RENEW: Efficacy and Safety of Targeted Intramyocardial Delivery of Auto CD34+ Stem Cells for Improving Exercise Capacity in Subjects With Refractory Angina
Sponsor
Caladrius Biosciences, Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT01508910
Collaborator
(none)
291
41
3
43
7.1
0.2
Study Details
Study Description
Brief Summary
The purpose of the study is to assess the safety and efficacy of targeted intramyocardial delivery of Auto-CD34+ cells for increasing exercise time and amelioration of anginal symptoms in subjects with refractory angina and chronic myocardial ischemia.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
Study Design
Study Type:
Interventional
Actual Enrollment
:
291 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
Official Title:
A Prospective, Randomized, Double-blinded, Active-control and Unblinded Standard of Care (SOC) Controlled Study to Determine the Efficacy and Safety of Targeted Intramyocardial Delivery of Autologous CD34+ Cells (Auto-CD34+ Cells) for Increasing Exercise Capacity During Standardized Exercise Testing in Subjects With Refractory Angina Pectoris and Chronic Myocardial Ischemia
Study Start Date
:
Apr 1, 2012
Actual Primary Completion Date
:
Nov 1, 2015
Actual Study Completion Date
:
Nov 1, 2015
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Treatment Arm Targeted intramyocardial delivery of 1 x 10^5 Auto-CD34+ cells after granulocyte-colony stimulating factor (G-CSF) mobilization and apheresis |
Biological: Auto-CD34+ cells
10 intramyocardial injections of 0.2 mL per injection site of Auto-CD34+ cells
|
| Placebo Comparator: Active Control Arm Targeted intramyocardial delivery of placebo after G-CSF mobilization and apheresis |
Biological: Placebo: Diluent used to suspend Auto-CD34+ cells
10 intramyocardial injections of 0.2 mL per injection site of placebo
|
| Other: Unblinded Standard of Care (SOC) Arm No study-related procedures will be performed. |
Other: Standard of care
Standard of care for refractory angina
|
Outcome Measures
Primary Outcome Measures
- Change From Baseline in Total Exercise Time on Exercise Tolerance Test (ETT) Using the Modified Bruce Protocol [Baseline and 12 month visit]
Baseline (BL) is the average of the two total exercise times measured during the screening period.
Secondary Outcome Measures
- Angina Frequency (Episodes Per Week) at the 12 Month Follow-up Visit [Baseline and 12 month visit]
Participants self-reported angina episodes utilizing an electronic diary for 4 weeks at baseline (screening period) and in the 4 weeks before the 3, 6 and 12 month follow-up visits.
- Change From Baseline in Total Exercise Time on Exercise Tolerance Test (ETT) at the 6 Month Follow-up Visit [Baseline and 6 month visit]
Baseline (BL) is the average of the two total exercise times measured during the screening period.
- Angina Frequency (Episodes Per Week) at the 6 Month Follow-up Visit [6 month visit]
- Percentage of Participants With Incidences of MACE From Randomization Until the End of the 24 Month Follow-up Period [From randomization until the end of the 24 month follow-up period]
Major adverse cardiac events (MACE) defined as death, cardiac hospitalization, non-fatal myocardial infarction and stroke, as adjudicated by an independent clinical endpoint classification (CEC) committee. The category Total MACE includes death, cardiovascular hospitalization, myocardial infarction or stroke.
- Percentage of Participants With at Least One Serious Adverse Event (SAE) From Randomization Until the End of the 24 Month Follow-up Period [From randomization until the end of the 24 month follow-up period]
Eligibility Criteria
Criteria
Ages Eligible for Study:
21 Years
to 80 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Main Inclusion Criteria:
-
Male or female participants who are 21 to 80 years of age at the time of signing the informed consent.
-
Participants with Canadian Cardiovascular Society (CCS) class III or IV chronic refractory angina.
-
Participants without control of their angina symptoms in spite of maximal tolerated doses of anti-angina drugs. Participants must be on optimal therapy for their angina and must have been on a stable anti-anginal medication regimen for at least 4 weeks before signing the informed consent form.
-
Participants with obstructive coronary disease unsuitable for conventional revascularization due to unsuitable anatomy or comorbidity as determined at the site and confirmed by an independent adjudication committee.
-
Participants must have evidence of inducible myocardial ischemia.
-
Participants must experience angina episodes.
-
Participants must be able to complete 2 exercise tolerance tests on the treadmill within 3 weeks of randomization.
-
If female of childbearing potential, subject must not be pregnant and agree to employ adequate birth control measures for the duration of the study.
Main Exclusion Criteria:
-
Cardiovascular hospitalization within 60 days prior to potential study enrollment. Participant has had a successful or partially successful coronary artery bypass graft (CABG) within 6 months or PCTA within 60 days of potential study enrollment.
-
Participant has had a placement of a bi-ventricular pacemaker for cardiac resynchronization therapy (CRT) for heart failure within 180 days of potential study enrollment.
-
Participant has documented stroke or transient ischemic attacks (TIAs) within 60 days of potential study enrollment.
-
Participant has a history of moderate to severe aortic stenosis; or severe aortic insufficiency; or severe mitral stenosis; or severe mitral insufficiency.
-
Participant has a prosthetic aortic valve or a mechanical mitral valve replacement.
-
Participant has severe co-morbidity associated with a reduction in life expectancy to less than 3 years as a result of chronic medical illnesses.
-
Participants with cancer are excluded with the following exceptions:
-
Subjects with in-situ non-melanoma skin cancer or in-situ cervical cancer are not excluded.
-
Participants that have been cancer free for >= 5 years as determined by their oncologist are not excluded. Subjects with a prior history of stem cell transplant for cancer are excluded no matter how long they have been cancer-free.
-
Participants with a history of leukemia or other bone marrow disease.
-
Participant has sickle cell disease or sickle cell trait.
-
Participants with proliferative retinopathy.
-
Participants with Hb A1c > 9%.
-
Participant has platelet counts >10% above the upper limit of normal (ULN) or platelet counts < 70,000.
-
Participant has a hematocrit < 30% prior to potential study enrollment.
-
Participant has a serum creatinine > 2.5 mg/dL prior to potential study enrollment.
-
Participant tests positive for HIV, hepatitis B, or hepatitis C, or is on chronic immunosuppressive medications, or has had a previous stem cell transplant.
-
Participant has a known contraindication to Neupogen (filgrastim) or G-CSF.
-
Participant was previously enrolled in an active treatment group of cell therapy trials for cardiovascular disease including any phase of CD34+ stem cell trials.
-
Left ventricular (LV) thickness of < 7 mm in the target areas of injection as measured by during a 2-D echocardiogram (ECHO).
-
Atrial fibrillation, atrial flutter, or other uncontrolled arrhythmias that would prohibit accurate electromechanical mapping and NOGA-guided intramyocardial injection.
