Trial Outcomes & Findings for Efficacy and Safety of Targeted Intramyocardial Delivery of Auto CD34+ Stem Cells for Improving Exercise Capacity in Subjects With Refractory Angina (NCT NCT01508910)
NCT ID: NCT01508910
Last Updated: 2018-12-19
Results Overview
Baseline (BL) is the average of the two total exercise times measured during the screening period.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
291 participants
Primary outcome timeframe
Baseline and 12 month visit
Results posted on
2018-12-19
Participant Flow
The study started in May 2012 and completed in November 2015.
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.
Participant milestones
| Measure |
Treatment Arm
Targeted intramyocardial delivery of 1 x 10\^5 Auto-CD34+ cells after granulocyte-colony stimulating factor (G-CSF) mobilization and apheresis.
|
Active Control Arm
Targeted intramyocardial delivery of placebo after granulocyte-colony stimulating factor (G-CSF) mobilization and apheresis.
|
Unblinded Standard of Care (SOC) Arm
No study-related procedures were performed.
|
Not Injected Arm
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.
|
|---|---|---|---|---|
|
Randomization
STARTED
|
57
|
27
|
28
|
0
|
|
Randomization
COMPLETED
|
57
|
27
|
28
|
0
|
|
Randomization
NOT COMPLETED
|
0
|
0
|
0
|
0
|
|
Treatment
STARTED
|
50
|
28
|
28
|
6
|
|
Treatment
COMPLETED
|
48
|
24
|
18
|
3
|
|
Treatment
NOT COMPLETED
|
2
|
4
|
10
|
3
|
Reasons for withdrawal
| Measure |
Treatment Arm
Targeted intramyocardial delivery of 1 x 10\^5 Auto-CD34+ cells after granulocyte-colony stimulating factor (G-CSF) mobilization and apheresis.
|
Active Control Arm
Targeted intramyocardial delivery of placebo after granulocyte-colony stimulating factor (G-CSF) mobilization and apheresis.
|
Unblinded Standard of Care (SOC) Arm
No study-related procedures were performed.
|
Not Injected Arm
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.
|
|---|---|---|---|---|
|
Treatment
Death
|
2
|
3
|
2
|
0
|
|
Treatment
Lost to Follow-up
|
0
|
0
|
2
|
1
|
|
Treatment
Withdrawal by Subject
|
0
|
1
|
6
|
1
|
|
Treatment
Sponsor Decision
|
0
|
0
|
0
|
1
|
Baseline Characteristics
Efficacy and Safety of Targeted Intramyocardial Delivery of Auto CD34+ Stem Cells for Improving Exercise Capacity in Subjects With Refractory Angina
Baseline characteristics by cohort
| Measure |
Treatment Arm
n=57 Participants
Targeted intramyocardial delivery of 1 x 10\^5 Auto-CD34+ cells after granulocyte-colony stimulating factor (G-CSF) mobilization and apheresis.
|
Active Control Arm
n=27 Participants
Targeted intramyocardial delivery of placebo after granulocyte-colony stimulating factor (G-CSF) mobilization and apheresis.
|
Unblinded Standard of Care (SOC) Arm
n=28 Participants
No study-related procedures will be performed.
|
Total
n=112 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
64 Years
STANDARD_DEVIATION 8 • n=5 Participants
|
64 Years
STANDARD_DEVIATION 8 • n=7 Participants
|
63 Years
STANDARD_DEVIATION 10 • n=5 Participants
|
64 Years
STANDARD_DEVIATION 8 • n=4 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
18 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
47 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
94 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Baseline and 12 month visitPopulation: 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.
Baseline (BL) is the average of the two total exercise times measured during the screening period.
Outcome measures
| Measure |
Treatment Arm
n=57 Participants
Targeted intramyocardial delivery of 1 x 10\^5 Auto-CD34+ cells after granulocyte-colony stimulating factor (G-CSF) mobilization and apheresis
|
Active Control Arm
n=27 Participants
Targeted intramyocardial delivery of placebo after G-CSF mobilization and apheresis
|
Unblinded Standard of Care (SOC) Arm
No study-related procedures will be performed.
|
Not Injected Arm
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.
|
|---|---|---|---|---|
|
Change From Baseline in Total Exercise Time on Exercise Tolerance Test (ETT) Using the Modified Bruce Protocol
|
108.7 seconds
Standard Deviation 194.3
|
90.0 seconds
Standard Deviation 184.7
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline and 12 month visitPopulation: 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.
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.
Outcome measures
| Measure |
Treatment Arm
n=57 Participants
Targeted intramyocardial delivery of 1 x 10\^5 Auto-CD34+ cells after granulocyte-colony stimulating factor (G-CSF) mobilization and apheresis
|
Active Control Arm
n=27 Participants
Targeted intramyocardial delivery of placebo after G-CSF mobilization and apheresis
|
Unblinded Standard of Care (SOC) Arm
No study-related procedures will be performed.
|
Not Injected Arm
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.
|
|---|---|---|---|---|
|
Angina Frequency (Episodes Per Week) at the 12 Month Follow-up Visit
Number of weekly angina episodes at Month 12 visit
|
7.7 angina episodes per week
Standard Deviation 9.5
|
5.4 angina episodes per week
Standard Deviation 7.4
|
—
|
—
|
|
Angina Frequency (Episodes Per Week) at the 12 Month Follow-up Visit
Number of weekly angina episodes at baseline
|
20.1 angina episodes per week
Standard Deviation 13.0
|
16.5 angina episodes per week
Standard Deviation 9.4
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline and 6 month visitPopulation: 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.
Baseline (BL) is the average of the two total exercise times measured during the screening period.
Outcome measures
| Measure |
Treatment Arm
n=57 Participants
Targeted intramyocardial delivery of 1 x 10\^5 Auto-CD34+ cells after granulocyte-colony stimulating factor (G-CSF) mobilization and apheresis
|
Active Control Arm
n=27 Participants
Targeted intramyocardial delivery of placebo after G-CSF mobilization and apheresis
|
Unblinded Standard of Care (SOC) Arm
No study-related procedures will be performed.
|
Not Injected Arm
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.
|
|---|---|---|---|---|
|
Change From Baseline in Total Exercise Time on Exercise Tolerance Test (ETT) at the 6 Month Follow-up Visit
|
126.5 seconds
Standard Deviation 161.1
|
93.5 seconds
Standard Deviation 138.6
|
—
|
—
|
SECONDARY outcome
Timeframe: 6 month visitPopulation: 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.
Outcome measures
| Measure |
Treatment Arm
n=57 Participants
Targeted intramyocardial delivery of 1 x 10\^5 Auto-CD34+ cells after granulocyte-colony stimulating factor (G-CSF) mobilization and apheresis
|
Active Control Arm
n=27 Participants
Targeted intramyocardial delivery of placebo after G-CSF mobilization and apheresis
|
Unblinded Standard of Care (SOC) Arm
No study-related procedures will be performed.
|
Not Injected Arm
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.
|
|---|---|---|---|---|
|
Angina Frequency (Episodes Per Week) at the 6 Month Follow-up Visit
|
8.0 angina episodes per week
Standard Deviation 9.6
|
8.4 angina episodes per week
Standard Deviation 9.8
|
—
|
—
|
SECONDARY outcome
Timeframe: From randomization until the end of the 24 month follow-up periodPopulation: Participants in the safety population as Treated.
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.
Outcome measures
| Measure |
Treatment Arm
n=50 Participants
Targeted intramyocardial delivery of 1 x 10\^5 Auto-CD34+ cells after granulocyte-colony stimulating factor (G-CSF) mobilization and apheresis
|
Active Control Arm
n=28 Participants
Targeted intramyocardial delivery of placebo after G-CSF mobilization and apheresis
|
Unblinded Standard of Care (SOC) Arm
n=28 Participants
No study-related procedures will be performed.
|
Not Injected Arm
n=6 Participants
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.
|
|---|---|---|---|---|
|
Percentage of Participants With Incidences of MACE From Randomization Until the End of the 24 Month Follow-up Period
Myocardial Perforation
|
4.0 percent
Interval 0.5 to 13.7
|
0 percent
Interval 0.0 to 0.0
|
0 percent
Interval 0.0 to 0.0
|
16.7 percent
Interval 0.4 to 64.1
|
|
Percentage of Participants With Incidences of MACE From Randomization Until the End of the 24 Month Follow-up Period
Ventricular Arrhythmia
|
2.0 percent
Interval 0.1 to 10.6
|
7.1 percent
Interval 0.9 to 23.5
|
3.6 percent
Interval 0.1 to 18.3
|
0 percent
Interval 0.0 to 0.0
|
|
Percentage of Participants With Incidences of MACE From Randomization Until the End of the 24 Month Follow-up Period
Cardiovascular Hospitalization
|
42.0 percent
Interval 28.2 to 56.8
|
32.1 percent
Interval 15.9 to 52.4
|
64.3 percent
Interval 44.1 to 81.4
|
33.3 percent
Interval 4.3 to 77.7
|
|
Percentage of Participants With Incidences of MACE From Randomization Until the End of the 24 Month Follow-up Period
Death
|
4.0 percent
Interval 0.5 to 13.7
|
10.7 percent
Interval 2.3 to 28.2
|
7.1 percent
Interval 0.9 to 23.5
|
0 percent
Interval 0.0 to 0.0
|
|
Percentage of Participants With Incidences of MACE From Randomization Until the End of the 24 Month Follow-up Period
Myocardial Infarction
|
10.0 percent
Interval 3.3 to 21.8
|
10.7 percent
Interval 2.3 to 28.2
|
7.1 percent
Interval 0.9 to 23.5
|
33.3 percent
Interval 4.3 to 77.7
|
|
Percentage of Participants With Incidences of MACE From Randomization Until the End of the 24 Month Follow-up Period
Stroke
|
0 percent
Interval 0.0 to 0.0
|
0 percent
Interval 0.0 to 0.0
|
0 percent
Interval 0.0 to 0.0
|
0 percent
Interval 0.0 to 0.0
|
|
Percentage of Participants With Incidences of MACE From Randomization Until the End of the 24 Month Follow-up Period
Total MACE (see outcome measure description)
|
46.0 percent
Interval 31.8 to 60.7
|
42.9 percent
Interval 24.5 to 62.8
|
67.9 percent
Interval 47.6 to 84.1
|
33.3 percent
Interval 4.3 to 77.7
|
SECONDARY outcome
Timeframe: From randomization until the end of the 24 month follow-up periodPopulation: Safety Population as Treated.
