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The purpose of this multi-center, open-label, safety and tolerability study was to assess the addition of oral treprostinil (UT-15C sustained release [SR] tablets) to subjects currently receiving Tyvaso (treprostinil) inhalation solution. During the 24-week evaluation period, the study evaluated the changes in the following assessments: hemodynamics, 6-minute walk test (6MWT), Borg dyspnea score, N-Terminal pro-brain natriuretic peptide (NT-proBNP), World Health Organization (WHO) Functional Class, and safety assessments.
Eligible subjects had a diagnosis of pulmonary arterial hypertension (PAH), currently were receiving Tyvaso, and may have been receiving other approved PAH specific oral therapies (endothelin receptor antagonists [ERAs] and/or phosphodiesterase type 5 inhibitor [PDE5-I], if at a stable dose for ≥30 days). At Baseline, subjects received the first dose of 0.125 mg UT-15C SR.
This was a multi-center, open-label, safety and tolerability study in WHO Group 1 PAH subjects adding UT-15C SR to Tyvaso and PAH approved background therapy. This study had a 24-week evaluation period followed by a long term safety period. Six study visits occurred in the first 24 weeks of study; Screening, Baseline, Week 4, Week 8, Week 12, and Week 24 visits. Right heart catheterization occurred between 2-4 hours following the last Tyvaso dose at Baseline (prior to the administration of UT-15C SR) and Week 24.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| UT-15C SR BID | Experimental | Initiated at 0.125 mg twice daily (BID), titrated as clinically indicated. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| UT-15C SR | Drug | Initiated at 0.125 mg BID, titrated as clinically indicated. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Hemodynamic Parameters From Baseline to Week 24. | Hemodynamics (via right heart catheterization [RHC]) were assessed at Baseline and Week 24 or at the time of premature termination of study drug if prior to the Week 24 visit. Cardiopulmonary hemodynamic measurements included the following: mean pulmonary arterial pressure (PAPm), mean systemic arterial pressure (SAPm), mean right atrial pressure (RAPm), and mean pulmonary capillary wedge pressure (PCWPm). | Baseline and Week 24 |
| Change in Hemodynamic Parameter (Heart Rate) From Baseline to Week 24. | Heart rate was assessed at Baseline and Week 24 or at the time of premature termination of study drug if prior to the Week 24 visit. | Baseline and Week 24 |
| Change in Hemodynamic Parameters (Arterial and Venous Oxygen Saturation) From Baseline to Week 24. | Hemodynamics (via right heart catheterization [RHC]) were assessed at Baseline and Week 24 or at the time of premature termination of study drug if prior to the Week 24 visit. Cardiopulmonary hemodynamic measurements included arterial oxygen saturation (SaO2) and mixed venous oxygen saturation (SvO2). | Baseline and Week 24 |
| Change in Hemodynamic Parameter (Cardiac Output) From Baseline to Week 24. | Hemodynamics (via right heart catheterization [RHC]) were assessed at Baseline and Week 24 or at the time of premature termination of study drug if prior to the Week 24 visit. | Baseline and Week 24 |
| Change in Hemodynamic Parameter (Cardiac Index) From Baseline to Week 24. | Hemodynamics (via right heart catheterization [RHC]) were assessed at Baseline and Week 24 or at the time of premature termination of study drug if prior to the Week 24 visit. Cardiopulmonary hemodynamic measurements included cardiac index (CI). |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Exercise Capacity as Measured by the 6-minute Walk Test (6MWT) Over the 24-week Treatment Period. | The 6MWT was conducted at Baseline, 2 to 4 hours after the last Tyvaso dose, and prior to first dose of UT-15C SR. The 6MWT was also performed at Weeks 4, 12, and 24, or at the time of premature termination of study drug if prior to the Week 24 visit. | Baseline and Weeks 4, 12, and 24 |
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Significant inclusion criteria included:
Significant exclusion criteria included:
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| Name | Affiliation | Role |
|---|---|---|
| Cynthia Madden, MD, MPH | Associate Director, Medical Development | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The University of Alabama at Birmingham | Birmingham | Alabama | 35294 | United States | ||
| Mayo Clinic |
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The recruitment period for this study was October 2011 to November 2013.
