NOCDURNA PASS Study Using Registries in Denmark, Germany and Sweden

Incidence rate of symptomatic hyponatraemia

Time frame · Through study completion, typically 2 months

Symptomatic hyponatraemia was defined as a primary or secondary diagnosis of hyponatraemia.

Incidence rate of hyponatraemia requiring hospital intensive care

Time frame · Through study completion, typically 2 months

Hyponatraemia requiring hospital intensive care was defined as a primary or secondary diagnosis of hyponatraemia recorded in an intensive care unit.

Incidence and severity of clinically significant hyponatraemia

Time frame · Through study completion, typically 2 months

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).

Rate of all-cause mortality

Time frame · Through study completion, typically 2 months

All-cause mortality was defined as death from any cause.

Incidence rate of major adverse cardiovascular events (MACE)

Time frame · Through study completion, typically 2 months

Major adverse cardiovascular events were defined as a record of myocardial infarction and stroke. Fatal and non-fatal events will be considered separately.

Incidence rate of major venous thromboembolic events (VTEs)

Time frame · Through study completion, typically 2 months

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.

Incidence rate acute exacerbation of congestive heart failure

Time frame · Through study completion, typically 2 months

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.

Incidence of serious adverse events of MACE and VTE in Sweden

Time frame · Through study completion, typically 2 months