Trial Outcomes & Findings for ACT34-CMI -- Adult Autologous CD34+ Cells (NCT NCT00300053)
NCT ID: NCT00300053
Last Updated: 2021-01-26
Results Overview
The number of angina episodes were collected via an electronic subject diary for four weeks at Baseline and at 6 and 12 months. The four-week angina episodes (per week mean) were used as the frequency for each visit. A lower number represents fewer angina episodes. A lower number is better.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
321 participants
Primary outcome timeframe
6 and 12 months
Results posted on
2021-01-26
Participant Flow
Enrollment was conducted at 26 clinical sites in the US.
Of 321 enrolled subjects, 147 were screen failures. Of 174 subjects who started cell mobilization, 1 did not complete the mobilization due to possible left ventricular mural thrombosis. Of 173 subjects who completed mobilization, 168 were randomized to 1 of 3 treatment groups, of which 1 was discontinued prior to treatment due to coagulopathy.
Participant milestones
| Measure |
CLBS14: Low-Dose Group
Intramyocardial injections of auto-CD34+ cells at low dose (1 x 10\^5 cells/kg bodyweight)
|
CLBS14: High-Dose Group
Intramyocardial injections of auto-CD34+ cells at high dose (5 x 10\^5 cells/kg bodyweight)
|
Placebo Control
Intramyocardial placebo injections
|
|---|---|---|---|
|
Overall Study
STARTED
|
55
|
56
|
56
|
|
Overall Study
3-Month Evaluation
|
55
|
56
|
54
|
|
Overall Study
6-Month Evaluation
|
54
|
55
|
53
|
|
Overall Study
COMPLETED
|
53
|
53
|
50
|
|
Overall Study
NOT COMPLETED
|
2
|
3
|
6
|
Reasons for withdrawal
| Measure |
CLBS14: Low-Dose Group
Intramyocardial injections of auto-CD34+ cells at low dose (1 x 10\^5 cells/kg bodyweight)
|
CLBS14: High-Dose Group
Intramyocardial injections of auto-CD34+ cells at high dose (5 x 10\^5 cells/kg bodyweight)
|
Placebo Control
Intramyocardial placebo injections
|
|---|---|---|---|
|
Overall Study
Patient/Caregiver Preference
|
2
|
2
|
3
|
|
Overall Study
Death
|
0
|
0
|
3
|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
0
|
Baseline Characteristics
ACT34-CMI -- Adult Autologous CD34+ Cells
Baseline characteristics by cohort
| Measure |
CLBS14: Low-Dose Group
n=55 Participants
Intramyocardial injections of auto-CD34+ cells at low dose (1 x 10\^5 cells/kg bodyweight)
|
CLBS14: High-Dose Group
n=56 Participants
Intramyocardial injections of auto-CD34+ cells at high dose (5 x 10\^5 cells/kg bodyweight)
|
Placebo Control
n=56 Participants
Intramyocardial placebo injections
|
Total
n=167 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
61.3 years
STANDARD_DEVIATION 9.1 • n=5 Participants
|
59.8 years
STANDARD_DEVIATION 9.2 • n=7 Participants
|
61.8 years
STANDARD_DEVIATION 8.5 • n=5 Participants
|
61.0 years
STANDARD_DEVIATION 8.9 • n=4 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
22 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
46 Participants
n=5 Participants
|
49 Participants
n=7 Participants
|
50 Participants
n=5 Participants
|
145 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
55 participants
n=5 Participants
|
56 participants
n=7 Participants
|
56 participants
n=5 Participants
|
167 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 6 and 12 monthsPopulation: Intent-to-treat (ITT) population
The number of angina episodes were collected via an electronic subject diary for four weeks at Baseline and at 6 and 12 months. The four-week angina episodes (per week mean) were used as the frequency for each visit. A lower number represents fewer angina episodes. A lower number is better.
Outcome measures
| Measure |
CLBS14: Low-Dose Group
n=50 Participants
Intramyocardial injections of auto-CD34+ cells at low dose (1 x 10\^5 cells/kg bodyweight)
|
CLBS14: High-Dose Group
n=50 Participants
Intramyocardial injections of auto-CD34+ cells at high dose (5 x 10\^5 cells/kg bodyweight)
|
Placebo Control
n=46 Participants
Intramyocardial placebo injections
|
|---|---|---|---|
|
Number of Angina Episodes Per Week at 6 and 12 Months
6 months
|
6.8 angina episodes/week
Standard Deviation 1.1
|
8.3 angina episodes/week
Standard Deviation 1.1
|
10.9 angina episodes/week
Standard Deviation 1.2
|
|
Number of Angina Episodes Per Week at 6 and 12 Months
12 months
|
6.3 angina episodes/week
Standard Deviation 1.2
|
7.2 angina episodes/week
Standard Deviation 1.1
|
11.0 angina episodes/week
Standard Deviation 1.2
|
SECONDARY outcome
Timeframe: Change from Baseline to 6 months and change from baseline to 12 months after treatmentPopulation: ITT population (note that the number of participants analyzed may differ due to missing data)
A modified Bruce Protocol Exercise Treadmill Test was used to evaluate duration of exercise in all subjects.
Outcome measures
| Measure |
CLBS14: Low-Dose Group
n=49 Participants
Intramyocardial injections of auto-CD34+ cells at low dose (1 x 10\^5 cells/kg bodyweight)
|
CLBS14: High-Dose Group
n=48 Participants
Intramyocardial injections of auto-CD34+ cells at high dose (5 x 10\^5 cells/kg bodyweight)
|
Placebo Control
n=41 Participants
Intramyocardial placebo injections
|
|---|---|---|---|
|
Exercise Treadmill Test According to Modified Bruce Protocol: Mean Change From Baseline in Duration of Exercise
Change from baseline to 6 months
|
139 seconds
Standard Deviation 151
|
110 seconds
Standard Deviation 155
|
69 seconds
Standard Deviation 122
|
|
Exercise Treadmill Test According to Modified Bruce Protocol: Mean Change From Baseline in Duration of Exercise
Change from baseline to 12 months
|
140 seconds
Standard Deviation 171
|
103 seconds
Standard Deviation 162
|
58 seconds
Standard Deviation 146
|
SECONDARY outcome
Timeframe: Baseline and 12 months after treatmentPopulation: ITT population (note that the number of participants analyzed may differ due to missing data)
The Canadian Cardiovascular Society (CCS) Functional Classification of Angina is as follows: * Class I - Angina only during strenuous or prolonged physical activity * Class II - Slight limitation, with angina only during vigorous physical activity * Class III - Symptoms with everyday living activities, i.e., moderate limitation * Class IV - Inability to perform any activity without angina or angina at rest, i.e., severe limitation
Outcome measures
| Measure |
CLBS14: Low-Dose Group
n=52 Participants
Intramyocardial injections of auto-CD34+ cells at low dose (1 x 10\^5 cells/kg bodyweight)
|
CLBS14: High-Dose Group
n=52 Participants
Intramyocardial injections of auto-CD34+ cells at high dose (5 x 10\^5 cells/kg bodyweight)
|
Placebo Control
n=46 Participants
Intramyocardial placebo injections
|
|---|---|---|---|
|
Number of Participants With Change in Canadian Cardiovascular Society Anginal Classification Levels
No change in CCS classification from baseline
|
16 Participants
|
19 Participants
|
16 Participants
|
|
Number of Participants With Change in Canadian Cardiovascular Society Anginal Classification Levels
Improvement by 1 level (CCS) from baseline
|
22 Participants
|
17 Participants
|
19 Participants
|
|
Number of Participants With Change in Canadian Cardiovascular Society Anginal Classification Levels
Improvement by 2 levels (CCS) from baseline
|
11 Participants
|
12 Participants
|
5 Participants
|
|
Number of Participants With Change in Canadian Cardiovascular Society Anginal Classification Levels
Worsening by 1 level (CCS) from baseline
|
2 Participants
|
3 Participants
|
4 Participants
|
|
Number of Participants With Change in Canadian Cardiovascular Society Anginal Classification Levels
Worsening by 2 levels (CCS) from baseline
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Baseline to 6 months after treatmentPopulation: ITT population (note that the number of participants analyzed may differ due to missing data)
Angina symptoms were evaluated based on the Seattle Angina Questionnaire (SAQ), which was used to analyze the following: physical limitations, angina stability, angina frequency, treatment satisfaction, and disease perception. The SAQ consisted of 11 questions with 5 or 6 possible responses. Responses were ordinal values (1-7, 10, 11, 97, depending on the type of question; no uniform ranges throughout); responses that corresponded to the lowest level of functioning (worse outcomes) were assigned values of 1, while responses that corresponded to higher functioning levels (better outcome) were assigned a higher ordinal value. If the response to any of these questions was 97 it was recoded as a missing value. Each scale can have a scored value ranging from 0 to 100. A larger number is better.
