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The purpose of this 8-week study is to compare the effects of switching from therapy with epoprostenol or Flolan to IV Remodulin. This study will also assess the effect that changing to Remodulin will have on patient satisfaction with their treatment and impact on quality of life.
Pulmonary arterial hypertension (PAH), which is defined as an elevation in pulmonary arterial pressure and pulmonary vascular resistance, is a severe hemodynamic abnormality common to a variety of diseases and syndromes. Elevation in pulmonary arterial pressure causes an increase in right ventricular afterload, impairing right ventricular function and ultimately leading to inactivity and death. The goal of PAH treatment is to lengthen survival time, to ameliorate symptoms of PAH and to improve health related quality of life (HRQOL).
Remodulin® (treprostinil sodium), a stable analogue of prostacyclin, possesses potent pulmonary and systemic vasodilatory and platelet anti-aggregatory actions in vitro and in vivo. Recently, Remodulin received FDA approval for intravenous therapy based upon bioequivalence of the IV and SC routes of administration. Remodulin is more chemically stable than epoprostenol and may offer potential safety and convenience advantages compared to intravenous epoprostenol that may impact Health Related Quality of Life (HRQOL) and/or patient satisfaction. Unlike epoprostenol, Remodulin does not need to be mixed daily and is stable at room temperature eliminating the need for ice packs. Furthermore, since Remodulin remains in the body longer than epoprostenol (4 hrs instead of less than 5 minutes) there is less risk of cardiovascular collapse from a sudden interruption of infusion, such as a line clog. In an open-label study in Europe, patients who were using a type of portable medication pump called the CADD Legacy pump were rapidly switched from Flolan to Remodulin with no serious side effects. This study will examine effects of switching from therapy with epoprostenol or Flolan to IV Remodulin and compare changes in HRQOL and treatment satisfaction before and after rapid switch from epoprostenol to Remodulin in patients with pulmonary hypertension using the CADD legacy pump.
Participation in this study will last approximately 10 weeks. Study procedures include routine blood tests, medical history, physical exams, disease evaluation, exercise tests and patient questionnaires. Participants will have 4 visits during the study and will spend at least 1 night in the hospital.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| treprostinil sodium | Drug | rapid switch from intravenous epoprostinol to intravenous remodulin on the CADD ambulatory pump |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in the Distance Transversed During the 6 Minute Walk Test From Baseline to Week 8. | Baseline and Week 8 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Borg Dyspnea Score Immediately After Six Minute Walk Test From Baseline to Week 8 | The Borg dyspnea score is a 10-point scale rating the maximum level of dyspnea experienced during the 6-minute walk test. The Borg dyspnea score was assessed immediately following the 6-minute walk test. Scores ranged from 0 (for no shortness of breath) to 10 (for greatest shortness of breath ever experienced). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Omar Minai, MD | The Cleveland Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cleveland Clinic Foundation | Cleveland | Ohio | 44195 | United States |
All subjects were required to be receiving continuous intravenous epoprostenol therapy for at least three months and at a stable dose for at least thirty days prior to enrollment in this study.
Subject participated in this study between July 2007 and January 2008.
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| ID | Title | Description |
|---|---|---|
| FG000 | Treprostinil Sodium | All subjects received active treatment with treprostinil sodium. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Treprostinil Sodium | All subjects received active treatment with treprostinil sodium. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 in the Distance Transversed During the 6 Minute Walk Test From Baseline to Week 8. | As this was a small open label study, the statistics applied to the results were descriptive. For all efficacy endpoints, data obtained from study assessments during the treatment phase were compared to Baseline. assessments | Posted | Mean | Standard Deviation | meters | Baseline and Week 8 |
|
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Treprostinil Sodium | All subjects received active treatment with treprostinil sodium. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Gastroenteritis | Gastrointestinal disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pain in extremity | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Rex Mauthe; Senior Director, Regulatory Affairs | United Therapeutics Corporation | 919-485-8350 | rmauthe@unither.com |
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| ID | Term |
|---|---|
| D006976 | Hypertension, Pulmonary |
| ID | Term |
|---|---|
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D006973 | Hypertension |