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| ID | Title | Description |
|---|---|---|
| FG000 | UT-15C SR BID | UT-15C SR: Initiated at 0.125 mg BID, titrated as clinically indicated. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | UT-15C SR BID | UT-15C SR: Initiated at 0.125 mg BID, titrated as clinically indicated. |
| 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 Hemodynamic Parameters From Baseline to Week 24. | Hemodynamics (via right heart catheterization [RHC]) were assessed at Baseline and Week 24 or at the time of premature termination of study drug if prior to the Week 24 visit. Cardiopulmonary hemodynamic measurements included the following: mean pulmonary arterial pressure (PAPm), mean systemic arterial pressure (SAPm), mean right atrial pressure (RAPm), and mean pulmonary capillary wedge pressure (PCWPm). | Intent-to-treat population with data available at Baseline and Week 24. | Posted | Median | Full Range | mmHg | Baseline and Week 24 |
|
Adverse events were recorded throughout the 24-week study, including the screening phase, as well as during the long-term follow-up period.
Adverse events were recorded throughout the course of the study, including a 24-week treatment period and a long-term follow up period through each subject's last study visit (up to 553 days).
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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 | UT-15C SR BID | UT-15C SR: Initiated at 0.125 mg BID, titrated as clinically indicated. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Ascites | Gastrointestinal disorders | MedDRA (11.1) | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhea | Gastrointestinal disorders | MedDRA (11.1) | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Kevin LaLiberte, PharmD | United Therapeutics Corp. | 919-425-8176 | KLaliberte@unither.com |
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| ID | Term |
|---|---|
| D000081029 | Pulmonary Arterial Hypertension |
| ID | Term |
|---|---|
| D006976 | Hypertension, Pulmonary |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| C427248 | treprostinil |
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| Tyvaso Inhalation Solution | Drug | Administered as at least 9 breaths 4 times daily for at least 4 weeks prior to Baseline |
|
|
| Baseline and Week 24 |
| Change in Hemodynamic Parameter (Pulmonary Vascular Resistance Index) From Baseline to Week 24. | Hemodynamics (via right heart catheterization [RHC]) were assessed at Baseline and Week 24 or at the time of premature termination of study drug if prior to the Week 24 visit. Cardiopulmonary hemodynamic measurements included the following: pulmonary vascular resistance index (PVRI). | Baseline and Week 24 |
| Time to Clinical Worsening Over the Treatment Period. | Clinical worsening was assessed continuously from Baseline through each subject's last study visit. Clinical worsening was defined as the occurrence of any one or more of the following: death (all causes), hospitalization as a result of worsening pulmonary arterial hypertension (PAH), and initiation of a parenteral prostacyclin. | Clinical worsening was assessed continuously from Baseline through each subject's last study visit |
| Shift From Baseline in World Health Organization (WHO) Functional Class Over the 24-week Treatment Period. | The WHO functional classification for pulmonary hypertension was assessed at Baseline prior to starting UT-15C SR, Weeks 4, 8, 12, and 24, or at the time of premature termination if prior to Week 24. The WHO functional classification ranges from I (patient's disease does not affect daily activities) to IV (patient's disease causes severe impairment). | Baseline and Weeks 4, 8, 12, and 24 |
| N-terminal Pro-Brain Natriuretic Peptide (NT-proBNP) Over the 24-week Treatment Period. | NT-proBNP was assessed at Baseline prior to starting UT-15C SR, Weeks 12 and 24, or at the time of premature termination if prior to Week 24. Blood for NT-proBNP assessment was collected before the 6MWT was conducted. | Baseline and Weeks 12 and 24 |
| Rochester |
| Minnesota |
| 55905 |
| United States |
| Washington University School of Medicine | St Louis | Missouri | 63110 | United States |
| Duke University Medical Center | Durham | North Carolina | 27710 | United States |
| Allegheny General Hospital | Pittsburgh | Pennsylvania | 15212 | United States |
| UT Southwestern Medical Center | Dallas | Texas | 75390 | United States |
| Participants |
|
| Age, Continuous | Mean | Full Range | years |
