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| ID | Type | Description | Link |
|---|---|---|---|
| 2014-002131-34 | EudraCT Number |
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The primary objective of this study is to evaluate the effect of selonsertib (GS-4997) on pulmonary vascular resistance (PVR), as measured by right heart catheterization (RHC) in adults with pulmonary arterial hypertension (PAH). The study will consist of a 24-week placebo-controlled treatment period and a long-term selonsertib treatment period. Participants completing the 24-week placebo-controlled period will be eligible to receive active treatment with selonsertib in the long-term treatment period.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Selonsertib 2 mg | Experimental | Participants will receive selonsertib 2 milligrams (mg) for 24 weeks and may continue on this dose during the long-term treatment phase. |
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| Selonsertib 6 mg | Experimental | Participants will receive selonsertib 6 mg for 24 weeks and may continue on this dose during the long-term treatment phase. |
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| Selonsertib 18 mg | Experimental | Participants will receive selonsertib 18 mg for 24 weeks and may continue on this dose during the long-term treatment phase. |
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| Placebo | Experimental | Participants will receive selonsertib placebo for 24 weeks, and may then be rerandomized 1:1:1 to selonsertib 2, 6, or 18 mg during the long-term treatment phase. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Drug | Tablet administered orally once daily |
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| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Pulmonary Vascular Resistance (PVR) at Week 24, as Measured by Right Heart Catheterization (RHC) | PVR is a measure of the extent to which pulmonary circulation resists cardiac output. Change from Baseline was calculated as the value at Week 24 minus the value at Baseline. The Week 24 value was defined as the last assessment at or prior to Week 24. | Baseline to Week 24 |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline at Week 24 in Other Cardiopulmonary Hemodynamic Measures: Cardiac Index | Cardiac index is the amount of blood pumped by the heart, per minute, per meter square of body surface area. Change from Baseline was calculated as the value at Week 24 minus the value at Baseline. The Week 24 value was defined as the last assessment at or prior to Week 24. | Baseline to Week 24 |
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Key Inclusion Criteria:
Diagnosis of idiopathic pulmonary arterial hypertension (IPAH), heritable pulmonary arterial hypertension (HPAH), drug- and toxin-induced PAH, or PAH associated with connective tissue disease, human immunodeficiency virus (HIV) infection, or congenital heart defects (repaired greater than 1 year prior to Screening)
Meet all of the following hemodynamic criteria by means of a screening right heart catheterization (RHC) completed prior to randomization:
Be able to walk a distance of at least 100 meters
Have World Health Organization (WHO) Functional Class II or III symptoms
Meet the following criteria determined by pulmonary function tests completed no more than 24 weeks prior to screening, performed with or without bronchodilation:
Receiving treatment with one or more drugs approved for PAH for ≥ 12 consecutive weeks and at stable dose for ≥ 8 consecutive weeks
Key Exclusion Criteria:
Individuals may be rescreened one additional time with prior notification to and approval by the sponsor.
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
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| Name | Affiliation | Role |
|---|---|---|
| Gilead Study Director | Gilead Sciences | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of South Alabama Medical Center | Mobile | Alabama | United States | |||
| Advanced Lung Disease Institute |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34425071 | Derived | Rosenkranz S, Feldman J, McLaughlin VV, Rischard F, Lange TJ, White RJ, Peacock AJ, Gerhardt F, Ebrahimi R, Brooks G, Satler C, Frantz RP; ARROW Study Group. Selonsertib in adults with pulmonary arterial hypertension (ARROW): a randomised, double-blind, placebo-controlled, phase 2 trial. Lancet Respir Med. 2022 Jan;10(1):35-46. doi: 10.1016/S2213-2600(21)00032-1. Epub 2021 Aug 20. |
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185 participants were screened.
Participants were enrolled at study sites in North America and Europe. The first participant was screened on 12 November 2014. The last study visit occurred on 13 December 2016.
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| ID | Title | Description |
|---|---|---|
| FG000 | Selonsertib 2 mg | Participants were randomized to receive selonsertib 2 mg tablet once daily for 24 weeks during the treatment phase (Period 1) and may have continued on this dosing during the long-term treatment phase (Period 2). |
| FG001 | Selonsertib 6 mg |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Treatment Period (24 Weeks) |
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| Selonsertib | Drug | Tablets administered orally once daily |
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| Change From Baseline at Week 24 in Other Cardiopulmonary Hemodynamic Measures: mPAP | mPAP is the mean blood pressure in the pulmonary artery. Change from Baseline was calculated as the value at Week 24 minus the value at Baseline. The Week 24 value was defined as the last assessment at or prior to Week 24. | Baseline to Week 24 |
| Change From Baseline at Week 24 in Other Cardiopulmonary Hemodynamic Measures: mRAP | mRAP is the mean blood pressure in the right atrium of the heart. Change from Baseline was calculated as the value at Week 24 minus the value at Baseline. The Week 24 value was defined as the last assessment at or prior to Week 24. | Baseline to Week 24 |
| Change From Baseline at Week 24 in Other Cardiopulmonary Hemodynamic Measures: Mixed Venous Oxygen Saturation (SVO2) (%) | SVO2 is the percentage of oxygen bound to hemoglobin in blood returning to the right side of the heart. Change from Baseline was calculated as the value at Week 24 minus the value at Baseline. The Week 24 value was defined as the last assessment at or prior to Week 24. | Baseline to Week 24 |
