Trial Outcomes & Findings for Allogenic Umbilical Cord Blood and Erythropoietin Combination Therapy for Cerebral Palsy (NCT NCT01193660)
NCT ID: NCT01193660
Last Updated: 2020-11-24
Results Overview
GMPM (Gross Motor Performance Measure) as a standardized measurement tool for assessing quality of movement regarding 3 properties of 5 ones; alignment, coordination, dissociated movement, stability, and weight shift (range: 0\~100, Higher value means better motor quality). We reported changes of GMPM score between each assessment time points. Categories of outcome table are baseline and values of just subtracting the latter raw scores from the former ones.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
105 participants
Primary outcome timeframe
Baseline -1 month - 3 months - 6 months
Results posted on
2020-11-24
Participant Flow
Enrollment Period: May 31, 2010 through April 9, 2011 All participants were recruited at CHA Bundang Medical Center.
We tried to recruit 106 subjects. Finally 105 patients were enrolled at the beginning of the overall study and none of the participants were washed out before assignment to groups.
Participant milestones
| Measure |
Umbilical Cord Blood & Erythropoietin & Rehabilitation
Allogeneic umbilical cord blood infusion (total nucleated cells \> 3x10\^7/kg intravenously), Erythropoietin injection (twice a week for 4 weeks with the dosage of 500 IU/kg for 2 times intravenously and 250 IU/kg subcutaneously for 6 times), and active rehabilitation
|
Erythropoietin & Rehabilitation
Erythropoietin injection (twice a week for 4 weeks with the dosage of 500 IU/kg for 2 times intravenously and 250 IU/kg subcutaneously for 6 times),and active rehabilitation
|
Only Rehabilitation
Active rehabilitation
|
|---|---|---|---|
|
Overall Study
STARTED
|
35
|
36
|
34
|
|
Overall Study
COMPLETED
|
31
|
33
|
32
|
|
Overall Study
NOT COMPLETED
|
4
|
3
|
2
|
Reasons for withdrawal
| Measure |
Umbilical Cord Blood & Erythropoietin & Rehabilitation
Allogeneic umbilical cord blood infusion (total nucleated cells \> 3x10\^7/kg intravenously), Erythropoietin injection (twice a week for 4 weeks with the dosage of 500 IU/kg for 2 times intravenously and 250 IU/kg subcutaneously for 6 times), and active rehabilitation
|
Erythropoietin & Rehabilitation
Erythropoietin injection (twice a week for 4 weeks with the dosage of 500 IU/kg for 2 times intravenously and 250 IU/kg subcutaneously for 6 times),and active rehabilitation
|
Only Rehabilitation
Active rehabilitation
|
|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
2
|
3
|
1
|
|
Overall Study
Death
|
1
|
0
|
0
|
|
Overall Study
Physician Decision
|
1
|
0
|
1
|
Baseline Characteristics
Allogenic Umbilical Cord Blood and Erythropoietin Combination Therapy for Cerebral Palsy
Baseline characteristics by cohort
| Measure |
Umbilical Cord Blood & Erythropoietin & Rehabilitation
n=35 Participants
Allogeneic umbilical cord blood infusion (total nucleated cells \> 3x10\^7/kg intravenously), Erythropoietin injection (twice a week for 4 weeks with the dosage of 500 IU/kg for 2 times intravenously and 250 IU/kg subcutaneously for 6 times), and active rehabilitation
|
Erythropoietin & Rehabilitation
n=36 Participants
Erythropoietin injection (twice a week for 4 weeks with the dosage of 500 IU/kg for 2 times intravenously and 250 IU/kg subcutaneously for 6 times),and active rehabilitation
|
Only Rehabilitation
n=34 Participants
Active rehabilitation
|
Total
n=105 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
35 Participants
n=5 Participants
|
36 Participants
n=7 Participants
|
34 Participants
n=5 Participants
|
105 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Continuous
|
45.71 months
STANDARD_DEVIATION 18.91 • n=5 Participants
|
50.05 months
STANDARD_DEVIATION 24.45 • n=7 Participants
|
46.0 months
STANDARD_DEVIATION 19.58 • n=5 Participants
|
47.30 months
STANDARD_DEVIATION 21.07 • n=4 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
33 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
22 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
72 Participants
n=4 Participants
|
|
Region of Enrollment
Korea, Republic of
|
35 participants
n=5 Participants
|
36 participants
n=7 Participants
|
34 participants
n=5 Participants
|
105 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Baseline -1 month - 3 months - 6 monthsPopulation: Intention to treat
GMPM (Gross Motor Performance Measure) as a standardized measurement tool for assessing quality of movement regarding 3 properties of 5 ones; alignment, coordination, dissociated movement, stability, and weight shift (range: 0\~100, Higher value means better motor quality). We reported changes of GMPM score between each assessment time points. Categories of outcome table are baseline and values of just subtracting the latter raw scores from the former ones.
