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This Post-Marketing Surveillance will be conducted in accordance with the local regulation of New Drug Re-examination. The surveillance will be conducted for 6 years of the re-examination period (01Sep2011~31Aug2017). Each subject will be observed at least for 4 days during the surveillance period.
This study will be conducted as a prospective, single-arm, multicenter study. Findings on examination, diagnosis, opinions and observations implemented as per general medical practice during the observational period will be documented in the case report forms by the investigators or responsible staffs at the institution since the surveillance is an observational study.
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| Measure | Description | Time Frame |
|---|---|---|
| Safety Measure | Adverse Events (AEs) | 4days |
| Measure | Description | Time Frame |
|---|---|---|
| Change of the Serum Sodium Level(mEq/L) at the First Visit and Day 4 After the First Visit | In the efficacy analysis set, mean change of serum sodium level (mEq/L)on the 4th day compared to the first visit | Follow-up at least 4 days after first Samsca® dose |
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Inclusion Criteria:
Subjects must meet all of the following inclusion criteria to be eligible for enrollment into the study :
Exclusion Criteria:
Subjects presenting with any of the following will not be included in the study:
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The treatment of clinically significant hypervolemic and euvolemic hyponatremia [serum sodium < 125 mEq/L or hyponatremia that is symptomatic and has resisted correction with fluid restriction], including patients with heart failure, cirrhosis, Syndrome of Inappropriate Antidiuretic Hormone (SIADH) and etc.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bong Seng Hospital | Busan | 47889 | South Korea | |||
| Daegu Catholic University Medical Center |
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| ID | Title | Description |
|---|---|---|
| FG000 | Samsca | Patients who have hyponatremia in euvolemic or hypervolemic states, defined as serum sodium level < 125 mEq/L or hyponatremia that is symptomatic and has resisted correction with fluid restriction. Patients who are prescribed Samsca® treatment as per investigator's medical judgment Patients who gave written authorization to use their personal and health data Patients starting Samsca® treatment after agreement is in place |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
all patients who received Samsca® tablets at least once and had at least one post-treatment assessment during the study in approved indication and dosage regimen
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| ID | Title | Description |
|---|---|---|
| BG000 | Safety Set | all patients who received Samsca® tablets at least once and had at least one post-treatment assessment during the study in approved indication and dosage regimen |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Safety Measure | Adverse Events (AEs) | Safety analysis set was defined as all patients who received Samsca® tablets at least once and had at least one post-treatment assessment during the study in approved indication and dosage regimen. | Posted | Number | 95% Confidence Interval | percentage of AE | 4days |
|
|
up to 4 days.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Safety Set | a safety evaluation was conducted on 668 patients out of 908 patients' collected survey |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Azotaemia | Renal and urinary disorders | WHOART | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Constipation | Gastrointestinal disorders | WHOART | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Huiyeong,Shim/Associate CTM for LPS & ISS | Korea Otsuka Pharmaceutical Co.,Ltd. | 02-3287-9220 | hyshim@otsuka.co.kr |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 20, 2016 | Jan 29, 2019 | Prot_SAP_000.pdf |
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| Daegu |
| 42472 |
| South Korea |
| Chungnam National University Hospital | Daejeon | 35015 | South Korea |
| Chung-Ang University Hospital | Seoul | 06973 | South Korea |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
|
| Secondary | Change of the Serum Sodium Level(mEq/L) at the First Visit and Day 4 After the First Visit | In the efficacy analysis set, mean change of serum sodium level (mEq/L)on the 4th day compared to the first visit | the efficacy set is patients who received Samsca® tablets for at least 4 consecutive days and had the data on serum sodium level(mEq/L) on the 4th day of receiving Samsca® tablets. | Posted | Mean | Standard Deviation | mean change of serum sodium level(mEq/L) | Follow-up at least 4 days after first Samsca® dose |
|
|
|
| 6 |
| 668 |
| 10 |
| 668 |
| 110 |
| 668 |
| Pyelonephritis | Renal and urinary disorders | WHOART | Non-systematic Assessment |
|
| Asthenia | General disorders | WHOART | Non-systematic Assessment |
|
| Condition aggravated | General disorders | WHOART | Non-systematic Assessment |
|
| Fever | General disorders | WHOART | Non-systematic Assessment |
|
| Delirium | Psychiatric disorders | WHOART | Non-systematic Assessment |
|