| Change From Baseline at Week 24 in Other Cardiopulmonary Hemodynamic Measures: Right Ventricular Cardiac Power (RVCP) | RVCP is a cardiopulmonary hemodynamic assessment. Change from Baseline was calculated as the value at Week 24 minus the value at Baseline. The Week 24 value was defined as the last assessment at or prior to Week 24. | Baseline to Week 24 |
| Change From Baseline at Week 24 in 6MWD Test | The 6MWD test was conducted according to the American Thoracic Society guidelines in accordance with local standard operating procedures. It measures the distance a participant is able to walk in a period of six minutes. Change from Baseline was calculated as the value at Week 24 minus the value at Baseline. The Week 24 value was defined as the last assessment at or prior to Week 24. | Baseline to Week 24 |
| Change From Baseline at Week 24 in BDI After the 6MWD Test | Immediately following completion of the 6-minute walk test, participants were asked to assess breathlessness using the BDI score as follows: 0 = no breathlessness, 10 = extremely strong (maximal breathlessness), any number > 10 = Highest possible. Therefore, the minimum for BDI score was 0 and there was no upper bound. Change from Baseline was calculated as the value at Week 24 minus the value at Baseline. The Week 24 value was defined as the last assessment at or prior to Week 24. | Baseline to Week 24 |
| Number of Participants Experiencing Change From Baseline at Week 24 in WHO Functional Class | Class I: no symptoms with exercise or at rest. Class II: No symptoms at rest but uncomfortable and short of breath with normal activity such as climbing a flight of stairs, grocery shopping, or making the bed. Class III: May not have symptoms at rest but activities greatly limited by shortness of breath, fatigue, or near fainting (e.g., doing normal chores around the house, have to take breaks while doing activities of daily living). Class IV: Symptoms at rest and severe symptoms with any activity. Most participants also have edema in the feet and ankles as result of right heart failure. The Week 24 value was defined as the last assessment at or prior to Week 24. | Baseline to Week 24 |
| Change From Baseline at Week 24 in NT-proBNP | NT-proBNP is used to detect, diagnose, and evaluate the severity of heart failure. In general, NT-proBNP levels are higher in participants with heart failure than those who have normal heart function. Change from Baseline was calculated as the value at Week 24 minus the value at Baseline. The Week 24 value was defined as the last assessment at or prior to Week 24. | Baseline to Week 24 |
| Change From Baseline at Week 24 in Short Form (SF-36) Physical Functioning Scale | Quality of life was assessed using the SF-36 questionnaire, a self-administered multi-item survey that asks 36 questions to measure functional health and well-being from the participant's point of view and consists of eight health domains (Physical Functioning, Role-Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role-Emotional, and Mental Health) as well as 2 summary measures (Physical Health and Mental Health). Data presented are for 1 of the domains only: Physical Functioning. Scores can range from 0 to 100, with a higher score representing a higher level of functioning. Change from Baseline was calculated as the value at Week 24 minus the value at Baseline. The Week 24 value was defined as the last assessment at or prior to Week 24. | Baseline to Week 24 |
| Change From Baseline at Week 24 in emPHasis-10 Questionnaire Score | Quality of life was assessed using the emPHasis-10 questionnaire, a disease-specific self-administered 10-question questionnaire designed for routine assessment of health-related quality of life in pulmonary hypertension. Total score can range from 0 to 50, with higher scores indicating a worse quality of life. Change from Baseline was calculated as the value at Week 24 minus the value at Baseline. The Week 24 value was defined as the last assessment at or prior to Week 24. | Baseline to Week 24 |
| Change From Baseline at Week 24 in Heart Rate Recovery (HRR) After the 6MWD Test | HRR was assessed after the 6MWD test. The HRR was calculated as the difference between the heart rate measured immediately after completing the 6MWD test and the second heart rate measured 1 minute after the 6MWD test. Change from Baseline was calculated as the value at Week 24 minus the value at Baseline. The Week 24 value was defined as the last assessment at or prior to Week 24. | Baseline to Week 24 |
| Kaplan-Meier Estimate of Time to Clinical Worsening (TTCW) Evaluated in Period 1 | TTCW was defined as time to the first occurrence of: death (all-cause), hospitalization for worsening pulmonary arterial hypertension (PAH) (any hospitalization for worsening PAH, lung or heart/lung transplant, atrial septostomy, or initiation of continuously infused prostanoid therapy), or disease progression (defined as both > 15% decrease from baseline in 6MWD test and WHO class III or IV symptoms at two consecutive postbaseline clinic visits separated by ≥ 14 days). TTCW was evaluated using Kaplan-Meier estimates. | Baseline up to Week 24 |
| Change From Baseline in Echocardiographic Measures of Right Ventricular Function at Week 24: TAPSE | TAPSE is an echocardiographic assessment of right ventricular function. Change from Baseline was calculated as the value at Week 24 minus the value at Baseline. The Week 24 value was defined as the last assessment at or prior to Week 24. | Baseline to Week 24 |
| Change From Baseline in Echocardiographic Measures of Right Ventricular Function at Week 24: Right Ventricular Myocardial Strain (%) | Right ventricular myocardial strain is an echocardiographic assessment of right ventricular function. Change from Baseline was calculated as the value at Week 24 minus the value at Baseline. The Week 24 value was defined as the last assessment at or prior to Week 24. | Baseline to Week 24 |
| Change From Baseline in Echocardiographic Measures of Right Ventricular Function at Week 24: Tricuspid Annular Peak Sys Myocard Velocity (TAS) | TAS is an echocardiographic assessment of right ventricular function. Change from Baseline was calculated as the value at Week 24 minus the value at Baseline. The Week 24 value was defined as the last assessment at or prior to Week 24. | Baseline to Week 24 |
