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This multi-center, open-label study will assess the tolerability and safety of transitioning subjects with stable Pulmonary Arterial Hypertension (PAH) from continuous intravenous (IV) or subcutaneous (SC) Remodulin infusion to oral treprostinil (UT-15C sustained release (SR) tablets).
This study will consist of an in-hospital transition phase, dose optimization/evaluation phase, and follow up phase.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| UT-15C SR | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| UT-15C SR | Drug | Subjects will transition in the hospital from Remodulin to UT-15C SR within 5 days of the start of the transition. The dose of Remodulin will be decreased as the dose of UT-15C SR is increased over the 5 days. Once subjects have been transitioned from Remodulin, the dose of UT-15C SR will continue to be modified / titrated to the appropriate optimal dose for that subject throughout the rest of the study. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants That Were Succesfully Transitioned From Parenteral Remodulin to UT-15C. | Successful transition was based on the number of participants that completely transitioned to oral treprostinil by the week 4 study visit and clinically maintained on oral treprostinil treatment through Week 24. | Up to 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Six-minute Walk Distance at Week 24 | The purpose of the 6MWT is to evaluate exercise capacity associated with carrying out activities of daily living. Patients were instructed to walk down a corridor at a comfortable speed as far as they could manage for six minutes, resting whenever they needed. Distance <500 meters suggests considerable exercise limitation; Distance 500-800 meters suggests moderate limitation; Distance >800 meters (with no rests) suggests mild or no limitation. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Cynthia Madden, MD, MPH | Senior Clinical Research Physician | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Arizona Pulmonary Specialists | Phoenix | Arizona | 85013 | United States | ||
| University of Arizona Clinical and Translational Science (CATS) Research Center |
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| ID | Title | Description |
|---|---|---|
| FG000 | UT-15C SR | UT-15C SR: Subjects will transition in the hospital from Remodulin to UT-15C SR within 5 days of the start of the transition. The dose of Remodulin will be decreased as the dose of UT-15C SR is increased over the 5 days. Once subjects have been transitioned from Remodulin, the dose of UT-15C SR will continue to be modified / titrated to the appropriate optimal dose for that subject throughout the rest of the study. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | UT-15C SR | UT-15C SR: Subjects will transition in the hospital from Remodulin to UT-15C SR within 5 days of the start of the transition. The dose of Remodulin will be decreased as the dose of UT-15C SR is increased over the 5 days. Once subjects have been transitioned from Remodulin, the dose of UT-15C SR will continue to be modified / titrated to the appropriate optimal dose for that subject throughout the rest of the study. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| 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 | Number of Participants That Were Succesfully Transitioned From Parenteral Remodulin to UT-15C. | Successful transition was based on the number of participants that completely transitioned to oral treprostinil by the week 4 study visit and clinically maintained on oral treprostinil treatment through Week 24. | Posted | Number | participants | Up to 24 weeks |
|
Adverse events were recorded throughout the 24-week study, including the screening and follow-up phase, as well as 30 days post end of study visit.