Outcome measures
| Measure |
CLBS14: Low-Dose Group
n=49 Participants
Intramyocardial injections of auto-CD34+ cells at low dose (1 x 10\^5 cells/kg bodyweight)
|
CLBS14: High-Dose Group
n=49 Participants
Intramyocardial injections of auto-CD34+ cells at high dose (5 x 10\^5 cells/kg bodyweight)
|
Placebo Control
n=49 Participants
Intramyocardial placebo injections
|
|---|---|---|---|
|
Changes From Baseline in Seattle Angina Questionnaire (SAQ) Scores at 6 Months
Physical limitations scale
|
12.4 score on a scale
Standard Deviation 15.6
|
10.5 score on a scale
Standard Deviation 17.1
|
10.7 score on a scale
Standard Deviation 15.2
|
|
Changes From Baseline in Seattle Angina Questionnaire (SAQ) Scores at 6 Months
Angina stability scale
|
29.8 score on a scale
Standard Deviation 30.1
|
25.5 score on a scale
Standard Deviation 30.3
|
13.8 score on a scale
Standard Deviation 31.9
|
|
Changes From Baseline in Seattle Angina Questionnaire (SAQ) Scores at 6 Months
Angina frequency scale
|
28.3 score on a scale
Standard Deviation 25.3
|
21.7 score on a scale
Standard Deviation 24.6
|
26.0 score on a scale
Standard Deviation 24.3
|
|
Changes From Baseline in Seattle Angina Questionnaire (SAQ) Scores at 6 Months
Treatment satisfaction scale
|
11.4 score on a scale
Standard Deviation 19.5
|
10.3 score on a scale
Standard Deviation 21.8
|
4.9 score on a scale
Standard Deviation 19.0
|
|
Changes From Baseline in Seattle Angina Questionnaire (SAQ) Scores at 6 Months
Disease perception scale
|
14.4 score on a scale
Standard Deviation 23.2
|
12.0 score on a scale
Standard Deviation 19.4
|
15.1 score on a scale
Standard Deviation 21.1
|
SECONDARY outcome
Timeframe: Baseline to 6 months after treatmentPopulation: ITT population (note that the number of participants analyzed may differ due to missing data)
The Short Form 36 (SF-36) health survey form was used to analyze physical functioning, role limitations due to physical health, bodily pain, general health perceptions, vitality, social functioning, role limitations due to emotional problems, general mental health, and health transition. Responses were coded as ordinal numbers going from worst (=1) to best (=highest number). These ordinal scores were transformed into scales ranging from 0 to 100. Higher numbers are generally considered better.
Outcome measures
| Measure |
CLBS14: Low-Dose Group
n=50 Participants
Intramyocardial injections of auto-CD34+ cells at low dose (1 x 10\^5 cells/kg bodyweight)
|
CLBS14: High-Dose Group
n=50 Participants
Intramyocardial injections of auto-CD34+ cells at high dose (5 x 10\^5 cells/kg bodyweight)
|
Placebo Control
n=47 Participants
Intramyocardial placebo injections
|
|---|---|---|---|
|
Changes From Baseline to 6 Months in Short Form 36 (SF-36) Parameters
Physical functioning
|
13.7 score on a scale
Standard Deviation 18.1
|
13.2 score on a scale
Standard Deviation 18.4
|
7.9 score on a scale
Standard Deviation 21.8
|
|
Changes From Baseline to 6 Months in Short Form 36 (SF-36) Parameters
Role-physical
|
17.5 score on a scale
Standard Deviation 35.1
|
15.9 score on a scale
Standard Deviation 33.6
|
19.4 score on a scale
Standard Deviation 33.2
|
|
Changes From Baseline to 6 Months in Short Form 36 (SF-36) Parameters
Bodily pain
|
13.5 score on a scale
Standard Deviation 22.1
|
13.5 score on a scale
Standard Deviation 21.6
|
9.4 score on a scale
Standard Deviation 25.1
|
|
Changes From Baseline to 6 Months in Short Form 36 (SF-36) Parameters
General health
|
7.6 score on a scale
Standard Deviation 15.5
|
6.0 score on a scale
Standard Deviation 15.3
|
6.3 score on a scale
Standard Deviation 15.4
|
|
Changes From Baseline to 6 Months in Short Form 36 (SF-36) Parameters
Vitality
|
14.6 score on a scale
Standard Deviation 18.0
|
14.0 score on a scale
Standard Deviation 20.7
|
8.9 score on a scale
Standard Deviation 23.2
|
|
Changes From Baseline to 6 Months in Short Form 36 (SF-36) Parameters
Social functioning
|
16.8 score on a scale
Standard Deviation 24.1
|
12.2 score on a scale
Standard Deviation 24.3
|
12.0 score on a scale
Standard Deviation 32.3
|
|
Changes From Baseline to 6 Months in Short Form 36 (SF-36) Parameters
Role emotional
|
10.7 score on a scale
Standard Deviation 43.9
|
17.9 score on a scale
Standard Deviation 51.8
|
9.7 score on a scale
Standard Deviation 50.5
|
|
Changes From Baseline to 6 Months in Short Form 36 (SF-36) Parameters
Mental health
|
6.2 score on a scale
Standard Deviation 16.0
|
8.4 score on a scale
Standard Deviation 17.9
|
3.6 score on a scale
Standard Deviation 13.6
|
|
Changes From Baseline to 6 Months in Short Form 36 (SF-36) Parameters
Health transition
|
40.4 score on a scale
Standard Deviation 32.5
|
32.7 score on a scale
Standard Deviation 31.1
|
29.6 score on a scale
Standard Deviation 30.0
|
SECONDARY outcome
Timeframe: Baseline to 6 monthsPopulation: ITT population (note that the number of participants analyzed may differ due to missing data)
The mean nitroglycerin use per week was analyzed at baseline and 6 months
Outcome measures
| Measure |
CLBS14: Low-Dose Group
n=46 Participants
Intramyocardial injections of auto-CD34+ cells at low dose (1 x 10\^5 cells/kg bodyweight)
|
CLBS14: High-Dose Group
n=50 Participants
Intramyocardial injections of auto-CD34+ cells at high dose (5 x 10\^5 cells/kg bodyweight)
|
Placebo Control
n=50 Participants
Intramyocardial placebo injections
|
|---|---|---|---|
|
Change in Anti-anginal Medication (ie, Nitroglycerin) Use
|
-6.3 nitroglycerin use (tablets per week)
Standard Deviation 8.1
|
-7.3 nitroglycerin use (tablets per week)
Standard Deviation 9.9
|
-4.2 nitroglycerin use (tablets per week)
Standard Deviation 8.8
|
Adverse Events
CLBS14: Low-Dose Group
Serious events: 21 serious events
Other events: 54 other events
Deaths: 0 deaths
CLBS14: High-Dose Group
Serious events: 24 serious events
Other events: 52 other events
Deaths: 0 deaths
Placebo Control
Serious events: 32 serious events
Other events: 52 other events
Deaths: 3 deaths
No Cell or Placebo Injection
Serious events: 5 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
CLBS14: Low-Dose Group
n=55 participants at risk
Intramyocardial injections of auto-CD34+ cells at low dose (1 x 10\^5 cells/kg bodyweight)
|
CLBS14: High-Dose Group
n=56 participants at risk
Intramyocardial injections of auto-CD34+ cells at high dose (5 x 10\^5 cells/kg bodyweight)
|
Placebo Control
n=56 participants at risk
Intramyocardial placebo injections
|
No Cell or Placebo Injection
n=7 participants at risk
Cell mobilization with G-CSF started but no cell or placebo injection administered
|
|---|---|---|---|---|
|
Cardiac disorders
Cardiac perforation
|
1.8%
1/55 • Number of events 1
The safety population comprises 174 subjects who received at least 1 dose of G-CSF.
|
0.00%
0/56
The safety population comprises 174 subjects who received at least 1 dose of G-CSF.
|
1.8%
1/56 • Number of events 1
The safety population comprises 174 subjects who received at least 1 dose of G-CSF.
|
0.00%
0/7
The safety population comprises 174 subjects who received at least 1 dose of G-CSF.
|
|
Cardiac disorders
Cardiac failure congestive
|
1.8%
1/55 • Number of events 3
The safety population comprises 174 subjects who received at least 1 dose of G-CSF.