| D014652 | Vascular Diseases |
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| ID | Term |
|---|---|
| C427248 | treprostinil |
| D011464 | Epoprostenol |
| ID | Term |
|---|---|
| D044062 | Prostaglandins I |
| D011453 | Prostaglandins |
| D015777 | Eicosanoids |
| D005231 | Fatty Acids, Unsaturated |
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| Baseline and Week 8 |
| Change in World Health Organization (WHO) Functional Classification of PAH From Baseline to Week 8 | Class I: Patients with pulmonary hypertension but without resulting limitation of physical activity. Ordinary physical activity does not cause undue dyspnea or fatigue, chest pain, or near syncope. Class II: Patients with pulmonary hypertension resulting in slight limitation of physical activity. These patients are comfortable at rest, but ordinary physical activity causes undue dyspnea or fatigue, chest pain or near syncope. Class III: Patients with pulmonary hypertension resulting in marked limitation of physical activity. They are comfortable at rest. Ordinary activity causes undue dyspnea or fatigue, chest pain, or near syncope. Class IV: Patients with pulmonary hypertension with inability to carry out any physical activity without symptoms. These patients manifest signs of right heart failure. Dyspnea and/or fatigue may be present even at rest. Discomfort is increased by any physical activity. | Baseline and Week 8 |
| Change in Symptoms of Dyspnea From Baseline to Week 8 | The presence or absence of dyspnea was documented. If present, the intensity of dyspnea was rated mild, moderate, or severe. | Baseline and Week 8 |
| Change in Symptoms of Edema From Baseline to Week 8 | The presence or absence of edema was documented. If present, the intensity of edema was rated mild, moderate, or severe. | Baseline to Week 8 |
| Change in Symptoms of Orthopnea From Baseline to Week 8 | The presence or absence of orthopnea was documented. If present, the intensity of orthopnea was rated mild, moderate, or severe. | Baseline and Week 8 |
| Change in Symptoms of Dizziness From Baseline to Week 8 | The presence or absence of dizziness was documented. If present, the intensity of dizziness was rated mild, moderate, or severe. | Baseline and Week 8 |
| Change in Symptoms of Fatigue From Baseline to Week 8 | The presence or absence of fatigue was documented. If present, the intensity of fatigue was rated mild, moderate, or severe. | Baseline and Week 8 |
| Change in Symptoms of Syncope From Baseline to Week 8 | The presence or absence of syncope was documented. If present, the intensity of syncope was rated mild, moderate, or severe. | Baseline and Week 8 |
| Change in Symptoms of Chest Pain From Baseline to Week 8 | The presence or absence of chest pain was documented. If present, the intensity of chest pain was rated mild, moderate, or severe. | Baseline and Week 8 |
| Change in Effectiveness Score on Treatment Satisfaction Scale From Baseline to Week 8 | The Treatment Satisfaction Questionnaire for Medication (TSQM) is a validated instrument that measures four major dimensions of patient satisfaction with medications: effectiveness, side effects, convenience, and global satisfaction. TSQM Scale scores are computed by adding the items loading on each factor. The lowest possible score is subtracted from this composite score and divided by the greatest possible score minus the lowest possible score. This provided a transformed score between 0 and 1 that should be multiplied by 100 (scale 0-100). A low score indicates low satisfaction and a high score indicates high satisfaction with treatment. | Baseline and Week 8 |
| Change in Side-Effects Score on Treatment Satisfaction Scale From Baseline to Week 8 | The Treatment Satisfaction Questionnaire for Medication (TSQM) is a validated instrument that measures four major dimensions of patient satisfaction with medications: effectiveness, side effects, convenience, and global satisfaction. TSQM Scale scores are computed by adding the items loading on each factor. The lowest possible score is subtracted from this composite score and divided by the greatest possible score minus the lowest possible score. This provided a transformed score between 0 and 1 that should be multiplied by 100 (scale 0-100). A low score indicates low satisfaction and a high score indicates high satisfaction with treatment. | Baseline and Week 8 |
| Change in Convenience Score on Treatment Satisfaction Scale From Baseline to Week 8 | The Treatment Satisfaction Questionnaire for Medication (TSQM) is a validated instrument that measures four major dimensions of patient satisfaction with medications: effectiveness, side effects, convenience, and global satisfaction. TSQM Scale scores are computed by adding the items loading on each factor. The lowest possible score is subtracted from this composite score and divided by the greatest possible score minus the lowest possible score. This provided a transformed score between 0 and 1 that should be multiplied by 100 (scale 0-100). A low score indicates low satisfaction and a high score indicates high satisfaction with treatment. | Baseline and Week 8 |