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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 | UT-15C SR: Subjects will transition in the hospital from Remodulin to UT-15C SR within 5 days of the start of the transition. The dose of Remodulin will be decreased as the dose of UT-15C SR is increased over the 5 days. Once subjects have been transitioned from Remodulin, the dose of UT-15C SR will continue to be modified / titrated to the appropriate optimal dose for that subject throughout the rest of the study. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhoea | Gastrointestinal disorders | MedDRA version 17.0 | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Headache | Nervous system disorders | MedDRA version 17.0 | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Nicole Leedom | United Therapeutics | 919-425-5870 | nleedom@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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|
| Baseline and week 24 |
| Change in Borg Dyspnea Score (Following 6MWT) From Baseline to Week 24 | The Borg dyspnea score is a 10-point scale rating the maximum level of dyspnea (difficulty in breathing) experienced during the six-minute walk test (6MWT). The Borg dyspnea score was assessed immediately following the 6MWT. Scores ranged from 0 (for no shortness of breath) to 10 (for the greatest shortness of breath ever experienced). | Baseline and week 24 |
| Change in Quality of Life (QoL) Assessment: Cambridge Pulmonary Hypertension Outcome Review (CAMPHOR) From Baseline to Week 24 | The CAMPHOR is a health related quality of life instrument validated for pulmonary hypertension that assesses impairment (symptoms), disability (activities) and quality of life. The questionnaire is divided into three sections; Symptoms (Scores 0-25; high scores indicate more symptoms), Activity (Score 0-30; low score indicates good functioning) and Quality of Life (0-25; high scores indicate poor QoL). The sum of these scores equates to the Total score (0-80). In the CAMPHOR scores, lower scores indicate improvements. | Baseline and week 24 |
| Change in World Health Organization (WHO) Functional Classification From Baseline to Week 24 | 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. | Baseline and Week 24 |
| Change in Dyspnea-fatigue Index From Baseline to Week 24 | The dyspnea-fatigue index has three components, each rated on a scale of 0 to 4, for the magnitude of the task that evokes dyspnea or fatigue, the magnitude of the pace (or effort) with which the task is performed and the associated functional impairment in general activities. The ratings for each component were added to form an aggregate score, which could range from 0, for the worst condition, to 12, for the best. | Baseline and Week 24 |
| Change From Baseline to Week 24 in Pharmacokinetic Parameters: Peak Plasma Concentration (Cmax), Average Plasma Concentration (Cavg), and Trough Plasma Concentration (Cmin) | Treprostinil pharmacokinetics (PK) were evaluated on two occasions during this study, once while the subject was still receiving Remodulin and again at Week 24 when the subject was receiving a stable dose of oral treprostinil. Blood samples were scheduled to be drawn from each subject initially at time 0 and the following subsequent times: 2, 4, 5, 6, 8, 10 and 12 hours after time of study drug administration (time 0) for a total of eight samples. | Baseline and Week 24 |
| Change From Baseline to Week 24 in Pharmacokinetics Parameter: Peak Time to Reach Peak Plasma Concentration [Tmax (h)] | Treprostinil pharmacokinetics (PK) were evaluated on two occasions during this study, once while the subject was still receiving Remodulin and again at Week 24 when the subject was receiving a stable dose of oral treprostinil. Blood samples were scheduled to be drawn from each subject initially at time 0 and the following subsequent times: 2, 4, 5, 6, 8, 10 and 12 hours after time of study drug administration (time 0) for a total of eight samples. | Baseline and Week 24 |
| Change From Baseline to Week 24 in Pharmacokinetics Parameters: Area Under the Plasma Concentration Curve (AUC) [h(ng/mL)] | Treprostinil pharmacokinetics (PK) were evaluated on two occasions during this study, once while the subject was still receiving Remodulin and again at Week 24 when the subject was receiving a stable dose of oral treprostinil. Blood samples were scheduled to be drawn from each subject initially at time 0 and the following subsequent times: 2, 4, 5, 6, 8, 10 and 12 hours after time of study drug administration (time 0) for a total of eight samples. | Baseline and Week 24 |