Outcome measures
| Measure |
Treatment Arm
n=50 Participants
Targeted intramyocardial delivery of 1 x 10\^5 Auto-CD34+ cells after granulocyte-colony stimulating factor (G-CSF) mobilization and apheresis
|
Active Control Arm
n=28 Participants
Targeted intramyocardial delivery of placebo after G-CSF mobilization and apheresis
|
Unblinded Standard of Care (SOC) Arm
n=28 Participants
No study-related procedures will be performed.
|
Not Injected Arm
n=6 Participants
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.
|
|---|---|---|---|---|
|
Percentage of Participants With at Least One Serious Adverse Event (SAE) From Randomization Until the End of the 24 Month Follow-up Period
|
62.0 percent
|
60.7 percent
|
78.6 percent
|
50.0 percent
|
Adverse Events
Treatment Arm
Serious events: 31 serious events
Other events: 48 other events
Deaths: 0 deaths
Active Control Arm
Serious events: 17 serious events
Other events: 26 other events
Deaths: 0 deaths
Unblinded Standard of Care (SOC) Arm
Serious events: 22 serious events
Other events: 23 other events
Deaths: 0 deaths
Not Treated Arm
Serious events: 3 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Treatment Arm
n=50 participants at risk
Targeted intramyocardial delivery of 1 x 10\^5 Auto-CD34+ cells after granulocyte-colony stimulating factor (G-CSF) mobilization and apheresis
|
Active Control Arm
n=28 participants at risk
Targeted intramyocardial delivery of placebo after G-CSF mobilization and apheresis
|
Unblinded Standard of Care (SOC) Arm
n=28 participants at risk
No study-related procedures will be performed.
|
Not Treated Arm
n=6 participants at risk
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.
|
|---|---|---|---|---|
|
Cardiac disorders
Angina pectoris
|
14.0%
7/50 • Number of events 9 • From randomization until the end of the 24 month follow-up period
|
7.1%
2/28 • Number of events 3 • From randomization until the end of the 24 month follow-up period
|
39.3%
11/28 • Number of events 18 • From randomization until the end of the 24 month follow-up period
|
0.00%
0/6 • From randomization until the end of the 24 month follow-up period
|
|
Cardiac disorders
Angina unstable
|
8.0%
4/50 • Number of events 7 • From randomization until the end of the 24 month follow-up period
|
7.1%
2/28 • Number of events 2 • From randomization until the end of the 24 month follow-up period
|
10.7%
3/28 • Number of events 3 • From randomization until the end of the 24 month follow-up period
|
16.7%
1/6 • Number of events 1 • From randomization until the end of the 24 month follow-up period
|
|
Cardiac disorders
Acute myocardial infarction
|
6.0%
3/50 • Number of events 3 • From randomization until the end of the 24 month follow-up period
|
10.7%
3/28 • Number of events 3 • From randomization until the end of the 24 month follow-up period
|
3.6%
1/28 • Number of events 1 • From randomization until the end of the 24 month follow-up period
|
16.7%
1/6 • Number of events 2 • From randomization until the end of the 24 month follow-up period
|
|
Cardiac disorders
Cardiac failure congestive
|
6.0%
3/50 • Number of events 4 • From randomization until the end of the 24 month follow-up period
|
7.1%
2/28 • Number of events 3 • From randomization until the end of the 24 month follow-up period
|
7.1%
2/28 • Number of events 2 • From randomization until the end of the 24 month follow-up period
|
0.00%
0/6 • From randomization until the end of the 24 month follow-up period
|
|
Cardiac disorders
Coronary artery disease
|
0.00%
0/50 • From randomization until the end of the 24 month follow-up period
|
3.6%
1/28 • Number of events 1 • From randomization until the end of the 24 month follow-up period
|
10.7%
3/28 • Number of events 3 • From randomization until the end of the 24 month follow-up period
|
0.00%
0/6 • From randomization until the end of the 24 month follow-up period
|
|
Cardiac disorders
Myocardial infarction
|
4.0%
2/50 • Number of events 2 • From randomization until the end of the 24 month follow-up period
|
0.00%
0/28 • From randomization until the end of the 24 month follow-up period
|
3.6%
1/28 • Number of events 1 • From randomization until the end of the 24 month follow-up period
|
0.00%
0/6 • From randomization until the end of the 24 month follow-up period
|
|
Cardiac disorders
Ventricular tachycardia
|
4.0%
2/50 • Number of events 2 • From randomization until the end of the 24 month follow-up period
|
3.6%
1/28 • Number of events 2 • From randomization until the end of the 24 month follow-up period
|
0.00%
0/28 • From randomization until the end of the 24 month follow-up period
|
0.00%
0/6 • From randomization until the end of the 24 month follow-up period
|
|
Cardiac disorders
Cardiac failure
|
4.0%
2/50 • Number of events 3 • From randomization until the end of the 24 month follow-up period
|
0.00%
0/28 • From randomization until the end of the 24 month follow-up period
|
0.00%
0/28 • From randomization until the end of the 24 month follow-up period
|
0.00%
0/6 • From randomization until the end of the 24 month follow-up period
|
|
Cardiac disorders
Cardiac failure acute
|
0.00%
0/50 • From randomization until the end of the 24 month follow-up period
|
3.6%
1/28 • Number of events 1 • From randomization until the end of the 24 month follow-up period
|
3.6%
1/28 • Number of events 1 • From randomization until the end of the 24 month follow-up period
|
0.00%
0/6 • From randomization until the end of the 24 month follow-up period
|
|
Cardiac disorders
Pericardial effusion
|
2.0%
1/50 • Number of events 1 • From randomization until the end of the 24 month follow-up period
|
0.00%
0/28 • From randomization until the end of the 24 month follow-up period
|
0.00%
0/28 • From randomization until the end of the 24 month follow-up period
|
16.7%
1/6 • Number of events 1 • From randomization until the end of the 24 month follow-up period
|
|
Cardiac disorders
Acute coronary syndrome
|
0.00%
0/50 • From randomization until the end of the 24 month follow-up period
|
0.00%
0/28 • From randomization until the end of the 24 month follow-up period
|
3.6%
1/28 • Number of events 1 • From randomization until the end of the 24 month follow-up period
|
0.00%
0/6 • From randomization until the end of the 24 month follow-up period
|
|
Cardiac disorders
Arrhythmia
|
2.0%
1/50 • Number of events 1 • From randomization until the end of the 24 month follow-up period
|
0.00%
0/28 • From randomization until the end of the 24 month follow-up period
|
0.00%
0/28 • From randomization until the end of the 24 month follow-up period
|
0.00%
0/6 • From randomization until the end of the 24 month follow-up period
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/50 • From randomization until the end of the 24 month follow-up period
|
3.6%
1/28 • Number of events 2 • From randomization until the end of the 24 month follow-up period
|
0.00%
0/28 • From randomization until the end of the 24 month follow-up period
|
0.00%
0/6 • From randomization until the end of the 24 month follow-up period
|
|
Cardiac disorders
atrioventricular block first degree
|
2.0%
1/50 • Number of events 1 • From randomization until the end of the 24 month follow-up period
|
0.00%
0/28 • From randomization until the end of the 24 month follow-up period
|
0.00%
0/28 • From randomization until the end of the 24 month follow-up period
|
0.00%
0/6 • From randomization until the end of the 24 month follow-up period
|
|
Cardiac disorders
Cardiac tamponade
|
2.0%
1/50 • Number of events 1 • From randomization until the end of the 24 month follow-up period
|
0.00%
0/28 • From randomization until the end of the 24 month follow-up period
|
0.00%
0/28 • From randomization until the end of the 24 month follow-up period
|
0.00%
0/6 • From randomization until the end of the 24 month follow-up period
|
|
Cardiac disorders
Cardiogenic shock
|
0.00%
0/50 • From randomization until the end of the 24 month follow-up period
|
3.6%
1/28 • Number of events 1 • From randomization until the end of the 24 month follow-up period
|
0.00%
0/28 • From randomization until the end of the 24 month follow-up period
|
0.00%
0/6 • From randomization until the end of the 24 month follow-up period
|
|
Cardiac disorders
Chronotropic incompetence
|
0.00%
0/50 • From randomization until the end of the 24 month follow-up period
|
0.00%
0/28 • From randomization until the end of the 24 month follow-up period
|
3.6%
1/28 • Number of events 1 • From randomization until the end of the 24 month follow-up period
|
0.00%
0/6 • From randomization until the end of the 24 month follow-up period
|
|
Cardiac disorders
Coronary artery perforation
|
2.0%
1/50 • Number of events 1 • From randomization until the end of the 24 month follow-up period
|
0.00%
0/28 • From randomization until the end of the 24 month follow-up period
|
0.00%
0/28 • From randomization until the end of the 24 month follow-up period
|
0.00%
0/6 • From randomization until the end of the 24 month follow-up period
|
|
Cardiac disorders
Ischaemic cardiomyopathy
|
0.00%
0/50 • From randomization until the end of the 24 month follow-up period
|
3.6%
1/28 • Number of events 1 • From randomization until the end of the 24 month follow-up period
|
0.00%
0/28 • From randomization until the end of the 24 month follow-up period
|
0.00%
0/6 • From randomization until the end of the 24 month follow-up period
|
|
Cardiac disorders
Left ventricular dysfunction
|
0.00%
0/50 • From randomization until the end of the 24 month follow-up period
|
0.00%
0/28 • From randomization until the end of the 24 month follow-up period
|
3.6%
1/28 • Number of events 1 • From randomization until the end of the 24 month follow-up period
|
0.00%
0/6 • From randomization until the end of the 24 month follow-up period
|
|
Cardiac disorders
Myocardial ischaemia
|
0.00%
0/50 • From randomization until the end of the 24 month follow-up period
|
0.00%
0/28 • From randomization until the end of the 24 month follow-up period
|
3.6%
1/28 • Number of events 1 • From randomization until the end of the 24 month follow-up period
|
0.00%
0/6 • From randomization until the end of the 24 month follow-up period
|
|
General disorders
Chest pain
|
4.0%
2/50 • Number of events 2 • From randomization until the end of the 24 month follow-up period
|
3.6%
1/28 • Number of events 1 • From randomization until the end of the 24 month follow-up period
|
7.1%
2/28 • Number of events 2 • From randomization until the end of the 24 month follow-up period
|
0.00%
0/6 • From randomization until the end of the 24 month follow-up period
|
|
General disorders
Non-cardiac chest pain
|
2.0%
1/50 • Number of events 2 • From randomization until the end of the 24 month follow-up period
