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| Name | Class |
|---|---|
| The Emmes Company, LLC | INDUSTRY |
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Thirty (30) patients with chronic ischemic left ventricular dysfunction secondary to MI scheduled to undergo cardiac catheterization will be enrolled in the study. This is a phase II study intended to gain additional safety and efficacy assessments among two dose levels previously studied in a phase I setting.
Thirty (30) patients with chronic ischemic left ventricular dysfunction secondary to MI scheduled to undergo cardiac catheterization will be enrolled in the study.This is a phase II study intended to gain additional safety and efficacy assessments among two dose levels previously studied in a phase I setting. In this study, a 20 million total hMSC dose and a 100 million total hMSC dose will be randomly allocated administered via the Biocardia Helical infusion system in a blinded manner.
The technique of transplanting progenitor cells into a region of damaged myocardium, termed cellular cardiomyoplasty, is a potentially new therapeutic modality designed to replace or repair necrotic, scarred, or dysfunctional myocardium. Ideally, graft cells should be readily available, easy to culture to ensure adequate quantities for transplantation, and able to survive in host myocardium, which is often a hostile environment of limited blood supply and immunorejection. Whether effective cellular regenerative strategies require that administered cells differentiate into adult cardiomyocytes and couple electromechanically with the surrounding myocardium is increasingly controversial and recent evidence suggests that this may not be required for effective cardiac repair. Most importantly, transplantation of graft cells should improve cardiac function and prevent adverse ventricular remodeling. To date, a number of candidate cells have been transplanted in experimental models, including fetal and neonatal cardiomyocytes, embryonic stem cell-derived myocytes, tissue engineered contractile grafts9, skeletal myoblasts, several cell types derived from adult bone marrow, and cardiac precursors residing within the heart itself. There has been substantial clinical development in the use of whole bone marrow and skeletal myoblast preparations in studies enrolling both post-infarction patients and patients with chronic ischemic left ventricular dysfunction and heart failure. The effects of bone marrow-derived mesenchymal stem cells (MSCs) have also been studied clinically.
Currently, bone marrow or bone marrow-derived cells represent a highly promising modality for cardiac repair. The totality of evidence from trials investigating autologous whole bone marrow infusions into patients following myocardial infarction supports the safety of this approach. In terms of efficacy, increases in ejection fraction are reported in the majority of the trials.
Chronic ischemic left ventricular dysfunction is a common and problematic condition; definitive therapy in the form of heart transplantation is available to only a tiny minority of eligible patients. Cellular cardiomyoplasty for chronic heart failure has been studied less than for acute MI, but represents a potentially important alternative for this disease.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1: 20 million Allogeneic hMSCs | Experimental | Fifteen (15) patients to be treated with Allo-hMSCs: 4 million cells/ml delivered in a dose of 0.5 ml per injection x 10 injections for a total of 0.2x 10^8 (20 million) Allo-hMSCs. |
|
| Group 2: 100 million Allogeneic hMSCs | Experimental | Fifteen (15) patients to be treated with Allo-hMSCs: 20 million cells/ml delivered in a dose of 0.5 ml per injection x 10 injections for a total of 1x 10^8 (100 million) Allo-hMSCs. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Allogeneic hMSCs | Biological | Allogeneic Adult Human Mesenchymal Stem Cells (MSCs) delivered via injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Treatment-emergent Serious Adverse Events (SAE). | Incidence (at one month post-catheterization) of any treatment-emergent serious adverse events, defined as the composite of: death, non-fatal MI, stroke, hospitalization for worsening heart failure, cardiac perforation, pericardial tamponade, sustained ventricular arrhythmias (characterized by ventricular arrhythmias lasting longer than 15 seconds or with hemodynamic compromise). | One month post-catheterization |
| Measure | Description | Time Frame |
|---|---|---|
| Infarct Scar Size (ISS) | Determined by delayed contrast enhanced Computed Tomography (CT) Scan | Baseline, 12 months |