-
Bleeding diathesis with an INR > 1.8 when not receiving anti-thrombotic therapy.
-
Hepatic dysfunction as evidenced by elevated AST or ALT levels > 2.5 x ULN.
-
Any previous transplant requiring immunosuppression.
-
Disease state requiring chronic immunosuppression.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Birmingham | Alabama | United States | ||
| 2 | Gilbert | Arizona | United States | ||
| 3 | Phoenix | Arizona | United States | ||
| 4 | La Jolla | California | United States | ||
| 5 | Los Angeles | California | United States | ||
| 6 | Oxnard | California | United States | ||
| 7 | San Diego | California | United States | ||
| 8 | Stanford | California | United States | ||
| 9 | Boynton Beach | Florida | United States | ||
| 10 | Daytona Beach | Florida | United States | ||
| 11 | Gainesville | Florida | United States | ||
| 12 | Jacksonville | Florida | United States | ||
| 13 | Miami | Florida | United States | ||
| 14 | Orlando | Florida | United States | ||
| 15 | Tampa | Florida | United States | ||
| 16 | Atlanta | Georgia | United States | ||
| 17 | Augusta | Georgia | United States | ||
| 18 | Chicago | Illinois | United States | ||
| 19 | Iowa City | Iowa | United States | ||
| 20 | Louisville | Kentucky | United States | ||
| 21 | New Orleans | Louisiana | United States | ||
| 22 | Boston | Massachusetts | United States | ||
| 23 | Saginaw | Michigan | United States | ||
| 24 | Minneapolis | Minnesota | United States | ||
| 25 | Rochester | Minnesota | United States | ||
| 26 | Haddon Heights | New Jersey | United States | ||
| 27 | Newark | New Jersey | United States | ||
| 28 | New York | New York | United States | ||
| 29 | Charlotte | North Carolina | United States | ||
| 30 | Durham | North Carolina | United States | ||
| 31 | Cincinnati | Ohio | United States | ||
| 32 | Cleveland | Ohio | United States | ||
| 33 | Philadelphia | Pennsylvania | United States | ||
| 34 | Pittsburgh | Pennsylvania | United States | ||
| 35 | Germantown | Tennessee | United States | ||
| 36 | Dallas | Texas | United States | ||
| 37 | Houston | Texas | United States | ||
| 38 | Salt Lake City | Utah | United States | ||
| 39 | Seattle | Washington | United States | ||
| 40 | Madison | Wisconsin | United States | ||
| 41 | Milwaukee | Wisconsin | United States |
Sponsors and Collaborators
- Caladrius Biosciences, Inc.
Investigators
- Study Director: Caladrius Study Director, Caladrius Biosciences
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Caladrius Biosciences, Inc.
ClinicalTrials.gov Identifier:
NCT01508910
Other Study ID Numbers:
- 901001
- RENEW Study
First Posted:
Jan 12, 2012
Last Update Posted:
Dec 19, 2018
Last Verified:
Nov 1, 2018
Additional relevant MeSH terms:
Study Results
Participant Flow
| Recruitment Details | The study started in May 2012 and completed in November 2015. |
|---|---|
| Pre-assignment Detail | 291 participants provided informed consent and were screened. There were 179 screen failures. 112 participants were randomized and treated. Note that during treatment the number of arms increased from 3 to 4 to include "Not Injected" arm as 6 participants in Treatment and Active Control Arms did not have intramyocardial injections. |
| Arm/Group Title | Treatment Arm | Active Control Arm | Unblinded Standard of Care (SOC) Arm | Not Injected Arm |
|---|---|---|---|---|
| Arm/Group Description | Targeted intramyocardial delivery of 1 x 10^5 Auto-CD34+ cells after granulocyte-colony stimulating factor (G-CSF) mobilization and apheresis. | Targeted intramyocardial delivery of placebo after granulocyte-colony stimulating factor (G-CSF) mobilization and apheresis. | No study-related procedures were performed. | Participants randomized into the Treatment Arm or Active Control Arm who did not undergo targeted intramyocardial delivery of 1 x 10^5 Auto-CD34+ cells or placebo, respectively. |
| Period Title: Randomization | ||||
| STARTED | 57 | 27 | 28 | 0 |
| COMPLETED | 57 | 27 | 28 | 0 |
| NOT COMPLETED | 0 | 0 | 0 | 0 |
| Period Title: Randomization | ||||
| STARTED | 50 | 28 | 28 | 6 |
| COMPLETED | 48 | 24 | 18 | 3 |
| NOT COMPLETED | 2 | 4 | 10 | 3 |
Baseline Characteristics
| Arm/Group Title | Treatment Arm | Active Control Arm | Unblinded Standard of Care (SOC) Arm | Total |
|---|---|---|---|---|
| Arm/Group Description | Targeted intramyocardial delivery of 1 x 10^5 Auto-CD34+ cells after granulocyte-colony stimulating factor (G-CSF) mobilization and apheresis. | Targeted intramyocardial delivery of placebo after granulocyte-colony stimulating factor (G-CSF) mobilization and apheresis. | No study-related procedures will be performed. | Total of all reporting groups |