| Change From Baseline in Echocardiographic Measures of Right Ventricular Function at Week 24: Right Ventricular Tei Index (RVTI) | The Tei-index is defined as the sum of the isovolumic contraction and the isovolumic relaxation time divided by ejection time, and thus incorporates elements of both systolic and diastolic phases in the assessment of global ventricular function. An increased Tei-index results from ventricular dysfunction and provides prognostic information for a variety of myocardial conditions. The RVTI is a candidate to increase the non-invasive diagnosis of PAH because it reflects the right ventricular function, is easy to assess, and can be estimated in the same session as the echocardiographic PAP. The normal value of the RVTI is 0.28 +/- 0.04. An increased RVTI is associated with either left ventricular diastolic abnormalities or pulmonary hypertension. This score has no bounds. Change from Baseline was calculated as the value at Week 24 minus the value at Baseline. The Week 24 value was defined as the last assessment at or prior to Week 24. | Baseline to Week 24 |
| Change From Baseline in Echocardiographic Measures of Right Ventricular Function at Week 24: Right Ventricular Fractional Area Change (RVFAC) | RVFAC is an echocardiographic assessment of right ventricular function. Change from Baseline was calculated as the value at Week 24 minus the value at Baseline. The Week 24 value was defined as the last assessment at or prior to Week 24. | Baseline to Week 24 |
| Phoenix |
| Arizona |
| United States |
| Arizona Pulmonary Specialist, Ltd | Phoenix | Arizona | United States |
| University of Arizona Clinical and Translational Science (CATS) Research Center | Tucson | Arizona | United States |
| VA Greater Los Angeles Healthcare System | Los Angeles | California | United States |
| University of California, Davis | Sacramento | California | United States |
| University of California, San Francisco | San Francisco | California | United States |
| LA Biomedical Research Institute Harbor-UCLA Medical Center | Torrance | California | United States |
| University of Colorado Cardiac and Vascular Center, Anschutz Inpatient Pavillion | Aurora | Colorado | United States |
| The Emory Clinic | Atlanta | Georgia | United States |
| University of Chicago Medicine | Chicago | Illinois | United States |
| Boston University Medical Center | Boston | Massachusetts | United States |
| Tufts Medical Center | Boston | Massachusetts | United States |
| University of Michigan Health System | Ann Arbor | Michigan | United States |
| University of Minnesota | Minneapolis | Minnesota | United States |
| Mayo Clinic | Rochester | Minnesota | United States |
| Washington University School of Medicine | St Louis | Missouri | United States |
| Mary M. Parkes Center // University of Rochester Medical Center | Rochester | New York | United States |
| Cleveland Clinic | Cleveland | Ohio | United States |
| Martha Morehouse Medical Pavilion | Columbus | Ohio | United States |
| Allegheny General Hospital | Pittsburgh | Pennsylvania | United States |
| UPMC Presbyterian Hospital | Pittsburgh | Pennsylvania | United States |
| UT Southwestern Medical Center | Dallas | Texas | United States |
| Inova Fairfax Medical Campus | Falls Church | Virginia | United States |
| Peter Lougheed Center | Calgary | Alberta | Canada |
| Vancouver General Hospital, The Lung Centre // Vancouver Coastal Health, Vancouver General Hospital | Vancouver | British Columbia | Canada |
| Victoria Hospital - London Health Sciences Centre | London | Ontario | Canada |
| University Health Network | Toronto | Ontario | Canada |
| Institut Universitaire de caridologie et de pneumologie de Quebee (IUCPQ) | Sainte-Foy | Quebec | Canada |
| CHU de Grenoble Clinique Universitaire de Pneumologie | Grenoble | France |
| CHU de Bicetre, Service de Pneumologie-Reanimation Respiratoire | Le Kremlin-Bicêtre | France |
| Hopital Cardiologique-CHRU Lille, Service de cardiologie | Lille | France |
| Universitatsklinikul Giessen und Marburg GmbH | Giessen | Hesse | Germany |
| Klinik III fur Innere Medizin, Herzzentrum Uniklinik Koln | Cologne | Germany |
| Universitätsklinikum Carl Gustav Carus | Dresden | Germany |
| Medizinische Hochschule Hannover | Hanover | Germany |
| Universitatsklinikum Leipzig | Leipzig | Germany |
| Klinik und Poliklinik fur Innere Medizin II, Universitatsklinikum Regensburg | Regensburg | Germany |
| Universita "Sapienza"-Azienda Policlinico Umberto 1 | Rome | Italy |
| VU University Medical Center | Amsterdam | Netherlands |
| Hospital Clinic de Barcelona | Barcelona | Spain |
| Hospital Universitari Vall d'Hebron | Barcelona | Spain |
| Hospital Universitario Doce (12) de Octubre | Madrid | Spain |
| Scottish Pulmonary Vascular Unit, Golden Jubilee National Hospital | Clydebank | West Dunbartonshire | United Kingdom |
| Royal Free Hampstead NHS Trust | London | United Kingdom |
| Clinical Research Facility, Royal Hallamshrie Hospital | Sheffield | United Kingdom |
Participants were randomized to receive selonsertib 6 mg tablet once daily for 24 weeks during the treatment phase (Period 1) and may have continued on this dosing during the long-term treatment phase (Period 2). |
| FG002 | Selonsertib 18 mg | Participants were randomized to receive selonsertib 18 mg tablet once daily for 24 weeks during the treatment phase (Period 1) and may have continued on this dosing during the long-term treatment phase (Period 2). |
| FG003 | Placebo | Participants were randomized received placebo tablet once daily for 24 weeks (Period 1) and may have been rerandomized 1:1:1 to selonsertib 2, 6, or 18 mg during the long-term treatment phase (Period 2). |
| FG004 | Placebo to Selonsertib 2 mg | Participants received placebo in Period 1 and were rerandomized to receive selonsertib 2 mg tablet once daily during the long-term treatment phase (Period 2). |
| FG005 | Placebo to Selonsertib 6 mg | Participants received placebo in Period 1 and were rerandomized to receive selonsertib 6 mg tablet once daily during the long-term treatment phase (Period 2). |
| FG006 | Placebo to Selonsertib 18 mg | Participants received placebo in Period 1 and were rerandomized to receive selonsertib 18 mg tablet once daily during the long-term treatment phase (Period 2). |
| COMPLETED |
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| NOT COMPLETED |
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| Long-Term Treatment Period |
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Safety Analysis Set included all randomized participants who received greater than or equal to (≥) 1 dose of study drug.