|
1.8%
1/56 • Number of events 1
The safety population comprises 174 subjects who received at least 1 dose of G-CSF.
|
3.6%
2/56 • Number of events 4
The safety population comprises 174 subjects who received at least 1 dose of G-CSF.
|
0.00%
0/7
The safety population comprises 174 subjects who received at least 1 dose of G-CSF.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/55
The safety population comprises 174 subjects who received at least 1 dose of G-CSF.
|
1.8%
1/56 • Number of events 1
The safety population comprises 174 subjects who received at least 1 dose of G-CSF.
|
1.8%
1/56 • Number of events 1
The safety population comprises 174 subjects who received at least 1 dose of G-CSF.
|
0.00%
0/7
The safety population comprises 174 subjects who received at least 1 dose of G-CSF.
|
|
Cardiac disorders
Myocardial infarction
|
5.5%
3/55 • Number of events 5
The safety population comprises 174 subjects who received at least 1 dose of G-CSF.
|
3.6%
2/56 • Number of events 3
The safety population comprises 174 subjects who received at least 1 dose of G-CSF.
|
5.4%
3/56 • Number of events 4
The safety population comprises 174 subjects who received at least 1 dose of G-CSF.
|
42.9%
3/7 • Number of events 3
The safety population comprises 174 subjects who received at least 1 dose of G-CSF.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory distress
|
0.00%
0/55
The safety population comprises 174 subjects who received at least 1 dose of G-CSF.
|
1.8%
1/56 • Number of events 1
The safety population comprises 174 subjects who received at least 1 dose of G-CSF.
|
0.00%
0/56
The safety population comprises 174 subjects who received at least 1 dose of G-CSF.
|
0.00%
0/7
The safety population comprises 174 subjects who received at least 1 dose of G-CSF.
|
|
Cardiac disorders
Angina pectoris
|
14.5%
8/55 • Number of events 15
The safety population comprises 174 subjects who received at least 1 dose of G-CSF.
|
14.3%
8/56 • Number of events 12
The safety population comprises 174 subjects who received at least 1 dose of G-CSF.
|
19.6%
11/56 • Number of events 19
The safety population comprises 174 subjects who received at least 1 dose of G-CSF.
|
0.00%
0/7
The safety population comprises 174 subjects who received at least 1 dose of G-CSF.
|
|
Vascular disorders
Hypotension
|
1.8%
1/55 • Number of events 1
The safety population comprises 174 subjects who received at least 1 dose of G-CSF.
|
3.6%
2/56 • Number of events 2
The safety population comprises 174 subjects who received at least 1 dose of G-CSF.
|
0.00%
0/56
The safety population comprises 174 subjects who received at least 1 dose of G-CSF.
|
0.00%
0/7
The safety population comprises 174 subjects who received at least 1 dose of G-CSF.
|
|
Injury, poisoning and procedural complications
Vascular access complication
|
1.8%
1/55 • Number of events 1
The safety population comprises 174 subjects who received at least 1 dose of G-CSF.
|
5.4%
3/56 • Number of events 3
The safety population comprises 174 subjects who received at least 1 dose of G-CSF.
|
3.6%
2/56 • Number of events 3
The safety population comprises 174 subjects who received at least 1 dose of G-CSF.
|
0.00%
0/7
The safety population comprises 174 subjects who received at least 1 dose of G-CSF.
|
|
Gastrointestinal disorders
Nausea
|
3.6%
2/55 • Number of events 2
The safety population comprises 174 subjects who received at least 1 dose of G-CSF.
|
0.00%
0/56
The safety population comprises 174 subjects who received at least 1 dose of G-CSF.
|
0.00%
0/56
The safety population comprises 174 subjects who received at least 1 dose of G-CSF.
|
0.00%
0/7
The safety population comprises 174 subjects who received at least 1 dose of G-CSF.
|
|
Gastrointestinal disorders
Vomiting
|
3.6%
2/55 • Number of events 2
The safety population comprises 174 subjects who received at least 1 dose of G-CSF.
|
0.00%
0/56
The safety population comprises 174 subjects who received at least 1 dose of G-CSF.
|
0.00%
0/56
The safety population comprises 174 subjects who received at least 1 dose of G-CSF.
|
0.00%
0/7
The safety population comprises 174 subjects who received at least 1 dose of G-CSF.
|
|
Cardiac disorders
Cardiac failure
|
1.8%
1/55 • Number of events 1
The safety population comprises 174 subjects who received at least 1 dose of G-CSF.
|
0.00%
0/56
The safety population comprises 174 subjects who received at least 1 dose of G-CSF.
|
3.6%
2/56 • Number of events 3
The safety population comprises 174 subjects who received at least 1 dose of G-CSF.
|
0.00%
0/7
The safety population comprises 174 subjects who received at least 1 dose of G-CSF.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/55
The safety population comprises 174 subjects who received at least 1 dose of G-CSF.
|
0.00%
0/56
The safety population comprises 174 subjects who received at least 1 dose of G-CSF.
|
1.8%
1/56 • Number of events 1
The safety population comprises 174 subjects who received at least 1 dose of G-CSF.
|
0.00%
0/7
The safety population comprises 174 subjects who received at least 1 dose of G-CSF.
|
|
Injury, poisoning and procedural complications
Vascular graft occlusion
|
1.8%
1/55 • Number of events 1
The safety population comprises 174 subjects who received at least 1 dose of G-CSF.
|
0.00%
0/56
The safety population comprises 174 subjects who received at least 1 dose of G-CSF.
|
0.00%
0/56
The safety population comprises 174 subjects who received at least 1 dose of G-CSF.
|
0.00%
0/7
The safety population comprises 174 subjects who received at least 1 dose of G-CSF.
|
|
Blood and lymphatic system disorders
Coagulopathy
|
0.00%
0/55
The safety population comprises 174 subjects who received at least 1 dose of G-CSF.
|
0.00%
0/56
The safety population comprises 174 subjects who received at least 1 dose of G-CSF.
|
0.00%
0/56
The safety population comprises 174 subjects who received at least 1 dose of G-CSF.
|
14.3%
1/7 • Number of events 1
The safety population comprises 174 subjects who received at least 1 dose of G-CSF.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/55
The safety population comprises 174 subjects who received at least 1 dose of G-CSF.
|
1.8%
1/56 • Number of events 1
The safety population comprises 174 subjects who received at least 1 dose of G-CSF.
|
1.8%
1/56 • Number of events 1
The safety population comprises 174 subjects who received at least 1 dose of G-CSF.
|
0.00%
0/7
The safety population comprises 174 subjects who received at least 1 dose of G-CSF.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
1.8%
1/55 • Number of events 1
The safety population comprises 174 subjects who received at least 1 dose of G-CSF.
|
1.8%
1/56 • Number of events 1
The safety population comprises 174 subjects who received at least 1 dose of G-CSF.
|
1.8%
1/56 • Number of events 1
The safety population comprises 174 subjects who received at least 1 dose of G-CSF.
|
0.00%
0/7
The safety population comprises 174 subjects who received at least 1 dose of G-CSF.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea exertional
|
0.00%
0/55
The safety population comprises 174 subjects who received at least 1 dose of G-CSF.
|
1.8%
1/56 • Number of events 1
The safety population comprises 174 subjects who received at least 1 dose of G-CSF.
|
0.00%
0/56
The safety population comprises 174 subjects who received at least 1 dose of G-CSF.
|
0.00%
0/7
The safety population comprises 174 subjects who received at least 1 dose of G-CSF.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/55
The safety population comprises 174 subjects who received at least 1 dose of G-CSF.
|
0.00%
0/56
The safety population comprises 174 subjects who received at least 1 dose of G-CSF.
|
1.8%
1/56 • Number of events 1
The safety population comprises 174 subjects who received at least 1 dose of G-CSF.
|
0.00%
0/7
The safety population comprises 174 subjects who received at least 1 dose of G-CSF.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/55
The safety population comprises 174 subjects who received at least 1 dose of G-CSF.
|
0.00%
0/56
The safety population comprises 174 subjects who received at least 1 dose of G-CSF.
|
1.8%
1/56 • Number of events 1
The safety population comprises 174 subjects who received at least 1 dose of G-CSF.
|
0.00%
0/7
The safety population comprises 174 subjects who received at least 1 dose of G-CSF.
|
|
Gastrointestinal disorders
Gastrointestinal ulcer hemorrhage
|
0.00%
0/55
The safety population comprises 174 subjects who received at least 1 dose of G-CSF.
|
0.00%
0/56
The safety population comprises 174 subjects who received at least 1 dose of G-CSF.