| Overall Participants | 57 | 27 | 28 | 112 |
| Age (Years) [Mean (Standard Deviation) ] | ||||
| Mean (Standard Deviation) [Years] |
64
(8)
|
64
(8)
|
63
(10)
|
64
(8)
|
| Sex: Female, Male (Count of Participants) | ||||
| Female |
10
17.5%
|
4
14.8%
|
4
14.3%
|
18
16.1%
|
| Male |
47
82.5%
|
23
85.2%
|
24
85.7%
|
94
83.9%
|
Outcome Measures
| Title | Change From Baseline in Total Exercise Time on Exercise Tolerance Test (ETT) Using the Modified Bruce Protocol |
|---|---|
| Description | Baseline (BL) is the average of the two total exercise times measured during the screening period. |
| Time Frame | Baseline and 12 month visit |
Outcome Measure Data
| Analysis Population Description |
|---|
| Participants in the Intent to Treat population defined as participants randomized to Treatment or Active Control arms. For participants not receiving intramyocardial injections, the missing values were imputed i.e. replaced with substituted values from the baseline. |
| Arm/Group Title | Treatment Arm | Active Control Arm |
|---|---|---|
| Arm/Group Description | Targeted intramyocardial delivery of 1 x 10^5 Auto-CD34+ cells after granulocyte-colony stimulating factor (G-CSF) mobilization and apheresis | Targeted intramyocardial delivery of placebo after G-CSF mobilization and apheresis |
| Measure Participants | 57 | 27 |
| Mean (Standard Deviation) [seconds] |
108.7
(194.3)
|
90.0
(184.7)
|
| Title | Angina Frequency (Episodes Per Week) at the 12 Month Follow-up Visit |
|---|---|
| Description | Participants self-reported angina episodes utilizing an electronic diary for 4 weeks at baseline (screening period) and in the 4 weeks before the 3, 6 and 12 month follow-up visits. |
| Time Frame | Baseline and 12 month visit |
Outcome Measure Data
| Analysis Population Description |
|---|
| Participants in the Intent to Treat population defined as participants randomized to Treatment or Active Control arms. For participants not receiving intramyocardial injections, the missing values were imputed i.e. replaced with substituted values from the baseline. |
| Arm/Group Title | Treatment Arm | Active Control Arm |
|---|---|---|
| Arm/Group Description | Targeted intramyocardial delivery of 1 x 10^5 Auto-CD34+ cells after granulocyte-colony stimulating factor (G-CSF) mobilization and apheresis | Targeted intramyocardial delivery of placebo after G-CSF mobilization and apheresis |
| Measure Participants | 57 | 27 |
| Number of weekly angina episodes at baseline |
20.1
(13.0)
|
16.5
(9.4)
|
| Number of weekly angina episodes at Month 12 visit |
7.7
(9.5)
|
5.4
(7.4)
|
| Title | Change From Baseline in Total Exercise Time on Exercise Tolerance Test (ETT) at the 6 Month Follow-up Visit |
|---|---|
| Description | Baseline (BL) is the average of the two total exercise times measured during the screening period. |
| Time Frame | Baseline and 6 month visit |
Outcome Measure Data
| Analysis Population Description |
|---|
| Participants in the Intent to Treat population defined as participants randomized to Treatment or Active Control arms. For participants not receiving intramyocardial injections, the missing values were imputed i.e. replaced with substituted values from the baseline. |
| Arm/Group Title | Treatment Arm | Active Control Arm |
|---|---|---|
| Arm/Group Description | Targeted intramyocardial delivery of 1 x 10^5 Auto-CD34+ cells after granulocyte-colony stimulating factor (G-CSF) mobilization and apheresis | Targeted intramyocardial delivery of placebo after G-CSF mobilization and apheresis |
| Measure Participants | 57 | 27 |
| Mean (Standard Deviation) [seconds] |
126.5
(161.1)
|
93.5
(138.6)
|
| Title | Angina Frequency (Episodes Per Week) at the 6 Month Follow-up Visit |
|---|---|
| Description | |
| Time Frame | 6 month visit |
Outcome Measure Data
| Analysis Population Description |
|---|
| Participants in the Intent to Treat population defined as participants randomized to Treatment or Active Control arms. For participants not receiving intramyocardial injections, the missing values were imputed i.e. replaced with substituted values from the baseline. |
| Arm/Group Title | Treatment Arm | Active Control Arm |
|---|---|---|
| Arm/Group Description | Targeted intramyocardial delivery of 1 x 10^5 Auto-CD34+ cells after granulocyte-colony stimulating factor (G-CSF) mobilization and apheresis | Targeted intramyocardial delivery of placebo after G-CSF mobilization and apheresis |