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| ID | Title | Description |
|---|---|---|
| BG000 | Selonsertib 2 mg | Participants received selonsertib 2 mg tablet once daily for 24 weeks during the treatment phase (Period 1). |
| BG001 | Selonsertib 6 mg | Participants received selonsertib 6 mg tablet once daily for 24 weeks during the treatment phase (Period 1). |
| BG002 | Selonsertib 18 mg | Participants received selonsertib 18 mg tablet once daily for 24 weeks during the treatment phase (Period 1). |
| BG003 | Placebo | Participants received placebo tablet once daily for 24 weeks (Period 1). |
| BG004 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| World Health Organization (WHO) Functional Class | Class I: no symptoms with exercise or at rest. Class II: No symptoms at rest but uncomfortable and short of breath with normal activity such as climbing a flight of stairs, grocery shopping, or making the bed. Class III: May not have symptoms at rest but activities greatly limited by shortness of breath, fatigue, or near fainting (e.g., doing normal chores around the house, have to take breaks while doing activities of daily living). Class IV: Symptoms at rest and severe symptoms with any activity. Most participants also have edema in the feet and ankles as result of right heart failure. | Count of Participants | Participants |
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| 6-Minute Walk Distance (6MWD) Test | The 6MWD test was conducted according to the American Thoracic Society guidelines in accordance with local standard operating procedures. It measures the distance a participant is able to walk in a period of six minutes. | Mean | Standard Deviation | meters |
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| N-terminal Pro-brain Natriuretic Peptide (NT-proBNP) | NT-proBNP is used to detect, diagnose, and evaluate the severity of heart failure. In general, NT-proBNP levels are higher in participants with heart failure than those who have normal heart function. | Geometric Mean | Inter-Quartile Range | picograms per milliliter (pg/mL) |
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| Borg Dyspnea Index (BDI) | Immediately following completion of the 6-minute walk test, participants were asked to assess breathlessness using the BDI score as follows: 0 = no breathlessness, 10 = extremely strong (maximal breathlessness), Any number greater than (>) 10 = Highest possible. Therefore, the minimum for BDI score was 0 and there was no upper bound. | Mean | Standard Deviation | units on a scale |
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| Right Ventricular Fractional Area Change (RVFAC) | RVFAC is an echocardiographic assessment of right ventricular function. | Participants in the Safety Analysis Set with available data were analyzed. | Mean | Standard Deviation | percentage of RV area |
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| Tricuspid Annular Plane Systolic Excursion (TAPSE) | TAPSE is an echocardiographic assessment of right ventricular function. | Participants in the Safety Analysis Set with available data were analyzed. | Mean | Standard Deviation | cm |
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| Mean Right Atrial Pressure (mRAP) | mRAP is the mean blood pressure in the right atrium of the heart. | Mean | Standard Deviation | millimeters of mercury (mm Hg) |
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| Mean Pulmonary Artery Pressure (mPAP) | mPAP is the mean blood pressure in the pulmonary artery. | Mean | Standard Deviation | mm Hg |
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| Pulmonary Vascular Resistance (PVR) | PVR is a measure of the extent to which pulmonary circulation resists cardiac output. | Participants in the Safety Analysis Set with available data were analyzed. | Mean | Standard Deviation | dynes*second/centimeter^5 (dyn*sec/cm^5) |
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| Cardiac Index | Cardiac index is the amount of blood pumped by the heart, per minute, per meter square of body surface area. | Mean | Standard Deviation | liters/minute/square meter (L/min/m^2) |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change From Baseline in Pulmonary Vascular Resistance (PVR) at Week 24, as Measured by Right Heart Catheterization (RHC) | PVR is a measure of the extent to which pulmonary circulation resists cardiac output. Change from Baseline was calculated as the value at Week 24 minus the value at Baseline. The Week 24 value was defined as the last assessment at or prior to Week 24. | Participants in the Full Analysis Set (all randomized participants who received ≥ 1 dose of study drug) with available data were analyzed. | Posted | Mean | Standard Error | dyne*sec/cm^5 | Baseline to Week 24 |
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| Secondary | Change From Baseline at Week 24 in Other Cardiopulmonary Hemodynamic Measures: Cardiac Index | Cardiac index is the amount of blood pumped by the heart, per minute, per meter square of body surface area. Change from Baseline was calculated as the value at Week 24 minus the value at Baseline. The Week 24 value was defined as the last assessment at or prior to Week 24. | Participants in the Full Analysis Set with available data were analyzed. | Posted | Mean | Standard Error | L/min/m^2 | Baseline to Week 24 |
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| Secondary | Change From Baseline at Week 24 in Other Cardiopulmonary Hemodynamic Measures: mPAP | mPAP is the mean blood pressure in the pulmonary artery. Change from Baseline was calculated as the value at Week 24 minus the value at Baseline. The Week 24 value was defined as the last assessment at or prior to Week 24. | Participants in the Full Analysis Set with available data were analyzed. | Posted | Mean | Standard Error | mm Hg | Baseline to Week 24 |
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| Secondary | Change From Baseline at Week 24 in Other Cardiopulmonary Hemodynamic Measures: mRAP | mRAP is the mean blood pressure in the right atrium of the heart. Change from Baseline was calculated as the value at Week 24 minus the value at Baseline. The Week 24 value was defined as the last assessment at or prior to Week 24. | Participants in the Full Analysis Set with available data were analyzed. | Posted | Mean | Standard Error | mm Hg | Baseline to Week 24 |
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| Secondary | Change From Baseline at Week 24 in Other Cardiopulmonary Hemodynamic Measures: Mixed Venous Oxygen Saturation (SVO2) (%) | SVO2 is the percentage of oxygen bound to hemoglobin in blood returning to the right side of the heart. Change from Baseline was calculated as the value at Week 24 minus the value at Baseline. The Week 24 value was defined as the last assessment at or prior to Week 24. | Participants in the Full Analysis Set with available data were analyzed. | Posted | Mean | Standard Error | percentage of oxygen saturation | Baseline to Week 24 |
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| Secondary | Change From Baseline at Week 24 in Other Cardiopulmonary Hemodynamic Measures: Right Ventricular Cardiac Power (RVCP) | RVCP is a cardiopulmonary hemodynamic assessment. Change from Baseline was calculated as the value at Week 24 minus the value at Baseline. The Week 24 value was defined as the last assessment at or prior to Week 24. | Participants in the Full Analysis Set with available data were analyzed. | Posted | Mean | Standard Error | watts | Baseline to Week 24 |
