Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The objective of this post-marketing surveillance study is to evaluate the incidence of adverse events in Japanese subjects with pulmonary arterial hypertension treated with ambrisentan basd on prescribing information under the conditions of general clinical practice and also to grasp the following items;
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Subjects prescribed ambrisentan | Subjects with pulmonary arterial hypertension (PAH) prescribed ambrisentan during study period |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ambrisentan | Drug | Ambrisentan |
|
| Measure | Description | Time Frame |
|---|---|---|
| The number of adverse events in Japanese subjects with pulmonary arterial hypertension treated with ambrisentan | 1 year | |
| The onset statuses of anemia, fluid retention, cardiac failure and hemorrhage | 1 year | |
| The number of adverse events and clinical course in subjects with hepatic dysfunction | 1 year |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
All Japanese subjects who have received ambrisentan for the first time for the treatment of pulmonary arterial hypertension (PAH) and have given their consent to participate in the study.
Not provided
| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
Not provided
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29282676 | Derived | Takahashi T, Hayata S, Kobayashi A, Onaka Y, Ebihara T, Hara T. Surveillance on The Safety and Efficacy of Ambrisentan (Volibris Tablet 2.5 mg) in Patients with Pulmonary Arterial Hypertension in Real Clinical Practice: Post-marketing Surveillance (Interim Analysis Report). Clin Drug Investig. 2018 Mar;38(3):219-229. doi: 10.1007/s40261-017-0602-4. |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D006976 | Hypertension, Pulmonary |
| ID | Term |
|---|---|
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D006973 | Hypertension |
| D014652 | Vascular Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C467894 | ambrisentan |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| D002318 |
| Cardiovascular Diseases |