A study using medical records to evaluate safety issues for the NOCDURNA drug using national register data from Denmark and Sweden, and a health care register covering parts of Germany.
Study Type
OBSERVATIONAL
Enrollment
1,099,551
Non intervention
Non intervention
Danish Health Care Registry
Copenhagen, Denmark
German Health Care Register
Bremen, Germany
Socialstryrelsen
Stockholm, Sweden
Incidence rate of symptomatic hyponatraemia
Symptomatic hyponatraemia was defined as a primary or secondary diagnosis of hyponatraemia.
Time frame: Through study completion, typically 2 months
Incidence rate of hyponatraemia requiring hospital intensive care
Hyponatraemia requiring hospital intensive care was defined as a primary or secondary diagnosis of hyponatraemia recorded in an intensive care unit.
Time frame: Through study completion, typically 2 months
Incidence and severity of clinically significant hyponatraemia
Clinically significant hyponatraemia was defined as a serum sodium concentration of \<130 mmol/L. Severity of hyponatraemia was categorized as mild hyponatraemia (serum sodium concentration: 130 to \<135 mmol/L), moderate hyponatraemia (serum sodium concentration: \>125 to \<130 mmol/L) and severe hyponatraemia (serum sodium concentration: less than equal to \[≤\]125 mmol/L).
Time frame: Through study completion, typically 2 months
Rate of all-cause mortality
All-cause mortality was defined as death from any cause.
Time frame: Through study completion, typically 2 months
Incidence rate of major adverse cardiovascular events (MACE)
Major adverse cardiovascular events were defined as a record of myocardial infarction and stroke. Fatal and non-fatal events will be considered separately.
Time frame: Through study completion, typically 2 months
Incidence rate of major venous thromboembolic events (VTEs)
Venous thromboembolic events were defined as a record of a deep vein thrombosis, pulmonary embolism or portal vein thrombosis. Fatal and non-fatal events will be considered separately.
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Time frame: Through study completion, typically 2 months
Incidence rate acute exacerbation of congestive heart failure
Acute exacerbation of congestive heart failure was defined as primary diagnosis of acute or acute-on-chronic heart failure from hospital inpatient care or the acute and emergency ward, or death from heart failure as the underlying or contributory cause.
Time frame: Through study completion, typically 2 months
Incidence of serious adverse events of MACE and VTE in Sweden
Time frame: Through study completion, typically 2 months