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| Secondary | Change From Baseline at Week 24 in 6MWD Test | The 6MWD test was conducted according to the American Thoracic Society guidelines in accordance with local standard operating procedures. It measures the distance a participant is able to walk in a period of six minutes. Change from Baseline was calculated as the value at Week 24 minus the value at Baseline. The Week 24 value was defined as the last assessment at or prior to Week 24. | Participants in the Full Analysis Set were analyzed. | Posted | Mean | Standard Error | meters | Baseline to Week 24 |
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| Secondary | Change From Baseline at Week 24 in BDI After the 6MWD Test | Immediately following completion of the 6-minute walk test, participants were asked to assess breathlessness using the BDI score as follows: 0 = no breathlessness, 10 = extremely strong (maximal breathlessness), any number > 10 = Highest possible. Therefore, the minimum for BDI score was 0 and there was no upper bound. Change from Baseline was calculated as the value at Week 24 minus the value at Baseline. The Week 24 value was defined as the last assessment at or prior to Week 24. | Participants in the Full Analysis Set were analyzed. | Posted | Mean | Standard Error | units on a scale | Baseline to Week 24 |
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| Secondary | Number of Participants Experiencing Change From Baseline at Week 24 in WHO Functional Class | Class I: no symptoms with exercise or at rest. Class II: No symptoms at rest but uncomfortable and short of breath with normal activity such as climbing a flight of stairs, grocery shopping, or making the bed. Class III: May not have symptoms at rest but activities greatly limited by shortness of breath, fatigue, or near fainting (e.g., doing normal chores around the house, have to take breaks while doing activities of daily living). Class IV: Symptoms at rest and severe symptoms with any activity. Most participants also have edema in the feet and ankles as result of right heart failure. The Week 24 value was defined as the last assessment at or prior to Week 24. | Participants in the Full Analysis Set with available data were analyzed. | Posted | Count of Participants | Participants | Baseline to Week 24 |
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| Secondary | Change From Baseline at Week 24 in NT-proBNP | NT-proBNP is used to detect, diagnose, and evaluate the severity of heart failure. In general, NT-proBNP levels are higher in participants with heart failure than those who have normal heart function. Change from Baseline was calculated as the value at Week 24 minus the value at Baseline. The Week 24 value was defined as the last assessment at or prior to Week 24. | Participants in the Full Analysis Set were analyzed. | Posted | Geometric Mean | Standard Error | pg/mL | Baseline to Week 24 |
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| Secondary | Change From Baseline at Week 24 in Short Form (SF-36) Physical Functioning Scale | Quality of life was assessed using the SF-36 questionnaire, a self-administered multi-item survey that asks 36 questions to measure functional health and well-being from the participant's point of view and consists of eight health domains (Physical Functioning, Role-Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role-Emotional, and Mental Health) as well as 2 summary measures (Physical Health and Mental Health). Data presented are for 1 of the domains only: Physical Functioning. Scores can range from 0 to 100, with a higher score representing a higher level of functioning. Change from Baseline was calculated as the value at Week 24 minus the value at Baseline. The Week 24 value was defined as the last assessment at or prior to Week 24. | Participants in the Full Analysis Set with available data were analyzed. | Posted | Mean | Standard Error | units on a scale | Baseline to Week 24 |
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| Secondary | Change From Baseline at Week 24 in emPHasis-10 Questionnaire Score | Quality of life was assessed using the emPHasis-10 questionnaire, a disease-specific self-administered 10-question questionnaire designed for routine assessment of health-related quality of life in pulmonary hypertension. Total score can range from 0 to 50, with higher scores indicating a worse quality of life. Change from Baseline was calculated as the value at Week 24 minus the value at Baseline. The Week 24 value was defined as the last assessment at or prior to Week 24. | Participants in the Full Analysis Set with available data were analyzed. | Posted | Mean | Standard Error | units on a scale | Baseline to Week 24 |
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| Secondary | Change From Baseline at Week 24 in Heart Rate Recovery (HRR) After the 6MWD Test | HRR was assessed after the 6MWD test. The HRR was calculated as the difference between the heart rate measured immediately after completing the 6MWD test and the second heart rate measured 1 minute after the 6MWD test. Change from Baseline was calculated as the value at Week 24 minus the value at Baseline. The Week 24 value was defined as the last assessment at or prior to Week 24. | Participants in the Full Analysis Set were analyzed. | Posted | Mean | Standard Error | beats per minute (bpm) | Baseline to Week 24 |
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| Secondary | Kaplan-Meier Estimate of Time to Clinical Worsening (TTCW) Evaluated in Period 1 | TTCW was defined as time to the first occurrence of: death (all-cause), hospitalization for worsening pulmonary arterial hypertension (PAH) (any hospitalization for worsening PAH, lung or heart/lung transplant, atrial septostomy, or initiation of continuously infused prostanoid therapy), or disease progression (defined as both > 15% decrease from baseline in 6MWD test and WHO class III or IV symptoms at two consecutive postbaseline clinic visits separated by ≥ 14 days). TTCW was evaluated using Kaplan-Meier estimates. | Participants in the Full Analysis Set were analyzed. | Posted | Median | Inter-Quartile Range | days | Baseline up to Week 24 |
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| Secondary | Change From Baseline in Echocardiographic Measures of Right Ventricular Function at Week 24: TAPSE | TAPSE is an echocardiographic assessment of right ventricular function. Change from Baseline was calculated as the value at Week 24 minus the value at Baseline. The Week 24 value was defined as the last assessment at or prior to Week 24. | Participants in the Full Analysis Set with available data were analyzed. | Posted | Mean | Standard Error | cm | Baseline to Week 24 |
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| Secondary | Change From Baseline in Echocardiographic Measures of Right Ventricular Function at Week 24: Right Ventricular Myocardial Strain (%) | Right ventricular myocardial strain is an echocardiographic assessment of right ventricular function. Change from Baseline was calculated as the value at Week 24 minus the value at Baseline. The Week 24 value was defined as the last assessment at or prior to Week 24. | Participants in the Full Analysis Set with available data were analyzed. | Posted | Mean | Standard Error | percentage of strain | Baseline to Week 24 |
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| Secondary | Change From Baseline in Echocardiographic Measures of Right Ventricular Function at Week 24: Tricuspid Annular Peak Sys Myocard Velocity (TAS) | TAS is an echocardiographic assessment of right ventricular function. Change from Baseline was calculated as the value at Week 24 minus the value at Baseline. The Week 24 value was defined as the last assessment at or prior to Week 24. | Participants in the Full Analysis Set with available data were analyzed. | Posted | Mean | Standard Error | centimeters per second (cm/sec) | Baseline to Week 24 |