|
1.8%
1/56 • Number of events 1
The safety population comprises 174 subjects who received at least 1 dose of G-CSF.
|
0.00%
0/7
The safety population comprises 174 subjects who received at least 1 dose of G-CSF.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
0.00%
0/55
The safety population comprises 174 subjects who received at least 1 dose of G-CSF.
|
0.00%
0/56
The safety population comprises 174 subjects who received at least 1 dose of G-CSF.
|
1.8%
1/56 • Number of events 1
The safety population comprises 174 subjects who received at least 1 dose of G-CSF.
|
0.00%
0/7
The safety population comprises 174 subjects who received at least 1 dose of G-CSF.
|
|
General disorders
Chest pain
|
0.00%
0/55
The safety population comprises 174 subjects who received at least 1 dose of G-CSF.
|
1.8%
1/56 • Number of events 4
The safety population comprises 174 subjects who received at least 1 dose of G-CSF.
|
3.6%
2/56 • Number of events 3
The safety population comprises 174 subjects who received at least 1 dose of G-CSF.
|
0.00%
0/7
The safety population comprises 174 subjects who received at least 1 dose of G-CSF.
|
|
Cardiac disorders
Acute coronary syndrome
|
0.00%
0/55
The safety population comprises 174 subjects who received at least 1 dose of G-CSF.
|
1.8%
1/56 • Number of events 1
The safety population comprises 174 subjects who received at least 1 dose of G-CSF.
|
1.8%
1/56 • Number of events 1
The safety population comprises 174 subjects who received at least 1 dose of G-CSF.
|
0.00%
0/7
The safety population comprises 174 subjects who received at least 1 dose of G-CSF.
|
|
Cardiac disorders
Ventricular tachycardia
|
1.8%
1/55 • Number of events 1
The safety population comprises 174 subjects who received at least 1 dose of G-CSF.
|
0.00%
0/56
The safety population comprises 174 subjects who received at least 1 dose of G-CSF.
|
1.8%
1/56 • Number of events 1
The safety population comprises 174 subjects who received at least 1 dose of G-CSF.
|
0.00%
0/7
The safety population comprises 174 subjects who received at least 1 dose of G-CSF.
|
|
Cardiac disorders
Ventricular fibrillation
|
0.00%
0/55
The safety population comprises 174 subjects who received at least 1 dose of G-CSF.
|
0.00%
0/56
The safety population comprises 174 subjects who received at least 1 dose of G-CSF.
|
1.8%
1/56 • Number of events 1
The safety population comprises 174 subjects who received at least 1 dose of G-CSF.
|
0.00%
0/7
The safety population comprises 174 subjects who received at least 1 dose of G-CSF.
|
|
Respiratory, thoracic and mediastinal disorders
Acute pulmonary edema
|
0.00%
0/55
The safety population comprises 174 subjects who received at least 1 dose of G-CSF.
|
0.00%
0/56
The safety population comprises 174 subjects who received at least 1 dose of G-CSF.
|
1.8%
1/56 • Number of events 1
The safety population comprises 174 subjects who received at least 1 dose of G-CSF.
|
0.00%
0/7
The safety population comprises 174 subjects who received at least 1 dose of G-CSF.
|
|
Blood and lymphatic system disorders
Pancytopenia
|
0.00%
0/55
The safety population comprises 174 subjects who received at least 1 dose of G-CSF.
|
1.8%
1/56 • Number of events 1
The safety population comprises 174 subjects who received at least 1 dose of G-CSF.
|
0.00%
0/56
The safety population comprises 174 subjects who received at least 1 dose of G-CSF.
|
0.00%
0/7
The safety population comprises 174 subjects who received at least 1 dose of G-CSF.
|
|
Respiratory, thoracic and mediastinal disorders
Sleep apnea syndrome
|
0.00%
0/55
The safety population comprises 174 subjects who received at least 1 dose of G-CSF.
|
1.8%
1/56 • Number of events 1
The safety population comprises 174 subjects who received at least 1 dose of G-CSF.
|
0.00%
0/56
The safety population comprises 174 subjects who received at least 1 dose of G-CSF.
|
0.00%
0/7
The safety population comprises 174 subjects who received at least 1 dose of G-CSF.
|
|
Psychiatric disorders
Depression
|
0.00%
0/55
The safety population comprises 174 subjects who received at least 1 dose of G-CSF.
|
1.8%
1/56 • Number of events 1
The safety population comprises 174 subjects who received at least 1 dose of G-CSF.
|
0.00%
0/56
The safety population comprises 174 subjects who received at least 1 dose of G-CSF.
|
0.00%
0/7
The safety population comprises 174 subjects who received at least 1 dose of G-CSF.
|
|
Musculoskeletal and connective tissue disorders
Tenosynovitis
|
0.00%
0/55
The safety population comprises 174 subjects who received at least 1 dose of G-CSF.
|
1.8%
1/56 • Number of events 1
The safety population comprises 174 subjects who received at least 1 dose of G-CSF.
|
0.00%
0/56
The safety population comprises 174 subjects who received at least 1 dose of G-CSF.
|
0.00%
0/7
The safety population comprises 174 subjects who received at least 1 dose of G-CSF.
|
|
Respiratory, thoracic and mediastinal disorders
Sinus disorder
|
0.00%
0/55
The safety population comprises 174 subjects who received at least 1 dose of G-CSF.
|
0.00%
0/56
The safety population comprises 174 subjects who received at least 1 dose of G-CSF.
|
1.8%
1/56 • Number of events 1
The safety population comprises 174 subjects who received at least 1 dose of G-CSF.
|
0.00%
0/7
The safety population comprises 174 subjects who received at least 1 dose of G-CSF.
|
|
Injury, poisoning and procedural complications
Concussion
|
1.8%
1/55 • Number of events 1
The safety population comprises 174 subjects who received at least 1 dose of G-CSF.
|
0.00%
0/56
The safety population comprises 174 subjects who received at least 1 dose of G-CSF.
|
0.00%
0/56
The safety population comprises 174 subjects who received at least 1 dose of G-CSF.
|
0.00%
0/7
The safety population comprises 174 subjects who received at least 1 dose of G-CSF.
|
|
Vascular disorders
Deep vein thrombosis (DVT)
|
1.8%
1/55 • Number of events 1
The safety population comprises 174 subjects who received at least 1 dose of G-CSF.
|
0.00%
0/56
The safety population comprises 174 subjects who received at least 1 dose of G-CSF.
|
0.00%
0/56
The safety population comprises 174 subjects who received at least 1 dose of G-CSF.
|
0.00%
0/7
The safety population comprises 174 subjects who received at least 1 dose of G-CSF.
|
|
Cardiac disorders
Angina unstable
|
3.6%
2/55 • Number of events 2
The safety population comprises 174 subjects who received at least 1 dose of G-CSF.
|
3.6%
2/56 • Number of events 2
The safety population comprises 174 subjects who received at least 1 dose of G-CSF.
|
0.00%
0/56
The safety population comprises 174 subjects who received at least 1 dose of G-CSF.
|
0.00%
0/7
The safety population comprises 174 subjects who received at least 1 dose of G-CSF.
|
|
Vascular disorders
Aortic aneurysm
|
1.8%
1/55 • Number of events 1
The safety population comprises 174 subjects who received at least 1 dose of G-CSF.
|
0.00%
0/56
The safety population comprises 174 subjects who received at least 1 dose of G-CSF.
|
0.00%
0/56
The safety population comprises 174 subjects who received at least 1 dose of G-CSF.
|
0.00%
0/7
The safety population comprises 174 subjects who received at least 1 dose of G-CSF.
|
|
Nervous system disorders
Syncope
|
0.00%
0/55
The safety population comprises 174 subjects who received at least 1 dose of G-CSF.
|
0.00%
0/56
The safety population comprises 174 subjects who received at least 1 dose of G-CSF.
|
1.8%
1/56 • Number of events 1
The safety population comprises 174 subjects who received at least 1 dose of G-CSF.
|
0.00%
0/7
The safety population comprises 174 subjects who received at least 1 dose of G-CSF.
