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

Primary outcomes

1. Safety Information (Adverse Event)

   Time frame: 90 days from the initiation of tolvaptan treatment

   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.

2. Safety Information (Special Situations)

   Time frame: 90 days from the initiation of tolvaptan treatment

   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

3. Safety Information (Number of off-Label Use)

   Time frame: 90 days from the initiation of tolvaptan treatment

   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.

4. Safety Information (Serious Adverse Event)

   Time frame: 90 days from the initiation of tolvaptan treatment

   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.

5. Safety Information (Non-serious Adverse Events)

   Time frame: 90 days from the initiation of tolvaptan treatment

   All Adverse Events that do not meet the definition of a serious Adverse Event are considered non-serious Adverse Events.