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| Secondary | Change From Baseline in Echocardiographic Measures of Right Ventricular Function at Week 24: Right Ventricular Tei Index (RVTI) | The Tei-index is defined as the sum of the isovolumic contraction and the isovolumic relaxation time divided by ejection time, and thus incorporates elements of both systolic and diastolic phases in the assessment of global ventricular function. An increased Tei-index results from ventricular dysfunction and provides prognostic information for a variety of myocardial conditions. The RVTI is a candidate to increase the non-invasive diagnosis of PAH because it reflects the right ventricular function, is easy to assess, and can be estimated in the same session as the echocardiographic PAP. The normal value of the RVTI is 0.28 +/- 0.04. An increased RVTI is associated with either left ventricular diastolic abnormalities or pulmonary hypertension. This score has no bounds. Change from Baseline was calculated as the value at Week 24 minus the value at Baseline. The Week 24 value was defined as the last assessment at or prior to Week 24. | Participants in the Full Analysis Set with available data were analyzed. | Posted | Mean | Standard Error | units on a scale | Baseline to Week 24 |
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| Secondary | Change From Baseline in Echocardiographic Measures of Right Ventricular Function at Week 24: Right Ventricular Fractional Area Change (RVFAC) | RVFAC is an echocardiographic assessment of right ventricular function. Change from Baseline was calculated as the value at Week 24 minus the value at Baseline. The Week 24 value was defined as the last assessment at or prior to Week 24. | Participants in the Full Analysis Set with available data were analyzed. | Posted | Mean | Standard Error | percentage of RV area | Baseline to Week 24 |
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Up to 97 weeks plus 30 days
Safety Analysis Set included all randomized participants who received ≥1 dose of study drug. 10, 12, and 10 participants (from Placebo Period 1 arm who were rerandomized to receive study drug) were included in selonsertib 2 mg, selonsertib 6 mg, and selonsertib 18 mg arms, respectively, for the purpose of Adverse Event (AE) data reporting.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Selonsertib 2 mg | Participants received selonsertib 2 mg for 24 weeks during the treatment phase (Period 1) and during the long-term treatment phase (Period 2). AEs in this reporting group include AEs that occurred in 10 participants who were rerandomized from the Placebo Period 1 group to receive selonsertib 2 mg during the long-term treatment phase. | 14 | 49 | 43 | 49 | ||
| EG001 | Selonsertib 6 mg | Participants received selonsertib 6 mg for 24 weeks during the treatment phase (Period 1) and during the long-term treatment phase (Period 2). AEs in this reporting group include AEs that occurred in 12 participants who were rerandomized from the Placebo Period 1 group to receive selonsertib 6 mg during the long-term treatment phase. | 17 | 49 | 44 | 49 | ||
| EG002 | Selonsertib 18 mg | Participants received selonsertib 18 mg for 24 weeks during the treatment phase (Period 1) and during the long-term treatment phase (Period 2). AEs in this reporting group include AEs that occurred in 10 participants who were rerandomized from the Placebo Period 1 group to receive selonsertib 18 mg during the long-term treatment phase. | 16 | 47 | 44 | 47 | ||
| EG003 | Placebo | Participants received placebo tablet once daily for 24 weeks (Period 1). AEs reported in this group only include AEs that occurred during Period 1. | 7 | 37 | 34 | 37 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Haemorrhagic anaemia | Blood and lymphatic system disorders | MedDRA 19.0 | Systematic Assessment |
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| Angina unstable | Cardiac disorders | MedDRA 19.0 | Systematic Assessment |
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| Arrhythmia | Cardiac disorders | MedDRA 19.0 | Systematic Assessment |
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| Atrial fibrillation | Cardiac disorders | MedDRA 19.0 | Systematic Assessment |
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| Cardiac failure acute | Cardiac disorders | MedDRA 19.0 | Systematic Assessment |
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| Palpitations | Cardiac disorders | MedDRA 19.0 | Systematic Assessment |
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| Right ventricular failure | Cardiac disorders | MedDRA 19.0 | Systematic Assessment |
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| Tachycardia | Cardiac disorders | MedDRA 19.0 | Systematic Assessment |
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| Ventricular extrasystoles | Cardiac disorders | MedDRA 19.0 | Systematic Assessment |
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| Ventricular tachycardia | Cardiac disorders | MedDRA 19.0 | Systematic Assessment |
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| Abdominal pain lower | Gastrointestinal disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Large intestinal obstruction | Gastrointestinal disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Oesophageal achalasia | Gastrointestinal disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Oesophagitis | Gastrointestinal disorders | MedDRA 19.0 | Systematic Assessment |
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| Pancreatitis acute | Gastrointestinal disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Upper gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Catheter site extravasation | General disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Chest pain | General disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Generalised oedema | General disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Infusion site inflammation | General disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 19.0 | Systematic Assessment |
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| Cholangitis | Hepatobiliary disorders | MedDRA 19.0 | Systematic Assessment |
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| Cholelithiasis | Hepatobiliary disorders | MedDRA 19.0 | Systematic Assessment |
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| Hepatomegaly | Hepatobiliary disorders | MedDRA 19.0 | Systematic Assessment |
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| Bacteraemia | Infections and infestations | MedDRA 19.0 | Systematic Assessment |
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| Cellulitis | Infections and infestations | MedDRA 19.0 | Systematic Assessment |
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| Device related infection | Infections and infestations | MedDRA 19.0 | Systematic Assessment |
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| Diverticulitis | Infections and infestations | MedDRA 19.0 | Systematic Assessment |
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| Gastroenteritis | Infections and infestations | MedDRA 19.0 | Systematic Assessment |
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| Infection | Infections and infestations | MedDRA 19.0 | Systematic Assessment |
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| Pneumonia | Infections and infestations | MedDRA 19.0 | Systematic Assessment |
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| Pyelonephritis | Infections and infestations | MedDRA 19.0 | Systematic Assessment |
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| Urinary tract infection | Infections and infestations | MedDRA 19.0 | Systematic Assessment |
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| Varicella | Infections and infestations | MedDRA 19.0 | Systematic Assessment |
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| Transplant dysfunction | Injury, poisoning and procedural complications | MedDRA 19.0 | Systematic Assessment |
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| Upper limb fracture | Injury, poisoning and procedural complications | MedDRA 19.0 | Systematic Assessment |
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| Hepatic enzyme increased | Investigations | MedDRA 19.0 | Systematic Assessment |
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| Transaminases increased | Investigations | MedDRA 19.0 | Systematic Assessment |
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| Fluid overload | Metabolism and nutrition disorders | MedDRA 19.0 | Systematic Assessment |
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| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 19.0 | Systematic Assessment |
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| Malnutrition | Metabolism and nutrition disorders | MedDRA 19.0 | Systematic Assessment |
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| Invasive ductal breast carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 19.0 | Systematic Assessment |
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| Dysarthria | Nervous system disorders | MedDRA 19.0 | Systematic Assessment |
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| Metabolic encephalopathy | Nervous system disorders | MedDRA 19.0 | Systematic Assessment |
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| Paraesthesia | Nervous system disorders | MedDRA 19.0 | Systematic Assessment |
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| Presyncope | Nervous system disorders | MedDRA 19.0 | Systematic Assessment |
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| Syncope | Nervous system disorders | MedDRA 19.0 | Systematic Assessment |
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| Device breakage | Product Issues | MedDRA 19.0 | Systematic Assessment |
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| Device dislocation | Product Issues | MedDRA 19.0 | Systematic Assessment |
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| Mental status changes | Psychiatric disorders | MedDRA 19.0 | Systematic Assessment |
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| Acute kidney injury | Renal and urinary disorders | MedDRA 19.0 | Systematic Assessment |
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| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 19.0 | Systematic Assessment |
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| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 19.0 | Systematic Assessment |
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| Dyspnoea exertional | Respiratory, thoracic and mediastinal disorders | MedDRA 19.0 | Systematic Assessment |
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| Haemoptysis | Respiratory, thoracic and mediastinal disorders | MedDRA 19.0 | Systematic Assessment |
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| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA 19.0 | Systematic Assessment |
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| Pulmonary arterial hypertension | Respiratory, thoracic and mediastinal disorders | MedDRA 19.0 | Systematic Assessment |
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| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 19.0 | Systematic Assessment |
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| Aortic arteriosclerosis | Vascular disorders | MedDRA 19.0 | Systematic Assessment |
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| Hypotension | Vascular disorders | MedDRA 19.0 | Systematic Assessment |
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| Peripheral ischaemia | Vascular disorders | MedDRA 19.0 | Systematic Assessment |
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| Shock haemorrhagic | Vascular disorders | MedDRA 19.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 19.0 | Systematic Assessment |
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| Iron deficiency anaemia | Blood and lymphatic system disorders | MedDRA 19.0 | Systematic Assessment |
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| Leukocytosis | Blood and lymphatic system disorders | MedDRA 19.0 | Systematic Assessment |
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| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 19.0 | Systematic Assessment |
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| Angina pectoris | Cardiac disorders | MedDRA 19.0 | Systematic Assessment |
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| Palpitations | Cardiac disorders | MedDRA 19.0 | Systematic Assessment |
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| Vertigo | Ear and labyrinth disorders | MedDRA 19.0 | Systematic Assessment |
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| Dry eye | Eye disorders | MedDRA 19.0 | Systematic Assessment |
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| Abdominal pain | Gastrointestinal disorders | MedDRA 19.0 | Systematic Assessment |
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| Abdominal pain upper | Gastrointestinal disorders | MedDRA 19.0 | Systematic Assessment |
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| Constipation | Gastrointestinal disorders | MedDRA 19.0 | Systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA 19.0 | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA 19.0 | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA 19.0 | Systematic Assessment |
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| Chest pain | General disorders | MedDRA 19.0 | Systematic Assessment |
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| Fatigue | General disorders | MedDRA 19.0 | Systematic Assessment |
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| Oedema peripheral | General disorders | MedDRA 19.0 | Systematic Assessment |
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| Pyrexia | General disorders | MedDRA 19.0 | Systematic Assessment |
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| Bronchitis | Infections and infestations | MedDRA 19.0 | Systematic Assessment |
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| Cellulitis | Infections and infestations | MedDRA 19.0 | Systematic Assessment |
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| Gastroenteritis | Infections and infestations | MedDRA 19.0 | Systematic Assessment |
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| Gastrointestinal viral infection | Infections and infestations | MedDRA 19.0 | Systematic Assessment |
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| Influenza | Infections and infestations | MedDRA 19.0 | Systematic Assessment |
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| Nasopharyngitis | Infections and infestations | MedDRA 19.0 | Systematic Assessment |
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| Pneumonia | Infections and infestations | MedDRA 19.0 | Systematic Assessment |
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| Respiratory tract infection | Infections and infestations | MedDRA 19.0 | Systematic Assessment |
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| Sepsis | Infections and infestations | MedDRA 19.0 | Systematic Assessment |
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| Sinusitis | Infections and infestations | MedDRA 19.0 | Systematic Assessment |
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| Upper respiratory tract infection | Infections and infestations | MedDRA 19.0 | Systematic Assessment |
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| International normalised ratio increased | Investigations | MedDRA 19.0 | Systematic Assessment |
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| Weight decreased | Investigations | MedDRA 19.0 | Systematic Assessment |
