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

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• Inappropriate ADH Syndrome 41

Inappropriate ADH Syndrome

41 studies on the registry are indexed under Inappropriate ADH Syndrome; 3 are open to participants now.

This study's planned enrollment of 300 is above the median of 143 across 16 observational studies indexed under Inappropriate ADH Syndrome.

Lead sponsor

Otsuka Pharmaceutical Co., Ltd. is the lead sponsor of 143 studies on the registry; 11 are open to participants now.

Study population

Interventions

• DrugTolvaptan (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.

Primary outcomes

1. 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.

   Time frame: 90 days from the initiation of tolvaptan treatment

2. 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

   Time frame: 90 days from the initiation of tolvaptan treatment

3. 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.

   Time frame: 90 days from the initiation of tolvaptan treatment

4. 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.

   Time frame: 90 days from the initiation of tolvaptan treatment

5. 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.

   Time frame: 90 days from the initiation of tolvaptan treatment