| Measure Participants | 57 | 27 |
| Mean (Standard Deviation) [angina episodes per week] |
8.0
(9.6)
|
8.4
(9.8)
|
| Title | Percentage of Participants With Incidences of MACE From Randomization Until the End of the 24 Month Follow-up Period |
|---|---|
| Description | Major adverse cardiac events (MACE) defined as death, cardiac hospitalization, non-fatal myocardial infarction and stroke, as adjudicated by an independent clinical endpoint classification (CEC) committee. The category Total MACE includes death, cardiovascular hospitalization, myocardial infarction or stroke. |
| Time Frame | From randomization until the end of the 24 month follow-up period |
Outcome Measure Data
| Analysis Population Description |
|---|
| Participants in the safety population as Treated. |
| Arm/Group Title | Treatment Arm | Active Control Arm | Unblinded Standard of Care (SOC) Arm | Not Injected Arm |
|---|---|---|---|---|
| Arm/Group Description | Targeted intramyocardial delivery of 1 x 10^5 Auto-CD34+ cells after granulocyte-colony stimulating factor (G-CSF) mobilization and apheresis. | Targeted intramyocardial delivery of placebo after G-CSF mobilization and apheresis. | No study-related procedures will be performed. | Participants randomized into the Treatment Arm or Active Control Arm who did not undergo targeted intramyocardial delivery of 1 x 10^5 Auto-CD34+ cells or placebo, respectively. |
| Measure Participants | 50 | 28 | 28 | 6 |
| Cardiovascular Hospitalization |
42.0
|
32.1
|
64.3
|
33.3
|
| Death |
4.0
|
10.7
|
7.1
|
0
|
| Myocardial Infarction |
10.0
|
10.7
|
7.1
|
33.3
|
| Stroke |
0
|
0
|
0
|
0
|
| Total MACE (see outcome measure description) |
46.0
|
42.9
|
67.9
|
33.3
|
| Myocardial Perforation |
4.0
|
0
|
0
|
16.7
|
| Ventricular Arrhythmia |
2.0
|
7.1
|
3.6
|
0
|
| Title | Percentage of Participants With at Least One Serious Adverse Event (SAE) From Randomization Until the End of the 24 Month Follow-up Period |
|---|---|
| Description | |
| Time Frame | From randomization until the end of the 24 month follow-up period |
Outcome Measure Data
| Analysis Population Description |
|---|
| Safety Population as Treated. |
| Arm/Group Title | Treatment Arm | Active Control Arm | Unblinded Standard of Care (SOC) Arm | Not Injected Arm |
|---|---|---|---|---|
| Arm/Group Description | Targeted intramyocardial delivery of 1 x 10^5 Auto-CD34+ cells after granulocyte-colony stimulating factor (G-CSF) mobilization and apheresis | Targeted intramyocardial delivery of placebo after G-CSF mobilization and apheresis | No study-related procedures will be performed. | Participants randomized into the Treatment Arm or Active Control Arm who did not undergo targeted intramyocardial delivery of 1 x 10^5 Auto-CD34+ cells or placebo, respectively. |
| Measure Participants | 50 | 28 | 28 | 6 |
| Number [percent] |
62.0
|
60.7
|
78.6
|
50.0
|
Adverse Events
| Time Frame | From randomization until the end of the 24 month follow-up period | |||||||
|---|---|---|---|---|---|---|---|---|
| Adverse Event Reporting Description | ||||||||
| Arm/Group Title | Treatment Arm | Active Control Arm | Unblinded Standard of Care (SOC) Arm | Not Treated Arm | ||||
| Arm/Group Description | Targeted intramyocardial delivery of 1 x 10^5 Auto-CD34+ cells after granulocyte-colony stimulating factor (G-CSF) mobilization and apheresis | Targeted intramyocardial delivery of placebo after G-CSF mobilization and apheresis | No study-related procedures will be performed. | Participants randomized into the Treatment Arm or Active Control Arm who did not undergo targeted intramyocardial delivery of 1 x 10^5 Auto-CD34+ cells or placebo, respectively. | ||||
All Cause Mortality |
||||||||
| Treatment Arm | Active Control Arm | Unblinded Standard of Care (SOC) Arm | Not Treated Arm | |||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | / (NaN) | / (NaN) | / (NaN) | / (NaN) | ||||
Serious Adverse Events |
||||||||
| Treatment Arm | Active Control Arm | Unblinded Standard of Care (SOC) Arm | Not Treated Arm | |||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 31/50 (62%) | 17/28 (60.7%) | 22/28 (78.6%) | 3/6 (50%) | ||||
| Blood and lymphatic system disorders | ||||||||
| Anaemia | 1/50 (2%) | 1 | 0/28 (0%) | 0 | 0/28 (0%) | 0 | 0/6 (0%) | 0 |
| Cardiac disorders | ||||||||
| Angina pectoris | 7/50 (14%) | 9 | 2/28 (7.1%) | 3 | 11/28 (39.3%) | 18 | 0/6 (0%) | 0 |
| Angina unstable | 4/50 (8%) | 7 | 2/28 (7.1%) | 2 | 3/28 (10.7%) | 3 | 1/6 (16.7%) | 1 |
