Samtasu Post-marketing General Drug Use-results Survey in Patients With Volume Overload in Heart Failure.

Primary Outcomes (5)

• 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 (see Annex Ⅳ, 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, whether or not it is considered causally related to the Medicinal Product.

  14 days from the initiation of tolvaptan sodium phosphate treatment

• Number of Special Situations

  Collecting any 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

  14 days from the initiation of tolvaptan sodium phosphate treatment

• 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 nonauthorized population categories not indicated in the label.

  14 days from the initiation of tolvaptan sodium phosphate treatment

• Incidence of Serious Adverse Event (e.g. resulting in death or life-threatening)

  Collecting the number of 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.

  14 days from the initiation of tolvaptan sodium phosphate treatment

• Incidence of Non-serious Adverse Events (i.e. all Adverse Events that do not meet the definition of a serious Adverse Event)

  Collecting the number of non-serious Adverse Events

  14 days from the initiation of tolvaptan sodium phosphate treatment

Conditions