|
| 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 |
|
| Units | Counts |
|---|
| Participants |
|
|
| Secondary | Change in Exercise Capacity as Measured by the 6-minute Walk Test (6MWT) Over the 24-week Treatment Period. | The 6MWT was conducted at Baseline, 2 to 4 hours after the last Tyvaso dose, and prior to first dose of UT-15C SR. The 6MWT was also performed at Weeks 4, 12, and 24, or at the time of premature termination of study drug if prior to the Week 24 visit. | Intent-to-treat population with data available at Baseline and Week 24. | Posted | Median | Full Range | Meters | Baseline and Weeks 4, 12, and 24 |
|
|
|
| Secondary | Time to Clinical Worsening Over the Treatment Period. | Clinical worsening was assessed continuously from Baseline through each subject's last study visit. Clinical worsening was defined as the occurrence of any one or more of the following: death (all causes), hospitalization as a result of worsening pulmonary arterial hypertension (PAH), and initiation of a parenteral prostacyclin. | Intent-to-treat population with data available at Baseline and Week 24. | Posted | Mean | Standard Deviation | Days | Clinical worsening was assessed continuously from Baseline through each subject's last study visit |
|
|
|
| Secondary | Shift From Baseline in World Health Organization (WHO) Functional Class Over the 24-week Treatment Period. | The WHO functional classification for pulmonary hypertension was assessed at Baseline prior to starting UT-15C SR, Weeks 4, 8, 12, and 24, or at the time of premature termination if prior to Week 24. The WHO functional classification ranges from I (patient's disease does not affect daily activities) to IV (patient's disease causes severe impairment). | Intent-to-treat population with data available at Baseline and Week 24. | Posted | Number | participants | Baseline and Weeks 4, 8, 12, and 24 |
|
|
|
| Secondary | N-terminal Pro-Brain Natriuretic Peptide (NT-proBNP) Over the 24-week Treatment Period. | NT-proBNP was assessed at Baseline prior to starting UT-15C SR, Weeks 12 and 24, or at the time of premature termination if prior to Week 24. Blood for NT-proBNP assessment was collected before the 6MWT was conducted. | Intent-to-treat population with data available at Baseline and Week 24. | Posted | Mean | Standard Deviation | pg/mL | Baseline and Weeks 12 and 24 |
|
|
|
| Primary | Change in Hemodynamic Parameter (Heart Rate) From Baseline to Week 24. | Heart rate was assessed at Baseline and Week 24 or at the time of premature termination of study drug if prior to the Week 24 visit. | Intent-to-treat population with data available at Baseline and Week 24. | Posted | Median | Full Range | beats/min | Baseline and Week 24 |
|
|
|
| Primary | Change in Hemodynamic Parameters (Arterial and Venous Oxygen Saturation) From Baseline to Week 24. | Hemodynamics (via right heart catheterization [RHC]) were assessed at Baseline and Week 24 or at the time of premature termination of study drug if prior to the Week 24 visit. Cardiopulmonary hemodynamic measurements included arterial oxygen saturation (SaO2) and mixed venous oxygen saturation (SvO2). | Intent-to-treat population with data available at Baseline and Week 24. | Posted | Median | Full Range | percentage bound to hemoglobin | Baseline and Week 24 |
|
|
|
| Primary | Change in Hemodynamic Parameter (Cardiac Output) From Baseline to Week 24. | Hemodynamics (via right heart catheterization [RHC]) were assessed at Baseline and Week 24 or at the time of premature termination of study drug if prior to the Week 24 visit. | Intent-to-treat population with data available at Baseline and Week 24. | Posted | Median | Full Range | L/min | Baseline and Week 24 |
|
|
|
| Primary | Change in Hemodynamic Parameter (Cardiac Index) From Baseline to Week 24. | Hemodynamics (via right heart catheterization [RHC]) were assessed at Baseline and Week 24 or at the time of premature termination of study drug if prior to the Week 24 visit. Cardiopulmonary hemodynamic measurements included cardiac index (CI). | Intent-to-treat population with data available at Baseline and Week 24. | Posted | Median | Full Range | L/min/m^2 | Baseline and Week 24 |
|
|
|
| Primary | Change in Hemodynamic Parameter (Pulmonary Vascular Resistance Index) From Baseline to Week 24. | Hemodynamics (via right heart catheterization [RHC]) were assessed at Baseline and Week 24 or at the time of premature termination of study drug if prior to the Week 24 visit. Cardiopulmonary hemodynamic measurements included the following: pulmonary vascular resistance index (PVRI). | Intent-to-treat population with data available at Baseline and Week 24. | Posted | Median | Full Range | dyn*s/cm^5*m^2 | Baseline and Week 24 |