|
0.00%
0/28 • From randomization until the end of the 24 month follow-up period
|
3.6%
1/28 • Number of events 1 • From randomization until the end of the 24 month follow-up period
|
0.00%
0/6 • From randomization until the end of the 24 month follow-up period
|
|
General disorders
Sudden cardiac death
|
0.00%
0/50 • From randomization until the end of the 24 month follow-up period
|
3.6%
1/28 • Number of events 1 • From randomization until the end of the 24 month follow-up period
|
3.6%
1/28 • Number of events 1 • From randomization until the end of the 24 month follow-up period
|
0.00%
0/6 • From randomization until the end of the 24 month follow-up period
|
|
General disorders
Asthenia
|
2.0%
1/50 • Number of events 1 • From randomization until the end of the 24 month follow-up period
|
0.00%
0/28 • From randomization until the end of the 24 month follow-up period
|
0.00%
0/28 • From randomization until the end of the 24 month follow-up period
|
0.00%
0/6 • From randomization until the end of the 24 month follow-up period
|
|
General disorders
Device electrical impedance issue
|
2.0%
1/50 • Number of events 1 • From randomization until the end of the 24 month follow-up period
|
0.00%
0/28 • From randomization until the end of the 24 month follow-up period
|
0.00%
0/28 • From randomization until the end of the 24 month follow-up period
|
0.00%
0/6 • From randomization until the end of the 24 month follow-up period
|
|
General disorders
Disease progression
|
2.0%
1/50 • Number of events 1 • From randomization until the end of the 24 month follow-up period
|
0.00%
0/28 • From randomization until the end of the 24 month follow-up period
|
0.00%
0/28 • From randomization until the end of the 24 month follow-up period
|
0.00%
0/6 • From randomization until the end of the 24 month follow-up period
|
|
General disorders
Electrocution
|
2.0%
1/50 • Number of events 1 • From randomization until the end of the 24 month follow-up period
|
0.00%
0/28 • From randomization until the end of the 24 month follow-up period
|
0.00%
0/28 • From randomization until the end of the 24 month follow-up period
|
0.00%
0/6 • From randomization until the end of the 24 month follow-up period
|
|
General disorders
Vascular complication associated with device
|
2.0%
1/50 • Number of events 1 • From randomization until the end of the 24 month follow-up period
|
0.00%
0/28 • From randomization until the end of the 24 month follow-up period
|
0.00%
0/28 • From randomization until the end of the 24 month follow-up period
|
0.00%
0/6 • From randomization until the end of the 24 month follow-up period
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/50 • From randomization until the end of the 24 month follow-up period
|
3.6%
1/28 • Number of events 1 • From randomization until the end of the 24 month follow-up period
|
0.00%
0/28 • From randomization until the end of the 24 month follow-up period
|
0.00%
0/6 • From randomization until the end of the 24 month follow-up period
|
|
Musculoskeletal and connective tissue disorders
Arthropathy
|
2.0%
1/50 • Number of events 1 • From randomization until the end of the 24 month follow-up period
|
0.00%
0/28 • From randomization until the end of the 24 month follow-up period
|
0.00%
0/28 • From randomization until the end of the 24 month follow-up period
|
0.00%
0/6 • From randomization until the end of the 24 month follow-up period
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
2.0%
1/50 • Number of events 1 • From randomization until the end of the 24 month follow-up period
|
0.00%
0/28 • From randomization until the end of the 24 month follow-up period
|
0.00%
0/28 • From randomization until the end of the 24 month follow-up period
|
0.00%
0/6 • From randomization until the end of the 24 month follow-up period
|
|
Musculoskeletal and connective tissue disorders
Lumbar spinal stenosis
|
0.00%
0/50 • From randomization until the end of the 24 month follow-up period
|
3.6%
1/28 • Number of events 1 • From randomization until the end of the 24 month follow-up period
|
0.00%
0/28 • From randomization until the end of the 24 month follow-up period
|
0.00%
0/6 • From randomization until the end of the 24 month follow-up period
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/50 • From randomization until the end of the 24 month follow-up period
|
0.00%
0/28 • From randomization until the end of the 24 month follow-up period
|
3.6%
1/28 • Number of events 1 • From randomization until the end of the 24 month follow-up period
|
0.00%
0/6 • From randomization until the end of the 24 month follow-up period
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/50 • From randomization until the end of the 24 month follow-up period
|
3.6%
1/28 • Number of events 1 • From randomization until the end of the 24 month follow-up period
|
0.00%
0/28 • From randomization until the end of the 24 month follow-up period
|
0.00%
0/6 • From randomization until the end of the 24 month follow-up period
|
|
Musculoskeletal and connective tissue disorders
Rhabdomyolysis
|
2.0%
1/50 • Number of events 1 • From randomization until the end of the 24 month follow-up period
|
0.00%
0/28 • From randomization until the end of the 24 month follow-up period
|
0.00%
0/28 • From randomization until the end of the 24 month follow-up period
|
0.00%
0/6 • From randomization until the end of the 24 month follow-up period
|
|
Musculoskeletal and connective tissue disorders
Rotator cuff syndrome
|
0.00%
0/50 • From randomization until the end of the 24 month follow-up period
|
3.6%
1/28 • Number of events 1 • From randomization until the end of the 24 month follow-up period
|
0.00%
0/28 • From randomization until the end of the 24 month follow-up period
|
0.00%
0/6 • From randomization until the end of the 24 month follow-up period
|
|
Musculoskeletal and connective tissue disorders
Spinal column stenosis
|
2.0%
1/50 • Number of events 1 • From randomization until the end of the 24 month follow-up period
|
0.00%
0/28 • From randomization until the end of the 24 month follow-up period
|
0.00%
0/28 • From randomization until the end of the 24 month follow-up period
|
0.00%
0/6 • From randomization until the end of the 24 month follow-up period
|
|
Musculoskeletal and connective tissue disorders
Spinal osteoarthritis
|
2.0%
1/50 • Number of events 1 • From randomization until the end of the 24 month follow-up period
|
0.00%
0/28 • From randomization until the end of the 24 month follow-up period
|
0.00%
0/28 • From randomization until the end of the 24 month follow-up period
|
0.00%
0/6 • From randomization until the end of the 24 month follow-up period
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.00%
0/50 • From randomization until the end of the 24 month follow-up period
|
3.6%
1/28 • Number of events 1 • From randomization until the end of the 24 month follow-up period
|
10.7%
3/28 • Number of events 3 • From randomization until the end of the 24 month follow-up period
|
0.00%
0/6 • From randomization until the end of the 24 month follow-up period
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
2.0%
1/50 • Number of events 1 • From randomization until the end of the 24 month follow-up period
|
0.00%
0/28 • From randomization until the end of the 24 month follow-up period
|
7.1%
2/28 • Number of events 2 • From randomization until the end of the 24 month follow-up period
|
0.00%
0/6 • From randomization until the end of the 24 month follow-up period
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
0.00%
0/50 • From randomization until the end of the 24 month follow-up period
|
0.00%
0/28 • From randomization until the end of the 24 month follow-up period
|
3.6%
1/28 • Number of events 1 • From randomization until the end of the 24 month follow-up period
|
0.00%
0/6 • From randomization until the end of the 24 month follow-up period
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
2.0%
1/50 • Number of events 1 • From randomization until the end of the 24 month follow-up period
|
0.00%
0/28 • From randomization until the end of the 24 month follow-up period
|
0.00%
0/28 • From randomization until the end of the 24 month follow-up period
|
0.00%
0/6 • From randomization until the end of the 24 month follow-up period
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
2.0%
1/50 • Number of events 1 • From randomization until the end of the 24 month follow-up period
|
0.00%
0/28 • From randomization until the end of the 24 month follow-up period
|
0.00%
0/28 • From randomization until the end of the 24 month follow-up period
|
0.00%
0/6 • From randomization until the end of the 24 month follow-up period
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/50 • From randomization until the end of the 24 month follow-up period
|
0.00%
0/28 • From randomization until the end of the 24 month follow-up period
|
0.00%
0/28 • From randomization until the end of the 24 month follow-up period
|
16.7%
1/6 • Number of events 1 • From randomization until the end of the 24 month follow-up period
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
4.0%
2/50 • Number of events 2 • From randomization until the end of the 24 month follow-up period
|
0.00%
0/28 • From randomization until the end of the 24 month follow-up period
|
0.00%
0/28 • From randomization until the end of the 24 month follow-up period
|
0.00%
0/6 • From randomization until the end of the 24 month follow-up period
|
|
Gastrointestinal disorders
Abdominal pain
|
2.0%
1/50 • Number of events 1 • From randomization until the end of the 24 month follow-up period
|
0.00%
0/28 • From randomization until the end of the 24 month follow-up period
|
0.00%
0/28 • From randomization until the end of the 24 month follow-up period
|
0.00%
0/6 • From randomization until the end of the 24 month follow-up period
|
|
Gastrointestinal disorders
Diabetic gastroparesis
|
2.0%
1/50 • Number of events 1 • From randomization until the end of the 24 month follow-up period
|
0.00%
0/28 • From randomization until the end of the 24 month follow-up period
|
0.00%
0/28 • From randomization until the end of the 24 month follow-up period
|
0.00%
0/6 • From randomization until the end of the 24 month follow-up period
|
|
Gastrointestinal disorders
Diverticulum intestinal haemorrhagic
|
0.00%
0/50 • From randomization until the end of the 24 month follow-up period
|
0.00%
0/28 • From randomization until the end of the 24 month follow-up period
|
3.6%
1/28 • Number of events 1 • From randomization until the end of the 24 month follow-up period
|
0.00%
0/6 • From randomization until the end of the 24 month follow-up period
|
|