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.00%
0/55
The safety population comprises 174 subjects who received at least 1 dose of G-CSF.
|
0.00%
0/56
The safety population comprises 174 subjects who received at least 1 dose of G-CSF.
|
1.8%
1/56 • Number of events 1
The safety population comprises 174 subjects who received at least 1 dose of G-CSF.
|
0.00%
0/7
The safety population comprises 174 subjects who received at least 1 dose of G-CSF.
|
|
Infections and infestations
Esophageal candidiasis
|
1.8%
1/55 • Number of events 1
The safety population comprises 174 subjects who received at least 1 dose of G-CSF.
|
0.00%
0/56
The safety population comprises 174 subjects who received at least 1 dose of G-CSF.
|
0.00%
0/56
The safety population comprises 174 subjects who received at least 1 dose of G-CSF.
|
0.00%
0/7
The safety population comprises 174 subjects who received at least 1 dose of G-CSF.
|
|
Infections and infestations
Pneumonia
|
1.8%
1/55 • Number of events 1
The safety population comprises 174 subjects who received at least 1 dose of G-CSF.
|
0.00%
0/56
The safety population comprises 174 subjects who received at least 1 dose of G-CSF.
|
1.8%
1/56 • Number of events 1
The safety population comprises 174 subjects who received at least 1 dose of G-CSF.
|
0.00%
0/7
The safety population comprises 174 subjects who received at least 1 dose of G-CSF.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/55
The safety population comprises 174 subjects who received at least 1 dose of G-CSF.
|
0.00%
0/56
The safety population comprises 174 subjects who received at least 1 dose of G-CSF.
|
1.8%
1/56 • Number of events 1
The safety population comprises 174 subjects who received at least 1 dose of G-CSF.
|
0.00%
0/7
The safety population comprises 174 subjects who received at least 1 dose of G-CSF.
|
|
Reproductive system and breast disorders
Menorrhagia
|
0.00%
0/55
The safety population comprises 174 subjects who received at least 1 dose of G-CSF.
|
0.00%
0/56
The safety population comprises 174 subjects who received at least 1 dose of G-CSF.
|
1.8%
1/56 • Number of events 1
The safety population comprises 174 subjects who received at least 1 dose of G-CSF.
|
0.00%
0/7
The safety population comprises 174 subjects who received at least 1 dose of G-CSF.
|
|
Blood and lymphatic system disorders
Anemia
|
0.00%
0/55
The safety population comprises 174 subjects who received at least 1 dose of G-CSF.
|
0.00%
0/56
The safety population comprises 174 subjects who received at least 1 dose of G-CSF.
|
1.8%
1/56 • Number of events 2
The safety population comprises 174 subjects who received at least 1 dose of G-CSF.
|
0.00%
0/7
The safety population comprises 174 subjects who received at least 1 dose of G-CSF.
|
|
Injury, poisoning and procedural complications
Device lead damage
|
0.00%
0/55
The safety population comprises 174 subjects who received at least 1 dose of G-CSF.
|
0.00%
0/56
The safety population comprises 174 subjects who received at least 1 dose of G-CSF.
|
1.8%
1/56 • Number of events 2
The safety population comprises 174 subjects who received at least 1 dose of G-CSF.
|
0.00%
0/7
The safety population comprises 174 subjects who received at least 1 dose of G-CSF.
|
|
Vascular disorders
Peripheral arterial occlusive disease
|
0.00%
0/55
The safety population comprises 174 subjects who received at least 1 dose of G-CSF.
|
0.00%
0/56
The safety population comprises 174 subjects who received at least 1 dose of G-CSF.
|
1.8%
1/56 • Number of events 1
The safety population comprises 174 subjects who received at least 1 dose of G-CSF.
|
0.00%
0/7
The safety population comprises 174 subjects who received at least 1 dose of G-CSF.
|
|
Renal and urinary disorders
Urinary tract obstruction
|
0.00%
0/55
The safety population comprises 174 subjects who received at least 1 dose of G-CSF.
|
0.00%
0/56
The safety population comprises 174 subjects who received at least 1 dose of G-CSF.
|
1.8%
1/56 • Number of events 1
The safety population comprises 174 subjects who received at least 1 dose of G-CSF.
|
0.00%
0/7
The safety population comprises 174 subjects who received at least 1 dose of G-CSF.
|
|
Infections and infestations
Septic phlebitis
|
0.00%
0/55
The safety population comprises 174 subjects who received at least 1 dose of G-CSF.
|
0.00%
0/56
The safety population comprises 174 subjects who received at least 1 dose of G-CSF.
|
1.8%
1/56 • Number of events 1
The safety population comprises 174 subjects who received at least 1 dose of G-CSF.
|
0.00%
0/7
The safety population comprises 174 subjects who received at least 1 dose of G-CSF.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/55
The safety population comprises 174 subjects who received at least 1 dose of G-CSF.
|
0.00%
0/56
The safety population comprises 174 subjects who received at least 1 dose of G-CSF.
|
1.8%
1/56 • Number of events 1
The safety population comprises 174 subjects who received at least 1 dose of G-CSF.
|
0.00%
0/7
The safety population comprises 174 subjects who received at least 1 dose of G-CSF.
|
|
Blood and lymphatic system disorders
Hypercoagulation
|
0.00%
0/55
The safety population comprises 174 subjects who received at least 1 dose of G-CSF.
|
0.00%
0/56
The safety population comprises 174 subjects who received at least 1 dose of G-CSF.
|
0.00%
0/56
The safety population comprises 174 subjects who received at least 1 dose of G-CSF.
|
14.3%
1/7 • Number of events 1
The safety population comprises 174 subjects who received at least 1 dose of G-CSF.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/55
The safety population comprises 174 subjects who received at least 1 dose of G-CSF.
|
1.8%
1/56 • Number of events 1
The safety population comprises 174 subjects who received at least 1 dose of G-CSF.
|
0.00%
0/56
The safety population comprises 174 subjects who received at least 1 dose of G-CSF.
|
0.00%
0/7
The safety population comprises 174 subjects who received at least 1 dose of G-CSF.
|
|
Cardiac disorders
Atrial fibrillation
|
3.6%
2/55 • Number of events 2
The safety population comprises 174 subjects who received at least 1 dose of G-CSF.
|
0.00%
0/56
The safety population comprises 174 subjects who received at least 1 dose of G-CSF.
|
0.00%
0/56
The safety population comprises 174 subjects who received at least 1 dose of G-CSF.
|
0.00%
0/7
The safety population comprises 174 subjects who received at least 1 dose of G-CSF.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/55
The safety population comprises 174 subjects who received at least 1 dose of G-CSF.
|
0.00%
0/56
The safety population comprises 174 subjects who received at least 1 dose of G-CSF.
|
1.8%
1/56 • Number of events 1
The safety population comprises 174 subjects who received at least 1 dose of G-CSF.
|
0.00%
0/7
The safety population comprises 174 subjects who received at least 1 dose of G-CSF.
|
|
Gastrointestinal disorders
Colitis ischaemic
|
0.00%
0/55
The safety population comprises 174 subjects who received at least 1 dose of G-CSF.
|
1.8%
1/56 • Number of events 1
The safety population comprises 174 subjects who received at least 1 dose of G-CSF.
|
0.00%
0/56
The safety population comprises 174 subjects who received at least 1 dose of G-CSF.
|
0.00%
0/7
The safety population comprises 174 subjects who received at least 1 dose of G-CSF.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/55
The safety population comprises 174 subjects who received at least 1 dose of G-CSF.
|
1.8%
1/56 • Number of events 1
The safety population comprises 174 subjects who received at least 1 dose of G-CSF.
|
0.00%
0/56
The safety population comprises 174 subjects who received at least 1 dose of G-CSF.
|
0.00%
0/7
The safety population comprises 174 subjects who received at least 1 dose of G-CSF.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
0.00%
0/55
The safety population comprises 174 subjects who received at least 1 dose of G-CSF.
|
1.8%
1/56 • Number of events 1
The safety population comprises 174 subjects who received at least 1 dose of G-CSF.
|
0.00%
0/56
The safety population comprises 174 subjects who received at least 1 dose of G-CSF.
|
0.00%
0/7
The safety population comprises 174 subjects who received at least 1 dose of G-CSF.
|
|
Nervous system disorders
Transient ischemic attack
|
0.00%
0/55
The safety population comprises 174 subjects who received at least 1 dose of G-CSF.
|
1.8%
1/56 • Number of events 1
The safety population comprises 174 subjects who received at least 1 dose of G-CSF.
|
0.00%
0/56
The safety population comprises 174 subjects who received at least 1 dose of G-CSF.
|
0.00%
0/7
The safety population comprises 174 subjects who received at least 1 dose of G-CSF.
|
|
Metabolism and nutrition disorders
Dehydration
|
1.8%
1/55 • Number of events 1
The safety population comprises 174 subjects who received at least 1 dose of G-CSF.
|
0.00%
0/56
The safety population comprises 174 subjects who received at least 1 dose of G-CSF.