| Pneumonia | Respiratory, thoracic and mediastinal disorders | WHOART | Non-systematic Assessment |
|
| Pulmonary oedema | Respiratory, thoracic and mediastinal disorders | WHOART | Non-systematic Assessment |
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| Dyspnoea | Respiratory, thoracic and mediastinal disorders | WHOART | Non-systematic Assessment |
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| Respiratory insufficiency | Respiratory, thoracic and mediastinal disorders | WHOART | Non-systematic Assessment |
|
| Cardiac failure | Vascular disorders | WHOART | Non-systematic Assessment |
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| Bilirubinaemia | Hepatobiliary disorders | WHOART | Non-systematic Assessment |
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| Heart valve disorders | Cardiac disorders | WHOART | Non-systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | WHOART | Non-systematic Assessment |
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| Nausea | Gastrointestinal disorders | WHOART | Non-systematic Assessment |
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| Vomiting | Gastrointestinal disorders | WHOART | Non-systematic Assessment |
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| Abdominal pain | Gastrointestinal disorders | WHOART | Non-systematic Assessment |
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| Indigestion | Gastrointestinal disorders | WHOART | Non-systematic Assessment |
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| Mouth dry | Gastrointestinal disorders | WHOART | Non-systematic Assessment |
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| Mucosal ulceration | Gastrointestinal disorders | WHOART | Non-systematic Assessment |
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| Haematemesis | Gastrointestinal disorders | WHOART | Non-systematic Assessment |
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| Tongue discolouration | Gastrointestinal disorders | WHOART | Non-systematic Assessment |
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| Hyperkalaemia | Metabolism and nutrition disorders | WHOART | Non-systematic Assessment |
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| Hypokalaemia | Metabolism and nutrition disorders | WHOART | Non-systematic Assessment |
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| Hypocalcaemia | Metabolism and nutrition disorders | WHOART | Non-systematic Assessment |
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| Thirst | Metabolism and nutrition disorders | WHOART | Non-systematic Assessment |
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| Weight decrease | Metabolism and nutrition disorders | WHOART | Non-systematic Assessment |
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| Hypernatraemia | Metabolism and nutrition disorders | WHOART | Non-systematic Assessment |
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| Hyponatraemia | Metabolism and nutrition disorders | WHOART | Non-systematic Assessment |
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| Hyperphosphataemia | Metabolism and nutrition disorders | WHOART | Non-systematic Assessment |
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| Hyperglycaemia | Metabolism and nutrition disorders | WHOART | Non-systematic Assessment |
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| Polydipsia | Metabolism and nutrition disorders | WHOART | Non-systematic Assessment |
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| Acidosis | Metabolism and nutrition disorders | WHOART | Non-systematic Assessment |
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| Hypophosphataemia | Metabolism and nutrition disorders | WHOART | Non-systematic Assessment |
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| Weight increase | Metabolism and nutrition disorders | WHOART | Non-systematic Assessment |
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| Fever | General disorders | WHOART | Non-systematic Assessment |
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| Back pain | General disorders | WHOART | Non-systematic Assessment |
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| Pain | General disorders | WHOART | Non-systematic Assessment |
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| Leg pain | General disorders | WHOART | Non-systematic Assessment |
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| Oedema peripheral | General disorders | WHOART | Non-systematic Assessment |
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| Asthenia | General disorders | WHOART | Non-systematic Assessment |
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| Hyperpyrexia | General disorders | WHOART | Non-systematic Assessment |
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| Fatigue | General disorders | WHOART | Non-systematic Assessment |
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| Medicine ineffective | General disorders | WHOART | Non-systematic Assessment |
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| Azotaemia | Renal and urinary disorders | WHOART | Non-systematic Assessment |
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| Pyelonephritis | Renal and urinary disorders | WHOART | Non-systematic Assessment |
