvaptan until last available measurement within 24 hours of initiation of tolvaptan | From Baseline (treatment initiation with tolvaptan) up to 24 hours afterwards | 
| Change in Sodium Levels 6 Weeks After Treatment Initiation | Change in sodium level from last value prior to receiving tolvaptan until last available measurement up to week 6 | From Baseline (treatment initiation with tolvaptan) up to 6 weeks afterwards | 
| Time (Hours) to Sodium Normalisation | Time (hours) to sodium normalisation, defined as a serum sodium level > 135 mmol/L, by evaluation of serum sodium levels in relation to the episode of hyponatraemia secondary to SIADH being captured in the study (up to 6 weeks after treatment initiation). | From Baseline (treatment initiation with tolvaptan) up to 6 weeks afterwards | 
| Percentage of Participants Distributed by the Primary Disease Diagnoses Leading to SIADH (Cancer, Pulmonary Disease, CNS Disorder, Etc.,) | Primary disease diagnoses leading to SIADH by evaluation of diagnosis information in relation to the episode of hyponatraemia being captured in the study from the patient's medical records | Baseline | 
| Symptoms Associated With Hyponatraemia (Number of Symptomatic/Asymptomatic Patients in the Study Population) | symptoms associated with hyponatraemia by evaluation of symptomatology information in relation to the episode of hyponatraemia being captured in the study from the patient's medical records | Baseline | 
| Percentage of Participants Distributed by the Specialties of Their Clinicians Prescribing Tolvaptan (e.g., Endocrinologists, Nephrologists, Oncologists, Etc.,) | specialty of the clinician prescribing tolvaptan by evaluation of details of the physician who prescribed tolvaptan for the episode of hyponatraemia being captured in the study from the patient's medical records | Baseline | 
| Average Daily Dose of Tolvaptan Used and Treatment Duration (Expressed in Days) for the Episode of Hyponatraemia Being Captured in the Study | Average daily dose of tolvaptan used and treatment duration (expressed in days) for the episode of hyponatraemia secondary to SIADH being captured in the study by evaluation of dosing information (and dates) from the patient's medical records (up to 6 weeks after the initiation of tolvaptan treatment). For these outcome measures, only days on treatment were considered (e.g. if tolvaptan treatment was interrupted and resumed afterwards, the days withot treatment were not considered). | From Baseline (treatment initiation with tolvaptan) up to 6 weeks afterwards | 
| Time (Days) to Sodium Normalisation | Time (days) to sodium normalisation, defined as a serum sodium level > 135 mmol/L, by evaluation of serum sodium levels in relation to the episode of hyponatraemia secondary to SIADH being captured in the study (up to 6 weeks after treatment initiation). | From Baseline (treatment initiation with tolvaptan) up to 6 weeks afterwards | 
| Number of Participants With Presence of Different Symptoms Associated With Hyponatraemia | symptoms associated with hyponatraemia by evaluation of symptomatology information in relation to the episode of hyponatraemia being captured in the study from the patient's medical records | Baseline | 
| Average Treatment Duration for the Episode of Hyponatraemia Being Captured in the Study | Average treatment duration for the episode of hyponatraemia secondary to SIADH being captured in the study by evaluation of dosing information (and dates) from the patient's medical records (up to 6 weeks after the initiation of tolvaptan treatment). For these outcome measures, only days on treatment were considered (e.g. if tolvaptan treatment was interrupted and resumed afterwards, the days withot treatment were not considered). | From Baseline (treatment initiation with tolvaptan) up to 6 weeks afterwards | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hyponatremia due to SIADH, tolvaptan