|
0.00%
0/56
The safety population comprises 174 subjects who received at least 1 dose of G-CSF.
|
0.00%
0/7
The safety population comprises 174 subjects who received at least 1 dose of G-CSF.
|
|
Infections and infestations
Sepsis
|
1.8%
1/55 • Number of events 1
The safety population comprises 174 subjects who received at least 1 dose of G-CSF.
|
0.00%
0/56
The safety population comprises 174 subjects who received at least 1 dose of G-CSF.
|
1.8%
1/56 • Number of events 1
The safety population comprises 174 subjects who received at least 1 dose of G-CSF.
|
0.00%
0/7
The safety population comprises 174 subjects who received at least 1 dose of G-CSF.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/55
The safety population comprises 174 subjects who received at least 1 dose of G-CSF.
|
0.00%
0/56
The safety population comprises 174 subjects who received at least 1 dose of G-CSF.
|
3.6%
2/56 • Number of events 2
The safety population comprises 174 subjects who received at least 1 dose of G-CSF.
|
0.00%
0/7
The safety population comprises 174 subjects who received at least 1 dose of G-CSF.
|
|
General disorders
Ischemic ulcer
|
0.00%
0/55
The safety population comprises 174 subjects who received at least 1 dose of G-CSF.
|
0.00%
0/56
The safety population comprises 174 subjects who received at least 1 dose of G-CSF.
|
1.8%
1/56 • Number of events 1
The safety population comprises 174 subjects who received at least 1 dose of G-CSF.
|
0.00%
0/7
The safety population comprises 174 subjects who received at least 1 dose of G-CSF.
|
|
Nervous system disorders
Presyncope
|
0.00%
0/55
The safety population comprises 174 subjects who received at least 1 dose of G-CSF.
|
1.8%
1/56 • Number of events 1
The safety population comprises 174 subjects who received at least 1 dose of G-CSF.
|
0.00%
0/56
The safety population comprises 174 subjects who received at least 1 dose of G-CSF.
|
0.00%
0/7
The safety population comprises 174 subjects who received at least 1 dose of G-CSF.
|
|
Nervous system disorders
Dizziness postural
|
0.00%
0/55
The safety population comprises 174 subjects who received at least 1 dose of G-CSF.
|
1.8%
1/56 • Number of events 1
The safety population comprises 174 subjects who received at least 1 dose of G-CSF.
|
0.00%
0/56
The safety population comprises 174 subjects who received at least 1 dose of G-CSF.
|
0.00%
0/7
The safety population comprises 174 subjects who received at least 1 dose of G-CSF.
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
0.00%
0/55
The safety population comprises 174 subjects who received at least 1 dose of G-CSF.
|
0.00%
0/56
The safety population comprises 174 subjects who received at least 1 dose of G-CSF.
|
1.8%
1/56 • Number of events 1
The safety population comprises 174 subjects who received at least 1 dose of G-CSF.
|
0.00%
0/7
The safety population comprises 174 subjects who received at least 1 dose of G-CSF.
|
|
Cardiac disorders
Bradycardia
|
0.00%
0/55
The safety population comprises 174 subjects who received at least 1 dose of G-CSF.
|
1.8%
1/56 • Number of events 1
The safety population comprises 174 subjects who received at least 1 dose of G-CSF.
|
0.00%
0/56
The safety population comprises 174 subjects who received at least 1 dose of G-CSF.
|
0.00%
0/7
The safety population comprises 174 subjects who received at least 1 dose of G-CSF.
|
|
Injury, poisoning and procedural complications
Cardiac pacemaker malfunction
|
0.00%
0/55
The safety population comprises 174 subjects who received at least 1 dose of G-CSF.
|
0.00%
0/56
The safety population comprises 174 subjects who received at least 1 dose of G-CSF.
|
1.8%
1/56 • Number of events 1
The safety population comprises 174 subjects who received at least 1 dose of G-CSF.
|
0.00%
0/7
The safety population comprises 174 subjects who received at least 1 dose of G-CSF.
|
|
Injury, poisoning and procedural complications
Device dislocation
|
0.00%
0/55
The safety population comprises 174 subjects who received at least 1 dose of G-CSF.
|
0.00%
0/56
The safety population comprises 174 subjects who received at least 1 dose of G-CSF.
|
1.8%
1/56 • Number of events 1
The safety population comprises 174 subjects who received at least 1 dose of G-CSF.
|
0.00%
0/7
The safety population comprises 174 subjects who received at least 1 dose of G-CSF.
|
|
Gastrointestinal disorders
Upper gastrointestinal hemorrhage
|
0.00%
0/55
The safety population comprises 174 subjects who received at least 1 dose of G-CSF.
|
0.00%
0/56
The safety population comprises 174 subjects who received at least 1 dose of G-CSF.
|
1.8%
1/56 • Number of events 1
The safety population comprises 174 subjects who received at least 1 dose of G-CSF.
|
0.00%
0/7
The safety population comprises 174 subjects who received at least 1 dose of G-CSF.
|
|
Gastrointestinal disorders
Hematochezia
|
0.00%
0/55
The safety population comprises 174 subjects who received at least 1 dose of G-CSF.
|
0.00%
0/56
The safety population comprises 174 subjects who received at least 1 dose of G-CSF.
|
1.8%
1/56 • Number of events 1
The safety population comprises 174 subjects who received at least 1 dose of G-CSF.
|
0.00%
0/7
The safety population comprises 174 subjects who received at least 1 dose of G-CSF.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer
|
0.00%
0/55
The safety population comprises 174 subjects who received at least 1 dose of G-CSF.
|
1.8%
1/56 • Number of events 1
The safety population comprises 174 subjects who received at least 1 dose of G-CSF.
|
0.00%
0/56
The safety population comprises 174 subjects who received at least 1 dose of G-CSF.
|
0.00%
0/7
The safety population comprises 174 subjects who received at least 1 dose of G-CSF.
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/55
The safety population comprises 174 subjects who received at least 1 dose of G-CSF.
|
0.00%
0/56
The safety population comprises 174 subjects who received at least 1 dose of G-CSF.
|
1.8%
1/56 • Number of events 2
The safety population comprises 174 subjects who received at least 1 dose of G-CSF.
|
0.00%
0/7
The safety population comprises 174 subjects who received at least 1 dose of G-CSF.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/55
The safety population comprises 174 subjects who received at least 1 dose of G-CSF.
|
0.00%
0/56
The safety population comprises 174 subjects who received at least 1 dose of G-CSF.
|
1.8%
1/56 • Number of events 1
The safety population comprises 174 subjects who received at least 1 dose of G-CSF.
|
0.00%
0/7
The safety population comprises 174 subjects who received at least 1 dose of G-CSF.
|
|
Infections and infestations
Osteomyelitis
|
1.8%
1/55 • Number of events 1
The safety population comprises 174 subjects who received at least 1 dose of G-CSF.
|
0.00%
0/56
The safety population comprises 174 subjects who received at least 1 dose of G-CSF.
|
0.00%
0/56
The safety population comprises 174 subjects who received at least 1 dose of G-CSF.
|
0.00%
0/7
The safety population comprises 174 subjects who received at least 1 dose of G-CSF.
|
|
Gastrointestinal disorders
Diverticular perforation
|
1.8%
1/55 • Number of events 1
The safety population comprises 174 subjects who received at least 1 dose of G-CSF.
|
0.00%
0/56
The safety population comprises 174 subjects who received at least 1 dose of G-CSF.
|
0.00%
0/56
The safety population comprises 174 subjects who received at least 1 dose of G-CSF.
|
0.00%
0/7
The safety population comprises 174 subjects who received at least 1 dose of G-CSF.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
1.8%
1/55 • Number of events 2
The safety population comprises 174 subjects who received at least 1 dose of G-CSF.
|
0.00%
0/56
The safety population comprises 174 subjects who received at least 1 dose of G-CSF.
|
0.00%
0/56
The safety population comprises 174 subjects who received at least 1 dose of G-CSF.
|
0.00%
0/7
The safety population comprises 174 subjects who received at least 1 dose of G-CSF.
|
|
Renal and urinary disorders
Renal failure acute
|
1.8%
1/55 • Number of events 1
The safety population comprises 174 subjects who received at least 1 dose of G-CSF.
|
0.00%
0/56
The safety population comprises 174 subjects who received at least 1 dose of G-CSF.
|
0.00%
0/56
The safety population comprises 174 subjects who received at least 1 dose of G-CSF.
|
0.00%
0/7
The safety population comprises 174 subjects who received at least 1 dose of G-CSF.