| Number of Participant With Reported Tissue Perfusion | Tissue perfusion measured by CT. |
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Inclusion Criteria:
In order to participate in this study, a patient MUST:
Exclusion Criteria:
In order to participate in this study, a patient MUST NOT:
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| Name | Affiliation | Role |
|---|---|---|
| Joshua M Hare, MD | ISCI / University of Miami Miller School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| ISCI / University of Miami | Miami | Florida | 33136 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28923793 | Background | Florea V, Rieger AC, DiFede DL, El-Khorazaty J, Natsumeda M, Banerjee MN, Tompkins BA, Khan A, Schulman IH, Landin AM, Mushtaq M, Golpanian S, Lowery MH, Byrnes JJ, Hendel RC, Cohen MG, Valasaki K, Pujol MV, Ghersin E, Miki R, Delgado C, Abuzeid F, Vidro-Casiano M, Saltzman RG, DaFonseca D, Caceres LV, Ramdas KN, Mendizabal A, Heldman AW, Mitrani RD, Hare JM. Dose Comparison Study of Allogeneic Mesenchymal Stem Cells in Patients With Ischemic Cardiomyopathy (The TRIDENT Study). Circ Res. 2017 Nov 10;121(11):1279-1290. doi: 10.1161/CIRCRESAHA.117.311827. Epub 2017 Sep 18. |
| Label | URL |
|---|---|
| Interdisciplinary Stem Cell Institute at the University of Miami Miller School of Medicine | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Group 1: 20 Million Allogeneic hMSCs | Fifteen (15) patients to be treated with Allo-hMSCs: 4 million cells/ml delivered in a dose of 0.5 ml per injection x 10 injections for a total of 0.2x 10^8 (20 million) Allo-hMSCs. Allogeneic hMSCs: Allogeneic Adult Human Mesenchymal Stem Cells (MSCs) delivered via injection |
| FG001 | Group 2: 100 Million Allogeneic hMSCs | Fifteen (15) patients to be treated with Allo-hMSCs: 20 million cells/ml delivered in a dose of 0.5 ml per injection x 10 injections for a total of 1x 10^8 (100 million) Allo-hMSCs. Allogeneic hMSCs: Allogeneic Adult Human Mesenchymal Stem Cells (MSCs) delivered via injection |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Group 1: 20 Million Allogeneic hMSCs | Fifteen (15) patients to be treated with Allo-hMSCs: 4 million cells/ml delivered in a dose of 0.5 ml per injection x 10 injections for a total of 0.2x 10^8 (20 million) Allo-hMSCs. Allogeneic hMSCs: Allogeneic Adult Human Mesenchymal Stem Cells (MSCs) delivered via injection |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 Treatment-emergent Serious Adverse Events (SAE). | Incidence (at one month post-catheterization) of any treatment-emergent serious adverse events, defined as the composite of: death, non-fatal MI, stroke, hospitalization for worsening heart failure, cardiac perforation, pericardial tamponade, sustained ventricular arrhythmias (characterized by ventricular arrhythmias lasting longer than 15 seconds or with hemodynamic compromise). | SAEs are collected for 12 months, however, outcome 1 is only for SAEs during the first month. | Posted | Count of Participants | Participants | One month post-catheterization |
|
Adverse events are collected over approximately 1 year period.
TE-SAE will only be reported for outcome 1 through 1 month post catheterization.
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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 | Group 1: 20 Million Allogeneic hMSCs | Fifteen (15) patients to be treated with Allo-hMSCs: 4 million cells/ml delivered in a dose of 0.5 ml per injection x 10 injections for a total of 0.2x 10^8 (20 million) Allo-hMSCs. Allogeneic hMSCs: Allogeneic Adult Human Mesenchymal Stem Cells (MSCs) delivered via injection |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Acute coronary syndrome | Cardiac disorders | Systematic Assessment | Serious adverse events within 6 months of injection for acute coronary syndrome |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Acute coronary syndrome | Cardiac disorders | Systematic Assessment | Adverse events within 12 months of injection |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Marietsy pujol / Senior Regulatory Specialist | ISCI / University of Miami Miller School of Medicine | 305-243-7273 | mpujol@med.miami.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 9, 2016 | May 29, 2018 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D009203 | Myocardial Infarction |
| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
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|
| 6 months, 12 months |
| Peak Oxygen Consumption (VO2) | Peak VO2 assessed via treadmill determination. | Baseline, 6 months, 12 months |
| Six-minute Walk Test. | A test that measures how far a patient can walk in 6 minutes. | Baseline, 3 months, 6 months, 12 months |
| Changed in New York Heart Association (NYHA) Functional Classification Based on Patient's Self Reported Activity Level. | Changed in NYHA Functional Classification will be evaluated. Worsened: Documented increase in limitation in physical activity. Improved: Documented decrease in limitation in physical activity. Unchanged: No documented change in limitation in physical activity. | Baseline to 3 months, Baseline to 6 months, Baseline to 12 months |
| Number of Incidents of Major Adverse Cardiac Events (MACE). | Incidence of the Major Adverse Cardiac Events (MACE) endpoint, defined as the composite incidence of (1) death, (2) hospitalization for worsening heart failure, or (3) non-fatal recurrent MI. | 1 month, 6 months, 12 months post injection. |
| Number of Participants With Treatment Emergent Adverse Event (AE) | Incidence of Treatment Emergent Adverse Event defined as any untoward medical occurrence in a patient or clinical investigation subject temporally associated with the use of the study product. | 6 months, 12 months |
| Minnesota Living With Heart Failure (MLHF) Questionnaire Scores | Minnesota Living with Heart Failure (MLHF) Questionnaire has a total score from 0 to 105. A higher score indicates that participant's heart failure is preventing them from living their life. | Baseline, 3 months, 6 months, 12 months |
| Echocardiographic-derived Measures of Left Ventricular Function | Left ventricular end diastolic wall thickness as determined by echocardiogram. | 6 months, 12 months |
| Difference Between Regional Left Ventricular Function (at the Site of Allogeneic Cell Injections) | As determined by Computed Tomography Scan | Baseline, 12 Months |
| Difference Between the Regional Left Ventricular Wall Thickening | As determined by Computed Tomography Scan | Baseline, Month 12 |
| Difference Between Left Ventricular End Diastolic Wall Thickness | As determined by Computed Tomography Scan | Baseline, 12 Months |
| Difference Between the Left Ventricular Ejection Fraction (LVEF) | Change in 1-year LVEF by CT as compared to baseline. | Baseline, 12 months |
| Difference in LVEF | As assessed via ECHO | Baseline, 6 months, 12 months |
| Difference in Left Ventricular Volume | Difference in left ventricular end diastolic and end systolic volume will be assessed via ECHO | Baseline, 6 months, 12 months |
| Difference in Left Ventricular Volume | Difference in left ventricular end diastolic and end systolic volume will be assessed via CT | Baseline, 12 months |
| Difference in Left Ventricular Regional Myocardial Perfusion | As measured via myocardial mass by CT | Baseline, 12 months |
| Number of Participants With Abnormal Electrocardiogram (ECG) Reads. | The number of participants with abnormal ECG readings via 24 hour ambulatory ECG recordings as assessed per treating physician discretion. | 12 months |
| Number of Clinically Significant of Abnormal Lab Values. | Clinical significance of abnormal lab values will be assessed by treating physician | 12 months |
| Serial Troponin I | Serial Troponin I values in ng/mL over time. | 12 hours, 24 hours post cardiac catheterization |
| Number of Participants With Abnormal ECHO Reading | The number of participants with abnormal reading post-cardiac catheterization. As assessed per treating physician discretion. | 6 hours post cardiac catheterization |
| Creatinine Kinase Muscle/Brain (CK-MB) | CK-MB values in ng/mL over time. | 12 hours, 24 hours post cardiac catheterization |
| Group 2: 100 Million Allogeneic hMSCs |
Fifteen (15) patients to be treated with Allo-hMSCs: 20 million cells/ml delivered in a dose of 0.5 ml per injection x 10 injections for a total of 1x 10^8 (100 million) Allo-hMSCs. Allogeneic hMSCs: Allogeneic Adult Human Mesenchymal Stem Cells (MSCs) delivered via injection |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Enrollment Ejection Fraction (%) | Mean | Standard Deviation | percentage |
|
| Enrollment Glomerular Filtration Rate (mL/Min) | Mean | Standard Deviation | mL/min |
|
| OG001 | Group 2: 100 Million Allogeneic hMSCs | Fifteen (15) patients to be treated with Allo-hMSCs: 20 million cells/ml delivered in a dose of 0.5 ml per injection x 10 injections for a total of 1x 10^8 (100 million) Allo-hMSCs. Allogeneic hMSCs: Allogeneic Adult Human Mesenchymal Stem Cells (MSCs) delivered via injection |
|
|
| Secondary | Infarct Scar Size (ISS) | Determined by delayed contrast enhanced Computed Tomography (CT) Scan | Not all participants were able to complete procedure. | Posted | Median | Inter-Quartile Range | Percent of Left Ventricular Mass | Baseline, 12 months |