|
|
|
| 2 |
| 18 |
| 18 |
| 18 |
| Diarrhea | Gastrointestinal disorders | MedDRA (11.1) | Non-systematic Assessment |
|
| Fluid overload | Metabolism and nutrition disorders | MedDRA (11.1) | Non-systematic Assessment |
|
| Hyponatremia | Metabolism and nutrition disorders | MedDRA (11.1) | Non-systematic Assessment |
|
| Renal failure acute | Renal and urinary disorders | MedDRA (11.1) | Non-systematic Assessment |
|
| Malnutrition | Metabolism and nutrition disorders | MedDRA (11.1) | Non-systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA (11.1) | Non-systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA (11.1) | Non-systematic Assessment |
|
| Flushing | Vascular disorders | MedDRA (11.1) | Non-systematic Assessment |
|
| Fatigue | General disorders | MedDRA (11.1) | Non-systematic Assessment |
|
| Dyspnea | Respiratory, thoracic and mediastinal disorders | MedDRA (11.1) | Non-systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (11.1) | Non-systematic Assessment |
|
| Edema peripheral | General disorders | MedDRA (11.1) | Non-systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA (11.1) | Non-systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA (11.1) | Non-systematic Assessment |
|
| Chest discomfort | General disorders | MedDRA (11.1) | Non-systematic Assessment |
|
| Chest pain | General disorders | MedDRA (11.1) | Non-systematic Assessment |
|
| Hypotension | Vascular disorders | MedDRA (11.1) | Non-systematic Assessment |
|
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA (11.1) | Non-systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA (11.1) | Non-systematic Assessment |
|
| Abdominal distension | Gastrointestinal disorders | MedDRA (11.1) | Non-systematic Assessment |
|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA (11.1) | Non-systematic Assessment |
|
| Anemia | Blood and lymphatic system disorders | MedDRA (11.1) | Non-systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (11.1) | Non-systematic Assessment |
|
| Blood urea increased | Investigations | MedDRA (11.1) | Non-systematic Assessment |
|
| Bronchitis | Infections and infestations | MedDRA (11.1) | Non-systematic Assessment |
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| Constipation | Gastrointestinal disorders | MedDRA (11.1) | Non-systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | MedDRA (11.1) | Non-systematic Assessment |
|
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA (11.1) | Non-systematic Assessment |
|
| Flatulence | Gastrointestinal disorders | MedDRA (11.1) | Non-systematic Assessment |
|
| Hypokalemia | Metabolism and nutrition disorders | MedDRA (11.1) | Non-systematic Assessment |
|
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA (11.1) | Non-systematic Assessment |
|
| Palpitations | Cardiac disorders | MedDRA (11.1) | Non-systematic Assessment |
|
| Presyncope | Nervous system disorders | MedDRA (11.1) | Non-systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA (11.1) | Non-systematic Assessment |
|
| Sinusitis | Infections and infestations | MedDRA (11.1) | Non-systematic Assessment |
|
| Syncope | Nervous system disorders | MedDRA (11.1) | Non-systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA (11.1) | Non-systematic Assessment |
|
| Anxiety | Psychiatric disorders | MedDRA (11.1) | Non-systematic Assessment |
|
| Arthritis | Musculoskeletal and connective tissue disorders | MedDRA (11.1) | Non-systematic Assessment |
|
| Atrial fibrillatioin | Cardiac disorders | MedDRA (11.1) | Non-systematic Assessment |
|
| Atypical pneumonia | Infections and infestations | MedDRA (11.1) | Non-systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (11.1) | Non-systematic Assessment |
|
| Blood creatinine increased | Investigations | MedDRA (11.1) | Non-systematic Assessment |
|
| Blood pressure increased | Investigations | MedDRA (11.1) | Non-systematic Assessment |
|
| Chills | General disorders | MedDRA (11.1) | Non-systematic Assessment |
|
| Depression | Psychiatric disorders | MedDRA (11.1) | Non-systematic Assessment |
|
| Dermatitis contact | Skin and subcutaneous tissue disorders | MedDRA (11.1) | Non-systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA (11.1) | Non-systematic Assessment |
|
| Duodenal polyp | Gastrointestinal disorders | MedDRA (11.1) | Non-systematic Assessment |
|