| Change in Global Satisfaction Score on Treatment Satisfaction Scale From Baseline to Week 8 | The Treatment Satisfaction Questionnaire for Medication (TSQM) is a validated instrument that measures four major dimensions of patient satisfaction with medications: effectiveness, side effects, convenience, and global satisfaction. TSQM Scale scores are computed by adding the items loading on each factor. The lowest possible score is subtracted from this composite score and divided by the greatest possible score minus the lowest possible score. This provided a transformed score between 0 and 1 that should be multiplied by 100 (scale 0-100). A low score indicates low satisfaction and a high score indicates high satisfaction with treatment. | Baseline and Week 8 |
| Change in Total Score on Quality of Life Questionnaire From Baseline to Week 8 | The Cambridge Pulmonary Hypertension Outcome Review (CAMPHOR) is a health related quality of life instrument specific to PAH. The total score can range from 0 -75; the higher the score, the worse the outcome. | Baseline and Week 8 |
| Change in Patient Impression of Change in Symptoms of PAH From Baseline to Week 8 | Subjects were asked to compare their symptoms of PAH as compared to 8 weeks prior and rate as much better, somewhat better, about the same, somewhat worse, or much worse. | Baseline and Week 8 |
| Change in Patient Impression of Change on Time Spent Dealing With Therapy From Baseline to Week 8 | Subjects were asked to compare their previous experience with Flolan and rate how much time was spent dealing with intravenous Remodulin therapy as much less, somewhat less, about the same, somewhat more, or much more. | Baseline and Week 8 |
| Change in Patient Impression of Change of Satisfaction With Therapy From Baseline to Week 8 | Subjects were asked to compare their previous experience with Flolan and rate satisfaction with intravenous Remodulin therapy over the past two weeks as much more satisfied, more satisfied, about the same, less satisfied, or much less satisfied. | Baseline and Week 8 |
| Change in Total Weekly Time Spent to Gather/Set-up Materials Associated With Intravenous Remodulin Therapy Compared to Same Activities With Intravenous Epoprostenol | Baseline and Week 8 |
| Change in Total Weekly Time Spent to Connect Drug With Intravenous Remodulin Therapy Compared to Same Activities With Intravenous Epoprostenol | Baseline and Week 8 |
| Change in Total Weekly Time Spent to Change Dressing With Intravenous Remodulin Therapy Compared to Same Activities With Intravenous Epoprostenol | Baseline and Week 8 |
| Change in Total Weekly Time Spent to Prepare Drug With Intravenous Remodulin Therapy Compared to Same Activities With Intravenous Epoprostenol | Baseline and Week 8 |
| Change in Total Number of Times Daily Required to Disconnect Infusion Pump With Intravenous Remodulin Therapy Compared to Same Activities With Intravenous Epoprostenol | Baseline and Week 8 |
| Change in Total Number of Times Daily Required to Check Infusion Pump With Intravenous Remodulin Therapy Compared to Same Activities With Intravenous Epoprostenol | Baseline and Week 8 |
| Change in Total Number of Times Daily Infusion Pump Alarms With Intravenous Remodulin Therapy Compared to Same Activities With Intravenous Epoprostenol | Baseline and Week 8 |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| PAH Etiology | Number | participants |
|
| World Health Organization (WHO) Functional Classification for PAH | Class I: No limitation of physical activity. Class II: Slight limitation of physical activity. Class III: Marked limitation of physical activity. Class IV: Inability to carry out any physical activity without symptoms. | Number | participants |
|
| Six minute walk distance | Mean | Full Range | meters |
|
| Epoprostenol dose | Mean | Full Range | ng/kg/min |
|
|
|
| Secondary | Change in Borg Dyspnea Score Immediately After Six Minute Walk Test From Baseline to Week 8 | The Borg dyspnea score is a 10-point scale rating the maximum level of dyspnea experienced during the 6-minute walk test. The Borg dyspnea score was assessed immediately following the 6-minute walk test. Scores ranged from 0 (for no shortness of breath) to 10 (for greatest shortness of breath ever experienced). | Posted | Mean | Standard Deviation | units on a scale | Baseline and Week 8 |
|
|
|
|
| Secondary | Change in World Health Organization (WHO) Functional Classification of PAH From Baseline to Week 8 | Class I: Patients with pulmonary hypertension but without resulting limitation of physical activity. Ordinary physical activity does not cause undue dyspnea or fatigue, chest pain, or near syncope. Class II: Patients with pulmonary hypertension resulting in slight limitation of physical activity. These patients are comfortable at rest, but ordinary physical activity causes undue dyspnea or fatigue, chest pain or near syncope. Class III: Patients with pulmonary hypertension resulting in marked limitation of physical activity. They are comfortable at rest. Ordinary activity causes undue dyspnea or fatigue, chest pain, or near syncope. Class IV: Patients with pulmonary hypertension with inability to carry out any physical activity without symptoms. These patients manifest signs of right heart failure. Dyspnea and/or fatigue may be present even at rest. Discomfort is increased by any physical activity. | Posted | Number | percentage of participants | Baseline and Week 8 |
