Samsca Post-marketing General Drug Use-results Survey in Patients With Hyponatremia in SIADH

Study Overview
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Brief Summary
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The purpose of this study is to confirm the safety of tolvaptan in patients with hyponatremia in syndrome of inappropriate antidiuretic hormone secretion (SIADH) in Japan

Official Title
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Samsca Post-marketing General Drug Use-results Survey in Patients With Hyponatremia in Syndrome of Inappropriate Antidiuretic Hormone Secretion (SIADH) in Japan

Conditions
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Antidiuretic Hormone, Inappropriate Secretion

Intervention / Treatment
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* Drug: Tolvaptan (SAMSCA)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects with a definite diagnosis of SIADH in reference to Diagnostic and Treatment Manual of the Hypersecretion of Vasopressin (SIADH), Revised in 2018 Exclusion Criteria: -
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

| Intervention/Treatment |
| --- |
|Drug: Tolvaptan (SAMSCA)|The usual adult dose of SAMSCA is 7.5 mg of tolvaptan once daily administered orally, increased stepwise to 60 mg daily until a desirable level of serum sodium concentration is achieved.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety Information (Adverse Event) | Any untoward medicinal occurrence in a patient or clinical study subject administered a Medicinal Product and which does not necessarily have a causal relationship with this treatment (ICH-E2A Guideline). An Adverse Event can therefore be any unfavorable and unintended sign (e.g. abnormal laboratory finding), symptom, or disease temporally associated with the use of a Medicinal Product (Samsca), whether or not it is considered causally related to the Medicinal Product. | 90 days from the initiation of tolvaptan treatment | 
| Safety Information (Special Situations) | Situations related to the use of an Otsuka product which may or may not be associated with an adverse event: Maternal (pregnancy and breastfeeding) or paternal (via semen) exposure; Exposure during breastfeeding; Overdose/Incorrect dosage, misuse, abuse (e.g. patient sharing products); Medication errors (e.g. patient took wrong dose); Lack of therapeutic efficacy (e.g. the product doesn't work); Occupational exposure (e.g.: nurse administering the product is exposed); Cases of suspected transmission of infectious agents; Use of suspected or confirmed falsified product(s) or quality defect of the product(s); Withdrawal reactions; Accidental exposure (e.g.: child takes parent's product); Drug-drug/drug-food interactions; Unintentional use of product in a non-approved population (e.g.: pediatric or geriatric population); Disease progression/exacerbation of existing disease | 90 days from the initiation of tolvaptan treatment | 
| Safety Information (Number of off-Label Use) | Collecting any type of off-Label Use that refers to situations where a product is intentionally used for a medical purpose not in accordance with the authorized product information. Off-label use also includes the intentional use in non-authorized population categories not indicated in the label. | 90 days from the initiation of tolvaptan treatment | 
| Safety Information (Serious Adverse Event) | Any adverse drug experience/event occurring at any dose which results in death is life-threatening requires inpatient hospitalization or prolonged of existing hospitalization results in persistent or significant disability or incapacity is a congenital anomaly/birth defect is medically significant. | 90 days from the initiation of tolvaptan treatment | 
| Safety Information (Non-serious Adverse Events) | All Adverse Events that do not meet the definition of a serious Adverse Event are considered non-serious Adverse Events. | 90 days from the initiation of tolvaptan treatment |