|
|
|
| Secondary | Number of Participant With Reported Tissue Perfusion | Tissue perfusion measured by CT. | Not all participants were able to complete procedure. | Posted | Count of Participants | Participants | 6 months, 12 months |
|
|
|
| Secondary | Peak Oxygen Consumption (VO2) | Peak VO2 assessed via treadmill determination. | Not all participants were able to complete procedure. | Posted | Mean | Standard Deviation | mL/kg/min | Baseline, 6 months, 12 months |
|
|
|
| Secondary | Six-minute Walk Test. | A test that measures how far a patient can walk in 6 minutes. | Not all participants were able to complete procedure. | Posted | Mean | Standard Deviation | Meters | Baseline, 3 months, 6 months, 12 months |
|
|
|
| Secondary | Changed in New York Heart Association (NYHA) Functional Classification Based on Patient's Self Reported Activity Level. | Changed in NYHA Functional Classification will be evaluated. Worsened: Documented increase in limitation in physical activity. Improved: Documented decrease in limitation in physical activity. Unchanged: No documented change in limitation in physical activity. | Not all participants were able to complete procedure. | Posted | Count of Participants | Participants | Baseline to 3 months, Baseline to 6 months, Baseline to 12 months |
|
|
|
| Secondary | Number of Incidents of Major Adverse Cardiac Events (MACE). | Incidence of the Major Adverse Cardiac Events (MACE) endpoint, defined as the composite incidence of (1) death, (2) hospitalization for worsening heart failure, or (3) non-fatal recurrent MI. | Not all participants were able to complete study. | Posted | Number | Incidents | 1 month, 6 months, 12 months post injection. |
|
|
|
| Secondary | Number of Participants With Treatment Emergent Adverse Event (AE) | Incidence of Treatment Emergent Adverse Event defined as any untoward medical occurrence in a patient or clinical investigation subject temporally associated with the use of the study product. | Not all participants were able to complete the study. | Posted | Count of Participants | Participants | 6 months, 12 months |
|
|
|
| Secondary | Minnesota Living With Heart Failure (MLHF) Questionnaire Scores | Minnesota Living with Heart Failure (MLHF) Questionnaire has a total score from 0 to 105. A higher score indicates that participant's heart failure is preventing them from living their life. | Not all participants were able to complete procedure. | Posted | Median | Inter-Quartile Range | score on a scale | Baseline, 3 months, 6 months, 12 months |
|
|
|
| Secondary | Echocardiographic-derived Measures of Left Ventricular Function | Left ventricular end diastolic wall thickness as determined by echocardiogram. | Not all participants were able to complete the procedure. | Posted | Median | Inter-Quartile Range | centimeters (cm) | 6 months, 12 months |
|
|
|
| Secondary | Difference Between Regional Left Ventricular Function (at the Site of Allogeneic Cell Injections) | As determined by Computed Tomography Scan | Data were not available to perform the statistical analyses as described in the protocol for this outcome. | Posted | Baseline, 12 Months |
|
|
| Secondary | Difference Between the Regional Left Ventricular Wall Thickening | As determined by Computed Tomography Scan | Data were not available to perform the statistical analyses as described in the protocol for this outcome. | Posted | Baseline, Month 12 |
|
|
| Secondary | Difference Between Left Ventricular End Diastolic Wall Thickness | As determined by Computed Tomography Scan | Data were not available to perform the statistical analyses as described in the protocol for this outcome. | Posted | Baseline, 12 Months |
|
|
| Secondary | Difference Between the Left Ventricular Ejection Fraction (LVEF) | Change in 1-year LVEF by CT as compared to baseline. | Not all participants were able to complete the procedure. | Posted | Median | Full Range | Percentage of ejected blood | Baseline, 12 months |
|
|
|
| Secondary | Difference in LVEF | As assessed via ECHO | Data were not available to perform the statistical analyses as described in the protocol for this outcome. | Posted | Baseline, 6 months, 12 months |
|
|
| Secondary | Difference in Left Ventricular Volume | Difference in left ventricular end diastolic and end systolic volume will be assessed via ECHO | Data were not available to perform the statistical analyses as described in the protocol for this outcome. | Posted | Baseline, 6 months, 12 months |
|
|
| Secondary | Difference in Left Ventricular Volume | Difference in left ventricular end diastolic and end systolic volume will be assessed via CT | Not all participants were able to complete the procedure. | Posted | Median | Full Range | ml | Baseline, 12 months |
|
|
|
| Secondary | Difference in Left Ventricular Regional Myocardial Perfusion | As measured via myocardial mass by CT | Data were not available to perform the statistical analyses as described in the protocol for this outcome. | Posted | Baseline, 12 months |
|
|
| Secondary | Number of Participants With Abnormal Electrocardiogram (ECG) Reads. | The number of participants with abnormal ECG readings via 24 hour ambulatory ECG recordings as assessed per treating physician discretion. | Not all participants were able to complete the procedure. | Posted | Count of Participants | Participants | 12 months |
|
|
|
| Secondary | Number of Clinically Significant of Abnormal Lab Values. | Clinical significance of abnormal lab values will be assessed by treating physician | Data were not available to perform the statistical analyses as described in the protocol for this outcome. | Posted | 12 months |
|
|
| Secondary | Serial Troponin I | Serial Troponin I values in ng/mL over time. | Not all participants were able to complete the procedure. | Posted | Median | Full Range | ng/ml | 12 hours, 24 hours post cardiac catheterization |
|
|
|
| Secondary | Number of Participants With Abnormal ECHO Reading | The number of participants with abnormal reading post-cardiac catheterization. As assessed per treating physician discretion. | Not all participants were able to complete the procedure. | Posted | Count of Participants | Participants | 6 hours post cardiac catheterization |
|
|
|
| Secondary | Creatinine Kinase Muscle/Brain (CK-MB) | CK-MB values in ng/mL over time. | Not all participants were able to complete the procedure. | Posted | Median | Full Range | ng/ml | 12 hours, 24 hours post cardiac catheterization |
|
|
|
| 0 |
| 15 |
| 4 |
| 15 |
| 8 |
| 15 |
| EG001 | Group 2: 100 Million Allogeneic hMSCs | Fifteen (15) patients to be treated with Allo-hMSCs: 20 million cells/ml delivered in a dose of 0.5 ml per injection x 10 injections for a total of 1x 10^8 (100 million) Allo-hMSCs. Allogeneic hMSCs: Allogeneic Adult Human Mesenchymal Stem Cells (MSCs) delivered via injection | 1 | 15 | 2 | 15 | 10 | 15 |
|
| Cardiac failure | Cardiac disorders | Systematic Assessment | Serious adverse events within 6 months of injection |
|
| cardiac failure congestive | Cardiac disorders | Systematic Assessment | Serious adverse events within 6 months of injection |
|
| Myocardial Infarction | Cardiac disorders | Systematic Assessment | Serious adverse events within 6 months of injection |
|
| Arterisolerosis | Vascular disorders | Systematic Assessment | Serious adverse events within 6 months of injection |
|
| Haematoma | Vascular disorders | Systematic Assessment | Serious adverse events within 6 months of injection |
|
| Hypotension | Vascular disorders | Systematic Assessment | Serious adverse events within 6 months of injection |
|
|
| Cardiac failure | Cardiac disorders | Systematic Assessment | Adverse events within 12 months of injection |
|
| Cardiac failure congestive | Cardiac disorders | Systematic Assessment | Adverse events within 12 months of injection |
|
| Myocardial Infarction | Cardiac disorders | Systematic Assessment | Adverse events within 12 months of injection |
|
| Sinus Arrest | Cardiac disorders | Systematic Assessment | Adverse events within 12 months of injection |
|
| Vertigo | Ear and labyrinth disorders | Systematic Assessment | Adverse events within 12 months of injection |
|
| Eye pruritus | Eye disorders | Systematic Assessment | Adverse events within 12 months of injection |
|
| Eye Swelling | Eye disorders | Systematic Assessment | Adverse events within 12 months of injection |
|
| Vision blurred | Eye disorders | Systematic Assessment | Adverse events within 12 months of injection |
|
| Dysphagia | Gastrointestinal disorders | Systematic Assessment | Adverse events within 12 months of injection |
|
| Nausea | Gastrointestinal disorders | Systematic Assessment | Adverse events within 12 months of injection |
|
| Fatigue | General disorders | Systematic Assessment | Adverse events within 12 months of injection |
|
| Gait disturbance | General disorders | Systematic Assessment | Adverse events within 12 months of injection |
|
| Pyrexia | General disorders | Systematic Assessment | Adverse events within 12 months of injection |
|
| Hordeolum | Infections and infestations | Systematic Assessment | Adverse events within 12 months of injection |
|
| Rhinitis | Infections and infestations | Systematic Assessment | Adverse events within 12 months of injection |
|
