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The purpose of this multicentre, open label, single-arm study in approximately 20 adult patients is to evaluate the Impact on lifestyle of a new thermo stable formulation of epoprostenol sodium in subjects with Pulmonary Arterial Hypertension (PAH).
This is a multicentre, open label, single-arm study in approximately 20 adult patients (18 - 75 years old) designed to evaluate the Impact on lifestyle of a new thermo stable formulation of epoprostenol sodium in subjects with Pulmonary Arterial Hypertension (PAH). The co-primary objectives are 1) to describe the effect of the new thermo stable formulation of epoprostenol sodium on quality of life and 2) to determine the dose titration requirement in patients switching from the currently marketed FLOLAN (epoprostenol sodium) to the new thermo stable formulation. Secondary objectives include assessing the safety, tolerability and efficacy of the thermo stable formulation of epoprostenol sodium and the exploratory objective is to evaluate the effect of the new thermo stable formulation of epoprostenol sodium on haemodynamic parameters in a subset of subjects.
Subjects who are already receiving FLOLAN (epoprostenol sodium) for the treatment of PAH and have been on a stable dose for at least 3 months and on stable doses of other PAH treatments for at least 30 days prior to screening will be enrolled. After a screening visit, eligible subjects will have a 4-week run-in period with their existing FLOLAN (epoprostenol sodium) treatment. At the end of the 4-week period, they will be admitted to the clinic for baseline assessments and for switching to study medication (the new thermo stable formulation of epoprostenol sodium). Subjects will remain in hospital for a minimum of 6 hours to ensure clinical and hemodynamic stability prior to discharge. Subjects may stay in hospital for up to 24-48 hours after switching to the new thermo stable formulation of epoprostenol sodium at the discretion of the investigator. Dose titration requirement will be assessed at the time of discharge. Haemodynamic parameters will be obtained in a subgroup of subjects enrolled in centres where the collection of haemodynamic data is considered part of the standard of care. Subjects will receive the study medication as a continuous intravenous infusion for a 4-week treatment period. Those who complete the 4-week treatment period will have the option of entering an extension phase of the study to continue receiving the new formulation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| All subjects | Experimental | Subjects enter the study already taking current marketed FLOLAN (epoprostenol sodium) and continue for 4 weeks (run-in). At baseline, they will be swopped to the new thermo stable formulation of epoprostenol sodium for 4 weeks (or longer if they continue in the extension phase of the study). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| current marketed FLOLAN (epoprostenol sodium) | Drug | continuous intravenous infusion |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Medical Outcomes Study Short Form 36 (SF-36) | Subject-rated measure of health status comprised of 36 items: 8 subscale scores (physical functioning, role limitations due to physical health problems, bodily pain, general health, vitality, social functioning, role limitations due to emotional problems, and mental health), 2 summary scores (physical component and mental component), and a self-evaluated change in health status. Subscale and summary scores range: 0-100. Higher subscale and summary scores was considered as better health status. Change from Baseline was calculated as score at observation minus score at baseline. Baseline was defined as Visit 2 i.e. Day-14 (+ or - 7 days). | Baseline (Visit 2 i.e. Day-14 [+ or - 7 days]) and Week 4 (Visit 3) |
| Change From Baseline in Study Specific Participant Acceptance Survey | Study-specific questionnaire comprised the pre-defined15 questions which included activities of daily living assessment. Participants rated the question on a scale of 1 to 10, where 1 was do not agree and 10 was strongly agree. Change from Baseline was calculated as score at observation minus score at Baseline. Changes from Baseline was assessed for Questions 2 to 12. Baseline was defined as Visit 2 i.e. Day-14 (+ or - 7 days). | Baseline (Visit 2 i.e. Day-14 [+ or - 7 days]) and Week 4 (Visit 3). |
| Change From Baseline in Dose of Thermo Stable Epoprostenol Sodium at Week 4 | Dose titration requirement was assessed at the time of discharge. Change from Baseline was calculated as score at observation minus score at Baseline. Units- nanogram per kilogram per minute (ng/kg/min). Baseline was Visit 2 i.e . Day-14 (+ or - 7 days). | Baseline (Visit 2 i.e. Day-14 [+ or - 7 days]) and Week 4 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Any Treatment Emergent Adverse Events (AEs) and Treatment Emergent Serious Adverse Events(SAEs) | An AE was defined as any untoward medical occurrence that occurred during the course of the trial after study treatment had started. An adverse event was therefore any unfavourable and unintended sign, symptom, or disease temporally associated with the use of study drug, whether or not considered related to the study drug. An SAE is any untoward medical occurrence that at any dose results in death, are life threatening, requires hospitalization or prolongation of hospitalization or results in disability/incapacity, congenital anomaly/birth defect and medically significant and all events of possible drug-induced liver injury with hyperbilirubinaemia. Only treatment emergent AEs and SAEs were reported in this outcome measure. Specifically, this study reported 2 SAEs, but only 1 was categorized as treatment emergent. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Miami Beach | Florida | 33140 | United States | ||
| GSK Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25793960 | Derived | Provencher S, Paruchuru P, Spezzi A, Waterhouse B, Gomberg-Maitland M; pH12 Flolan reformulation study group. Quality of life, safety and efficacy profile of thermostable flolan in pulmonary arterial hypertension. PLoS One. 2015 Mar 20;10(3):e0120657. doi: 10.1371/journal.pone.0120657. eCollection 2015. |
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There was a 4-week run-in period during which 1 participant was assessed to be a screen failure at the Baseline Visit (Visit 2) due to the participant self-titrating their epoprostenol sodium. During the 4-week run-in period, participants received currently marketed epoprostenol sodium.