| Acute myocardial infarction | 3/50 (6%) | 3 | 3/28 (10.7%) | 3 | 1/28 (3.6%) | 1 | 1/6 (16.7%) | 2 |
| Cardiac failure congestive | 3/50 (6%) | 4 | 2/28 (7.1%) | 3 | 2/28 (7.1%) | 2 | 0/6 (0%) | 0 |
| Coronary artery disease | 0/50 (0%) | 0 | 1/28 (3.6%) | 1 | 3/28 (10.7%) | 3 | 0/6 (0%) | 0 |
| Myocardial infarction | 2/50 (4%) | 2 | 0/28 (0%) | 0 | 1/28 (3.6%) | 1 | 0/6 (0%) | 0 |
| Ventricular tachycardia | 2/50 (4%) | 2 | 1/28 (3.6%) | 2 | 0/28 (0%) | 0 | 0/6 (0%) | 0 |
| Cardiac failure | 2/50 (4%) | 3 | 0/28 (0%) | 0 | 0/28 (0%) | 0 | 0/6 (0%) | 0 |
| Cardiac failure acute | 0/50 (0%) | 0 | 1/28 (3.6%) | 1 | 1/28 (3.6%) | 1 | 0/6 (0%) | 0 |
| Pericardial effusion | 1/50 (2%) | 1 | 0/28 (0%) | 0 | 0/28 (0%) | 0 | 1/6 (16.7%) | 1 |
| Acute coronary syndrome | 0/50 (0%) | 0 | 0/28 (0%) | 0 | 1/28 (3.6%) | 1 | 0/6 (0%) | 0 |
| Arrhythmia | 1/50 (2%) | 1 | 0/28 (0%) | 0 | 0/28 (0%) | 0 | 0/6 (0%) | 0 |
| Atrial fibrillation | 0/50 (0%) | 0 | 1/28 (3.6%) | 2 | 0/28 (0%) | 0 | 0/6 (0%) | 0 |
| atrioventricular block first degree | 1/50 (2%) | 1 | 0/28 (0%) | 0 | 0/28 (0%) | 0 | 0/6 (0%) | 0 |
| Cardiac tamponade | 1/50 (2%) | 1 | 0/28 (0%) | 0 | 0/28 (0%) | 0 | 0/6 (0%) | 0 |
| Cardiogenic shock | 0/50 (0%) | 0 | 1/28 (3.6%) | 1 | 0/28 (0%) | 0 | 0/6 (0%) | 0 |
| Chronotropic incompetence | 0/50 (0%) | 0 | 0/28 (0%) | 0 | 1/28 (3.6%) | 1 | 0/6 (0%) | 0 |
| Coronary artery perforation | 1/50 (2%) | 1 | 0/28 (0%) | 0 | 0/28 (0%) | 0 | 0/6 (0%) | 0 |
| Ischaemic cardiomyopathy | 0/50 (0%) | 0 | 1/28 (3.6%) | 1 | 0/28 (0%) | 0 | 0/6 (0%) | 0 |
| Left ventricular dysfunction | 0/50 (0%) | 0 | 0/28 (0%) | 0 | 1/28 (3.6%) | 1 | 0/6 (0%) | 0 |
| Myocardial ischaemia | 0/50 (0%) | 0 | 0/28 (0%) | 0 | 1/28 (3.6%) | 1 | 0/6 (0%) | 0 |
| Eye disorders | ||||||||
| Retinal infarction | 0/50 (0%) | 0 | 0/28 (0%) | 0 | 1/28 (3.6%) | 1 | 0/6 (0%) | 0 |
| Gastrointestinal disorders | ||||||||
| Small intestinal obstruction | 2/50 (4%) | 2 | 0/28 (0%) | 0 | 0/28 (0%) | 0 | 0/6 (0%) | 0 |
| Abdominal pain | 1/50 (2%) | 1 | 0/28 (0%) | 0 | 0/28 (0%) | 0 | 0/6 (0%) | 0 |
| Diabetic gastroparesis | 1/50 (2%) | 1 | 0/28 (0%) | 0 | 0/28 (0%) | 0 | 0/6 (0%) | 0 |
| Diverticulum intestinal haemorrhagic | 0/50 (0%) | 0 | 0/28 (0%) | 0 | 1/28 (3.6%) | 1 | 0/6 (0%) | 0 |
| Gastric ulcer | 0/50 (0%) | 0 | 0/28 (0%) | 0 | 1/28 (3.6%) | 1 | 0/6 (0%) | 0 |
| Gastrooesophageal reflux disease | 0/50 (0%) | 0 | 1/28 (3.6%) | 1 | 0/28 (0%) | 0 | 0/6 (0%) | 0 |
| Ileus | 1/50 (2%) | 1 | 0/28 (0%) | 0 | 0/28 (0%) | 0 | 0/6 (0%) | 0 |
| Oesophagitis ulcerative | 0/50 (0%) | 0 | 0/28 (0%) | 0 | 1/28 (3.6%) | 1 | 0/6 (0%) | 0 |
| Pancreatitis acute | 0/50 (0%) | 0 | 0/28 (0%) | 0 | 1/28 (3.6%) | 1 | 0/6 (0%) | 0 |
| General disorders | ||||||||
| Chest pain | 2/50 (4%) | 2 | 1/28 (3.6%) | 1 | 2/28 (7.1%) | 2 | 0/6 (0%) | 0 |
| Non-cardiac chest pain | 1/50 (2%) | 2 | 0/28 (0%) | 0 | 1/28 (3.6%) | 1 | 0/6 (0%) | 0 |
| Sudden cardiac death | 0/50 (0%) | 0 | 1/28 (3.6%) | 1 | 1/28 (3.6%) | 1 | 0/6 (0%) | 0 |
| Asthenia | 1/50 (2%) | 1 | 0/28 (0%) | 0 | 0/28 (0%) | 0 | 0/6 (0%) | 0 |
| Device electrical impedance issue | 1/50 (2%) | 1 | 0/28 (0%) | 0 | 0/28 (0%) | 0 | 0/6 (0%) | 0 |
| Disease progression | 1/50 (2%) | 1 | 0/28 (0%) | 0 | 0/28 (0%) | 0 | 0/6 (0%) | 0 |
| Electrocution | 1/50 (2%) | 1 | 0/28 (0%) | 0 | 0/28 (0%) | 0 | 0/6 (0%) | 0 |
| Vascular complication associated with device | 1/50 (2%) | 1 | 0/28 (0%) | 0 | 0/28 (0%) | 0 | 0/6 (0%) | 0 |
| Hepatobiliary disorders | ||||||||
| Non-alcoholic steatohepatitis | 0/50 (0%) | 0 | 1/28 (3.6%) | 1 | 0/28 (0%) | 0 | 0/6 (0%) | 0 |
| Infections and infestations | ||||||||
| Cellulitis | 2/50 (4%) | 2 | 0/28 (0%) | 0 | 0/28 (0%) | 0 | 0/6 (0%) | 0 |
| Pneumonia | 0/50 (0%) | 0 | 0/28 (0%) | 0 | 2/28 (7.1%) | 2 | 0/6 (0%) | 0 |
| Appendicitis | 1/50 (2%) | 1 | 0/28 (0%) | 0 | 0/28 (0%) | 0 | 0/6 (0%) | 0 |
| Cholecystitis infective | 0/50 (0%) | 0 | 1/28 (3.6%) | 1 | 0/28 (0%) | 0 | 0/6 (0%) | 0 |
| Endocarditis bacterial | 1/50 (2%) | 1 | 0/28 (0%) | 0 | 0/28 (0%) | 0 | 0/6 (0%) | 0 |
| Urinary Tract Infection | 1/50 (2%) | 1 | 0/28 (0%) | 0 | 0/28 (0%) | 0 | 0/6 (0%) | 0 |
| Injury, poisoning and procedural complications | ||||||||
| Fall | 1/50 (2%) | 1 | 0/28 (0%) | 0 | 0/28 (0%) | 0 | 0/6 (0%) | 0 |
| Humerus fracture | 0/50 (0%) | 0 | 1/28 (3.6%) | 1 | 0/28 (0%) | 0 | 0/6 (0%) | 0 |
| Injury | 0/50 (0%) | 0 | 0/28 (0%) | 0 | 1/28 (3.6%) | 1 | 0/6 (0%) | 0 |
| Meniscus lesion | 1/50 (2%) | 1 | 0/28 (0%) | 0 | 0/28 (0%) | 0 | 0/6 (0%) | 0 |