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| Urinary tract infection | Renal and urinary disorders | WHOART | Non-systematic Assessment |
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| Cystitis | Renal and urinary disorders | WHOART | Non-systematic Assessment |
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| Dysuria | Renal and urinary disorders | WHOART | Non-systematic Assessment |
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| Urinary incontinence | Renal and urinary disorders | WHOART | Non-systematic Assessment |
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| Oliguria | Renal and urinary disorders | WHOART | Non-systematic Assessment |
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| Insomnia | Psychiatric disorders | WHOART | Non-systematic Assessment |
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| Delirium | Psychiatric disorders | WHOART | Non-systematic Assessment |
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| Anorexia | Psychiatric disorders | WHOART | Non-systematic Assessment |
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| Anxiety | Psychiatric disorders | WHOART | Non-systematic Assessment |
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| Dyspnoea | Respiratory, thoracic and mediastinal disorders | WHOART | Non-systematic Assessment |
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| Coughing | Respiratory, thoracic and mediastinal disorders | WHOART | Non-systematic Assessment |
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| Pneumonia | Respiratory, thoracic and mediastinal disorders | WHOART | Non-systematic Assessment |
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| Sputum increased | Respiratory, thoracic and mediastinal disorders | WHOART | Non-systematic Assessment |
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| Pharyngitis | Respiratory, thoracic and mediastinal disorders | WHOART | Non-systematic Assessment |
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| Respiratory disorder | Respiratory, thoracic and mediastinal disorders | WHOART | Non-systematic Assessment |
|
| Hypotension | Vascular disorders | WHOART | Non-systematic Assessment |
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| Hypertension | Vascular disorders | WHOART | Non-systematic Assessment |
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| Headache | Nervous system disorders | WHOART | Non-systematic Assessment |
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| Dizziness | Nervous system disorders | WHOART | Non-systematic Assessment |
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| Hyperkinesia | Nervous system disorders | WHOART | Non-systematic Assessment |
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| Pruritus | Skin and subcutaneous tissue disorders | WHOART | Non-systematic Assessment |
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| Rash maculo-papular | Skin and subcutaneous tissue disorders | WHOART | Non-systematic Assessment |
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| Skin disorder | Skin and subcutaneous tissue disorders | WHOART | Non-systematic Assessment |
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| Rash erythematous | Skin and subcutaneous tissue disorders | WHOART | Non-systematic Assessment |
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| Skeletal pain | Musculoskeletal and connective tissue disorders | WHOART | Non-systematic Assessment |
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| Arthralgia | Musculoskeletal and connective tissue disorders | WHOART | Non-systematic Assessment |
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| Myalgia | Musculoskeletal and connective tissue disorders | WHOART | Non-systematic Assessment |
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| Palpitation | Cardiac disorders | WHOART | Non-systematic Assessment |
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| Tachycardia ventricular | Cardiac disorders | WHOART | Non-systematic Assessment |
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| Tachycardia | Cardiac disorders | WHOART | Non-systematic Assessment |
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| ALT increased | Hepatobiliary disorders | WHOART | Non-systematic Assessment |
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| AST increased | Hepatobiliary disorders | WHOART | Non-systematic Assessment |
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| Post-operative haemorrhage | Investigations | WHOART | Non-systematic Assessment |
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| Decubitus ulcer | Investigations | WHOART | Non-systematic Assessment |
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| Infection | Immune system disorders | WHOART | Non-systematic Assessment |
|
| Myocardial ischaemia | Cardiac disorders | WHOART | Non-systematic Assessment |
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| Anaemia | Blood and lymphatic system disorders | WHOART | Non-systematic Assessment |
|
| Thrombocytopenia | Blood and lymphatic system disorders | WHOART | Non-systematic Assessment |
|
| Leucopenia | Blood and lymphatic system disorders | WHOART | Non-systematic Assessment |
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