A total of 17 participants were recruited from 23 November 2011 to 16 May 2012, out of which 16 participants entered the treatment phase. Study was conducted across 5 centres in the United States, 1 centre in Canada and 1 centre in the Netherlands.
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| ID | Title | Description |
|---|---|---|
| FG000 | Epoprostenol Sodium for Injection | Participants received new thermo stable 100 milliliter (mL) formulation of epoprostenol sodium via intravenous infusion each day for 4-week treatment period. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| new thermo stable formulation of epoprostenol sodium |
| Drug |
continuous intravenous infusion |
|
| Up to visit 3 (Week 4) |
| Number of Participants With Infusion Site Reactions During Treatment Period | Infusion site reactions were reported during the treatment period. Infusion site was inspected for erythema, excoriation, induration, skin necrosis or signs of local sepsis. | Baseline visit (Visit 2) to Week 4 (Visit 3) |
| Change From Baseline in Vital Signs at Week 4 : Systolic and Diastolic Blood Pressure | Systolic blood pressure is a measure of blood pressure while the heart is beating. Diastolic blood pressure is a measure of blood pressure while the heart is relaxed. Change from Baseline was calculated as the value at the indicated time points minus the value at Baseline. Baseline was Visit 2 i.e. Day-14 (+ or - 7 days). | Baseline (Visit 2 i.e. Day-14 [+ or - 7 days]) and Week 4(Visit 3) |
| Change From Baseline in Vital Signs at Week 4: Heart Rate | Summary mean change in heart rate measured in beats per minute (beats/min or BPM). Change from Baseline was calculated as the value at the indicated time points minus the value at Baseline. Baseline was Visit 2 i.e. Day-14 (+ or - 7 days). | Baseline (Visit 2 i.e. Day-14 [+ or - 7 days]) to Week 4 |
| Number of Participants With Abnormal Clinical Chemistry | Abnormal clinical chemistry was analyzed as follows: serum alanine aminotransferase (ALT/SGPT) >= 3 x upper limit of normal (ULN) , aspartate aminotransferase (AST/SGOT) >= 3 x ULN , total bilirubin >= 34.2, creatinine >= 176.8. | Up to 1 week after Week 4 (Follow-up) |
| Number of Participants With Abnormal Hematology | Values for hemoglobin, hematocrit, and platelet count were analyzed. Participants with abnormal values have been reported. The low and high value concern were as follows: hemoglobin (Males < 98, >180.0) (females <91, >161.0)grams per litre (g/L); hematocrit (Males < 32.0, >54.0) (females <29.0, >50.6) fraction (1); platelet count (< 100, > 500) gram international units per litre (gI/L). | Up to 1 week after Week 4 (Follow-up) |
| Number of Participants With Abnormal Urinalysis | Dipstick method was used to measure blood, glucose and protein. Data was analyzed up to 1 week after Week 4 (Follow-up visit). | Up to 1 week after Week 4 (Follow-up) |
| Change From Baseline in Six Minute Walk Distance Test (6MWD) After 4-weeks of Treatment | This assessment was a non-encouraged test that measures the distance walked for a duration of 6 minutes. Change from Baseline was calculated as value at observation minus value at Baseline. Baseline visit was Visit 2 i.e. Day-14 (+ or - 7 days). | Baseline (Visit 2 i.e. Day-14 [+ or - 7 days]) and Week 4 |
| Breathlessness After 6MWD - Borg Dyspnoea Index (BDI) | The BDI was calculated by using a 10-point scale (0 = None, 10 = Maximum) and indicates the degree of breathlessness after completion of the 6-minute walk test. The BDI scale was assessed by each participant. Change from Baseline = score at observation minus score at Baseline. Baseline visit was Visit 2 i.e. Day-14 (+ or - 7 days). | Baseline (Visit 2 i.e. Day-14 [+ or - 7 days]) to Week 4 |
| World Health Organization [WHO] Functional Class at Baseline and After 4- Weeks of Treatment | World Health Organization functional class was analyzed as class I, class II, class III and class IV. World Health Organization functional class was analyzed at Baseline (Visit 2 i.e. Day-14 [+ or - 7 days]) and Week 4. The classed were defined as Class I: No symptoms of pulmonary arterial hypertension with exercise or at rest, Class II: No symptoms at rest but uncomfortable and short of breath with normal activity, Class III: May not have symptoms at rest but activities greatly limited by shortness of breath, fatigue, or near fainting and Class IV: Symptoms at rest and severe symptoms with any activity. Hence the severity increased from class I (better) to Class IV (worse). | Baseline (Visit 2 i.e. Day-14 [+ or - 7 days]) and Week 4 |