| Spinal compression fracture | 1/50 (2%) | 1 | 0/28 (0%) | 0 | 0/28 (0%) | 0 | 0/6 (0%) | 0 |
| Subdural haematoma | 0/50 (0%) | 0 | 0/28 (0%) | 0 | 1/28 (3.6%) | 1 | 0/6 (0%) | 0 |
| Investigations | ||||||||
| Ejection fraction decreased | 0/50 (0%) | 0 | 0/28 (0%) | 0 | 0/28 (0%) | 0 | 1/6 (16.7%) | 1 |
| Metabolism and nutrition disorders | ||||||||
| Hypokalaemia | 1/50 (2%) | 1 | 0/28 (0%) | 0 | 1/28 (3.6%) | 1 | 0/6 (0%) | 0 |
| Dehydration | 0/50 (0%) | 0 | 1/28 (3.6%) | 1 | 0/28 (0%) | 0 | 0/6 (0%) | 0 |
| Diabetes mellitus inadequate control | 0/50 (0%) | 0 | 0/28 (0%) | 0 | 1/28 (3.6%) | 1 | 0/6 (0%) | 0 |
| Diabetic ketoacidosis | 0/50 (0%) | 0 | 1/28 (3.6%) | 1 | 0/28 (0%) | 0 | 0/6 (0%) | 0 |
| Obesity | 0/50 (0%) | 0 | 0/28 (0%) | 0 | 1/28 (3.6%) | 1 | 0/6 (0%) | 0 |
| Musculoskeletal and connective tissue disorders | ||||||||
| Arthritis | 0/50 (0%) | 0 | 1/28 (3.6%) | 1 | 0/28 (0%) | 0 | 0/6 (0%) | 0 |
| Arthropathy | 1/50 (2%) | 1 | 0/28 (0%) | 0 | 0/28 (0%) | 0 | 0/6 (0%) | 0 |
| Back pain | 1/50 (2%) | 1 | 0/28 (0%) | 0 | 0/28 (0%) | 0 | 0/6 (0%) | 0 |
| Lumbar spinal stenosis | 0/50 (0%) | 0 | 1/28 (3.6%) | 1 | 0/28 (0%) | 0 | 0/6 (0%) | 0 |
| Musculoskeletal chest pain | 0/50 (0%) | 0 | 0/28 (0%) | 0 | 1/28 (3.6%) | 1 | 0/6 (0%) | 0 |
| Osteoarthritis | 0/50 (0%) | 0 | 1/28 (3.6%) | 1 | 0/28 (0%) | 0 | 0/6 (0%) | 0 |
| Rhabdomyolysis | 1/50 (2%) | 1 | 0/28 (0%) | 0 | 0/28 (0%) | 0 | 0/6 (0%) | 0 |
| Rotator cuff syndrome | 0/50 (0%) | 0 | 1/28 (3.6%) | 1 | 0/28 (0%) | 0 | 0/6 (0%) | 0 |
| Spinal column stenosis | 1/50 (2%) | 1 | 0/28 (0%) | 0 | 0/28 (0%) | 0 | 0/6 (0%) | 0 |
| Spinal osteoarthritis | 1/50 (2%) | 1 | 0/28 (0%) | 0 | 0/28 (0%) | 0 | 0/6 (0%) | 0 |
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||||||||
| Brain neoplasm benign | 0/50 (0%) | 0 | 0/28 (0%) | 0 | 1/28 (3.6%) | 1 | 0/6 (0%) | 0 |
| Meningioma malignant | 0/50 (0%) | 0 | 0/28 (0%) | 0 | 1/28 (3.6%) | 1 | 0/6 (0%) | 0 |
| Nervous system disorders | ||||||||
| Syncope | 0/50 (0%) | 0 | 2/28 (7.1%) | 2 | 2/28 (7.1%) | 2 | 0/6 (0%) | 0 |
| Carotid sinus syndrome | 0/50 (0%) | 0 | 0/28 (0%) | 0 | 1/28 (3.6%) | 1 | 0/6 (0%) | 0 |
| Epilepsy | 0/50 (0%) | 0 | 1/28 (3.6%) | 2 | 0/28 (0%) | 0 | 0/6 (0%) | 0 |
| Transient ischaemic attack | 0/50 (0%) | 0 | 1/28 (3.6%) | 1 | 0/28 (0%) | 0 | 0/6 (0%) | 0 |
| Psychiatric disorders | ||||||||
| Mental status changes | 0/50 (0%) | 0 | 0/28 (0%) | 0 | 1/28 (3.6%) | 1 | 0/6 (0%) | 0 |
| Respiratory, thoracic and mediastinal disorders | ||||||||
| Chronic obstructive pulmonary disease | 0/50 (0%) | 0 | 1/28 (3.6%) | 1 | 3/28 (10.7%) | 3 | 0/6 (0%) | 0 |
| Dyspnoea | 1/50 (2%) | 1 | 0/28 (0%) | 0 | 2/28 (7.1%) | 2 | 0/6 (0%) | 0 |
| Dyspnoea exertional | 0/50 (0%) | 0 | 0/28 (0%) | 0 | 1/28 (3.6%) | 1 | 0/6 (0%) | 0 |
| Epistaxis | 1/50 (2%) | 1 | 0/28 (0%) | 0 | 0/28 (0%) | 0 | 0/6 (0%) | 0 |
| Haemoptysis | 1/50 (2%) | 1 | 0/28 (0%) | 0 | 0/28 (0%) | 0 | 0/6 (0%) | 0 |
| Pleural effusion | 0/50 (0%) | 0 | 0/28 (0%) | 0 | 0/28 (0%) | 0 | 1/6 (16.7%) | 1 |
| Vascular disorders | ||||||||
| Hypotension | 0/50 (0%) | 0 | 0/28 (0%) | 0 | 1/28 (3.6%) | 1 | 1/6 (16.7%) | 1 |
| Intermittent claudication | 1/50 (2%) | 1 | 1/28 (3.6%) | 1 | 0/28 (0%) | 0 | 0/6 (0%) | 0 |
| Peripheral vascular disorder | 1/50 (2%) | 1 | 1/28 (3.6%) | 1 | 0/28 (0%) | 0 | 0/6 (0%) | 0 |
| Hypertensive crisis | 1/50 (2%) | 1 | 0/28 (0%) | 0 | 0/28 (0%) | 0 | 0/6 (0%) | 0 |
| Peripheral artery aneurysm | 1/50 (2%) | 1 | 0/28 (0%) | 0 | 0/28 (0%) | 0 | 0/6 (0%) | 0 |
Other (Not Including Serious) Adverse Events |
||||||||
| Treatment Arm | Active Control Arm | Unblinded Standard of Care (SOC) Arm | Not Treated Arm | |||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 48/50 (96%) | 26/28 (92.9%) | 23/28 (82.1%) | 5/6 (83.3%) | ||||
| Blood and lymphatic system disorders | ||||||||
| Anaemia | 5/50 (10%) | 5 | 3/28 (10.7%) | 3 | 0/28 (0%) | 0 | 1/6 (16.7%) | 1 |
| Thrombocytopenia | 3/50 (6%) | 3 | 2/28 (7.1%) | 2 | 0/28 (0%) | 0 | 0/6 (0%) | 0 |
| Cardiac disorders | ||||||||
| Angina pectoris | 17/50 (34%) | 26 | 11/28 (39.3%) | 15 | 4/28 (14.3%) | 4 | 2/6 (33.3%) | 4 |
| Atrial fibrillation | 0/50 (0%) | 0 | 0/28 (0%) | 0 | 0/28 (0%) | 0 | 1/6 (16.7%) | 1 |
| Cardiac failure | 3/50 (6%) | 3 | 0/28 (0%) | 0 | 0/28 (0%) | 0 | 0/6 (0%) | 0 |
| Cardiac failure congestive | 4/50 (8%) | 5 | 2/28 (7.1%) | 2 | 0/28 (0%) | 0 | 0/6 (0%) | 0 |
| Myocardial ischaemia | 0/50 (0%) | 0 | 0/28 (0%) | 0 | 2/28 (7.1%) | 2 | 0/6 (0%) | 0 |
