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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NOCDURNA cohort |
| ||
| Lower urinary tract symptoms (LUTS) Cohort |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NOCDURNA Cohort | Other | Non intervention |
| |
| LUTS Cohort |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence rate of symptomatic hyponatraemia | Symptomatic hyponatraemia was defined as a primary or secondary diagnosis of hyponatraemia. | Through study completion, typically 2 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Through study completion, typically 2 months |
| Incidence and severity of clinically significant hyponatraemia |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with usage of NOCDURNA identified as dispensations/prescriptions or dispensations/prescription of drugs for LUTS
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| Name | Affiliation | Role |
|---|---|---|
| Global Clinical Compliance | Ferring Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Danish Health Care Registry | Copenhagen | Denmark | ||||
| German Health Care Register |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41281576 | Result | Johansson G, Reinold J, Shapero NL, Rosell TL, Jorgensen LA, Koenen N, Frosig C, Falkenberg M, Holdrup L, Juul K. Real-life safety assessment of orally disintegrating desmopressin tablet: Incidence of diagnosed hyponatraemia and other events across three European countries. Glob Epidemiol. 2025 Oct 31;10:100228. doi: 10.1016/j.gloepi.2025.100228. eCollection 2025 Dec. |
| Label | URL |
|---|---|
| DOI: 10.1016/j.gloepi.2025.100228 | View source |
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| ID | Term |
|---|---|
| D064420 | Drug-Related Side Effects and Adverse Reactions |
| D053158 | Nocturia |
| ID | Term |
|---|---|
| D064419 | Chemically-Induced Disorders |
| D059411 | Lower Urinary Tract Symptoms |
| D020924 | Urological Manifestations |
| D012816 | Signs and Symptoms |
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| Other |
Non intervention |
|
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). |
| Through study completion, typically 2 months |
| Rate of all-cause mortality | All-cause mortality was defined as death from any cause. | 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. | 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. | 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. | Through study completion, typically 2 months |
| Incidence of serious adverse events of MACE and VTE in Sweden | Through study completion, typically 2 months |
| Bremen |
| Germany |
| Socialstryrelsen | Stockholm | Sweden |
| D013568 | Pathological Conditions, Signs and Symptoms |