| Mean Oxygen Saturation in Blood Over Time | Pulse oximetry (oxygen saturation) was analyzed. Data for Pulse oximetry (oxygen saturation) was analyzed up to the treatment follow up (1 week after Visit 3 [Week 4]). | up to the treatment follow up (1 week after Visit 3 [Week 4]) |
| Number of Participants With Urine Pregnancy Test Positive | Urine samples were collected for urine pregnancy test. Urine samples were collected at up to the treatment follow up (1 week after Visit 3 [Week 4]). Number of participants with urine pregnancy test positive has been reported. | up to the treatment follow up (1 week after Visit 3 [Week 4]) |
| Chicago |
| Illinois |
| 60637 |
| United States |
| GSK Investigational Site | Baltimore | Maryland | 21205 | United States |
| GSK Investigational Site | Boston | Massachusetts | 02118-2393 | United States |
| GSK Investigational Site | Columbus | Ohio | 43221 | United States |
| GSK Investigational Site | Dallas | Texas | 75390-8550 | United States |
| GSK Investigational Site | Québec | Quebec | G1V 4G5 | Canada |
| GSK Investigational Site | Amsterdam | 1081 HV | Netherlands |
| COMPLETED |
|
| NOT COMPLETED |
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Epoprostenol Sodium for Injection | Participants received new thermo stable 100 mL formulation of epoprostenol sodium via intravenous infusion each day for 4-week treatment period. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | 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 From Baseline in Medical Outcomes Study Short Form 36 (SF-36) | Subject-rated measure of health status comprised of 36 items: 8 subscale scores (physical functioning, role limitations due to physical health problems, bodily pain, general health, vitality, social functioning, role limitations due to emotional problems, and mental health), 2 summary scores (physical component and mental component), and a self-evaluated change in health status. Subscale and summary scores range: 0-100. Higher subscale and summary scores was considered as better health status. Change from Baseline was calculated as score at observation minus score at baseline. Baseline was defined as Visit 2 i.e. Day-14 (+ or - 7 days). | Intent-to-Treat (ITT) population consisted of all participants who received at least one dose of epoprostenol sodium during the Run-in period (either currently marketed epoprostenol sodium or the study drug). | Posted | Mean | Standard Deviation | Score on a scale | Baseline (Visit 2 i.e. Day-14 [+ or - 7 days]) and Week 4 (Visit 3) |
|
|
| |||||||||||||||||||||||||||||||||||
| Primary | Change From Baseline in Study Specific Participant Acceptance Survey | Study-specific questionnaire comprised the pre-defined15 questions which included activities of daily living assessment. Participants rated the question on a scale of 1 to 10, where 1 was do not agree and 10 was strongly agree. Change from Baseline was calculated as score at observation minus score at Baseline. Changes from Baseline was assessed for Questions 2 to 12. Baseline was defined as Visit 2 i.e. Day-14 (+ or - 7 days). | ITT population. | Posted | Mean | Standard Deviation | Score on a scale | Baseline (Visit 2 i.e. Day-14 [+ or - 7 days]) and Week 4 (Visit 3). |
|
| ||||||||||||||||||||||||||||||||||||
| Primary | Change From Baseline in Dose of Thermo Stable Epoprostenol Sodium at Week 4 | Dose titration requirement was assessed at the time of discharge. Change from Baseline was calculated as score at observation minus score at Baseline. Units- nanogram per kilogram per minute (ng/kg/min). Baseline was Visit 2 i.e . Day-14 (+ or - 7 days). | ITT population. | Posted | Mean | Standard Deviation | ng/kg/min | Baseline (Visit 2 i.e. Day-14 [+ or - 7 days]) and Week 4 |
|
| ||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Any Treatment Emergent Adverse Events (AEs) and Treatment Emergent Serious Adverse Events(SAEs) | An AE was defined as any untoward medical occurrence that occurred during the course of the trial after study treatment had started. An adverse event was therefore any unfavourable and unintended sign, symptom, or disease temporally associated with the use of study drug, whether or not considered related to the study drug. An SAE is any untoward medical occurrence that at any dose results in death, are life threatening, requires hospitalization or prolongation of hospitalization or results in disability/incapacity, congenital anomaly/birth defect and medically significant and all events of possible drug-induced liver injury with hyperbilirubinaemia. Only treatment emergent AEs and SAEs were reported in this outcome measure. Specifically, this study reported 2 SAEs, but only 1 was categorized as treatment emergent. | ITT population. | Posted | Count of Participants | Participants | Up to visit 3 (Week 4) |