| Urinary tract infection | Infections and infestations | Systematic Assessment | Adverse events within 12 months of injection |
|
| Fall | Injury, poisoning and procedural complications | Systematic Assessment | Adverse events within 12 months of injection |
|
| Prostatic specific antigen | Investigations | Systematic Assessment | Adverse events within 12 months of injection |
|
| Dehydration | Metabolism and nutrition disorders | Systematic Assessment | Adverse events within 12 months of injection |
|
| Gout | Metabolism and nutrition disorders | Systematic Assessment | Adverse events within 12 months of injection |
|
| Inguinal Mass | Musculoskeletal and connective tissue disorders | Systematic Assessment | Adverse events within 12 months of injection |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | Systematic Assessment | Adverse events within 12 months of injection |
|
| Squamous cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment | Adverse events within 12 months of injection |
|
| Headache | Nervous system disorders | Systematic Assessment | Adverse events within 12 months of injection |
|
| Haematuria | Renal and urinary disorders | Systematic Assessment | Adverse events within 12 months of injection |
|
| Pollakiuria | Renal and urinary disorders | Systematic Assessment | Adverse events within 12 months of injection |
|
| Prostatitis | Reproductive system and breast disorders | Systematic Assessment | Adverse events within 12 months of injection |
|
| Asthma | Respiratory, thoracic and mediastinal disorders | Systematic Assessment | Adverse events within 12 months of injection |
|
| Cough | Respiratory, thoracic and mediastinal disorders | Systematic Assessment | Adverse events within 12 months of injection |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | Systematic Assessment | Adverse events within 12 months of injection |
|
| Epistaxis | Respiratory, thoracic and mediastinal disorders | Systematic Assessment | Adverse events within 12 months of injection |
|
| Alopecia | Skin and subcutaneous tissue disorders | Systematic Assessment | Adverse events within 12 months of injection |
|
| Stasis dematitis | Skin and subcutaneous tissue disorders | Systematic Assessment | Adverse events within 12 months of injection |
|
| Arteriosclerosis | Vascular disorders | Systematic Assessment | Adverse events within 12 months of injection |
|
| Haematoma | Vascular disorders | Systematic Assessment | Adverse events within 12 months of injection |
|
| Hypotension | Vascular disorders | Systematic Assessment | Adverse events within 12 months of injection |
|
| Chest Pain | General disorders | Systematic Assessment | Adverse events within 12 months of injection |
|
| Chronic Sinusitis | Infections and infestations | Systematic Assessment | Adverse events within 12 months of injection |
|
| Cardioversion | Surgical and medical procedures | Systematic Assessment | Adverse events within 12 months of injection |
|
| Impantable defibrillator replacement | Surgical and medical procedures | Systematic Assessment | Adverse events within 12 months of injection |
|
| Tooth Extraction | Surgical and medical procedures | Systematic Assessment | Adverse events within 12 months of injection |
|
| Breast mass | Reproductive system and breast disorders | Systematic Assessment | Adverse events within 12 months of injection |
|
| Spinal column ste | Musculoskeletal and connective tissue disorders | Systematic Assessment | Adverse events within 12 months of injection |
|
Not provided
Not provided
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| D007238 |
| Infarction |
| D007511 | Ischemia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009336 | Necrosis |
| 12 Months |
|
|
| at 12 months |
|
|
| 6 months |
|
|
| 12 months |
|
|
| 3 months |
|
|
| 6 months |
|
|
| 12 months |
|
|
| Baseline to 3 months, Unchanged |
|
|
| Baseline to 3 months, Worsened |
|
|
| Baseline to 6 months, Improved |
|
|
| Baseline to 6 months, Unchanged |
|
|
| Baseline to 6 months, Worsened |
|
|
| Baseline to 12 months, Improved |
|
|
| Baseline to 12 months, Unchanged |
|
|
| Baseline to 12 months, Worsened |
|
|
| 6 months from injection |
|
|
| 12 months from injection |
|
|
| Treatment emergent AE (12 months) |
|
|
| 3 months |
|
|
| 6 months |
|
|
| 12 months |
|
|
| Month 12 |
|
|
| baseline, abnormal not clinically significant |
|
|
| baseline, abnormal, clinically significant |
|
|
| 12 months, normal |
|
|
| 12 months, abnormal not clinically significant |
|
|
| 12 months, abnormal, clinically significant |
|
|
| 24-hours post-catheterization |
|
|
| Abnormal, Clinically Significant |
|
| 24 hour post catheterization |
|
|