| Change From Baseline to Week 24 in Hemodynamics Parameters: Mean Pulmonary Artery Pressure (PAPm), Mean Right Atrial Pressure (RAPm) and Mean Pulmonary Capillary Wedge Pressure (PCWPm) | Pulmonary hypertension (PH) is an increase in pressure in the pulmonary vasculature defined as a mean pulmonary artery pressure (PAPm) greater than 25 mmHg at rest or greater than 30 mmHg with exercise, as measured by right heart catheterization. Right Atrial Pressure (RAP) is the pressure of blood in the right atrium of the heart. Pulmonary Capillary Wedge Pressure (PCWP) is used to calculated pulmonary vascular resistance and can help guide therapeutic efficacy. The PAPm, RAPm and PCWPm values and their respective changes from Baseline to Week 24 at peak exercise were measured by Swan-Ganz right heart catheterization. | Baseline and week 24 |
| Change From Baseline to Week 24 in Hemodynamics Parameters: Arterial Oxygen Saturation (SaO2) (%) and Mixed Venous Oxygen Saturation (SvO2) (%) | SaO2 measured by Arterial Blood Draw and Blood Gas Analyzer and SvO2 measured via Pulmonary Artery Catheter, are both Hemodynamics Parameters collected during right heart catheterization. Mixed venous oxygen saturation (SvO2) can help to determine whether the cardiac output and oxygen delivery is high enough to meet a patient's needs | Baseline and Week 24 |
| Change From Baseline to Week 24 in Hemodynamics Parameters: Cardiac Output (CO) (L/Min) | Cardiac Output (CO) is the volume of blood ejected by the heart per minute, as measured by right heart catheterization. The value and change from Baseline to Week 24 at peak exercise was measured by Swan-Ganz right heart catheterization. | Baseline and week 24 |
| Change From Baseline to Week 24 in Hemodynamics Parameters: Cardiac Index (CI) (L/Min/m^2) | Cardiac Index (CI) relates the cardiac output (CO) from left ventricle to body surface area (BSA), thus relating heart performance to the size of the individual. The CI values and their respective changes from Baseline to Week 24 at peak exercise was measured by Swan-Ganz right heart catheterization. | Baseline and week 24 |
| Change From Baseline to Week 24 in Hemodynamics Parameters: Pulmonary Vascular Resistance Index (PVRI) (mmHg*Min*m^2/L) | Pulmonary Vascular Resistance Index (PVRI) is calculated using Mean Pulmonary Arterial Pressure(PAPm), Pulmonary Capillary Wedge Pressure (PCWP) and Cardiac Index (CI ), to provide information about right ventricular overload. The PVRI values and their respective changes from Baseline to Week 24 at peak exercise was measured by Swan-Ganz right heart catheterization. | Baseline and week 24 |
| Change From Baseline to Week 24 in Hemodynamics Parameters: Pulmonary Vascular Resistance (PVR) (mmHg*Min/L) | pulmonary vascular resistance (PVR) is the resistance the right ventricle must overcome to pump blood into the pulmonary arteries. The change in PVR values from Baseline to Week 24 at peak exercise were measured by Swan-Ganz right heart catheterization. | Baseline and week 24 |
| Tucson |
| Arizona |
| 85724 |
| United States |
| Washington University School of Medicine | St Louis | Missouri | 63110 | United States |
| University of Rochester | Rochester | New York | 14642 | United States |
| The Ohio State University | Columbus | Ohio | 43221 | United States |
| University of Pittsburgh Medical Center (UPMC) | Pittsburgh | Pennsylvania | 15213 | United States |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Secondary | Change From Baseline in Six-minute Walk Distance at Week 24 | The purpose of the 6MWT is to evaluate exercise capacity associated with carrying out activities of daily living. Patients were instructed to walk down a corridor at a comfortable speed as far as they could manage for six minutes, resting whenever they needed. Distance <500 meters suggests considerable exercise limitation; Distance 500-800 meters suggests moderate limitation; Distance >800 meters (with no rests) suggests mild or no limitation. | One subject completed the Week 24 visit but was unable to undergo all assessments. As such, the evaluable data at Week 24 was summarized mainly using an N of 30 subjects. | Posted | Median | Full Range | meters | Baseline and week 24 |