|
| |||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Infusion Site Reactions During Treatment Period | Infusion site reactions were reported during the treatment period. Infusion site was inspected for erythema, excoriation, induration, skin necrosis or signs of local sepsis. | ITT population. | Posted | Count of Participants | Participants | Baseline visit (Visit 2) to Week 4 (Visit 3) |
|
| |||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Vital Signs at Week 4 : Systolic and Diastolic Blood Pressure | Systolic blood pressure is a measure of blood pressure while the heart is beating. Diastolic blood pressure is a measure of blood pressure while the heart is relaxed. Change from Baseline was calculated as the value at the indicated time points minus the value at Baseline. Baseline was Visit 2 i.e. Day-14 (+ or - 7 days). | ITT population. | Posted | Mean | Standard Deviation | Millimeter of mercury (mmHg) | Baseline (Visit 2 i.e. Day-14 [+ or - 7 days]) and Week 4(Visit 3) |
|
| ||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Vital Signs at Week 4: Heart Rate | Summary mean change in heart rate measured in beats per minute (beats/min or BPM). Change from Baseline was calculated as the value at the indicated time points minus the value at Baseline. Baseline was Visit 2 i.e. Day-14 (+ or - 7 days). | ITT population. | Posted | Mean | Standard Deviation | beats/min | Baseline (Visit 2 i.e. Day-14 [+ or - 7 days]) to Week 4 |
|
| ||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Abnormal Clinical Chemistry | Abnormal clinical chemistry was analyzed as follows: serum alanine aminotransferase (ALT/SGPT) >= 3 x upper limit of normal (ULN) , aspartate aminotransferase (AST/SGOT) >= 3 x ULN , total bilirubin >= 34.2, creatinine >= 176.8. | ITT population. | Posted | Count of Participants | Participants | Up to 1 week after Week 4 (Follow-up) |
|
| |||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Abnormal Hematology | Values for hemoglobin, hematocrit, and platelet count were analyzed. Participants with abnormal values have been reported. The low and high value concern were as follows: hemoglobin (Males < 98, >180.0) (females <91, >161.0)grams per litre (g/L); hematocrit (Males < 32.0, >54.0) (females <29.0, >50.6) fraction (1); platelet count (< 100, > 500) gram international units per litre (gI/L). | ITT population. Only those participant available at the indicated time points were analyzed. | Posted | Count of Participants | Participants | Up to 1 week after Week 4 (Follow-up) |
|
| |||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Abnormal Urinalysis | Dipstick method was used to measure blood, glucose and protein. Data was analyzed up to 1 week after Week 4 (Follow-up visit). | ITT population. | Posted | Count of Participants | Participants | Up to 1 week after Week 4 (Follow-up) |
|
| |||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Six Minute Walk Distance Test (6MWD) After 4-weeks of Treatment | This assessment was a non-encouraged test that measures the distance walked for a duration of 6 minutes. Change from Baseline was calculated as value at observation minus value at Baseline. Baseline visit was Visit 2 i.e. Day-14 (+ or - 7 days). | ITT population. | Posted | Mean | Standard Deviation | meters | Baseline (Visit 2 i.e. Day-14 [+ or - 7 days]) and Week 4 |
|
| ||||||||||||||||||||||||||||||||||||
| Secondary | Breathlessness After 6MWD - Borg Dyspnoea Index (BDI) | The BDI was calculated by using a 10-point scale (0 = None, 10 = Maximum) and indicates the degree of breathlessness after completion of the 6-minute walk test. The BDI scale was assessed by each participant. Change from Baseline = score at observation minus score at Baseline. Baseline visit was Visit 2 i.e. Day-14 (+ or - 7 days). | ITT population. | Posted | Mean | Standard Deviation | Score on a scale | Baseline (Visit 2 i.e. Day-14 [+ or - 7 days]) to Week 4 |
|
| ||||||||||||||||||||||||||||||||||||
| Secondary | World Health Organization [WHO] Functional Class at Baseline and After 4- Weeks of Treatment | World Health Organization functional class was analyzed as class I, class II, class III and class IV. World Health Organization functional class was analyzed at Baseline (Visit 2 i.e. Day-14 [+ or - 7 days]) and Week 4. The classed were defined as Class I: No symptoms of pulmonary arterial hypertension with exercise or at rest, Class II: No symptoms at rest but uncomfortable and short of breath with normal activity, Class III: May not have symptoms at rest but activities greatly limited by shortness of breath, fatigue, or near fainting and Class IV: Symptoms at rest and severe symptoms with any activity. Hence the severity increased from class I (better) to Class IV (worse). | ITT population. Only those participants with data available at the specified time point were analyzed. | Posted | Count of Participants | Participants | Baseline (Visit 2 i.e. Day-14 [+ or - 7 days]) and Week 4 |