| Dysguesia | Nervous system disorders | MedDRA (11.1) | Non-systematic Assessment |
|
| Dysphonia | Respiratory, thoracic and mediastinal disorders | MedDRA (11.1) | Non-systematic Assessment |
|
| Dyspnea paroxysmal nocturnal | Respiratory, thoracic and mediastinal disorders | MedDRA (11.1) | Non-systematic Assessment |
|
| Eye burns | Injury, poisoning and procedural complications | MedDRA (11.1) | Non-systematic Assessment |
|
| Face edema | General disorders | MedDRA (11.1) | Non-systematic Assessment |
|
| Gastroesophageal reflux disease | Gastrointestinal disorders | MedDRA (11.1) | Non-systematic Assessment |
|
| Gingival bleeding | Gastrointestinal disorders | MedDRA (11.1) | Non-systematic Assessment |
|
| Groin pain | Musculoskeletal and connective tissue disorders | MedDRA (11.1) | Non-systematic Assessment |
|
| Hematocrit decreased | Investigations | MedDRA (11.1) | Non-systematic Assessment |
|
| Hematuria | Renal and urinary disorders | MedDRA (11.1) | Non-systematic Assessment |
|
| Hemoglobin decreased | Investigations | MedDRA (11.1) | Non-systematic Assessment |
|
| Hiatus hernia | Gastrointestinal disorders | MedDRA (11.1) | Non-systematic Assessment |
|
| Hiccups | Respiratory, thoracic and mediastinal disorders | MedDRA (11.1) | Non-systematic Assessment |
|
| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA (11.1) | Non-systematic Assessment |
|
| Influenza | Infections and infestations | MedDRA (11.1) | Non-systematic Assessment |
|
| Local swelling | General disorders | MedDRA (11.1) | Non-systematic Assessment |
|
| Lower respiratory tract infection | Infections and infestations | MedDRA (11.1) | Non-systematic Assessment |
|
| Edema | General disorders | MedDRA (11.1) | Non-systematic Assessment |
|
| Pain | General disorders | MedDRA (11.1) | Non-systematic Assessment |
|
| Pain in jaw | Musculoskeletal and connective tissue disorders | MedDRA (11.1) | Non-systematic Assessment |
|
| Pericarditis | Cardiac disorders | MedDRA (11.1) | Non-systematic Assessment |
|
| Productive cough | Respiratory, thoracic and mediastinal disorders | MedDRA (11.1) | Non-systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA (11.1) | Non-systematic Assessment |
|
| Red blood cell count decreased | Investigations | MedDRA (11.1) | Non-systematic Assessment |
|
| Renal cyst | Renal and urinary disorders | MedDRA (11.1) | Non-systematic Assessment |
|
| Restlessness | Psychiatric disorders | MedDRA (11.1) | Non-systematic Assessment |
|
| Sinus bradycardia | Cardiac disorders | MedDRA (11.1) | Non-systematic Assessment |
|
| Sinus congestion | Respiratory, thoracic and mediastinal disorders | MedDRA (11.1) | Non-systematic Assessment |
|
| Skin papilloma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (11.1) | Non-systematic Assessment |
|
| Synovial cyst | Musculoskeletal and connective tissue disorders | MedDRA (11.1) | Non-systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA (11.1) | Non-systematic Assessment |
|
| Weight decreased | Investigations | MedDRA (11.1) | Non-systematic Assessment |
|
| Weight increased | Investigations | MedDRA (11.1) | Non-systematic Assessment |
|
| Muscle tightness | Musculoskeletal and connective tissue disorders | MedDRA (11.1) | Non-systematic Assessment |
|
| Muscle strain | Injury, poisoning and procedural complications | MedDRA (11.1) | Non-systematic Assessment |
|
| Contusion | Injury, poisoning and procedural complications | MedDRA (11.1) | Non-systematic Assessment |
|
| Affect lability | Psychiatric disorders | MedDRA (11.1) | Non-systematic Assessment |
|
| Hot flush | Vascular disorders | MedDRA (11.1) | Non-systematic Assessment |
|
| Respiratory tract infection | Infections and infestations | MedDRA (11.1) | Non-systematic Assessment |
|
Institution and/or Principal Investigator agree not to publish or publicly present any interim results of the study without the prior written consent of Sponsor, not to be unreasonably withheld or delayed, except as provided below. Institution and/or Principal Investigator further agree to provide Sponsor with drafts of any such publication or presentation for review and approval no less than 30 days prior to submission for publication or the date of public presentation.
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| Week 24 |
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| Week 8 |
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| Week 12 |
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| Week 24 |
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