Adverse Drug Event
Conditions
Keywords
Nocturia, NOCDURNA, Post-authorisation Safety Study
Brief summary
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.
Interventions
OTHERNOCDURNA Cohort
Non intervention
OTHERLUTS Cohort
Non intervention
Sponsors
Ferring Pharmaceuticals
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Usage of NOCDURNA recorded as dispensations in adults or usage of drugs for LUTS.
Exclusion criteria
* Multiple dispensations of NOCDURNA on the same day or treatment with vasopressin 6 months before study start.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence rate of symptomatic hyponatraemia | Through study completion, typically 2 months | Symptomatic hyponatraemia was defined as a primary or secondary diagnosis of hyponatraemia. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence rate of hyponatraemia requiring hospital intensive care | 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 | 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 | Through study completion, typically 2 months | All-cause mortality was defined as death from any cause. |
| Incidence rate of major adverse cardiovascular events (MACE) | 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) | 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 | 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 | Through study completion, typically 2 months | — |
Countries
Denmark, Germany, Sweden
Outcome results
None listed