|
| |||||||||||||||||||||||||||||||||||||
| Secondary | Mean Oxygen Saturation in Blood Over Time | Pulse oximetry (oxygen saturation) was analyzed. Data for Pulse oximetry (oxygen saturation) was analyzed up to the treatment follow up (1 week after Visit 3 [Week 4]). | ITT population. Only those participant available at the indicated time points were analyzed. | Posted | Mean | Standard Deviation | Percentage of oxygen in blood | up to the treatment follow up (1 week after Visit 3 [Week 4]) |
|
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| Secondary | Number of Participants With Urine Pregnancy Test Positive | Urine samples were collected for urine pregnancy test. Urine samples were collected at up to the treatment follow up (1 week after Visit 3 [Week 4]). Number of participants with urine pregnancy test positive has been reported. | ITT population. Only those participants with data available at the indicated time point were analyzed. | Posted | Count of Participants | Participants | up to the treatment follow up (1 week after Visit 3 [Week 4]) |
|
|
Up to 1 week after Week 4 (Follow-up) for SAEs and Up to Visit 3 (Week 4) for non-serious adverse events.
ITT population was used for the analysis of AEs and SAEs.
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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 | Epoprostenol Sodium for Injection | Participants received new thermo stable 100 mL formulation of epoprostenol sodium via intravenous infusion each day for 4-week treatment period. | 0 | 16 | 2 | 16 | 9 | 16 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Device related infection | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Catheter site haemorrhage | General disorders | MedDRA | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Ascites | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Paraesthesia oral | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
| |
| Muscle tightness | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA | Systematic Assessment |
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| Catheter site infection | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Ear infection | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Staphylococcal infection | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Thyroiditis | Endocrine disorders | MedDRA | Systematic Assessment |
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| Haematoma | Vascular disorders | MedDRA | Systematic Assessment |
|
GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| GSK Response Center | GlaxoSmithKline | 866-435-7343 |
| ID | Term |
|---|---|
| D006976 | Hypertension, Pulmonary |
| D000081029 | Pulmonary Arterial Hypertension |
| ID | Term |
|---|---|
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D006973 | Hypertension |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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Not provided
| ID | Term |
|---|---|
| D011464 | Epoprostenol |
| ID | Term |
|---|---|
| D044062 | Prostaglandins I |
| D011453 | Prostaglandins |
| D015777 | Eicosanoids |
| D005231 | Fatty Acids, Unsaturated |
| D005227 | Fatty Acids |
| D008055 | Lipids |
| D012898 | Autacoids |
| D018836 | Inflammation Mediators |
| D001685 | Biological Factors |
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Not provided
| Unknown or Not Reported |
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| Title | Measurements |
|---|---|
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| Vitality |
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| Mental Health |
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| Social Functioning |
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| Bodily Pain |
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| General Health |
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| Physical Health Component |
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| Mental Health Component |
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| Title | Denominators | Categories | ||||
|---|---|---|---|---|---|---|
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