Gastrointestinal disorders
Gastric ulcer
|
0.00%
0/50 • From randomization until the end of the 24 month follow-up period
|
0.00%
0/28 • From randomization until the end of the 24 month follow-up period
|
3.6%
1/28 • Number of events 1 • From randomization until the end of the 24 month follow-up period
|
0.00%
0/6 • From randomization until the end of the 24 month follow-up period
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/50 • From randomization until the end of the 24 month follow-up period
|
3.6%
1/28 • Number of events 1 • From randomization until the end of the 24 month follow-up period
|
0.00%
0/28 • From randomization until the end of the 24 month follow-up period
|
0.00%
0/6 • From randomization until the end of the 24 month follow-up period
|
|
Gastrointestinal disorders
Ileus
|
2.0%
1/50 • Number of events 1 • From randomization until the end of the 24 month follow-up period
|
0.00%
0/28 • From randomization until the end of the 24 month follow-up period
|
0.00%
0/28 • From randomization until the end of the 24 month follow-up period
|
0.00%
0/6 • From randomization until the end of the 24 month follow-up period
|
|
Gastrointestinal disorders
Oesophagitis ulcerative
|
0.00%
0/50 • From randomization until the end of the 24 month follow-up period
|
0.00%
0/28 • From randomization until the end of the 24 month follow-up period
|
3.6%
1/28 • Number of events 1 • From randomization until the end of the 24 month follow-up period
|
0.00%
0/6 • From randomization until the end of the 24 month follow-up period
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.00%
0/50 • From randomization until the end of the 24 month follow-up period
|
0.00%
0/28 • From randomization until the end of the 24 month follow-up period
|
3.6%
1/28 • Number of events 1 • From randomization until the end of the 24 month follow-up period
|
0.00%
0/6 • From randomization until the end of the 24 month follow-up period
|
|
Vascular disorders
Hypotension
|
0.00%
0/50 • From randomization until the end of the 24 month follow-up period
|
0.00%
0/28 • From randomization until the end of the 24 month follow-up period
|
3.6%
1/28 • Number of events 1 • From randomization until the end of the 24 month follow-up period
|
16.7%
1/6 • Number of events 1 • From randomization until the end of the 24 month follow-up period
|
|
Vascular disorders
Intermittent claudication
|
2.0%
1/50 • Number of events 1 • From randomization until the end of the 24 month follow-up period
|
3.6%
1/28 • Number of events 1 • From randomization until the end of the 24 month follow-up period
|
0.00%
0/28 • From randomization until the end of the 24 month follow-up period
|
0.00%
0/6 • From randomization until the end of the 24 month follow-up period
|
|
Vascular disorders
Peripheral vascular disorder
|
2.0%
1/50 • Number of events 1 • From randomization until the end of the 24 month follow-up period
|
3.6%
1/28 • Number of events 1 • From randomization until the end of the 24 month follow-up period
|
0.00%
0/28 • From randomization until the end of the 24 month follow-up period
|
0.00%
0/6 • From randomization until the end of the 24 month follow-up period
|
|
Vascular disorders
Hypertensive crisis
|
2.0%
1/50 • Number of events 1 • From randomization until the end of the 24 month follow-up period
|
0.00%
0/28 • From randomization until the end of the 24 month follow-up period
|
0.00%
0/28 • From randomization until the end of the 24 month follow-up period
|
0.00%
0/6 • From randomization until the end of the 24 month follow-up period
|
|
Vascular disorders
Peripheral artery aneurysm
|
2.0%
1/50 • Number of events 1 • From randomization until the end of the 24 month follow-up period
|
0.00%
0/28 • From randomization until the end of the 24 month follow-up period
|
0.00%
0/28 • From randomization until the end of the 24 month follow-up period
|
0.00%
0/6 • From randomization until the end of the 24 month follow-up period
|
|
Infections and infestations
Cellulitis
|
4.0%
2/50 • Number of events 2 • From randomization until the end of the 24 month follow-up period
|
0.00%
0/28 • From randomization until the end of the 24 month follow-up period
|
0.00%
0/28 • From randomization until the end of the 24 month follow-up period
|
0.00%
0/6 • From randomization until the end of the 24 month follow-up period
|
|
Infections and infestations
Pneumonia
|
0.00%
0/50 • From randomization until the end of the 24 month follow-up period
|
0.00%
0/28 • From randomization until the end of the 24 month follow-up period
|
7.1%
2/28 • Number of events 2 • From randomization until the end of the 24 month follow-up period
|
0.00%
0/6 • From randomization until the end of the 24 month follow-up period
|
|
Infections and infestations
Appendicitis
|
2.0%
1/50 • Number of events 1 • From randomization until the end of the 24 month follow-up period
|
0.00%
0/28 • From randomization until the end of the 24 month follow-up period
|
0.00%
0/28 • From randomization until the end of the 24 month follow-up period
|
0.00%
0/6 • From randomization until the end of the 24 month follow-up period
|
|
Infections and infestations
Cholecystitis infective
|
0.00%
0/50 • From randomization until the end of the 24 month follow-up period
|
3.6%
1/28 • Number of events 1 • From randomization until the end of the 24 month follow-up period
|
0.00%
0/28 • From randomization until the end of the 24 month follow-up period
|
0.00%
0/6 • From randomization until the end of the 24 month follow-up period
|
|
Infections and infestations
Endocarditis bacterial
|
2.0%
1/50 • Number of events 1 • From randomization until the end of the 24 month follow-up period
|
0.00%
0/28 • From randomization until the end of the 24 month follow-up period
|
0.00%
0/28 • From randomization until the end of the 24 month follow-up period
|
0.00%
0/6 • From randomization until the end of the 24 month follow-up period
|
|
Infections and infestations
Urinary Tract Infection
|
2.0%
1/50 • Number of events 1 • From randomization until the end of the 24 month follow-up period
|
0.00%
0/28 • From randomization until the end of the 24 month follow-up period
|
0.00%
0/28 • From randomization until the end of the 24 month follow-up period
|
0.00%
0/6 • From randomization until the end of the 24 month follow-up period
|
|
Injury, poisoning and procedural complications
Fall
|
2.0%
1/50 • Number of events 1 • From randomization until the end of the 24 month follow-up period
|
0.00%
0/28 • From randomization until the end of the 24 month follow-up period
|
0.00%
0/28 • From randomization until the end of the 24 month follow-up period
|
0.00%
0/6 • From randomization until the end of the 24 month follow-up period
|
|
Injury, poisoning and procedural complications
Humerus fracture
|
0.00%
0/50 • From randomization until the end of the 24 month follow-up period
|
3.6%
1/28 • Number of events 1 • From randomization until the end of the 24 month follow-up period
|
0.00%
0/28 • From randomization until the end of the 24 month follow-up period
|
0.00%
0/6 • From randomization until the end of the 24 month follow-up period
|
|
Injury, poisoning and procedural complications
Injury
|
0.00%
0/50 • From randomization until the end of the 24 month follow-up period
|
0.00%
0/28 • From randomization until the end of the 24 month follow-up period
|
3.6%
1/28 • Number of events 1 • From randomization until the end of the 24 month follow-up period
|
0.00%
0/6 • From randomization until the end of the 24 month follow-up period
|
|
Injury, poisoning and procedural complications
Meniscus lesion
|
2.0%
1/50 • Number of events 1 • From randomization until the end of the 24 month follow-up period
|
0.00%
0/28 • From randomization until the end of the 24 month follow-up period
|
0.00%
0/28 • From randomization until the end of the 24 month follow-up period
|
0.00%
0/6 • From randomization until the end of the 24 month follow-up period
|
|
Injury, poisoning and procedural complications
Spinal compression fracture
|
2.0%
1/50 • Number of events 1 • From randomization until the end of the 24 month follow-up period
|
0.00%
0/28 • From randomization until the end of the 24 month follow-up period
|
0.00%
0/28 • From randomization until the end of the 24 month follow-up period
|
0.00%
0/6 • From randomization until the end of the 24 month follow-up period
|
|
Injury, poisoning and procedural complications
Subdural haematoma
|
0.00%
0/50 • From randomization until the end of the 24 month follow-up period
|
0.00%
0/28 • From randomization until the end of the 24 month follow-up period
|
3.6%
1/28 • Number of events 1 • From randomization until the end of the 24 month follow-up period
|
0.00%
0/6 • From randomization until the end of the 24 month follow-up period
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
2.0%
1/50 • Number of events 1 • From randomization until the end of the 24 month follow-up period
|
0.00%
0/28 • From randomization until the end of the 24 month follow-up period
|
3.6%
1/28 • Number of events 1 • From randomization until the end of the 24 month follow-up period
|
0.00%
0/6 • From randomization until the end of the 24 month follow-up period
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/50 • From randomization until the end of the 24 month follow-up period
|
3.6%
1/28 • Number of events 1 • From randomization until the end of the 24 month follow-up period
|
0.00%
0/28 • From randomization until the end of the 24 month follow-up period
|
0.00%
0/6 • From randomization until the end of the 24 month follow-up period
|
|
Metabolism and nutrition disorders
Diabetes mellitus inadequate control
|
0.00%
0/50 • From randomization until the end of the 24 month follow-up period
|
0.00%
0/28 • From randomization until the end of the 24 month follow-up period
|
3.6%
1/28 • Number of events 1 • From randomization until the end of the 24 month follow-up period
|
0.00%
0/6 • From randomization until the end of the 24 month follow-up period
|
|
Metabolism and nutrition disorders
Diabetic ketoacidosis
|
0.00%
0/50 • From randomization until the end of the 24 month follow-up period
|
3.6%
1/28 • Number of events 1 • From randomization until the end of the 24 month follow-up period
|
0.00%
0/28 • From randomization until the end of the 24 month follow-up period
|
0.00%
0/6 • From randomization until the end of the 24 month follow-up period
|
|
Metabolism and nutrition disorders
Obesity
|
0.00%
0/50 • From randomization until the end of the 24 month follow-up period
|
0.00%
0/28 • From randomization until the end of the 24 month follow-up period
|
3.6%
1/28 • Number of events 1 • From randomization until the end of the 24 month follow-up period
|
0.00%
