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The purpose of the study is to evaluate the safety and tolerability of a rapid dose titration regimen of subcutaneous Remodulin® therapy in patients with PAH.
This is an open label, single territory, multi-centre study in subjects with pulmonary arterial.
hypertension (PAH). Subjects were treatment naïve or receiving an approved endothelin receptor antagonist (ERA) and / or phosphodiesterase (PDE)-5 inhibitor for at least 60 days prior to screening and maintained on a stable dose for at least 30 days.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Remodulin | Experimental | Remodulin will be initiated, whilst subjects are hospitalized (minimum of 72 hours) and under medical supervision, at approximately 2 ng/kg/min as a continuous SC infusion with dose increments of 1-2 ng/kg/min applied approximately every 12 hours according to clinical response and tolerability. Following discharge, dose rate increments are permitted at 1-2 ng/kg/min with a minimum of 24 hours between each dose up-titration. Once a dose rate of 20 ng/kg/min is achieved, the dose increments can be increased up to 4 ng/kg/min with dose increments separated by at least 24 hours. The aim is to achieve a target dose of 10, 20, and 30 ng/kg/min by the end of weeks 1, 4 and 12, respectively. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Remodulin | Drug | Treatment will be initiated whilst hospitalized at approximately 2.0 ng/kg/min with dose increments of 1- 2 ng/kg/min approximately every 12 hours according to clinical response and tolerability. Following subject discharge, the dose rate is increased by 1-2 ng/kg/min with dose increments separated by at least 24 hours. When a dose rate of 20 ng/kg/min is achieved dose increments can be increased at a rate of up to 4 ng/kg/min with dose increments separated by at least 24 hours depending on tolerability. The aim is to achieve a dose rate of at least 10, 20 and 30 ng/kg/min by the end of weeks 1, 4 and 12, respectively and a dose rate by the end of week 16 that achieves pre-defined treatment goals subject to clinical response and tolerability. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Successful Completion of the 16 Week Treatment Period. | Successful completion was defined as completion of the 16 week treatment period of the study without experiencing any serious adverse events considered by the investigator to be possibly related to Remodulin. | Baseline to week 16 |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Six Minute Walk Distance at Week 16. | The purpose of the six minute walk test (6MWT) was 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:
The subject is at least 18 years of age at screening.
The subject weigh a minimum of 40 kg with a body mass index less than 40 kg/m^2 at screening.
Sexually active women of childbearing potential must use two different forms of highly effective contraception. Males participating in the study must use a condom during the length of the study, and for at least 64 days after discontinuing study drug.
The subject has a diagnosis of symptomatic idiopathic or heritable PAH (IPAH or HPAH).
A Baseline 6MWD between 150 and 550 metres is required, in the absence of a concurrent injury, illness (other than PAH or a PAH related condition), or other confounding factors that would effect the subject's exercise capacity.
The subject is either treatment naïve or receiving an approved PDE-5 inhibitor and / or an approved ERA for at least 60 days prior to screening and is on a stable dose for 30 days and is willing to remain on a PDE-5 inhibitor and / or an ERA at the same dose for the duration of the 16-week treatment phase.
The subject must be optimally treated with conventional pulmonary hypertension therapy (e.g., oral vasodilators, oxygen, digoxin, etc.) with no additions, discontinuations, or dose changes for at least 14 days prior to screening (excluding diuretics and anticoagulant dose adjustments).
The subject has undergone right heart catheterisation at screening (or within 8 weeks before screening) and has been documented to have a mean pulmonary artery pressure (PAPm) of greater than or equal to 25 mmHg, a pulmonary capillary wedge pressure (PCWP) of less than or equal to 15 mmHg, and pulmonary vascular resistance (PVR) of more than 3 Wood units.
The subject has undergone echocardiography at screening with evidence of clinically normal left systolic and diastolic ventricular function, absence of any clinically significant left sided heart disease (e.g., mitral valve stenosis) and absence of unrepaired congenital heart disease.