|
|
Metabolism and nutrition disorders
Gout
|
0.00%
0/55
The safety population comprises 174 subjects who received at least 1 dose of G-CSF.
|
0.00%
0/56
The safety population comprises 174 subjects who received at least 1 dose of G-CSF.
|
1.8%
1/56 • Number of events 1
The safety population comprises 174 subjects who received at least 1 dose of G-CSF.
|
0.00%
0/7
The safety population comprises 174 subjects who received at least 1 dose of G-CSF.
|
|
Infections and infestations
Gastroenteritis viral
|
1.8%
1/55 • Number of events 1
The safety population comprises 174 subjects who received at least 1 dose of G-CSF.
|
0.00%
0/56
The safety population comprises 174 subjects who received at least 1 dose of G-CSF.
|
0.00%
0/56
The safety population comprises 174 subjects who received at least 1 dose of G-CSF.
|
0.00%
0/7
The safety population comprises 174 subjects who received at least 1 dose of G-CSF.
|
Other adverse events
| Measure |
CLBS14: Low-Dose Group
n=55 participants at risk
Intramyocardial injections of auto-CD34+ cells at low dose (1 x 10\^5 cells/kg bodyweight)
|
CLBS14: High-Dose Group
n=56 participants at risk
Intramyocardial injections of auto-CD34+ cells at high dose (5 x 10\^5 cells/kg bodyweight)
|
Placebo Control
n=56 participants at risk
Intramyocardial placebo injections
|
No Cell or Placebo Injection
n=7 participants at risk
Cell mobilization with G-CSF started but no cell or placebo injection administered
|
|---|---|---|---|---|
|
Cardiac disorders
Angina Pectoris
|
36.4%
20/55 • Number of events 25
The safety population comprises 174 subjects who received at least 1 dose of G-CSF.
|
25.0%
14/56 • Number of events 18
The safety population comprises 174 subjects who received at least 1 dose of G-CSF.
|
21.4%
12/56 • Number of events 16
The safety population comprises 174 subjects who received at least 1 dose of G-CSF.
|
14.3%
1/7 • Number of events 1
The safety population comprises 174 subjects who received at least 1 dose of G-CSF.
|
|
Cardiac disorders
Palpitations
|
3.6%
2/55 • Number of events 2
The safety population comprises 174 subjects who received at least 1 dose of G-CSF.
|
7.1%
4/56 • Number of events 4
The safety population comprises 174 subjects who received at least 1 dose of G-CSF.
|
5.4%
3/56 • Number of events 3
The safety population comprises 174 subjects who received at least 1 dose of G-CSF.
|
0.00%
0/7
The safety population comprises 174 subjects who received at least 1 dose of G-CSF.
|
|
Gastrointestinal disorders
Diarrhea
|
10.9%
6/55 • Number of events 6
The safety population comprises 174 subjects who received at least 1 dose of G-CSF.
|
8.9%
5/56 • Number of events 6
The safety population comprises 174 subjects who received at least 1 dose of G-CSF.
|
8.9%
5/56 • Number of events 5
The safety population comprises 174 subjects who received at least 1 dose of G-CSF.
|
0.00%
0/7
The safety population comprises 174 subjects who received at least 1 dose of G-CSF.
|
|
Gastrointestinal disorders
Nausea
|
23.6%
13/55 • Number of events 14
The safety population comprises 174 subjects who received at least 1 dose of G-CSF.
|
19.6%
11/56 • Number of events 16
The safety population comprises 174 subjects who received at least 1 dose of G-CSF.
|
16.1%
9/56 • Number of events 10
The safety population comprises 174 subjects who received at least 1 dose of G-CSF.
|
0.00%
0/7
The safety population comprises 174 subjects who received at least 1 dose of G-CSF.
|
|
Gastrointestinal disorders
Vomiting
|
9.1%
5/55 • Number of events 5
The safety population comprises 174 subjects who received at least 1 dose of G-CSF.
|
7.1%
4/56 • Number of events 6
The safety population comprises 174 subjects who received at least 1 dose of G-CSF.
|
1.8%
1/56 • Number of events 1
The safety population comprises 174 subjects who received at least 1 dose of G-CSF.
|
0.00%
0/7
The safety population comprises 174 subjects who received at least 1 dose of G-CSF.
|
|
General disorders
Chest Pain
|
9.1%
5/55 • Number of events 5
The safety population comprises 174 subjects who received at least 1 dose of G-CSF.
|
5.4%
3/56 • Number of events 21
The safety population comprises 174 subjects who received at least 1 dose of G-CSF.
|
3.6%
2/56 • Number of events 3
The safety population comprises 174 subjects who received at least 1 dose of G-CSF.
|
14.3%
1/7 • Number of events 1
The safety population comprises 174 subjects who received at least 1 dose of G-CSF.
|
|
General disorders
Fatigue
|
27.3%
15/55 • Number of events 15
The safety population comprises 174 subjects who received at least 1 dose of G-CSF.
|
16.1%
9/56 • Number of events 9
The safety population comprises 174 subjects who received at least 1 dose of G-CSF.
|
19.6%
11/56 • Number of events 11
The safety population comprises 174 subjects who received at least 1 dose of G-CSF.
|
0.00%
0/7
The safety population comprises 174 subjects who received at least 1 dose of G-CSF.
|
|
General disorders
Edema Peripheral
|
5.5%
3/55 • Number of events 3
The safety population comprises 174 subjects who received at least 1 dose of G-CSF.
|
8.9%
5/56 • Number of events 5
The safety population comprises 174 subjects who received at least 1 dose of G-CSF.
|
10.7%
6/56 • Number of events 6
The safety population comprises 174 subjects who received at least 1 dose of G-CSF.
|
0.00%
0/7
The safety population comprises 174 subjects who received at least 1 dose of G-CSF.
|
|
General disorders
Pain
|
12.7%
7/55 • Number of events 8
The safety population comprises 174 subjects who received at least 1 dose of G-CSF.
|
16.1%
9/56 • Number of events 9
The safety population comprises 174 subjects who received at least 1 dose of G-CSF.
|
10.7%
6/56 • Number of events 6
The safety population comprises 174 subjects who received at least 1 dose of G-CSF.
|
28.6%
2/7 • Number of events 2
The safety population comprises 174 subjects who received at least 1 dose of G-CSF.
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
12.7%
7/55 • Number of events 9
The safety population comprises 174 subjects who received at least 1 dose of G-CSF.
|
3.6%
2/56 • Number of events 2
The safety population comprises 174 subjects who received at least 1 dose of G-CSF.
|
7.1%
4/56 • Number of events 5
The safety population comprises 174 subjects who received at least 1 dose of G-CSF.
|
0.00%
0/7
The safety population comprises 174 subjects who received at least 1 dose of G-CSF.
|
|
Injury, poisoning and procedural complications
Vascular Access Complication
|
25.5%
14/55 • Number of events 22
The safety population comprises 174 subjects who received at least 1 dose of G-CSF.
|
25.0%
14/56 • Number of events 18
The safety population comprises 174 subjects who received at least 1 dose of G-CSF.
|
19.6%
11/56 • Number of events 22
The safety population comprises 174 subjects who received at least 1 dose of G-CSF.
|
14.3%
1/7 • Number of events 1
The safety population comprises 174 subjects who received at least 1 dose of G-CSF.
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
14.5%
8/55 • Number of events 8
The safety population comprises 174 subjects who received at least 1 dose of G-CSF.
|
16.1%
9/56 • Number of events 9
The safety population comprises 174 subjects who received at least 1 dose of G-CSF.
|
7.1%
4/56 • Number of events 4
The safety population comprises 174 subjects who received at least 1 dose of G-CSF.
|
0.00%
0/7
The safety population comprises 174 subjects who received at least 1 dose of G-CSF.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
7.3%
4/55 • Number of events 4
The safety population comprises 174 subjects who received at least 1 dose of G-CSF.
|
7.1%
4/56 • Number of events 4
The safety population comprises 174 subjects who received at least 1 dose of G-CSF.
|
10.7%
6/56 • Number of events 8
The safety population comprises 174 subjects who received at least 1 dose of G-CSF.
|
28.6%
2/7 • Number of events 2
The safety population comprises 174 subjects who received at least 1 dose of G-CSF.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
21.8%
12/55 • Number of events 15
The safety population comprises 174 subjects who received at least 1 dose of G-CSF.
|
21.4%
12/56 • Number of events 14
The safety population comprises 174 subjects who received at least 1 dose of G-CSF.
|
14.3%
8/56 • Number of events 9
The safety population comprises 174 subjects who received at least 1 dose of G-CSF.
|
0.00%
0/7
The safety population comprises 174 subjects who received at least 1 dose of G-CSF.