0/6 • From randomization until the end of the 24 month follow-up period
|
|
Nervous system disorders
Syncope
|
0.00%
0/50 • From randomization until the end of the 24 month follow-up period
|
7.1%
2/28 • Number of events 2 • From randomization until the end of the 24 month follow-up period
|
7.1%
2/28 • Number of events 2 • From randomization until the end of the 24 month follow-up period
|
0.00%
0/6 • From randomization until the end of the 24 month follow-up period
|
|
Nervous system disorders
Carotid sinus syndrome
|
0.00%
0/50 • From randomization until the end of the 24 month follow-up period
|
0.00%
0/28 • From randomization until the end of the 24 month follow-up period
|
3.6%
1/28 • Number of events 1 • From randomization until the end of the 24 month follow-up period
|
0.00%
0/6 • From randomization until the end of the 24 month follow-up period
|
|
Nervous system disorders
Epilepsy
|
0.00%
0/50 • From randomization until the end of the 24 month follow-up period
|
3.6%
1/28 • Number of events 2 • From randomization until the end of the 24 month follow-up period
|
0.00%
0/28 • From randomization until the end of the 24 month follow-up period
|
0.00%
0/6 • From randomization until the end of the 24 month follow-up period
|
|
Nervous system disorders
Transient ischaemic attack
|
0.00%
0/50 • From randomization until the end of the 24 month follow-up period
|
3.6%
1/28 • Number of events 1 • From randomization until the end of the 24 month follow-up period
|
0.00%
0/28 • From randomization until the end of the 24 month follow-up period
|
0.00%
0/6 • From randomization until the end of the 24 month follow-up period
|
|
Blood and lymphatic system disorders
Anaemia
|
2.0%
1/50 • Number of events 1 • From randomization until the end of the 24 month follow-up period
|
0.00%
0/28 • From randomization until the end of the 24 month follow-up period
|
0.00%
0/28 • From randomization until the end of the 24 month follow-up period
|
0.00%
0/6 • From randomization until the end of the 24 month follow-up period
|
|
Eye disorders
Retinal infarction
|
0.00%
0/50 • From randomization until the end of the 24 month follow-up period
|
0.00%
0/28 • From randomization until the end of the 24 month follow-up period
|
3.6%
1/28 • Number of events 1 • From randomization until the end of the 24 month follow-up period
|
0.00%
0/6 • From randomization until the end of the 24 month follow-up period
|
|
Hepatobiliary disorders
Non-alcoholic steatohepatitis
|
0.00%
0/50 • From randomization until the end of the 24 month follow-up period
|
3.6%
1/28 • Number of events 1 • From randomization until the end of the 24 month follow-up period
|
0.00%
0/28 • From randomization until the end of the 24 month follow-up period
|
0.00%
0/6 • From randomization until the end of the 24 month follow-up period
|
|
Investigations
Ejection fraction decreased
|
0.00%
0/50 • From randomization until the end of the 24 month follow-up period
|
0.00%
0/28 • From randomization until the end of the 24 month follow-up period
|
0.00%
0/28 • From randomization until the end of the 24 month follow-up period
|
16.7%
1/6 • Number of events 1 • From randomization until the end of the 24 month follow-up period
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Brain neoplasm benign
|
0.00%
0/50 • From randomization until the end of the 24 month follow-up period
|
0.00%
0/28 • From randomization until the end of the 24 month follow-up period
|
3.6%
1/28 • Number of events 1 • From randomization until the end of the 24 month follow-up period
|
0.00%
0/6 • From randomization until the end of the 24 month follow-up period
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Meningioma malignant
|
0.00%
0/50 • From randomization until the end of the 24 month follow-up period
|
0.00%
0/28 • From randomization until the end of the 24 month follow-up period
|
3.6%
1/28 • Number of events 1 • From randomization until the end of the 24 month follow-up period
|
0.00%
0/6 • From randomization until the end of the 24 month follow-up period
|
|
Psychiatric disorders
Mental status changes
|
0.00%
0/50 • From randomization until the end of the 24 month follow-up period
|
0.00%
0/28 • From randomization until the end of the 24 month follow-up period
|
3.6%
1/28 • Number of events 1 • From randomization until the end of the 24 month follow-up period
|
0.00%
0/6 • From randomization until the end of the 24 month follow-up period
|
Other adverse events
| Measure |
Treatment Arm
n=50 participants at risk
Targeted intramyocardial delivery of 1 x 10\^5 Auto-CD34+ cells after granulocyte-colony stimulating factor (G-CSF) mobilization and apheresis
|
Active Control Arm
n=28 participants at risk
Targeted intramyocardial delivery of placebo after G-CSF mobilization and apheresis
|
Unblinded Standard of Care (SOC) Arm
n=28 participants at risk
No study-related procedures will be performed.
|
Not Treated Arm
n=6 participants at risk
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.
|
|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
10.0%
5/50 • Number of events 5 • From randomization until the end of the 24 month follow-up period
|
10.7%
3/28 • Number of events 3 • From randomization until the end of the 24 month follow-up period
|
0.00%
0/28 • From randomization until the end of the 24 month follow-up period
|
16.7%
1/6 • Number of events 1 • From randomization until the end of the 24 month follow-up period
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
6.0%
3/50 • Number of events 3 • From randomization until the end of the 24 month follow-up period
|
7.1%
2/28 • Number of events 2 • From randomization until the end of the 24 month follow-up period
|
0.00%
0/28 • From randomization until the end of the 24 month follow-up period
|
0.00%
0/6 • From randomization until the end of the 24 month follow-up period
|
|
Cardiac disorders
Angina pectoris
|
34.0%
17/50 • Number of events 26 • From randomization until the end of the 24 month follow-up period
|
39.3%
11/28 • Number of events 15 • From randomization until the end of the 24 month follow-up period
|
14.3%
4/28 • Number of events 4 • From randomization until the end of the 24 month follow-up period
|
33.3%
2/6 • Number of events 4 • From randomization until the end of the 24 month follow-up period
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/50 • From randomization until the end of the 24 month follow-up period
|
0.00%
0/28 • From randomization until the end of the 24 month follow-up period
|
0.00%
0/28 • From randomization until the end of the 24 month follow-up period
|
16.7%
1/6 • Number of events 1 • From randomization until the end of the 24 month follow-up period
|
|
Cardiac disorders
Cardiac failure
|
6.0%
3/50 • Number of events 3 • From randomization until the end of the 24 month follow-up period
|
0.00%
0/28 • From randomization until the end of the 24 month follow-up period
|
0.00%
0/28 • From randomization until the end of the 24 month follow-up period
|
0.00%
0/6 • From randomization until the end of the 24 month follow-up period
|
|
Cardiac disorders
Cardiac failure congestive
|
8.0%
4/50 • Number of events 5 • From randomization until the end of the 24 month follow-up period
|
7.1%
2/28 • Number of events 2 • From randomization until the end of the 24 month follow-up period
|
0.00%
0/28 • From randomization until the end of the 24 month follow-up period
|
0.00%
0/6 • From randomization until the end of the 24 month follow-up period
|
|
Cardiac disorders
Myocardial ischaemia
|
0.00%
0/50 • From randomization until the end of the 24 month follow-up period
|
0.00%
0/28 • From randomization until the end of the 24 month follow-up period
|
7.1%
2/28 • Number of events 2 • From randomization until the end of the 24 month follow-up period
|
0.00%
0/6 • From randomization until the end of the 24 month follow-up period
|
|
Cardiac disorders
Palpitations
|
0.00%
0/50 • From randomization until the end of the 24 month follow-up period
|
10.7%
3/28 • Number of events 3 • From randomization until the end of the 24 month follow-up period
|
0.00%
0/28 • From randomization until the end of the 24 month follow-up period
|
16.7%
1/6 • Number of events 1 • From randomization until the end of the 24 month follow-up period
|
|
Cardiac disorders
Ventricular extrasystoles
|
0.00%
0/50 • From randomization until the end of the 24 month follow-up period
|
10.7%
3/28 • Number of events 3 • From randomization until the end of the 24 month follow-up period
|
0.00%
0/28 • From randomization until the end of the 24 month follow-up period
|
0.00%
0/6 • From randomization until the end of the 24 month follow-up period
|
|
Cardiac disorders
Ventricular tachycardia
|
0.00%
0/50 • From randomization until the end of the 24 month follow-up period
|
7.1%
2/28 • Number of events 2 • From randomization until the end of the 24 month follow-up period
|
0.00%
0/28 • From randomization until the end of the 24 month follow-up period
|
16.7%
1/6 • Number of events 1 • From randomization until the end of the 24 month follow-up period
|
|
Eye disorders
Cataract
|
0.00%
0/50 • From randomization until the end of the 24 month follow-up period
|
10.7%
3/28 • Number of events 3 • From randomization until the end of the 24 month follow-up period
|
0.00%
0/28 • From randomization until the end of the 24 month follow-up period
|
0.00%
0/6 • From randomization until the end of the 24 month follow-up period
|
|
Eye disorders
Conjunctivitis
|
0.00%
0/50 • From randomization until the end of the 24 month follow-up period
|
0.00%
0/28 • From randomization until the end of the 24 month follow-up period
|
7.1%
2/28 • Number of events 2 • From randomization until the end of the 24 month follow-up period
|
0.00%
0/6 • From randomization until the end of the 24 month follow-up period
|
|
Eye disorders
Macular degeneration
|
0.00%
0/50 • From randomization until the end of the 24 month follow-up period
|
0.00%
0/28 • From randomization until the end of the 24 month follow-up period
|
0.00%
0/28 • From randomization until the end of the 24 month follow-up period
|
16.7%
1/6 • Number of events 1 • From randomization until the end of the 24 month follow-up period
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/50 • From randomization until the end of the 24 month follow-up period
|
10.7%
3/28 • Number of events 3 • From randomization until the end of the 24 month follow-up period
|
0.00%
0/28 • From randomization until the end of the 24 month follow-up period
|
0.00%
0/6 • From randomization until the end of the 24 month follow-up period
|
|
Gastrointestinal disorders
Abdominal pain lower
|
0.00%
0/50 • From randomization until the end of the 24 month follow-up period