|
|
|
|
| Secondary | Change in Symptoms of Dyspnea From Baseline to Week 8 | The presence or absence of dyspnea was documented. If present, the intensity of dyspnea was rated mild, moderate, or severe. | Posted | Number | percentage of participants | Baseline and Week 8 |
|
|
|
|
| Secondary | Change in Symptoms of Edema From Baseline to Week 8 | The presence or absence of edema was documented. If present, the intensity of edema was rated mild, moderate, or severe. | Posted | Number | percentage of participants | Baseline to Week 8 |
|
|
|
|
| Secondary | Change in Symptoms of Orthopnea From Baseline to Week 8 | The presence or absence of orthopnea was documented. If present, the intensity of orthopnea was rated mild, moderate, or severe. | Posted | Number | percentage of participants | Baseline and Week 8 |
|
|
|
|
| Secondary | Change in Symptoms of Dizziness From Baseline to Week 8 | The presence or absence of dizziness was documented. If present, the intensity of dizziness was rated mild, moderate, or severe. | Posted | Number | percentage of participants | Baseline and Week 8 |
|
|
|
|
| Secondary | Change in Symptoms of Fatigue From Baseline to Week 8 | The presence or absence of fatigue was documented. If present, the intensity of fatigue was rated mild, moderate, or severe. | Posted | Number | percentage of participants | Baseline and Week 8 |
|
|
|
|
| Secondary | Change in Symptoms of Syncope From Baseline to Week 8 | The presence or absence of syncope was documented. If present, the intensity of syncope was rated mild, moderate, or severe. | Posted | Number | percentage of participants | Baseline and Week 8 |
|
|
|
|
| Secondary | Change in Symptoms of Chest Pain From Baseline to Week 8 | The presence or absence of chest pain was documented. If present, the intensity of chest pain was rated mild, moderate, or severe. | Posted | Number | percentage of participants | Baseline and Week 8 |
|
|
|
|
| Secondary | Change in Effectiveness Score on Treatment Satisfaction Scale From Baseline to Week 8 | The Treatment Satisfaction Questionnaire for Medication (TSQM) is a validated instrument that measures four major dimensions of patient satisfaction with medications: effectiveness, side effects, convenience, and global satisfaction. TSQM Scale scores are computed by adding the items loading on each factor. The lowest possible score is subtracted from this composite score and divided by the greatest possible score minus the lowest possible score. This provided a transformed score between 0 and 1 that should be multiplied by 100 (scale 0-100). A low score indicates low satisfaction and a high score indicates high satisfaction with treatment. | Posted | Mean | Standard Deviation | units on a scale | Baseline and Week 8 |
|
|
|
|
| Secondary | Change in Side-Effects Score on Treatment Satisfaction Scale From Baseline to Week 8 | The Treatment Satisfaction Questionnaire for Medication (TSQM) is a validated instrument that measures four major dimensions of patient satisfaction with medications: effectiveness, side effects, convenience, and global satisfaction. TSQM Scale scores are computed by adding the items loading on each factor. The lowest possible score is subtracted from this composite score and divided by the greatest possible score minus the lowest possible score. This provided a transformed score between 0 and 1 that should be multiplied by 100 (scale 0-100). A low score indicates low satisfaction and a high score indicates high satisfaction with treatment. | Posted | Mean | Standard Deviation | units on a scale | Baseline and Week 8 |
|
|
|
|
| Secondary | Change in Convenience Score on Treatment Satisfaction Scale From Baseline to Week 8 | The Treatment Satisfaction Questionnaire for Medication (TSQM) is a validated instrument that measures four major dimensions of patient satisfaction with medications: effectiveness, side effects, convenience, and global satisfaction. TSQM Scale scores are computed by adding the items loading on each factor. The lowest possible score is subtracted from this composite score and divided by the greatest possible score minus the lowest possible score. This provided a transformed score between 0 and 1 that should be multiplied by 100 (scale 0-100). A low score indicates low satisfaction and a high score indicates high satisfaction with treatment. | Posted | Mean | Standard Deviation | units on a scale | Baseline and Week 8 |
|
|
|
|
| Secondary | Change in Global Satisfaction Score on Treatment Satisfaction Scale From Baseline to Week 8 | The Treatment Satisfaction Questionnaire for Medication (TSQM) is a validated instrument that measures four major dimensions of patient satisfaction with medications: effectiveness, side effects, convenience, and global satisfaction. TSQM Scale scores are computed by adding the items loading on each factor. The lowest possible score is subtracted from this composite score and divided by the greatest possible score minus the lowest possible score. This provided a transformed score between 0 and 1 that should be multiplied by 100 (scale 0-100). A low score indicates low satisfaction and a high score indicates high satisfaction with treatment. | Posted | Mean | Standard Deviation | units on a scale | Baseline and Week 8 |