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
30.9%
17/55 • Number of events 18
The safety population comprises 174 subjects who received at least 1 dose of G-CSF.
|
33.9%
19/56 • Number of events 25
The safety population comprises 174 subjects who received at least 1 dose of G-CSF.
|
19.6%
11/56 • Number of events 11
The safety population comprises 174 subjects who received at least 1 dose of G-CSF.
|
0.00%
0/7
The safety population comprises 174 subjects who received at least 1 dose of G-CSF.
|
|
Musculoskeletal and connective tissue disorders
Bone Pain
|
23.6%
13/55 • Number of events 13
The safety population comprises 174 subjects who received at least 1 dose of G-CSF.
|
19.6%
11/56 • Number of events 14
The safety population comprises 174 subjects who received at least 1 dose of G-CSF.
|
17.9%
10/56 • Number of events 10
The safety population comprises 174 subjects who received at least 1 dose of G-CSF.
|
14.3%
1/7 • Number of events 1
The safety population comprises 174 subjects who received at least 1 dose of G-CSF.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal Chest Pain
|
7.3%
4/55 • Number of events 8
The safety population comprises 174 subjects who received at least 1 dose of G-CSF.
|
5.4%
3/56 • Number of events 4
The safety population comprises 174 subjects who received at least 1 dose of G-CSF.
|
8.9%
5/56 • Number of events 5
The safety population comprises 174 subjects who received at least 1 dose of G-CSF.
|
0.00%
0/7
The safety population comprises 174 subjects who received at least 1 dose of G-CSF.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal Pain
|
9.1%
5/55 • Number of events 7
The safety population comprises 174 subjects who received at least 1 dose of G-CSF.
|
7.1%
4/56 • Number of events 7
The safety population comprises 174 subjects who received at least 1 dose of G-CSF.
|
0.00%
0/56
The safety population comprises 174 subjects who received at least 1 dose of G-CSF.
|
0.00%
0/7
The safety population comprises 174 subjects who received at least 1 dose of G-CSF.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
5.5%
3/55 • Number of events 3
The safety population comprises 174 subjects who received at least 1 dose of G-CSF.
|
7.1%
4/56 • Number of events 4
The safety population comprises 174 subjects who received at least 1 dose of G-CSF.
|
7.1%
4/56 • Number of events 4
The safety population comprises 174 subjects who received at least 1 dose of G-CSF.
|
14.3%
1/7 • Number of events 1
The safety population comprises 174 subjects who received at least 1 dose of G-CSF.
|
|
Musculoskeletal and connective tissue disorders
Neck Pain
|
3.6%
2/55 • Number of events 2
The safety population comprises 174 subjects who received at least 1 dose of G-CSF.
|
10.7%
6/56 • Number of events 6
The safety population comprises 174 subjects who received at least 1 dose of G-CSF.
|
3.6%
2/56 • Number of events 2
The safety population comprises 174 subjects who received at least 1 dose of G-CSF.
|
0.00%
0/7
The safety population comprises 174 subjects who received at least 1 dose of G-CSF.
|
|
Musculoskeletal and connective tissue disorders
Pain in Extremity
|
12.7%
7/55 • Number of events 12
The safety population comprises 174 subjects who received at least 1 dose of G-CSF.
|
12.5%
7/56 • Number of events 8
The safety population comprises 174 subjects who received at least 1 dose of G-CSF.
|
10.7%
6/56 • Number of events 7
The safety population comprises 174 subjects who received at least 1 dose of G-CSF.
|
0.00%
0/7
The safety population comprises 174 subjects who received at least 1 dose of G-CSF.
|
|
Nervous system disorders
Dizziness
|
14.5%
8/55 • Number of events 8
The safety population comprises 174 subjects who received at least 1 dose of G-CSF.
|
8.9%
5/56 • Number of events 6
The safety population comprises 174 subjects who received at least 1 dose of G-CSF.
|
10.7%
6/56 • Number of events 6
The safety population comprises 174 subjects who received at least 1 dose of G-CSF.
|
0.00%
0/7
The safety population comprises 174 subjects who received at least 1 dose of G-CSF.
|
|
Nervous system disorders
Headache
|
29.1%
16/55 • Number of events 20
The safety population comprises 174 subjects who received at least 1 dose of G-CSF.
|
44.6%
25/56 • Number of events 31
The safety population comprises 174 subjects who received at least 1 dose of G-CSF.
|
17.9%
10/56 • Number of events 10
The safety population comprises 174 subjects who received at least 1 dose of G-CSF.
|
57.1%
4/7 • Number of events 4
The safety population comprises 174 subjects who received at least 1 dose of G-CSF.
|
|
Nervous system disorders
Paresthesia
|
21.8%
12/55 • Number of events 15
The safety population comprises 174 subjects who received at least 1 dose of G-CSF.
|
26.8%
15/56 • Number of events 15
The safety population comprises 174 subjects who received at least 1 dose of G-CSF.
|
30.4%
17/56 • Number of events 24
The safety population comprises 174 subjects who received at least 1 dose of G-CSF.
|
28.6%
2/7 • Number of events 2
The safety population comprises 174 subjects who received at least 1 dose of G-CSF.
|
|
Psychiatric disorders
Anxiety
|
5.5%
3/55 • Number of events 3
The safety population comprises 174 subjects who received at least 1 dose of G-CSF.
|
7.1%
4/56 • Number of events 4
The safety population comprises 174 subjects who received at least 1 dose of G-CSF.
|
3.6%
2/56 • Number of events 2
The safety population comprises 174 subjects who received at least 1 dose of G-CSF.
|
14.3%
1/7 • Number of events 1
The safety population comprises 174 subjects who received at least 1 dose of G-CSF.
|
|
Psychiatric disorders
Insomnia
|
10.9%
6/55 • Number of events 6
The safety population comprises 174 subjects who received at least 1 dose of G-CSF.
|
12.5%
7/56 • Number of events 8
The safety population comprises 174 subjects who received at least 1 dose of G-CSF.
|
10.7%
6/56 • Number of events 6
The safety population comprises 174 subjects who received at least 1 dose of G-CSF.
|
14.3%
1/7 • Number of events 1
The safety population comprises 174 subjects who received at least 1 dose of G-CSF.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
7.3%
4/55 • Number of events 4
The safety population comprises 174 subjects who received at least 1 dose of G-CSF.
|
8.9%
5/56 • Number of events 5
The safety population comprises 174 subjects who received at least 1 dose of G-CSF.
|
3.6%
2/56 • Number of events 2
The safety population comprises 174 subjects who received at least 1 dose of G-CSF.
|
0.00%
0/7
The safety population comprises 174 subjects who received at least 1 dose of G-CSF.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
9.1%
5/55 • Number of events 5
The safety population comprises 174 subjects who received at least 1 dose of G-CSF.
|
12.5%
7/56 • Number of events 8
The safety population comprises 174 subjects who received at least 1 dose of G-CSF.
|
25.0%
14/56 • Number of events 16
The safety population comprises 174 subjects who received at least 1 dose of G-CSF.
|
14.3%
1/7 • Number of events 1
The safety population comprises 174 subjects who received at least 1 dose of G-CSF.
|
|
Vascular disorders
Hypertension
|
5.5%
3/55 • Number of events 3
The safety population comprises 174 subjects who received at least 1 dose of G-CSF.
|
5.4%
3/56 • Number of events 3
The safety population comprises 174 subjects who received at least 1 dose of G-CSF.
|
7.1%
4/56 • Number of events 5
The safety population comprises 174 subjects who received at least 1 dose of G-CSF.
|
14.3%
1/7 • Number of events 1
The safety population comprises 174 subjects who received at least 1 dose of G-CSF.
|
|
Vascular disorders
Hypotension
|
5.5%
3/55 • Number of events 3
The safety population comprises 174 subjects who received at least 1 dose of G-CSF.
|
10.7%
6/56 • Number of events 7
The safety population comprises 174 subjects who received at least 1 dose of G-CSF.
|
7.1%
4/56 • Number of events 5
The safety population comprises 174 subjects who received at least 1 dose of G-CSF.
|
14.3%
1/7 • Number of events 1
The safety population comprises 174 subjects who received at least 1 dose of G-CSF.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee For this study, PIs are restricted from independently publishing results before completion of a single multicenter publication or one year after study completion, whichever occurs first. Baxter requires a review of the intended publication at least 60 days prior to submission. Baxter may request an additional delay of 45 days to secure patent and/or other proprietary protection.
- Publication restrictions are in place
Restriction type: OTHER