The subject has a previous ventilation perfusion lung scan and / or high resolution computerised tomography scan of the chest and / or pulmonary angiography that is consistent with the diagnosis of PAH (e.g., low probability of pulmonary embolism; absence of major perfusion defects).
The subject has pulmonary function tests done within 9 months of screening with the following:
In the opinion of the Principal Investigator, the subject is able to communicate effectively with study personnel, was considered reliable, willing and likely to be cooperative with protocol requirements.
The subject voluntarily gives written informed consent to participate in the study.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Grünig | Thoraxklinik am Universitätsklinikum, Heidelberg, Germany | Principal Investigator |
| Klose | Universitätsklinikum Hamburg-Eppendorf | Principal Investigator |
| Rosenkranz | Universitätsklinikum Köln, Köln, Germany | Principal Investigator |
| Höffken | Universitaetsklinikum Dresden, Dresden, Germany | Principal Investigator |
| Lange | Universitätsklinikum Regensburg, Regensburg, Germany | Principal Investigator |
| Wirtz | Universitätsklinikum Leipzig, Leipzig, Germany | Principal Investigator |
| Neurohr | Klinikum Großhadern der LMU, Munich, Germany | Principal Investigator |
| Wilkens | Universitätsklinikum Klinik, Homburg, Germany | Principal Investigator |
| Held | Missionsärztliche Klinik, Würzburg, Germany | Principal Investigator |
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| ID | Title | Description |
|---|---|---|
| FG000 | Remodulin | Remodulin was initiated, whilst subjects were hospitalized, at approximately 2 ng/kg/min as a continuous SC infusion with dose increments of 1-2 ng/kg/min applied approximately every 12 hours according to clinical response and tolerability. Following discharge, dose rate increments were permitted at 1-2 ng/kg/min with a minimum of 24 hours between each dose up-titration. Once a dose rate of 20 ng/kg/min was achieved, the dose increments could be increased up to 4 ng/kg/min, with dose increments separated by at least 24 hours. The aim was to achieve a target dose rate of 10, 20, and 30 ng/kg/min by the end of Weeks 1, 4, and 12, respectively. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Remodulin | Remodulin was initiated, whilst subjects were hospitalized, at approximately 2 ng/kg/min as a continuous SC infusion with dose increments of 1-2 ng/kg/min applied approximately every 12 hours according to clinical response and tolerability. Following discharge, dose rate increments were permitted at 1-2 ng/kg/min with a minimum of 24 hours between each dose up-titration. Once a dose rate of 20 ng/kg/min was achieved, the dose increments could be increased up to 4 ng/kg/min, with dose increments separated by at least 24 hours. The aim was to achieve a target dose rate of 10, 20, and 30 ng/kg/min by the end of Weeks 1, 4, and 12, respectively. |
| 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 | Number of Participants With Successful Completion of the 16 Week Treatment Period. | Successful completion was defined as completion of the 16 week treatment period of the study without experiencing any serious adverse events considered by the investigator to be possibly related to Remodulin. | Posted | Number | participants | Baseline to week 16 |
|
Adverse events were recorded throughout the 16-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 | Remodulin | Remodulin was initiated, whilst subjects were hospitalized, at approximately 2 ng/kg/min as a continuous SC infusion with dose increments of 1-2 ng/kg/min applied approximately every 12 hours according to clinical response and tolerability. Following discharge, dose rate increments were permitted at 1-2 ng/kg/min with a minimum of 24 hours between each dose up-titration. Once a dose rate of 20 ng/kg/min was achieved, the dose increments could be increased up to 4 ng/kg/min, with dose increments separated by at least 24 hours. The aim was to achieve a target dose of 10, 20, and 30 ng/kg/min by the end of Weeks 1, 4, and 12, respectively. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Right Ventricular Failure (RVF) | Cardiac disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Iron Deficiency Anemia | Blood and lymphatic system disorders | MedDRA (Unspecified) | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Leigh Peterson, Director, Product Development, Product Development & Global Clinical Operations | United Therapeutics Corporation | 919-425-8165 | lpeterson@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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|
|
| Baseline to week 16 |
| Change in Borg Dyspnea Score (Following 6MWT) From Baseline to Week 16 | The Borg dyspnea score is a 10 point scale rating the maximum level of dyspnea (difficulty in breathing) experienced during the 6MWT. The Borg dyspnea score was assessed immediately following the 6MWT. Scores range from 0 (for no shortness of breath) to 10 (for the greatest shortness of breath ever experienced). | Baseline to week 16 |