|
7.1%
2/28 • Number of events 2 • From randomization until the end of the 24 month follow-up period
|
0.00%
0/28 • From randomization until the end of the 24 month follow-up period
|
16.7%
1/6 • Number of events 1 • From randomization until the end of the 24 month follow-up period
|
|
Gastrointestinal disorders
Constipation
|
16.0%
8/50 • Number of events 8 • From randomization until the end of the 24 month follow-up period
|
0.00%
0/28 • From randomization until the end of the 24 month follow-up period
|
10.7%
3/28 • Number of events 3 • From randomization until the end of the 24 month follow-up period
|
0.00%
0/6 • From randomization until the end of the 24 month follow-up period
|
|
Gastrointestinal disorders
Diarrhoea
|
6.0%
3/50 • Number of events 3 • From randomization until the end of the 24 month follow-up period
|
10.7%
3/28 • Number of events 4 • From randomization until the end of the 24 month follow-up period
|
7.1%
2/28 • Number of events 2 • From randomization until the end of the 24 month follow-up period
|
33.3%
2/6 • Number of events 3 • From randomization until the end of the 24 month follow-up period
|
|
Gastrointestinal disorders
Diverticulum
|
0.00%
0/50 • From randomization until the end of the 24 month follow-up period
|
0.00%
0/28 • From randomization until the end of the 24 month follow-up period
|
7.1%
2/28 • Number of events 2 • From randomization until the end of the 24 month follow-up period
|
0.00%
0/6 • From randomization until the end of the 24 month follow-up period
|
|
Gastrointestinal disorders
Gastric polyps
|
0.00%
0/50 • From randomization until the end of the 24 month follow-up period
|
0.00%
0/28 • From randomization until the end of the 24 month follow-up period
|
7.1%
2/28 • Number of events 2 • From randomization until the end of the 24 month follow-up period
|
0.00%
0/6 • From randomization until the end of the 24 month follow-up period
|
|
Gastrointestinal disorders
Gastric ulcer
|
0.00%
0/50 • From randomization until the end of the 24 month follow-up period
|
0.00%
0/28 • From randomization until the end of the 24 month follow-up period
|
0.00%
0/28 • From randomization until the end of the 24 month follow-up period
|
16.7%
1/6 • Number of events 1 • From randomization until the end of the 24 month follow-up period
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/50 • From randomization until the end of the 24 month follow-up period
|
7.1%
2/28 • Number of events 3 • From randomization until the end of the 24 month follow-up period
|
0.00%
0/28 • From randomization until the end of the 24 month follow-up period
|
0.00%
0/6 • From randomization until the end of the 24 month follow-up period
|
|
Gastrointestinal disorders
Nausea
|
14.0%
7/50 • Number of events 7 • From randomization until the end of the 24 month follow-up period
|
17.9%
5/28 • Number of events 6 • From randomization until the end of the 24 month follow-up period
|
7.1%
2/28 • Number of events 2 • From randomization until the end of the 24 month follow-up period
|
16.7%
1/6 • Number of events 1 • From randomization until the end of the 24 month follow-up period
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/50 • From randomization until the end of the 24 month follow-up period
|
0.00%
0/28 • From randomization until the end of the 24 month follow-up period
|
7.1%
2/28 • Number of events 2 • From randomization until the end of the 24 month follow-up period
|
0.00%
0/6 • From randomization until the end of the 24 month follow-up period
|
|
General disorders
Chest discomfort
|
0.00%
0/50 • From randomization until the end of the 24 month follow-up period
|
7.1%
2/28 • Number of events 2 • From randomization until the end of the 24 month follow-up period
|
0.00%
0/28 • From randomization until the end of the 24 month follow-up period
|
0.00%
0/6 • From randomization until the end of the 24 month follow-up period
|
|
General disorders
Chest pain
|
0.00%
0/50 • From randomization until the end of the 24 month follow-up period
|
7.1%
2/28 • Number of events 3 • From randomization until the end of the 24 month follow-up period
|
0.00%
0/28 • From randomization until the end of the 24 month follow-up period
|
0.00%
0/6 • From randomization until the end of the 24 month follow-up period
|
|
General disorders
Chills
|
6.0%
3/50 • Number of events 3 • From randomization until the end of the 24 month follow-up period
|
0.00%
0/28 • From randomization until the end of the 24 month follow-up period
|
0.00%
0/28 • From randomization until the end of the 24 month follow-up period
|
0.00%
0/6 • From randomization until the end of the 24 month follow-up period
|
|
General disorders
Fatigue
|
18.0%
9/50 • Number of events 9 • From randomization until the end of the 24 month follow-up period
|
28.6%
8/28 • Number of events 9 • From randomization until the end of the 24 month follow-up period
|
10.7%
3/28 • Number of events 3 • From randomization until the end of the 24 month follow-up period
|
33.3%
2/6 • Number of events 2 • From randomization until the end of the 24 month follow-up period
|
|
General disorders
Influenza like illness
|
0.00%
0/50 • From randomization until the end of the 24 month follow-up period
|
0.00%
0/28 • From randomization until the end of the 24 month follow-up period
|
0.00%
0/28 • From randomization until the end of the 24 month follow-up period
|
16.7%
1/6 • Number of events 1 • From randomization until the end of the 24 month follow-up period
|
|
General disorders
Malaise
|
0.00%
0/50 • From randomization until the end of the 24 month follow-up period
|
7.1%
2/28 • Number of events 2 • From randomization until the end of the 24 month follow-up period
|
0.00%
0/28 • From randomization until the end of the 24 month follow-up period
|
0.00%
0/6 • From randomization until the end of the 24 month follow-up period
|
|
General disorders
Oedema peripheral
|
10.0%
5/50 • Number of events 6 • From randomization until the end of the 24 month follow-up period
|
7.1%
2/28 • Number of events 4 • From randomization until the end of the 24 month follow-up period
|
21.4%
6/28 • Number of events 6 • From randomization until the end of the 24 month follow-up period
|
0.00%
0/6 • From randomization until the end of the 24 month follow-up period
|
|
General disorders
Pain
|
0.00%
0/50 • From randomization until the end of the 24 month follow-up period
|
7.1%
2/28 • Number of events 2 • From randomization until the end of the 24 month follow-up period
|
0.00%
0/28 • From randomization until the end of the 24 month follow-up period
|
16.7%
1/6 • Number of events 1 • From randomization until the end of the 24 month follow-up period
|
|
General disorders
Vessel puncture site haematoma
|
0.00%
0/50 • From randomization until the end of the 24 month follow-up period
|
10.7%
3/28 • Number of events 3 • From randomization until the end of the 24 month follow-up period
|
0.00%
0/28 • From randomization until the end of the 24 month follow-up period
|
16.7%
1/6 • Number of events 1 • From randomization until the end of the 24 month follow-up period
|
|
Immune system disorders
Drug hypersensitivity
|
0.00%
0/50 • From randomization until the end of the 24 month follow-up period
|
0.00%
0/28 • From randomization until the end of the 24 month follow-up period
|
0.00%
0/28 • From randomization until the end of the 24 month follow-up period
|
16.7%
1/6 • Number of events 1 • From randomization until the end of the 24 month follow-up period
|
|
Infections and infestations
Breast infection
|
0.00%
0/50 • From randomization until the end of the 24 month follow-up period
|
0.00%
0/28 • From randomization until the end of the 24 month follow-up period
|
0.00%
0/28 • From randomization until the end of the 24 month follow-up period
|
16.7%
1/6 • Number of events 1 • From randomization until the end of the 24 month follow-up period
|
|
Infections and infestations
Bronchitis
|
10.0%
5/50 • Number of events 6 • From randomization until the end of the 24 month follow-up period
|
14.3%
4/28 • Number of events 5 • From randomization until the end of the 24 month follow-up period
|
17.9%
5/28 • Number of events 7 • From randomization until the end of the 24 month follow-up period
|
0.00%
0/6 • From randomization until the end of the 24 month follow-up period
|
|
Infections and infestations
Ear infection
|
0.00%
0/50 • From randomization until the end of the 24 month follow-up period
|
0.00%
0/28 • From randomization until the end of the 24 month follow-up period
|
0.00%
0/28 • From randomization until the end of the 24 month follow-up period
|
16.7%
1/6 • Number of events 1 • From randomization until the end of the 24 month follow-up period
|
|
Infections and infestations
Herpes zoster
|
0.00%
0/50 • From randomization until the end of the 24 month follow-up period
|
0.00%
0/28 • From randomization until the end of the 24 month follow-up period
|
7.1%
2/28 • Number of events 2 • From randomization until the end of the 24 month follow-up period
|
0.00%
0/6 • From randomization until the end of the 24 month follow-up period
|
|
Infections and infestations
Influenza
|
6.0%
3/50 • Number of events 3 • From randomization until the end of the 24 month follow-up period
|
10.7%
3/28 • Number of events 3 • From randomization until the end of the 24 month follow-up period
|
10.7%
3/28 • Number of events 3 • From randomization until the end of the 24 month follow-up period
|
0.00%
0/6 • From randomization until the end of the 24 month follow-up period
|
|
Infections and infestations
Nasopharyngitis
|
6.0%
3/50 • Number of events 3 • From randomization until the end of the 24 month follow-up period
|
7.1%
2/28 • Number of events 2 • From randomization until the end of the 24 month follow-up period
|
0.00%
0/28 • From randomization until the end of the 24 month follow-up period
|
0.00%
0/6 • From randomization until the end of the 24 month follow-up period
|
|
Infections and infestations
Oral herpes
|
0.00%
0/50 • From randomization until the end of the 24 month follow-up period
|
0.00%
0/28 • From randomization until the end of the 24 month follow-up period
|
0.00%
0/28 • From randomization until the end of the 24 month follow-up period
|
16.7%
1/6 • Number of events 1 • From randomization until the end of the 24 month follow-up period
|
|
Infections and infestations
Sinusitis
|
18.0%
9/50 • Number of events 10 • From randomization until the end of the 24 month follow-up period
|
7.1%
2/28 • Number of events 2 • From randomization until the end of the 24 month follow-up period
|
0.00%
0/28 • From randomization until the end of the 24 month follow-up period
|
0.00%
