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| ID | Type | Description | Link |
|---|---|---|---|
| AD1301 | Other Identifier | company internal |
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In accordance with the regulatory guidance this registry has been designed to collect information about the long-term safety of Adempas in real clinical practice outside the regulated environment of a controlled clinical study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 | Patients who have been prescribed Adempas for a medically appropriate use |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Riociguat (Adempas, BAY63-2521) | Drug | The decision on clinical management of the patient including the actual treatment duration will be determined solely by the physician not by the clinical study protocol (CSP) |
| Measure | Description | Time Frame |
|---|---|---|
| Number of adverse events | Up to 4 years | |
| Number of serious adverse events | Up to 4 years | |
| All-cause mortality | Up to 4 years |
| Measure | Description | Time Frame |
|---|---|---|
| Number of adverse event (AE) in the different pulmonary hypertension(PH) indications (pulmonary arterial hypertension (PAH) chronic thromboembolic pulmonary hypertension(CTEPH) | Up to 4 years | |
| Number of serious adverse event (SAE) in different PH indications (PAH and CTEPH) |
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Inclusion Criteria:
Exclusion Criteria:
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Patients who have been prescribed Adempas® for a medically appropriate use
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| Name | Affiliation | Role |
|---|---|---|
| Bayer Study Director | Bayer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Multiple Locations | Argentina | |||||
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| Up to 4 years |
| Incidence of AE of special interest overall | Up to 4 years |
| Incidence of AE of special interest in different PH indications (PAH, CTEPH) | Up to 4 years |
| 6 minute walking distance | Up to 4 years |
| Functional class of pulmonary hypertension according to NYHA/ WHO | NYHA/ WHO: New York Heart Association / World Health Organization | Up to 4 years |
| Borg Dyspnoea Index | Up to 4 years |
| EQ5D visual analogue scale (VAS) score | EQ5D: EurQuol 5 dimensions (questionnaire) | Up to 4 years |
| Number of patients with hemodynamic measurements | Up to 4 years |
| Concentration of biomarkers for heart insufficiency (Brain Natriuretic Peptide (BNP) and N-Terminal pro BNP (NTpro BNP)) | Up to 4 years |
| Number of hospitalization | Up to 4 years |
| Number of outpatient visits | Up to 4 years |
| Number of days in home care | Up to 4 years |
| Number of days in rehabilitation | Up to 4 years |
| Number of days in nursery home | Up to 4 years |
| Drug treatment for PH | Up to 4 years |
| Multiple Locations |
| Australia |
| Multiple Locations | Austria |
| Multiple Locations | Belgium |
| Multiple Locations | Canada |
| Multiple Locations | Colombia |
| Multiple Locations | Czechia |
| Multiple Locations | Denmark |
| Multiple Locations | Estonia |
| Multiple Locations | Finland |
| Multiple Locations | France |
| Multiple Locations | Germany |
| Multiple Locations | Greece |
| Multiple Locations | Ireland |
| Multiple Locations | Italy |
| Multiple Locations | Luxembourg |
| Multiple Locations | Netherlands |
| Multiple Locations | Norway |
| Multiple Locations | Portugal |
| Multiple Locations | Russia |
| Multiple Locations | Saudi Arabia |
| Multiple Locations | Slovakia |
| Multiple Locations | Spain |
| Multiple Locations | Sweden |
| Multiple Locations | Switzerland |
| Multiple Locations | Taiwan |
| Multiple Locations | Turkey (Türkiye) |
| Multiple Locations | United Kingdom |
| ID | Term |
|---|---|
| D006976 | Hypertension, Pulmonary |
| ID | Term |
|---|---|
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D006973 | Hypertension |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| C542595 | riociguat |
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