| Palpitations | 0/50 (0%) | 0 | 3/28 (10.7%) | 3 | 0/28 (0%) | 0 | 1/6 (16.7%) | 1 |
| Ventricular extrasystoles | 0/50 (0%) | 0 | 3/28 (10.7%) | 3 | 0/28 (0%) | 0 | 0/6 (0%) | 0 |
| Ventricular tachycardia | 0/50 (0%) | 0 | 2/28 (7.1%) | 2 | 0/28 (0%) | 0 | 1/6 (16.7%) | 1 |
| Eye disorders | ||||||||
| Cataract | 0/50 (0%) | 0 | 3/28 (10.7%) | 3 | 0/28 (0%) | 0 | 0/6 (0%) | 0 |
| Conjunctivitis | 0/50 (0%) | 0 | 0/28 (0%) | 0 | 2/28 (7.1%) | 2 | 0/6 (0%) | 0 |
| Macular degeneration | 0/50 (0%) | 0 | 0/28 (0%) | 0 | 0/28 (0%) | 0 | 1/6 (16.7%) | 1 |
| Gastrointestinal disorders | ||||||||
| Abdominal pain | 0/50 (0%) | 0 | 3/28 (10.7%) | 3 | 0/28 (0%) | 0 | 0/6 (0%) | 0 |
| Abdominal pain lower | 0/50 (0%) | 0 | 2/28 (7.1%) | 2 | 0/28 (0%) | 0 | 1/6 (16.7%) | 1 |
| Constipation | 8/50 (16%) | 8 | 0/28 (0%) | 0 | 3/28 (10.7%) | 3 | 0/6 (0%) | 0 |
| Diarrhoea | 3/50 (6%) | 3 | 3/28 (10.7%) | 4 | 2/28 (7.1%) | 2 | 2/6 (33.3%) | 3 |
| Diverticulum | 0/50 (0%) | 0 | 0/28 (0%) | 0 | 2/28 (7.1%) | 2 | 0/6 (0%) | 0 |
| Gastric polyps | 0/50 (0%) | 0 | 0/28 (0%) | 0 | 2/28 (7.1%) | 2 | 0/6 (0%) | 0 |
| Gastric ulcer | 0/50 (0%) | 0 | 0/28 (0%) | 0 | 0/28 (0%) | 0 | 1/6 (16.7%) | 1 |
| Gastrooesophageal reflux disease | 0/50 (0%) | 0 | 2/28 (7.1%) | 3 | 0/28 (0%) | 0 | 0/6 (0%) | 0 |
| Nausea | 7/50 (14%) | 7 | 5/28 (17.9%) | 6 | 2/28 (7.1%) | 2 | 1/6 (16.7%) | 1 |
| Vomiting | 0/50 (0%) | 0 | 0/28 (0%) | 0 | 2/28 (7.1%) | 2 | 0/6 (0%) | 0 |
| General disorders | ||||||||
| Chest discomfort | 0/50 (0%) | 0 | 2/28 (7.1%) | 2 | 0/28 (0%) | 0 | 0/6 (0%) | 0 |
| Chest pain | 0/50 (0%) | 0 | 2/28 (7.1%) | 3 | 0/28 (0%) | 0 | 0/6 (0%) | 0 |
| Chills | 3/50 (6%) | 3 | 0/28 (0%) | 0 | 0/28 (0%) | 0 | 0/6 (0%) | 0 |
| Fatigue | 9/50 (18%) | 9 | 8/28 (28.6%) | 9 | 3/28 (10.7%) | 3 | 2/6 (33.3%) | 2 |
| Influenza like illness | 0/50 (0%) | 0 | 0/28 (0%) | 0 | 0/28 (0%) | 0 | 1/6 (16.7%) | 1 |
| Malaise | 0/50 (0%) | 0 | 2/28 (7.1%) | 2 | 0/28 (0%) | 0 | 0/6 (0%) | 0 |
| Oedema peripheral | 5/50 (10%) | 6 | 2/28 (7.1%) | 4 | 6/28 (21.4%) | 6 | 0/6 (0%) | 0 |
| Pain | 0/50 (0%) | 0 | 2/28 (7.1%) | 2 | 0/28 (0%) | 0 | 1/6 (16.7%) | 1 |
| Vessel puncture site haematoma | 0/50 (0%) | 0 | 3/28 (10.7%) | 3 | 0/28 (0%) | 0 | 1/6 (16.7%) | 1 |
| Immune system disorders | ||||||||
| Drug hypersensitivity | 0/50 (0%) | 0 | 0/28 (0%) | 0 | 0/28 (0%) | 0 | 1/6 (16.7%) | 1 |
| Infections and infestations | ||||||||
| Breast infection | 0/50 (0%) | 0 | 0/28 (0%) | 0 | 0/28 (0%) | 0 | 1/6 (16.7%) | 1 |
| Bronchitis | 5/50 (10%) | 6 | 4/28 (14.3%) | 5 | 5/28 (17.9%) | 7 | 0/6 (0%) | 0 |
| Ear infection | 0/50 (0%) | 0 | 0/28 (0%) | 0 | 0/28 (0%) | 0 | 1/6 (16.7%) | 1 |
| Herpes zoster | 0/50 (0%) | 0 | 0/28 (0%) | 0 | 2/28 (7.1%) | 2 | 0/6 (0%) | 0 |
| Influenza | 3/50 (6%) | 3 | 3/28 (10.7%) | 3 | 3/28 (10.7%) | 3 | 0/6 (0%) | 0 |
| Nasopharyngitis | 3/50 (6%) | 3 | 2/28 (7.1%) | 2 | 0/28 (0%) | 0 | 0/6 (0%) | 0 |
| Oral herpes | 0/50 (0%) | 0 | 0/28 (0%) | 0 | 0/28 (0%) | 0 | 1/6 (16.7%) | 1 |
| Sinusitis | 9/50 (18%) | 10 | 2/28 (7.1%) | 2 | 0/28 (0%) | 0 | 0/6 (0%) | 0 |
| Tooth infection | 3/50 (6%) | 3 | 0/28 (0%) | 0 | 0/28 (0%) | 0 | 0/6 (0%) | 0 |
| Upper respiratory tract infection | 13/50 (26%) | 14 | 8/28 (28.6%) | 13 | 2/28 (7.1%) | 3 | 0/6 (0%) | 0 |
| Urinary tract infection | 5/50 (10%) | 16 | 0/28 (0%) | 0 | 0/28 (0%) | 0 | 0/6 (0%) | 0 |
| Injury, poisoning and procedural complications | ||||||||
| Contusion | 0/50 (0%) | 0 | 0/28 (0%) | 0 | 2/28 (7.1%) | 2 | 0/6 (0%) | 0 |
| Procedural pain | 0/50 (0%) | 0 | 2/28 (7.1%) | 2 | 2/28 (7.1%) | 2 | 0/6 (0%) | 0 |
| Investigations | ||||||||
| Blood creatine phosphokinase MB increased | 4/50 (8%) | 4 | 6/28 (21.4%) | 6 | 0/28 (0%) | 0 | 0/6 (0%) | 0 |
| Blood creatinine increased | 5/50 (10%) | 9 | 0/28 (0%) | 0 | 0/28 (0%) | 0 | 0/6 (0%) | 0 |
| Blood glucose increased | 3/50 (6%) | 3 | 0/28 (0%) | 0 | 0/28 (0%) | 0 | 0/6 (0%) | 0 |
| Blood urea increased | 3/50 (6%) | 3 | 0/28 (0%) | 0 | 0/28 (0%) | 0 | 0/6 (0%) | 0 |
| C-reactive protein increased | 5/50 (10%) | 5 | 0/28 (0%) | 0 | 0/28 (0%) | 0 | 0/6 (0%) | 0 |
| Haematology test abnormal | 0/50 (0%) | 0 | 0/28 (0%) | 0 | 0/28 (0%) | 0 | 1/6 (16.7%) | 1 |
| Neutrophil count increased | 5/50 (10%) | 5 | 0/28 (0%) | 0 | 0/28 (0%) | 0 | 0/6 (0%) | 0 |
| Platelet count decreased | 4/50 (8%) | 4 | 5/28 (17.9%) | 5 | 0/28 (0%) | 0 | 0/6 (0%) | 0 |
| Prostatic specific antigen increased | 0/50 (0%) | 0 | 2/28 (7.1%) | 2 | 0/28 (0%) | 0 | 0/6 (0%) | 0 |