| Change in N-terminal Pro-B-type Natriuretic Peptide (NT-proBNP) Concentrations From Baseline to Week 16. | The level of this biomarker of the (NT-proBNP) serum concentration was assessed to compare the severity of heart failure at Baseline and Week 16. | Baseline to week 16 |
| Number of Participants With a Change From Baseline World Health Organization (WHO) Functional Classification at Week 16. | The WHO Functional Class of pulmonary hypertension is a physical activity rating scale as follows: 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 to week 16 |
| Change in Quality of Life (QoL) Assessment: Cambridge Pulmonary Hypertension Outcome Review (CAMPHOR) From Baseline to Week 16. | 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, negative change scores indicate improvements. | Baseline to week 16 |
| Change From Baseline to Week 16 in Hemodynamic Parameters: Mean Pulmonary Artery Pressure (PAPm), Mean Right Atrial Pressure (RAPm) and Mean Pulmonary Capillary Wedge Pressure (PCWPm). | Pulmonary hypertension, 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 Swan-Ganz right heart catheterization. The PAPm, RAPm and PCWPm values and their respective changes from Baseline to Week 16 were measured by SwanGanz right heart catheterization and summarized. | Baseline to week 16 |
| Change From Baseline to Week 16 in Hemodynamic Parameters: Cardiac Index (CI) (L/Min/m^2) | Cardiac Index (CI) relates the cardiac output (CO) 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 16 were measured by SwanGanz right heart catheterization and summarized. | Baseline to week 16 |
| Change From Baseline to Week 16 in HemodynamicParameters: 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 load. The PVRI values and their respective changes from Baseline to Week 16 were measured by SwanGanz right heart catheterization. | Baseline to week 16 |
| Krüger |
| Herzzentrum Duisburg, Duisburg, Germany |
| Principal Investigator |
| Physician Decision |
|
| Participants |
|
| Age, Continuous | Median | Full Range | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| Secondary | Change From Baseline in Six Minute Walk Distance at Week 16. | The purpose of the six minute walk test (6MWT) was 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. | Two subjects that completed the treatment period did not complete the six minute walk test at week 16. As such, the evaluable data for the six minute walk test at Week 16 was summarized using an N of 30 subjects. | Posted | Median | Full Range | meters | Baseline to week 16 |
|
|
|
| Secondary | Change in Borg Dyspnea Score (Following 6MWT) From Baseline to Week 16 | The Borg dyspnea score is a 10 point scale rating the maximum level of dyspnea (difficulty in breathing) experienced during the 6MWT. The Borg dyspnea score was assessed immediately following the 6MWT. Scores range from 0 (for no shortness of breath) to 10 (for the greatest shortness of breath ever experienced). | Two subjects that completed the treatment period did not complete the six minute walk test at week 16. As such, the evaluable data for the six minute walk test at Week 16 was summarized using an N of 30 subjects. | Posted | Median | Full Range | units on a scale | Baseline to week 16 |
|
|
|
| Secondary | Change in N-terminal Pro-B-type Natriuretic Peptide (NT-proBNP) Concentrations From Baseline to Week 16. | The level of this biomarker of the (NT-proBNP) serum concentration was assessed to compare the severity of heart failure at Baseline and Week 16. | Posted | Median | Full Range | pg/mL | Baseline to week 16 |
|
|
|
| Secondary | Number of Participants With a Change From Baseline World Health Organization (WHO) Functional Classification at Week 16. | The WHO Functional Class of pulmonary hypertension is a physical activity rating scale as follows: 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. | Posted | Count of Participants | Participants | No | Baseline to week 16 |
|
|
|
| Secondary | Change in Quality of Life (QoL) Assessment: Cambridge Pulmonary Hypertension Outcome Review (CAMPHOR) From Baseline to Week 16. | 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, negative change scores indicate improvements. | Scores could not be tabulated for one subject due to missing responses to individual questions | Posted | Median | Full Range | units on a scale | Baseline to week 16 |
|
|
|
| Secondary | Change From Baseline to Week 16 in Hemodynamic Parameters: Mean Pulmonary Artery Pressure (PAPm), Mean Right Atrial Pressure (RAPm) and Mean Pulmonary Capillary Wedge Pressure (PCWPm). | Pulmonary hypertension, 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 Swan-Ganz right heart catheterization. The PAPm, RAPm and PCWPm values and their respective changes from Baseline to Week 16 were measured by SwanGanz right heart catheterization and summarized. | Only 29 of the 32 subjects that completed the 16 week treatment period completed these hemodynamic assessments. | Posted | Mean | Standard Deviation | mmHG | Baseline to week 16 |