0/6 • From randomization until the end of the 24 month follow-up period
|
|
Infections and infestations
Tooth infection
|
6.0%
3/50 • Number of events 3 • From randomization until the end of the 24 month follow-up period
|
0.00%
0/28 • From randomization until the end of the 24 month follow-up period
|
0.00%
0/28 • From randomization until the end of the 24 month follow-up period
|
0.00%
0/6 • From randomization until the end of the 24 month follow-up period
|
|
Infections and infestations
Upper respiratory tract infection
|
26.0%
13/50 • Number of events 14 • From randomization until the end of the 24 month follow-up period
|
28.6%
8/28 • Number of events 13 • From randomization until the end of the 24 month follow-up period
|
7.1%
2/28 • Number of events 3 • From randomization until the end of the 24 month follow-up period
|
0.00%
0/6 • From randomization until the end of the 24 month follow-up period
|
|
Infections and infestations
Urinary tract infection
|
10.0%
5/50 • Number of events 16 • From randomization until the end of the 24 month follow-up period
|
0.00%
0/28 • From randomization until the end of the 24 month follow-up period
|
0.00%
0/28 • From randomization until the end of the 24 month follow-up period
|
0.00%
0/6 • From randomization until the end of the 24 month follow-up period
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/50 • From randomization until the end of the 24 month follow-up period
|
0.00%
0/28 • From randomization until the end of the 24 month follow-up period
|
7.1%
2/28 • Number of events 2 • From randomization until the end of the 24 month follow-up period
|
0.00%
0/6 • From randomization until the end of the 24 month follow-up period
|
|
Injury, poisoning and procedural complications
Procedural pain
|
0.00%
0/50 • From randomization until the end of the 24 month follow-up period
|
7.1%
2/28 • Number of events 2 • From randomization until the end of the 24 month follow-up period
|
7.1%
2/28 • Number of events 2 • From randomization until the end of the 24 month follow-up period
|
0.00%
0/6 • From randomization until the end of the 24 month follow-up period
|
|
Investigations
Blood creatine phosphokinase MB increased
|
8.0%
4/50 • Number of events 4 • From randomization until the end of the 24 month follow-up period
|
21.4%
6/28 • Number of events 6 • From randomization until the end of the 24 month follow-up period
|
0.00%
0/28 • From randomization until the end of the 24 month follow-up period
|
0.00%
0/6 • From randomization until the end of the 24 month follow-up period
|
|
Investigations
Blood creatinine increased
|
10.0%
5/50 • Number of events 9 • From randomization until the end of the 24 month follow-up period
|
0.00%
0/28 • From randomization until the end of the 24 month follow-up period
|
0.00%
0/28 • From randomization until the end of the 24 month follow-up period
|
0.00%
0/6 • From randomization until the end of the 24 month follow-up period
|
|
Investigations
Blood glucose increased
|
6.0%
3/50 • Number of events 3 • From randomization until the end of the 24 month follow-up period
|
0.00%
0/28 • From randomization until the end of the 24 month follow-up period
|
0.00%
0/28 • From randomization until the end of the 24 month follow-up period
|
0.00%
0/6 • From randomization until the end of the 24 month follow-up period
|
|
Investigations
Blood urea increased
|
6.0%
3/50 • Number of events 3 • From randomization until the end of the 24 month follow-up period
|
0.00%
0/28 • From randomization until the end of the 24 month follow-up period
|
0.00%
0/28 • From randomization until the end of the 24 month follow-up period
|
0.00%
0/6 • From randomization until the end of the 24 month follow-up period
|
|
Investigations
C-reactive protein increased
|
10.0%
5/50 • Number of events 5 • From randomization until the end of the 24 month follow-up period
|
0.00%
0/28 • From randomization until the end of the 24 month follow-up period
|
0.00%
0/28 • From randomization until the end of the 24 month follow-up period
|
0.00%
0/6 • From randomization until the end of the 24 month follow-up period
|
|
Investigations
Haematology test abnormal
|
0.00%
0/50 • From randomization until the end of the 24 month follow-up period
|
0.00%
0/28 • From randomization until the end of the 24 month follow-up period
|
0.00%
0/28 • From randomization until the end of the 24 month follow-up period
|
16.7%
1/6 • Number of events 1 • From randomization until the end of the 24 month follow-up period
|
|
Investigations
Neutrophil count increased
|
10.0%
5/50 • Number of events 5 • From randomization until the end of the 24 month follow-up period
|
0.00%
0/28 • From randomization until the end of the 24 month follow-up period
|
0.00%
0/28 • From randomization until the end of the 24 month follow-up period
|
0.00%
0/6 • From randomization until the end of the 24 month follow-up period
|
|
Investigations
Platelet count decreased
|
8.0%
4/50 • Number of events 4 • From randomization until the end of the 24 month follow-up period
|
17.9%
5/28 • Number of events 5 • From randomization until the end of the 24 month follow-up period
|
0.00%
0/28 • From randomization until the end of the 24 month follow-up period
|
0.00%
0/6 • From randomization until the end of the 24 month follow-up period
|
|
Investigations
Prostatic specific antigen increased
|
0.00%
0/50 • From randomization until the end of the 24 month follow-up period
|
7.1%
2/28 • Number of events 2 • From randomization until the end of the 24 month follow-up period
|
0.00%
0/28 • From randomization until the end of the 24 month follow-up period
|
0.00%
0/6 • From randomization until the end of the 24 month follow-up period
|
|
Investigations
Troponin increased
|
0.00%
0/50 • From randomization until the end of the 24 month follow-up period
|
10.7%
3/28 • Number of events 3 • From randomization until the end of the 24 month follow-up period
|
0.00%
0/28 • From randomization until the end of the 24 month follow-up period
|
0.00%
0/6 • From randomization until the end of the 24 month follow-up period
|
|
Investigations
White blood cell count increased
|
6.0%
3/50 • Number of events 4 • From randomization until the end of the 24 month follow-up period
|
7.1%
2/28 • Number of events 2 • From randomization until the end of the 24 month follow-up period
|
0.00%
0/28 • From randomization until the end of the 24 month follow-up period
|
0.00%
0/6 • From randomization until the end of the 24 month follow-up period
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
0.00%
0/50 • From randomization until the end of the 24 month follow-up period
|
7.1%
2/28 • Number of events 2 • From randomization until the end of the 24 month follow-up period
|
0.00%
0/28 • From randomization until the end of the 24 month follow-up period
|
0.00%
0/6 • From randomization until the end of the 24 month follow-up period
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
6.0%
3/50 • Number of events 3 • From randomization until the end of the 24 month follow-up period
|
7.1%
2/28 • Number of events 2 • From randomization until the end of the 24 month follow-up period
|
0.00%
0/28 • From randomization until the end of the 24 month follow-up period
|
0.00%
0/6 • From randomization until the end of the 24 month follow-up period
|
|
Metabolism and nutrition disorders
Vitamin D deficiency
|
0.00%
0/50 • From randomization until the end of the 24 month follow-up period
|
10.7%
3/28 • Number of events 3 • From randomization until the end of the 24 month follow-up period
|
0.00%
0/28 • From randomization until the end of the 24 month follow-up period
|
0.00%
0/6 • From randomization until the end of the 24 month follow-up period
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
18.0%
9/50 • Number of events 12 • From randomization until the end of the 24 month follow-up period
|
39.3%
11/28 • Number of events 16 • From randomization until the end of the 24 month follow-up period
|
10.7%
3/28 • Number of events 3 • From randomization until the end of the 24 month follow-up period
|
0.00%
0/6 • From randomization until the end of the 24 month follow-up period
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
18.0%
9/50 • Number of events 12 • From randomization until the end of the 24 month follow-up period
|
42.9%
12/28 • Number of events 14 • From randomization until the end of the 24 month follow-up period
|
17.9%
5/28 • Number of events 7 • From randomization until the end of the 24 month follow-up period
|
16.7%
1/6 • Number of events 2 • From randomization until the end of the 24 month follow-up period
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
12.0%
6/50 • Number of events 8 • From randomization until the end of the 24 month follow-up period
|
7.1%
2/28 • Number of events 2 • From randomization until the end of the 24 month follow-up period
|
0.00%
0/28 • From randomization until the end of the 24 month follow-up period
|
16.7%
1/6 • Number of events 1 • From randomization until the end of the 24 month follow-up period
|
|
Musculoskeletal and connective tissue disorders
Bursitis
|
0.00%
0/50 • From randomization until the end of the 24 month follow-up period
|
0.00%
0/28 • From randomization until the end of the 24 month follow-up period
|
7.1%
2/28 • Number of events 2 • From randomization until the end of the 24 month follow-up period
|
0.00%
0/6 • From randomization until the end of the 24 month follow-up period
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/50 • From randomization until the end of the 24 month follow-up period
|
7.1%
2/28 • Number of events 2 • From randomization until the end of the 24 month follow-up period
|
0.00%
0/28 • From randomization until the end of the 24 month follow-up period
|
0.00%
0/6 • From randomization until the end of the 24 month follow-up period
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/50 • From randomization until the end of the 24 month follow-up period
|
0.00%
0/28 • From randomization until the end of the 24 month follow-up period
|
7.1%
2/28 • Number of events 2 • From randomization until the end of the 24 month follow-up period
|
0.00%
0/6 • From randomization until the end of the 24 month follow-up period
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
6.0%
3/50 • Number of events 3 • From randomization until the end of the 24 month follow-up period
|
25.0%
7/28 • Number of events 7 • From randomization until the end of the 24 month follow-up period
|
7.1%
2/28 • Number of events 2 • From randomization until the end of the 24 month follow-up period
|
0.00%
0/6 • From randomization until the end of the 24 month follow-up period
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal discomfort