|
|
|
|
| Secondary | Change in Total Score on Quality of Life Questionnaire From Baseline to Week 8 | The Cambridge Pulmonary Hypertension Outcome Review (CAMPHOR) is a health related quality of life instrument specific to PAH. The total score can range from 0 -75; the higher the score, the worse the outcome. | Posted | Mean | Standard Deviation | units on a scale | Baseline and Week 8 |
|
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|
|
| Secondary | Change in Patient Impression of Change in Symptoms of PAH From Baseline to Week 8 | Subjects were asked to compare their symptoms of PAH as compared to 8 weeks prior and rate as much better, somewhat better, about the same, somewhat worse, or much worse. | Posted | Number | participants | Baseline and Week 8 |
|
|
|
| Secondary | Change in Patient Impression of Change on Time Spent Dealing With Therapy From Baseline to Week 8 | Subjects were asked to compare their previous experience with Flolan and rate how much time was spent dealing with intravenous Remodulin therapy as much less, somewhat less, about the same, somewhat more, or much more. | Posted | Number | participants | Baseline and Week 8 |
|
|
|
| Secondary | Change in Patient Impression of Change of Satisfaction With Therapy From Baseline to Week 8 | Subjects were asked to compare their previous experience with Flolan and rate satisfaction with intravenous Remodulin therapy over the past two weeks as much more satisfied, more satisfied, about the same, less satisfied, or much less satisfied. | Posted | Number | participants | Baseline and Week 8 |
|
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| Secondary | Change in Total Weekly Time Spent to Gather/Set-up Materials Associated With Intravenous Remodulin Therapy Compared to Same Activities With Intravenous Epoprostenol | Posted | Mean | Standard Deviation | minutes | Baseline and Week 8 |
|
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|
| Secondary | Change in Total Weekly Time Spent to Connect Drug With Intravenous Remodulin Therapy Compared to Same Activities With Intravenous Epoprostenol | Posted | Mean | Standard Deviation | minutes | Baseline and Week 8 |
|
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|
| Secondary | Change in Total Weekly Time Spent to Change Dressing With Intravenous Remodulin Therapy Compared to Same Activities With Intravenous Epoprostenol | Posted | Mean | Standard Deviation | minutes | Baseline and Week 8 |
|
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|
| Secondary | Change in Total Weekly Time Spent to Prepare Drug With Intravenous Remodulin Therapy Compared to Same Activities With Intravenous Epoprostenol | Posted | Mean | Standard Deviation | minutes | Baseline and Week 8 |
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| Secondary | Change in Total Number of Times Daily Required to Disconnect Infusion Pump With Intravenous Remodulin Therapy Compared to Same Activities With Intravenous Epoprostenol | Posted | Mean | Standard Deviation | number of times per day | Baseline and Week 8 |
|
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|
| Secondary | Change in Total Number of Times Daily Required to Check Infusion Pump With Intravenous Remodulin Therapy Compared to Same Activities With Intravenous Epoprostenol | Posted | Mean | Standard Deviation | number of times per day | Baseline and Week 8 |
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| Secondary | Change in Total Number of Times Daily Infusion Pump Alarms With Intravenous Remodulin Therapy Compared to Same Activities With Intravenous Epoprostenol | Posted | Mean | Standard Deviation | number of times per day | Baseline and Week 8 |
|
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|
| 2 |
| 10 |
| 9 |
| 10 |
| Headache | General disorders | Systematic Assessment |
|
| Restless Leg Syndrome | Nervous system disorders | Systematic Assessment |
|
| Atrial fibrillation | Cardiac disorders | Systematic Assessment |
|
| Diarrhea | Gastrointestinal disorders | Systematic Assessment |
|
| Hand fracture | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Injection site erythema | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Muscle spasms | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | Systematic Assessment |
|
| Peripheral edema | Vascular disorders | Systematic Assessment |
|
| Sinus congestion | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Upper respiratory tract infection | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | Systematic Assessment |
|
| catheter site inflammation | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
Not provided
| D002318 |
| Cardiovascular Diseases |
| D005227 |
| Fatty Acids |
| D008055 | Lipids |
| D012898 | Autacoids |
| D018836 | Inflammation Mediators |
| D001685 | Biological Factors |
| Title | Measurements |
|---|
|
| Somewhat worse |
|
| Much worse |
|
|
| Somewhat more |
|
| Much more |
|
| Title | Measurements |
|---|
|
| Less satisfied |
|
| Much less satisfied |
|