|
|
|
| Secondary | Change From Baseline to Week 16 in Hemodynamic Parameters: Cardiac Index (CI) (L/Min/m^2) | Cardiac Index (CI) relates the cardiac output (CO) 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 16 were measured by SwanGanz right heart catheterization and summarized. | Only 29 of the 32 subjects that completed the 16 week treatment period completed these hemodynamic assessments. | Posted | Mean | Standard Deviation | L/min/m^2 | Baseline to week 16 |
|
|
|
| Secondary | Change From Baseline to Week 16 in HemodynamicParameters: 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 load. The PVRI values and their respective changes from Baseline to Week 16 were measured by SwanGanz right heart catheterization. | Only 29 of the 32 subjects that completed the 16 week treatment period completed these hemodynamic assessments. | Posted | Mean | Standard Deviation | mmHg*min*m^2/L | Baseline to week 16 |
|
|
|
| 0 |
| 39 |
| 11 |
| 39 |
| 39 |
| 39 |
| Fluid Overload | Metabolism and nutrition disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Diarrhoea, | Gastrointestinal disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Infusion Site Pain | Skin and subcutaneous tissue disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Rib Fracture | Musculoskeletal and connective tissue disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Hypotension | Vascular disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Atrial fibrillation | Cardiac disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Syncope | Nervous system disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Fatigue | General disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Non-Cardiac Chest Pain | General disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Renal Impairment | Renal and urinary disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Back Pain | Musculoskeletal and connective tissue disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Dehydration | Metabolism and nutrition disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Bronchitis | Infections and infestations | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Pneumonia, bacterial | Infections and infestations | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Angina pectoris | Cardiac disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Tachycardia | Cardiac disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Vertigo | Ear and labyrinth disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Abdominal distension | Gastrointestinal disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Infusion Site Pain | General disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Infusion Site Erythema | General disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Oedema Peripheral | General disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Infusion Site Haemorrhage | General disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Fatigue | General disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Infusion Site Irritation | General disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Infusion Site Swelling | General disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Local swelling | General disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Infusion Site Infection | Infections and infestations | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Decreased Appetite | Metabolism and nutrition disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Pain in jaw | Musculoskeletal and connective tissue disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Rheumatic disorder | Musculoskeletal and connective tissue disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Back Pain | Musculoskeletal and connective tissue disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Bone Pain | Musculoskeletal and connective tissue disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Groin Pain | Musculoskeletal and connective tissue disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Eczema | Skin and subcutaneous tissue disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Hypotension | Vascular disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Flushing | Vascular disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Injection Site Inflammation | General disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Oedema | General disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Sleep disorder | Psychiatric disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Presyncope | Nervous system disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Infusion site abscess | Infections and infestations | MedDRA (Unspecified) | 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 |
|---|
|
| III to III |
|
| III to IV |
|
| Title | Measurements |
|---|---|
|