|
|
|
| Secondary | Change in Borg Dyspnea Score (Following 6MWT) From Baseline to Week 24 | The Borg dyspnea score is a 10-point scale rating the maximum level of dyspnea (difficulty in breathing) experienced during the six-minute walk test (6MWT). The Borg dyspnea score was assessed immediately following the 6MWT. Scores ranged from 0 (for no shortness of breath) to 10 (for the greatest shortness of breath ever experienced). | One subject completed the Week 24 visit but was unable to undergo all assessments. As such, the evaluable data at Week 24 was summarized mainly using an N of 30 subjects. | Posted | Median | Full Range | units on a scale | Baseline and week 24 |
|
|
|
| Secondary | Change in Quality of Life (QoL) Assessment: Cambridge Pulmonary Hypertension Outcome Review (CAMPHOR) From Baseline to Week 24 | The CAMPHOR is a health related quality of life instrument validated for pulmonary hypertension that assesses impairment (symptoms), disability (activities) and quality of life. The questionnaire is divided into three sections; Symptoms (Scores 0-25; high scores indicate more symptoms), Activity (Score 0-30; low score indicates good functioning) and Quality of Life (0-25; high scores indicate poor QoL). The sum of these scores equates to the Total score (0-80). In the CAMPHOR scores, lower scores indicate improvements. | Posted | Median | Full Range | units on a scale | Baseline and week 24 |
|
|
|
| Secondary | Change in World Health Organization (WHO) Functional Classification From Baseline to Week 24 | 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. | The World Health Organization (WHO) Functional Classification was only conducted at baseline for one subject, because the subject discontinued the study prior to the collection of this assessment at the next visit. One subject had this assessment prior to study discontinuation. | Posted | Number | participants | Baseline and Week 24 |
|
|
|
| Secondary | Change in Dyspnea-fatigue Index From Baseline to Week 24 | The dyspnea-fatigue index has three components, each rated on a scale of 0 to 4, for the magnitude of the task that evokes dyspnea or fatigue, the magnitude of the pace (or effort) with which the task is performed and the associated functional impairment in general activities. The ratings for each component were added to form an aggregate score, which could range from 0, for the worst condition, to 12, for the best. | Posted | Median | Full Range | units on a scale | Baseline and Week 24 |
|
|
|
| Secondary | Change From Baseline to Week 24 in Pharmacokinetic Parameters: Peak Plasma Concentration (Cmax), Average Plasma Concentration (Cavg), and Trough Plasma Concentration (Cmin) | Treprostinil pharmacokinetics (PK) were evaluated on two occasions during this study, once while the subject was still receiving Remodulin and again at Week 24 when the subject was receiving a stable dose of oral treprostinil. Blood samples were scheduled to be drawn from each subject initially at time 0 and the following subsequent times: 2, 4, 5, 6, 8, 10 and 12 hours after time of study drug administration (time 0) for a total of eight samples. | Dosing frequency was modified for BID to TID during the study, reported separately for patients on BID vs TID dosing at week 24. The number of participants analyzed is inconsistent with participant flow because it includes data from an early termination patient. A pharmacokinetics sample collected at early termination was included in the analysis. | Posted | Median | Full Range | (ng/mL) | Baseline and Week 24 |
|
|
|
| Secondary | Change From Baseline to Week 24 in Pharmacokinetics Parameter: Peak Time to Reach Peak Plasma Concentration [Tmax (h)] | Treprostinil pharmacokinetics (PK) were evaluated on two occasions during this study, once while the subject was still receiving Remodulin and again at Week 24 when the subject was receiving a stable dose of oral treprostinil. Blood samples were scheduled to be drawn from each subject initially at time 0 and the following subsequent times: 2, 4, 5, 6, 8, 10 and 12 hours after time of study drug administration (time 0) for a total of eight samples. | Dosing frequency was modified for BID to TID during the study, reported separately for patients on BID vs TID dosing at week 24. The number of participants analyzed is inconsistent with participant flow because it includes data from an early termination patient. A pharmacokinetics sample collected at early termination was included in the analysis. | Posted | Mean | Full Range | [Tmax (h)] | Baseline and Week 24 |
|
|
|
| Secondary | Change From Baseline to Week 24 in Pharmacokinetics Parameters: Area Under the Plasma Concentration Curve (AUC) [h(ng/mL)] | Treprostinil pharmacokinetics (PK) were evaluated on two occasions during this study, once while the subject was still receiving Remodulin and again at Week 24 when the subject was receiving a stable dose of oral treprostinil. Blood samples were scheduled to be drawn from each subject initially at time 0 and the following subsequent times: 2, 4, 5, 6, 8, 10 and 12 hours after time of study drug administration (time 0) for a total of eight samples. | The number of participants analyzed is inconsistent with participant flow because it includes data from an early termination patient. A pharmacokinetics sample collected at early termination was included in the analysis. | Posted | Median | Full Range | [h(ng/mL)] | Baseline and Week 24 |
|
|
|
| Secondary | Change From Baseline to Week 24 in Hemodynamics Parameters: Mean Pulmonary Artery Pressure (PAPm), Mean Right Atrial Pressure (RAPm) and Mean Pulmonary Capillary Wedge Pressure (PCWPm) | Pulmonary hypertension (PH) is an increase in pressure in the pulmonary vasculature defined as a mean pulmonary artery pressure (PAPm) greater than 25 mmHg at rest or greater than 30 mmHg with exercise, as measured by right heart catheterization. Right Atrial Pressure (RAP) is the pressure of blood in the right atrium of the heart. Pulmonary Capillary Wedge Pressure (PCWP) is used to calculated pulmonary vascular resistance and can help guide therapeutic efficacy. The PAPm, RAPm and PCWPm values and their respective changes from Baseline to Week 24 at peak exercise were measured by Swan-Ganz right heart catheterization. | One subject completed the Week 24 visit but was unable to undergo these assessments. As such, the evaluable data at Week 24 was summarized using an N of 30 subjects, which is why the number of participants analyzed is inconsistent with the participant flow module. | Posted | Mean | Standard Deviation | mmHg | Baseline and week 24 |
|
|
|
| Secondary | Change From Baseline to Week 24 in Hemodynamics Parameters: Arterial Oxygen Saturation (SaO2) (%) and Mixed Venous Oxygen Saturation (SvO2) (%) | SaO2 measured by Arterial Blood Draw and Blood Gas Analyzer and SvO2 measured via Pulmonary Artery Catheter, are both Hemodynamics Parameters collected during right heart catheterization. Mixed venous oxygen saturation (SvO2) can help to determine whether the cardiac output and oxygen delivery is high enough to meet a patient's needs | One subject completed the Week 24 visit but was unable to undergo all assessments. As such, the evaluable data at Week 24 was summarized mainly using an N of 30 subjects. | Posted | Mean | Standard Deviation | Percent of Oxygen saturation | Baseline and Week 24 |
|
|
|
| Secondary | Change From Baseline to Week 24 in Hemodynamics Parameters: Cardiac Output (CO) (L/Min) | Cardiac Output (CO) is the volume of blood ejected by the heart per minute, as measured by right heart catheterization. The value and change from Baseline to Week 24 at peak exercise was measured by Swan-Ganz right heart catheterization. | One subject completed the Week 24 visit but was unable to undergo all assessments. As such, the evaluable data at Week 24 was summarized mainly using an N of 30 subjects. | Posted | Mean | Standard Deviation | L/min | Baseline and week 24 |
|
|
|
| Secondary | Change From Baseline to Week 24 in Hemodynamics Parameters: Cardiac Index (CI) (L/Min/m^2) | Cardiac Index (CI) relates the cardiac output (CO) from left ventricle to body surface area (BSA), thus relating heart performance to the size of the individual. The CI values and their respective changes from Baseline to Week 24 at peak exercise was measured by Swan-Ganz right heart catheterization. | Both the Thermodilution (n=6) and Fick (n=29) methods were used to determine CO and in some cases both methods were utilized; however, only the Fick method was used for (CI) for the purpose of this analysis and included only 29 subjects. | Posted | Mean | Standard Deviation | L/min/m^2 | Baseline and week 24 |