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| Weight increased | Investigations | MedDRA 19.0 | Systematic Assessment |
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| White blood cell count decreased | Investigations | MedDRA 19.0 | Systematic Assessment |
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| Decreased appetite | Metabolism and nutrition disorders | MedDRA 19.0 | Systematic Assessment |
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| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 19.0 | Systematic Assessment |
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| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 19.0 | Systematic Assessment |
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| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 19.0 | Systematic Assessment |
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| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA 19.0 | Systematic Assessment |
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| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA 19.0 | Systematic Assessment |
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| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 19.0 | Systematic Assessment |
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| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 19.0 | Systematic Assessment |
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| Pain in jaw | Musculoskeletal and connective tissue disorders | MedDRA 19.0 | Systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA 19.0 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 19.0 | Systematic Assessment |
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| Presyncope | Nervous system disorders | MedDRA 19.0 | Systematic Assessment |
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| Syncope | Nervous system disorders | MedDRA 19.0 | Systematic Assessment |
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| Abnormal dreams | Psychiatric disorders | MedDRA 19.0 | Systematic Assessment |
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| Anxiety | Psychiatric disorders | MedDRA 19.0 | Systematic Assessment |
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| Insomnia | Psychiatric disorders | MedDRA 19.0 | Systematic Assessment |
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| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 19.0 | Systematic Assessment |
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| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 19.0 | Systematic Assessment |
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| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 19.0 | Systematic Assessment |
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| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 19.0 | Systematic Assessment |
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| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 19.0 | Systematic Assessment |
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| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 19.0 | Systematic Assessment |
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| Flushing | Vascular disorders | MedDRA 19.0 | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA 19.0 | Systematic Assessment |
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After conclusion of the study and without prior written approval from Gilead, investigators in this study may communicate, orally present, or publish in scientific journals or other media only after the following conditions have been met:
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Gilead Clinical Study Information Center | Gilead Sciences | 1-833-445-3230 (GILEAD-0) | GileadClinicalTrials@gilead.com |
| ID | Term |
|---|---|
| D000081029 | Pulmonary Arterial Hypertension |
| ID | Term |
|---|---|
| D006976 | Hypertension, Pulmonary |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C000654501 | selonsertib |
Not provided
Not provided
Not provided
| Investigator's discretion |
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| Adverse Event |
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| Withdrew Consent |
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| Study Discontinued by Sponsor |
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Nonparametric pairwise comparison
| The protocol-specified primary analysis was to compare each selonsertib dose group with the placebo group, using Wilcoxon (van Elteren) test, with respect to change from baseline in PVR at Week 24, stratifying by randomization stratum (the underlying etiology of PAH idiopathic/heritable [yes/no] and the number of background PAH therapies they were receiving [1, 2, or ≥ 3]). | gvE/vE | = 0.270 | P-value was calculated using the generalized van Elteren test/van Elteren test (gvE/vE; stratified Wilcoxon rank sum test). | Other | Nonparametric pairwise comparison |
| The protocol-specified primary analysis was to compare each selonsertib dose group with the placebo group, using Wilcoxon (van Elteren) test, with respect to change from baseline in PVR at Week 24, stratifying by randomization stratum (the underlying etiology of PAH idiopathic/heritable [yes/no] and the number of background PAH therapies they were receiving [1, 2, or ≥ 3]). | gvE/vE | = 0.604 | P-value was calculated using the generalized van Elteren test/van Elteren test (gvE/vE; stratified Wilcoxon rank sum test) | Other | Nonparametric pairwise comparison |
Participants received placebo tablet once daily for 24 weeks (Period 1).
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Participants received placebo tablet once daily for 24 weeks (Period 1).
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Participants received placebo tablet once daily for 24 weeks (Period 1).
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| Placebo |
Participants received placebo tablet once daily for 24 weeks (Period 1). |
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Participants received selonsertib 18 mg tablet once daily for 24 weeks during the treatment phase (Period 1).
| OG003 | Placebo | Participants received placebo tablet once daily for 24 weeks (Period 1). |
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Participants received placebo tablet once daily for 24 weeks (Period 1).
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Participants received selonsertib 18 mg tablet once daily for 24 weeks during the treatment phase (Period 1). |
| OG003 | Placebo | Participants received placebo tablet once daily for 24 weeks (Period 1). |
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| OG003 |
| Placebo |
Participants received placebo tablet once daily for 24 weeks (Period 1). |
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Participants received placebo tablet once daily for 24 weeks (Period 1). |
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| OG003 | Placebo | Participants received placebo tablet once daily for 24 weeks (Period 1). |
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Participants received placebo tablet once daily for 24 weeks (Period 1).
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Participants received placebo tablet once daily for 24 weeks (Period 1).
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| OG002 | Selonsertib 18 mg | Participants received selonsertib 18 mg tablet once daily for 24 weeks during the treatment phase (Period 1). |
| OG003 | Placebo | Participants received placebo tablet once daily for 24 weeks (Period 1). |
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Participants received placebo tablet once daily for 24 weeks (Period 1).
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