| Troponin increased | 0/50 (0%) | 0 | 3/28 (10.7%) | 3 | 0/28 (0%) | 0 | 0/6 (0%) | 0 |
| White blood cell count increased | 3/50 (6%) | 4 | 2/28 (7.1%) | 2 | 0/28 (0%) | 0 | 0/6 (0%) | 0 |
| Metabolism and nutrition disorders | ||||||||
| Hypocalcaemia | 0/50 (0%) | 0 | 2/28 (7.1%) | 2 | 0/28 (0%) | 0 | 0/6 (0%) | 0 |
| Hypokalaemia | 3/50 (6%) | 3 | 2/28 (7.1%) | 2 | 0/28 (0%) | 0 | 0/6 (0%) | 0 |
| Vitamin D deficiency | 0/50 (0%) | 0 | 3/28 (10.7%) | 3 | 0/28 (0%) | 0 | 0/6 (0%) | 0 |
| Musculoskeletal and connective tissue disorders | ||||||||
| Arthralgia | 9/50 (18%) | 12 | 11/28 (39.3%) | 16 | 3/28 (10.7%) | 3 | 0/6 (0%) | 0 |
| Back pain | 9/50 (18%) | 12 | 12/28 (42.9%) | 14 | 5/28 (17.9%) | 7 | 1/6 (16.7%) | 2 |
| Bone pain | 6/50 (12%) | 8 | 2/28 (7.1%) | 2 | 0/28 (0%) | 0 | 1/6 (16.7%) | 1 |
| Bursitis | 0/50 (0%) | 0 | 0/28 (0%) | 0 | 2/28 (7.1%) | 2 | 0/6 (0%) | 0 |
| Muscle spasms | 0/50 (0%) | 0 | 2/28 (7.1%) | 2 | 0/28 (0%) | 0 | 0/6 (0%) | 0 |
| Muscular weakness | 0/50 (0%) | 0 | 0/28 (0%) | 0 | 2/28 (7.1%) | 2 | 0/6 (0%) | 0 |
| Musculoskeletal chest pain | 3/50 (6%) | 3 | 7/28 (25%) | 7 | 2/28 (7.1%) | 2 | 0/6 (0%) | 0 |
| Musculoskeletal discomfort | 5/50 (10%) | 6 | 0/28 (0%) | 0 | 0/28 (0%) | 0 | 0/6 (0%) | 0 |
| Musculoskeletal pain | 3/50 (6%) | 4 | 6/28 (21.4%) | 6 | 0/28 (0%) | 0 | 0/6 (0%) | 0 |
| Myalgia | 7/50 (14%) | 7 | 5/28 (17.9%) | 6 | 0/28 (0%) | 0 | 1/6 (16.7%) | 1 |
| Neck pain | 3/50 (6%) | 4 | 2/28 (7.1%) | 2 | 2/28 (7.1%) | 2 | 1/6 (16.7%) | 1 |
| Pain in extremity | 3/50 (6%) | 4 | 0/28 (0%) | 0 | 5/28 (17.9%) | 6 | 1/6 (16.7%) | 1 |
| Nervous system disorders | ||||||||
| Dizziness | 7/50 (14%) | 8 | 7/28 (25%) | 7 | 2/28 (7.1%) | 2 | 2/6 (33.3%) | 2 |
| Headache | 9/50 (18%) | 10 | 5/28 (17.9%) | 9 | 0/28 (0%) | 0 | 1/6 (16.7%) | 1 |
| Hypoaesthesia | 3/50 (6%) | 3 | 2/28 (7.1%) | 2 | 0/28 (0%) | 0 | 2/6 (33.3%) | 2 |
| Memory impairment | 0/50 (0%) | 0 | 3/28 (10.7%) | 3 | 0/28 (0%) | 0 | 0/6 (0%) | 0 |
| Paraesthesia | 0/50 (0%) | 0 | 0/28 (0%) | 0 | 0/28 (0%) | 0 | 2/6 (33.3%) | 2 |
| Restless legs syndrome | 0/50 (0%) | 0 | 0/28 (0%) | 0 | 2/28 (7.1%) | 2 | 0/6 (0%) | 0 |
| Syncope | 0/50 (0%) | 0 | 0/28 (0%) | 0 | 0/28 (0%) | 0 | 1/6 (16.7%) | 2 |
| Psychiatric disorders | ||||||||
| Anxiety | 3/50 (6%) | 3 | 6/28 (21.4%) | 6 | 0/28 (0%) | 0 | 0/6 (0%) | 0 |
| Depression | 3/50 (6%) | 3 | 2/28 (7.1%) | 2 | 0/28 (0%) | 0 | 0/6 (0%) | 0 |
| Insomnia | 3/50 (6%) | 3 | 0/28 (0%) | 0 | 2/28 (7.1%) | 2 | 0/6 (0%) | 0 |
| Renal and urinary disorders | ||||||||
| Haematuria | 0/50 (0%) | 0 | 3/28 (10.7%) | 3 | 0/28 (0%) | 0 | 0/6 (0%) | 0 |
| Renal failure acute | 0/50 (0%) | 0 | 3/28 (10.7%) | 4 | 0/28 (0%) | 0 | 1/6 (16.7%) | 1 |
| Respiratory, thoracic and mediastinal disorders | ||||||||
| Chronic obstructive pulmonary disease | 0/50 (0%) | 0 | 0/28 (0%) | 0 | 2/28 (7.1%) | 7 | 0/6 (0%) | 0 |
| Cough | 4/50 (8%) | 6 | 0/28 (0%) | 0 | 2/28 (7.1%) | 2 | 0/6 (0%) | 0 |
| Dyspnoea | 7/50 (14%) | 8 | 3/28 (10.7%) | 3 | 2/28 (7.1%) | 2 | 1/6 (16.7%) | 1 |
| Epistaxis | 3/50 (6%) | 4 | 0/28 (0%) | 0 | 0/28 (0%) | 0 | 0/6 (0%) | 0 |
| Skin and subcutaneous tissue disorders | ||||||||
| Dermal cyst | 0/50 (0%) | 0 | 0/28 (0%) | 0 | 0/28 (0%) | 0 | 1/6 (16.7%) | 1 |
| Nail discolouration | 0/50 (0%) | 0 | 0/28 (0%) | 0 | 0/28 (0%) | 0 | 1/6 (16.7%) | 1 |
| Vascular disorders | ||||||||
| Hypertension | 0/50 (0%) | 0 | 2/28 (7.1%) | 2 | 2/28 (7.1%) | 2 | 0/6 (0%) | 0 |
| Hypotension | 5/50 (10%) | 6 | 3/28 (10.7%) | 3 | 0/28 (0%) | 0 | 1/6 (16.7%) | 1 |
| Peripheral arterial occlusive disease | 0/50 (0%) | 0 | 2/28 (7.1%) | 2 | 0/28 (0%) | 0 | 0/6 (0%) | 0 |
Limitations/Caveats
Study terminated early due to business considerations. Participants in Treatment or Active Control arms who did not have injection of target cells/placebo assigned to Not Injected Arm. Not included in efficacy analysis but in safety follow-up.
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
Baxalta's agreements with PIs may vary per requirements of individual PI, but contain common elements. For this study, results may not be published without prior written approval of Sponsor.
Results Point of Contact
| Name/Title | Clinical Trial Registries and Results Disclosure |
|---|---|
| Organization | Baxalta US Inc. |
| Phone | |
| ClinicalTrialsDisclosure@baxalta.com |
Responsible Party:
Caladrius Biosciences, Inc.
ClinicalTrials.gov Identifier:
NCT01508910
Other Study ID Numbers:
- 901001
- RENEW Study
First Posted:
Jan 12, 2012
Last Update Posted:
Dec 19, 2018
Last Verified:
Nov 1, 2018