|
10.0%
5/50 • Number of events 6 • From randomization until the end of the 24 month follow-up period
|
0.00%
0/28 • From randomization until the end of the 24 month follow-up period
|
0.00%
0/28 • From randomization until the end of the 24 month follow-up period
|
0.00%
0/6 • From randomization until the end of the 24 month follow-up period
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
6.0%
3/50 • Number of events 4 • From randomization until the end of the 24 month follow-up period
|
21.4%
6/28 • Number of events 6 • From randomization until the end of the 24 month follow-up period
|
0.00%
0/28 • From randomization until the end of the 24 month follow-up period
|
0.00%
0/6 • From randomization until the end of the 24 month follow-up period
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
14.0%
7/50 • Number of events 7 • From randomization until the end of the 24 month follow-up period
|
17.9%
5/28 • Number of events 6 • From randomization until the end of the 24 month follow-up period
|
0.00%
0/28 • From randomization until the end of the 24 month follow-up period
|
16.7%
1/6 • Number of events 1 • From randomization until the end of the 24 month follow-up period
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
6.0%
3/50 • Number of events 4 • From randomization until the end of the 24 month follow-up period
|
7.1%
2/28 • Number of events 2 • From randomization until the end of the 24 month follow-up period
|
7.1%
2/28 • Number of events 2 • From randomization until the end of the 24 month follow-up period
|
16.7%
1/6 • Number of events 1 • From randomization until the end of the 24 month follow-up period
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
6.0%
3/50 • Number of events 4 • From randomization until the end of the 24 month follow-up period
|
0.00%
0/28 • From randomization until the end of the 24 month follow-up period
|
17.9%
5/28 • Number of events 6 • From randomization until the end of the 24 month follow-up period
|
16.7%
1/6 • Number of events 1 • From randomization until the end of the 24 month follow-up period
|
|
Nervous system disorders
Dizziness
|
14.0%
7/50 • Number of events 8 • From randomization until the end of the 24 month follow-up period
|
25.0%
7/28 • Number of events 7 • From randomization until the end of the 24 month follow-up period
|
7.1%
2/28 • Number of events 2 • From randomization until the end of the 24 month follow-up period
|
33.3%
2/6 • Number of events 2 • From randomization until the end of the 24 month follow-up period
|
|
Nervous system disorders
Headache
|
18.0%
9/50 • Number of events 10 • From randomization until the end of the 24 month follow-up period
|
17.9%
5/28 • Number of events 9 • From randomization until the end of the 24 month follow-up period
|
0.00%
0/28 • From randomization until the end of the 24 month follow-up period
|
16.7%
1/6 • Number of events 1 • From randomization until the end of the 24 month follow-up period
|
|
Nervous system disorders
Hypoaesthesia
|
6.0%
3/50 • Number of events 3 • From randomization until the end of the 24 month follow-up period
|
7.1%
2/28 • Number of events 2 • From randomization until the end of the 24 month follow-up period
|
0.00%
0/28 • From randomization until the end of the 24 month follow-up period
|
33.3%
2/6 • Number of events 2 • From randomization until the end of the 24 month follow-up period
|
|
Nervous system disorders
Memory impairment
|
0.00%
0/50 • From randomization until the end of the 24 month follow-up period
|
10.7%
3/28 • Number of events 3 • From randomization until the end of the 24 month follow-up period
|
0.00%
0/28 • From randomization until the end of the 24 month follow-up period
|
0.00%
0/6 • From randomization until the end of the 24 month follow-up period
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/50 • From randomization until the end of the 24 month follow-up period
|
0.00%
0/28 • From randomization until the end of the 24 month follow-up period
|
0.00%
0/28 • From randomization until the end of the 24 month follow-up period
|
33.3%
2/6 • Number of events 2 • From randomization until the end of the 24 month follow-up period
|
|
Nervous system disorders
Restless legs syndrome
|
0.00%
0/50 • From randomization until the end of the 24 month follow-up period
|
0.00%
0/28 • From randomization until the end of the 24 month follow-up period
|
7.1%
2/28 • Number of events 2 • From randomization until the end of the 24 month follow-up period
|
0.00%
0/6 • From randomization until the end of the 24 month follow-up period
|
|
Nervous system disorders
Syncope
|
0.00%
0/50 • From randomization until the end of the 24 month follow-up period
|
0.00%
0/28 • From randomization until the end of the 24 month follow-up period
|
0.00%
0/28 • From randomization until the end of the 24 month follow-up period
|
16.7%
1/6 • Number of events 2 • From randomization until the end of the 24 month follow-up period
|
|
Psychiatric disorders
Anxiety
|
6.0%
3/50 • Number of events 3 • From randomization until the end of the 24 month follow-up period
|
21.4%
6/28 • Number of events 6 • From randomization until the end of the 24 month follow-up period
|
0.00%
0/28 • From randomization until the end of the 24 month follow-up period
|
0.00%
0/6 • From randomization until the end of the 24 month follow-up period
|
|
Psychiatric disorders
Depression
|
6.0%
3/50 • Number of events 3 • From randomization until the end of the 24 month follow-up period
|
7.1%
2/28 • Number of events 2 • From randomization until the end of the 24 month follow-up period
|
0.00%
0/28 • From randomization until the end of the 24 month follow-up period
|
0.00%
0/6 • From randomization until the end of the 24 month follow-up period
|
|
Psychiatric disorders
Insomnia
|
6.0%
3/50 • Number of events 3 • From randomization until the end of the 24 month follow-up period
|
0.00%
0/28 • From randomization until the end of the 24 month follow-up period
|
7.1%
2/28 • Number of events 2 • From randomization until the end of the 24 month follow-up period
|
0.00%
0/6 • From randomization until the end of the 24 month follow-up period
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/50 • From randomization until the end of the 24 month follow-up period
|
10.7%
3/28 • Number of events 3 • From randomization until the end of the 24 month follow-up period
|
0.00%
0/28 • From randomization until the end of the 24 month follow-up period
|
0.00%
0/6 • From randomization until the end of the 24 month follow-up period
|
|
Renal and urinary disorders
Renal failure acute
|
0.00%
0/50 • From randomization until the end of the 24 month follow-up period
|
10.7%
3/28 • Number of events 4 • From randomization until the end of the 24 month follow-up period
|
0.00%
0/28 • From randomization until the end of the 24 month follow-up period
|
16.7%
1/6 • Number of events 1 • From randomization until the end of the 24 month follow-up period
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.00%
0/50 • From randomization until the end of the 24 month follow-up period
|
0.00%
0/28 • From randomization until the end of the 24 month follow-up period
|
7.1%
2/28 • Number of events 7 • From randomization until the end of the 24 month follow-up period
|
0.00%
0/6 • From randomization until the end of the 24 month follow-up period
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
8.0%
4/50 • Number of events 6 • From randomization until the end of the 24 month follow-up period
|
0.00%
0/28 • From randomization until the end of the 24 month follow-up period
|
7.1%
2/28 • Number of events 2 • From randomization until the end of the 24 month follow-up period
|
0.00%
0/6 • From randomization until the end of the 24 month follow-up period
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
14.0%
7/50 • Number of events 8 • From randomization until the end of the 24 month follow-up period
|
10.7%
3/28 • Number of events 3 • From randomization until the end of the 24 month follow-up period
|
7.1%
2/28 • Number of events 2 • From randomization until the end of the 24 month follow-up period
|
16.7%
1/6 • Number of events 1 • From randomization until the end of the 24 month follow-up period
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
6.0%
3/50 • Number of events 4 • From randomization until the end of the 24 month follow-up period
|
0.00%
0/28 • From randomization until the end of the 24 month follow-up period
|
0.00%
0/28 • From randomization until the end of the 24 month follow-up period
|
0.00%
0/6 • From randomization until the end of the 24 month follow-up period
|
|
Skin and subcutaneous tissue disorders
Dermal cyst
|
0.00%
0/50 • From randomization until the end of the 24 month follow-up period
|
0.00%
0/28 • From randomization until the end of the 24 month follow-up period
|
0.00%
0/28 • From randomization until the end of the 24 month follow-up period
|
16.7%
1/6 • Number of events 1 • From randomization until the end of the 24 month follow-up period
|
|
Skin and subcutaneous tissue disorders
Nail discolouration
|
0.00%
0/50 • From randomization until the end of the 24 month follow-up period
|
0.00%
0/28 • From randomization until the end of the 24 month follow-up period
|
0.00%
0/28 • From randomization until the end of the 24 month follow-up period
|
16.7%
1/6 • Number of events 1 • From randomization until the end of the 24 month follow-up period
|
|
Vascular disorders
Hypertension
|
0.00%
0/50 • From randomization until the end of the 24 month follow-up period
|
7.1%
2/28 • Number of events 2 • From randomization until the end of the 24 month follow-up period
|
7.1%
2/28 • Number of events 2 • From randomization until the end of the 24 month follow-up period
|
0.00%
0/6 • From randomization until the end of the 24 month follow-up period
|
|
Vascular disorders
Hypotension
|
10.0%
5/50 • Number of events 6 • From randomization until the end of the 24 month follow-up period
|
10.7%
3/28 • Number of events 3 • From randomization until the end of the 24 month follow-up period
|
0.00%
0/28 • From randomization until the end of the 24 month follow-up period
|
16.7%
1/6 • Number of events 1 • From randomization until the end of the 24 month follow-up period
|
|
Vascular disorders
Peripheral arterial occlusive disease
|
0.00%
0/50 • From randomization until the end of the 24 month follow-up period
|
7.1%
2/28 • Number of events 2 • From randomization until the end of the 24 month follow-up period
|
0.00%
0/28 • From randomization until the end of the 24 month follow-up period
|
0.00%
0/6 • From randomization until the end of the 24 month follow-up period
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER