Trial Outcomes & Findings for Samsca Post Marketing Surveillance Study (NCT NCT02722863)
NCT ID: NCT02722863
Last Updated: 2020-03-06
Results Overview
Adverse Events (AEs)
Recruitment status
COMPLETED
Target enrollment
908 participants
Primary outcome timeframe
4days
Results posted on
2020-03-06
Participant Flow
Participant milestones
| Measure |
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
|
|---|---|
|
Overall Study
STARTED
|
908
|
|
Overall Study
COMPLETED
|
908
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Safety Set
n=668 Participants
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
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=668 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
154 Participants
n=668 Participants
|
|
Age, Categorical
>=65 years
|
514 Participants
n=668 Participants
|
|
Sex: Female, Male
Female
|
326 Participants
n=668 Participants
|
|
Sex: Female, Male
Male
|
342 Participants
n=668 Participants
|
PRIMARY outcome
Timeframe: 4daysPopulation: 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.
Adverse Events (AEs)
Outcome measures
| Measure |
Safety Set
n=668 Participants
a safety evaluation was conducted on 668 patients out of 908 patients' collected survey
|
|---|---|
|
Safety Measure
|
17.37 percentage of AE
Interval 14.57 to 20.46
|
SECONDARY outcome
Timeframe: Follow-up at least 4 days after first Samsca® dosePopulation: 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.
In the efficacy analysis set, mean change of serum sodium level (mEq/L)on the 4th day compared to the first visit
Outcome measures
| Measure |
Safety Set
n=452 Participants
a safety evaluation was conducted on 668 patients out of 908 patients' collected survey
|
|---|---|
|
Change of the Serum Sodium Level(mEq/L) at the First Visit and Day 4 After the First Visit
Firtst visit
|
123.78 mean change of serum sodium level(mEq/L)
Standard Deviation 4.81
|
|
Change of the Serum Sodium Level(mEq/L) at the First Visit and Day 4 After the First Visit
4th day
|
134.83 mean change of serum sodium level(mEq/L)
Standard Deviation 5.69
|
Adverse Events
Safety Set
Serious events: 10 serious events
Other events: 110 other events
Deaths: 6 deaths
Serious adverse events
| Measure |
Safety Set
n=668 participants at risk
a safety evaluation was conducted on 668 patients out of 908 patients' collected survey
|
|---|---|
|
Renal and urinary disorders
Azotaemia
|
0.30%
2/668 • Number of events 2 • up to 4 days.
|
|
Renal and urinary disorders
Pyelonephritis
|
0.15%
1/668 • Number of events 1 • up to 4 days.
|
|
General disorders
Asthenia
|
0.15%
1/668 • Number of events 1 • up to 4 days.
|
|
General disorders
Condition aggravated
|
0.15%
1/668 • Number of events 1 • up to 4 days.
|
|
General disorders
Fever
|
0.15%
1/668 • Number of events 1 • up to 4 days.
|
|
Psychiatric disorders
Delirium
|
0.15%
1/668 • Number of events 1 • up to 4 days.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia
|
0.15%
1/668 • Number of events 1 • up to 4 days.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
0.15%
1/668 • Number of events 1 • up to 4 days.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.15%
1/668 • Number of events 1 • up to 4 days.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory insufficiency
|
0.15%
1/668 • Number of events 1 • up to 4 days.
|
|
Vascular disorders
Cardiac failure
|
0.15%
1/668 • Number of events 1 • up to 4 days.
|
|
Hepatobiliary disorders
Bilirubinaemia
|
0.15%
1/668 • Number of events 1 • up to 4 days.
|
|
Cardiac disorders
Heart valve disorders
|
0.15%
1/668 • Number of events 1 • up to 4 days.
|
Other adverse events
| Measure |
Safety Set
n=668 participants at risk
a safety evaluation was conducted on 668 patients out of 908 patients' collected survey
|
|---|---|
|
Gastrointestinal disorders
Constipation
|
6.4%
43/668 • Number of events 55 • up to 4 days.
|
|
Gastrointestinal disorders
Diarrhoea
|
2.4%
16/668 • Number of events 16 • up to 4 days.
|
|
Gastrointestinal disorders
Nausea
|
1.5%
10/668 • Number of events 11 • up to 4 days.
|
|
Gastrointestinal disorders
Vomiting
|
1.2%
8/668 • Number of events 8 • up to 4 days.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.90%
6/668 • Number of events 6 • up to 4 days.
|
|
Gastrointestinal disorders
Indigestion
|
0.60%
4/668 • Number of events 5 • up to 4 days.
|
|
Gastrointestinal disorders
Mouth dry
|
0.60%
4/668 • Number of events 5 • up to 4 days.
|
|
Gastrointestinal disorders
Mucosal ulceration
|
0.15%
1/668 • Number of events 1 • up to 4 days.
|
|
Gastrointestinal disorders
Haematemesis
|
0.15%
1/668 • Number of events 1 • up to 4 days.
|
|
Gastrointestinal disorders
Tongue discolouration
|
0.15%
1/668 • Number of events 1 • up to 4 days.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.75%
5/668 • Number of events 5 • up to 4 days.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.75%
5/668 • Number of events 5 • up to 4 days.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
0.60%
4/668 • Number of events 4 • up to 4 days.
|
|
Metabolism and nutrition disorders
Thirst
|
0.45%
3/668 • Number of events 3 • up to 4 days.
|
|
Metabolism and nutrition disorders
Weight decrease
|
0.45%
3/668 • Number of events 3 • up to 4 days.
|
|
Metabolism and nutrition disorders
Hypernatraemia
|
0.45%
3/668 • Number of events 3 • up to 4 days.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.30%
2/668 • Number of events 2 • up to 4 days.
|
|
Metabolism and nutrition disorders
Hyperphosphataemia
|
0.30%
2/668 • Number of events 2 • up to 4 days.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.15%
1/668 • Number of events 1 • up to 4 days.
|
|
Metabolism and nutrition disorders
Polydipsia
|
0.15%
1/668 • Number of events 1 • up to 4 days.
|
|
Metabolism and nutrition disorders
Acidosis
|
0.15%
1/668 • Number of events 1 • up to 4 days.
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
0.15%
1/668 • Number of events 1 • up to 4 days.
|
|
Metabolism and nutrition disorders
Weight increase
|
0.15%
1/668 • Number of events 1 • up to 4 days.
|
|
General disorders
Fever
|
1.2%
8/668 • Number of events 8 • up to 4 days.
|
|
General disorders
Back pain
|
0.45%
3/668 • Number of events 3 • up to 4 days.
|
|
General disorders
Pain
|
0.45%
3/668 • Number of events 3 • up to 4 days.
|
|
General disorders
Leg pain
|
0.30%
2/668 • Number of events 2 • up to 4 days.
|
|
General disorders
Oedema peripheral
|
0.30%
2/668 • Number of events 2 • up to 4 days.
|
|
General disorders
Asthenia
|
0.15%
1/668 • Number of events 1 • up to 4 days.
|
|
General disorders
Hyperpyrexia
|
0.15%
1/668 • Number of events 1 • up to 4 days.
|
|
General disorders
Fatigue
|
0.15%
1/668 • Number of events 1 • up to 4 days.
|
|
General disorders
Medicine ineffective
|
0.15%
1/668 • Number of events 1 • up to 4 days.
|
|
Renal and urinary disorders
Azotaemia
|
0.75%
5/668 • Number of events 5 • up to 4 days.
|
|
Renal and urinary disorders
Pyelonephritis
|
0.15%
1/668 • Number of events 1 • up to 4 days.
|
|
Renal and urinary disorders
Urinary tract infection
|
0.30%
2/668 • Number of events 2 • up to 4 days.
|
|
Renal and urinary disorders
Cystitis
|
0.15%
1/668 • Number of events 1 • up to 4 days.
|
|
Renal and urinary disorders
Dysuria
|
0.15%
1/668 • Number of events 1 • up to 4 days.
|
|
Renal and urinary disorders
Urinary incontinence
|
0.15%
1/668 • Number of events 1 • up to 4 days.
|
|
Renal and urinary disorders
Oliguria
|
0.15%
1/668 • Number of events 1 • up to 4 days.
|
|
Psychiatric disorders
Insomnia
|
0.60%
4/668 • Number of events 4 • up to 4 days.
|
|
Psychiatric disorders
Delirium
|
0.45%
3/668 • Number of events 3 • up to 4 days.
|
|
Psychiatric disorders
Anorexia
|
0.60%
4/668 • Number of events 4 • up to 4 days.
|
|
Psychiatric disorders
Anxiety
|
0.30%
2/668 • Number of events 2 • up to 4 days.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.60%
4/668 • Number of events 4 • up to 4 days.
|
|
Respiratory, thoracic and mediastinal disorders
Coughing
|
0.45%
3/668 • Number of events 3 • up to 4 days.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia
|
0.15%
1/668 • Number of events 1 • up to 4 days.
|
|
Respiratory, thoracic and mediastinal disorders
Sputum increased
|
0.15%
1/668 • Number of events 1 • up to 4 days.
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngitis
|
0.15%
1/668 • Number of events 1 • up to 4 days.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory disorder
|
0.15%
1/668 • Number of events 1 • up to 4 days.
|
|
Vascular disorders
Hypotension
|
1.2%
8/668 • Number of events 8 • up to 4 days.
|
|
Vascular disorders
Hypertension
|
0.60%
4/668 • Number of events 4 • up to 4 days.
|
|
Nervous system disorders
Headache
|
0.90%
6/668 • Number of events 6 • up to 4 days.
|
|
Nervous system disorders
Dizziness
|
0.60%
4/668 • Number of events 4 • up to 4 days.
|
|
Nervous system disorders
Hyperkinesia
|
0.15%
1/668 • Number of events 1 • up to 4 days.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.75%
5/668 • Number of events 5 • up to 4 days.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.15%
1/668 • Number of events 1 • up to 4 days.
|
|
Skin and subcutaneous tissue disorders
Skin disorder
|
0.15%
1/668 • Number of events 1 • up to 4 days.
|
|
Skin and subcutaneous tissue disorders
Rash erythematous
|
0.15%
1/668 • Number of events 1 • up to 4 days.
|
|
Musculoskeletal and connective tissue disorders
Skeletal pain
|
0.45%
3/668 • Number of events 3 • up to 4 days.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.30%
2/668 • Number of events 2 • up to 4 days.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.30%
2/668 • Number of events 2 • up to 4 days.
|
|
Cardiac disorders
Palpitation
|
0.30%
2/668 • Number of events 2 • up to 4 days.
|
|
Cardiac disorders
Tachycardia ventricular
|
0.30%
2/668 • Number of events 2 • up to 4 days.
|
|
Cardiac disorders
Tachycardia
|
0.15%
1/668 • Number of events 1 • up to 4 days.
|
|
Hepatobiliary disorders
ALT increased
|
0.15%
1/668 • Number of events 1 • up to 4 days.
|
|
Hepatobiliary disorders
AST increased
|
0.15%
1/668 • Number of events 1 • up to 4 days.
|
|
Investigations
Post-operative haemorrhage
|
0.15%
1/668 • Number of events 1 • up to 4 days.
|
|
Investigations
Decubitus ulcer
|
0.15%
1/668 • Number of events 1 • up to 4 days.
|
|
Immune system disorders
Infection
|
0.30%
2/668 • Number of events 2 • up to 4 days.
|
|
Cardiac disorders
Myocardial ischaemia
|
0.15%
1/668 • Number of events 1 • up to 4 days.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.30%
2/668 • Number of events 2 • up to 4 days.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.30%
2/668 • Number of events 2 • up to 4 days.
|
|
Blood and lymphatic system disorders
Leucopenia
|
0.15%
1/668 • Number of events 1 • up to 4 days.
|
Additional Information
Huiyeong,Shim/Associate CTM for LPS & ISS
Korea Otsuka Pharmaceutical Co.,Ltd.
Phone: 02-3287-9220
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place