|
|
|
| Secondary | Change From Baseline to Week 24 in Hemodynamics Parameters: Pulmonary Vascular Resistance Index (PVRI) (mmHg*Min*m^2/L) | Pulmonary Vascular Resistance Index (PVRI) is calculated using Mean Pulmonary Arterial Pressure(PAPm), Pulmonary Capillary Wedge Pressure (PCWP) and Cardiac Index (CI ), to provide information about right ventricular overload. The PVRI values and their respective changes from Baseline to Week 24 at peak exercise was measured by Swan-Ganz right heart catheterization. | One subject completed the Week 24 visit but was unable to undergo all assessments. As such, the evaluable data at Week 24 was summarized mainly using an N of 30 subjects. | Posted | Mean | Standard Deviation | mmHg*min*m^2/L | Baseline and week 24 |
|
|
|
| Secondary | Change From Baseline to Week 24 in Hemodynamics Parameters: Pulmonary Vascular Resistance (PVR) (mmHg*Min/L) | pulmonary vascular resistance (PVR) is the resistance the right ventricle must overcome to pump blood into the pulmonary arteries. The change in PVR values from Baseline to Week 24 at peak exercise were measured by Swan-Ganz right heart catheterization. | One subject completed the Week 24 visit but was unable to undergo all assessments. As such, the evaluable data at Week 24 was summarized mainly using an N of 30 subjects. | Posted | Mean | Standard Deviation | mmHg*min/L | Baseline and week 24 |
|
|
|
| 9 |
| 33 |
| 32 |
| 33 |
| Nausea | Gastrointestinal disorders | MedDRA version 17.0 | Non-systematic Assessment |
|
| Vertigo | Nervous system disorders | MedDRA version 17.0 | Non-systematic Assessment |
|
| Abdominal Distension | Gastrointestinal disorders | MedDRA version 17.0 | Non-systematic Assessment |
|
| Anemia | Blood and lymphatic system disorders | MedDRA version 17.0 | Non-systematic Assessment |
|
| Ascites | Hepatobiliary disorders | MedDRA version 17.0 | Non-systematic Assessment |
|
| Atrial Flutter | Cardiac disorders | MedDRA version 17.0 | Non-systematic Assessment |
|
| Dyspnea | Respiratory, thoracic and mediastinal disorders | MedDRA version 17.0 | Non-systematic Assessment |
|
| Gastric Ulcer | Gastrointestinal disorders | MedDRA version 17.0 | Non-systematic Assessment |
|
| Gastroenteritis Viral | Infections and infestations | MedDRA version 17.0 | Non-systematic Assessment |
|
| Lung carcinoma cell type unspecified stage IV | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 17.0 | Non-systematic Assessment |
|
| Metastases to bone | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 17.0 | Non-systematic Assessment |
|
| Palpitations | Cardiac disorders | MedDRA version 17.0 | Non-systematic Assessment |
|
| Pleurisy | Cardiac disorders | MedDRA version 17.0 | Non-systematic Assessment |
|
| Renal Failure Acute | Renal and urinary disorders | MedDRA version 17.0 | Non-systematic Assessment |
|
| Systemic Lupus Erythematosus | Immune system disorders | MedDRA version 17.0 | Non-systematic Assessment |
|
| Ventricular Extrasystoles | Cardiac disorders | MedDRA version 17.0 | Non-systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA version 17.0 | Non-systematic Assessment |
|
| Chronic Hepatic Failure | Hepatobiliary disorders | MedDRA version 17.0 | Non-systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA version 17.0 | Non-systematic Assessment |
|
| Flushing | Vascular disorders | MedDRA version 17.0 | Non-systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA version 17.0 | Non-systematic Assessment |
|
| Fatigue | General disorders | MedDRA version 17.0 | Non-systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA version 17.0 | Non-systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | MedDRA version 17.0 | Non-systematic Assessment |
|
| Dyspnea | Respiratory, thoracic and mediastinal disorders | MedDRA version 17.0 | Non-systematic Assessment |
|
| Upper Resipiratory Tract Infection | Respiratory, thoracic and mediastinal disorders | MedDRA version 17.0 | Non-systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA version 17.0 | Non-systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA version 17.0 | Non-systematic Assessment |
|
| Pain in jaw | Musculoskeletal and connective tissue disorders | MedDRA version 17.0 | Non-systematic Assessment |
|
| Fluid Retention | Metabolism and nutrition disorders | MedDRA version 17.0 | Non-systematic Assessment |
|
| Nasal Congestion | Respiratory, thoracic and mediastinal disorders | MedDRA version 17.0 | Non-systematic Assessment |
|
| Abdominal distension | Gastrointestinal disorders | MedDRA version 17.0 | Non-systematic Assessment |
|
| Abdominal Pain | Gastrointestinal disorders | MedDRA version 17.0 | Non-systematic Assessment |
|
| Back Pain | Musculoskeletal and connective tissue disorders | MedDRA version 17.0 | Non-systematic Assessment |
|
| Palpitations | Cardiac disorders | MedDRA version 17.0 | Non-systematic Assessment |
|
| Tachycardia | Cardiac disorders | MedDRA version 17.0 | Non-systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA version 17.0 | Non-systematic Assessment |
|
| Insomnia | Psychiatric disorders | MedDRA version 17.0 | Non-systematic Assessment |
|
| Edema Peripheral | Eye disorders | MedDRA version 17.0 | Non-systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA version 17.0 | Non-systematic Assessment |
|
| Anxiety | Psychiatric disorders | MedDRA version 17.0 | Non-systematic Assessment |
|
| Bronchitis | Respiratory, thoracic and mediastinal disorders | MedDRA version 17.0 | Non-systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA version 17.0 | Non-systematic Assessment |
|
| Nasopharyngitis | Respiratory, thoracic and mediastinal disorders | MedDRA version 17.0 | Non-systematic Assessment |
|
| Pain | General disorders | MedDRA version 17.0 | Non-systematic Assessment |
|
| Renal Failure Acute | Renal and urinary disorders | MedDRA version 17.0 | Non-systematic Assessment |
|
| Weight Decreased | Investigations | MedDRA version 17.0 | Non-systematic Assessment |
|
| Weight Increased | Investigations | MedDRA version 17.0 | Non-systematic Assessment |
|
| Decreased Appetite | Metabolism and nutrition disorders | MedDRA version 17.0 | Non-systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA version 17.0 | Non-systematic Assessment |
|
| Chest Discomfort | Respiratory, thoracic and mediastinal disorders | MedDRA version 17.0 | Non-systematic Assessment |
|
| Chills | General disorders | MedDRA version 17.0 | Non-systematic Assessment |
|
| Dermatitis | Skin and subcutaneous tissue disorders | MedDRA version 17.0 | Non-systematic Assessment |
|
| Dry Mouth | General disorders | MedDRA version 17.0 | Non-systematic Assessment |
|
| Dyspnea Exertional | Respiratory, thoracic and mediastinal disorders | MedDRA version 17.0 | Non-systematic Assessment |
|
| Epistaxis | Vascular disorders | MedDRA version 17.0 | Non-systematic Assessment |
|
| Gastroenteritis | Gastrointestinal disorders | MedDRA version 17.0 | Non-systematic Assessment |
|
| Hypotension | Vascular disorders | MedDRA version 17.0 | Non-systematic Assessment |
|
| Iron Deficiency Anemia | Blood and lymphatic system disorders | MedDRA version 17.0 | Non-systematic Assessment |
|
| Muscle Spasms | Musculoskeletal and connective tissue disorders | MedDRA version 17.0 | Non-systematic Assessment |
|
| Musculoskeletal Pain | Musculoskeletal and connective tissue disorders | MedDRA version 17.0 | Non-systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA version 17.0 | Non-systematic Assessment |
|
| Ocular hyperemia | Eye disorders | MedDRA version 17.0 | Non-systematic Assessment |
|
| Pyrexia | General disorders | MedDRA version 17.0 | Non-systematic Assessment |
|
| Rectal Hemorrhage | Gastrointestinal disorders | MedDRA version 17.0 | Non-systematic Assessment |
|
| Rhinitis | Respiratory, thoracic and mediastinal disorders | MedDRA version 17.0 | Non-systematic Assessment |
|
| Rhinorrhea | Respiratory, thoracic and mediastinal disorders | MedDRA version 17.0 | Non-systematic Assessment |
|
| Sinusitis | Immune system disorders | MedDRA version 17.0 | Non-systematic Assessment |
|
| Wheezing | Respiratory, thoracic and mediastinal disorders | MedDRA version 17.0 | 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.
| Title | Measurements |
|---|---|
|
| Total Camphor Score |
|
| Title | Measurements |
|---|
|
| II to I |
|
| II to II |
|
| II to III |
|
| Missing |
|
|
| Cmin (ng/mL) |
|
| Title | Measurements |
|---|---|
|