Outcome measures
| Measure |
Umbilical Cord Blood & Erythropoietin & Rehabilitation
n=31 Participants
Allogeneic umbilical cord blood infusion (total nucleated cells \> 3x10\^7/kg intravenously), Erythropoietin injection (twice a week for 4 weeks with the dosage of 500 IU/kg for 2 times intravenously and 250 IU/kg subcutaneously for 6 times), and active rehabilitation
|
Erythropoietin & Rehabilitation
n=33 Participants
Erythropoietin injection (twice a week for 4 weeks with the dosage of 500 IU/kg for 2 times intravenously and 250 IU/kg subcutaneously for 6 times),and active rehabilitation
|
Only Rehabilitation
n=32 Participants
Active rehabilitation
|
|---|---|---|---|
|
Changes in Motor Performance
Baseline
|
34.5 units on a scale
Standard Error 2.7
|
38.2 units on a scale
Standard Error 2.8
|
35.5 units on a scale
Standard Error 2.9
|
|
Changes in Motor Performance
1 month - Baseline
|
7.00 units on a scale
Standard Error 1.3
|
4.5 units on a scale
Standard Error 0.6
|
6.0 units on a scale
Standard Error 1.0
|
|
Changes in Motor Performance
3 months - Baseline
|
11.5 units on a scale
Standard Error 1.5
|
7.5 units on a scale
Standard Error 0.8
|
8.1 units on a scale
Standard Error 1.2
|
|
Changes in Motor Performance
6 months - Baseline
|
14.5 units on a scale
Standard Error 1.8
|
9.2 units on a scale
Standard Error 0.8
|
9.6 units on a scale
Standard Error 1.2
|
|
Changes in Motor Performance
3 months - 1 month
|
4.5 units on a scale
Standard Error 0.7
|
2.9 units on a scale
Standard Error 0.5
|
2.1 units on a scale
Standard Error 0.6
|
|
Changes in Motor Performance
6 months - 1 month
|
7.5 units on a scale
Standard Error 0.9
|
4.7 units on a scale
Standard Error 0.7
|
3.6 units on a scale
Standard Error 0.7
|
|
Changes in Motor Performance
6 months - 3 months
|
3.1 units on a scale
Standard Error 0.6
|
1.7 units on a scale
Standard Error 0.5
|
1.5 units on a scale
Standard Error 0.4
|
PRIMARY outcome
Timeframe: Baseline - 1 month - 3 months - 6 monthsPopulation: Intention to treat
GMFM (Gross Motor Function Measure) as a standardized measurement tool for assessing Gross Motor Function consisting of sub-scales; lying \& rolling, sitting, crawling \& kneeling, standing, walking, running \& jumping (range: 0\~100 , Higher value means better gross motor function). We reported changes of GMFM between each assessment time points. Categories of outcome table are baseline and values of just subtracting the latter raw scores from the former ones.
Outcome measures
| Measure |
Umbilical Cord Blood & Erythropoietin & Rehabilitation
n=31 Participants
Allogeneic umbilical cord blood infusion (total nucleated cells \> 3x10\^7/kg intravenously), Erythropoietin injection (twice a week for 4 weeks with the dosage of 500 IU/kg for 2 times intravenously and 250 IU/kg subcutaneously for 6 times), and active rehabilitation
|
Erythropoietin & Rehabilitation
n=33 Participants
Erythropoietin injection (twice a week for 4 weeks with the dosage of 500 IU/kg for 2 times intravenously and 250 IU/kg subcutaneously for 6 times),and active rehabilitation
|
Only Rehabilitation
n=32 Participants
Active rehabilitation
|
|---|---|---|---|
|
Changes in Standardized Gross Motor Function
Baseline
|
36.0 units on a scale
Standard Error 4.7
|
42.6 units on a scale
Standard Error 4.9
|
36.8 units on a scale
Standard Error 4.5
|
|
Changes in Standardized Gross Motor Function
1 month - Baseline
|
3.7 units on a scale
Standard Error 0.4
|
4.3 units on a scale
Standard Error 0.5
|
4.6 units on a scale
Standard Error 0.6
|
|
Changes in Standardized Gross Motor Function
3 months - Baseline
|
6.5 units on a scale
Standard Error 0.9
|
6.8 units on a scale
Standard Error 0.8
|
6.4 units on a scale
Standard Error 0.7
|
|
Changes in Standardized Gross Motor Function
6 months - Baseline
|
9.1 units on a scale
Standard Error 1.2
|
9.0 units on a scale
Standard Error 1.1
|
7.8 units on a scale
Standard Error 0.9
|
|
Changes in Standardized Gross Motor Function
3 months - 1 month
|
2.9 units on a scale
Standard Error 0.8
|
2.5 units on a scale
Standard Error 0.5
|
1.8 units on a scale
Standard Error 0.4
|
|
Changes in Standardized Gross Motor Function
6 months - 1 month
|
5.4 units on a scale
Standard Error 1.2
|
4.7 units on a scale
Standard Error 0.9
|
3.1 units on a scale
Standard Error 0.6
|
|
Changes in Standardized Gross Motor Function
6 months - 3 months
|
2.6 units on a scale
Standard Error 0.5
|
2.2 units on a scale
Standard Error 0.6
|
1.3 units on a scale
Standard Error 0.4
|
SECONDARY outcome
Timeframe: Baseline -1 month - 3 months - 6 monthsPopulation: Intention to treat
Korean version of Bayley Scale of Infant Development-II (K-BSID-II) Mental Scales (higher value means better mental function: 0 - worst, 178 - best). We reported changes of BSID-II Mental Scale raw score between each assessment time points. Categories of outcome data are values of subtracting the latter scores from the former ones.
Outcome measures
| Measure |
Umbilical Cord Blood & Erythropoietin & Rehabilitation
n=31 Participants
Allogeneic umbilical cord blood infusion (total nucleated cells \> 3x10\^7/kg intravenously), Erythropoietin injection (twice a week for 4 weeks with the dosage of 500 IU/kg for 2 times intravenously and 250 IU/kg subcutaneously for 6 times), and active rehabilitation
|
Erythropoietin & Rehabilitation
n=33 Participants
Erythropoietin injection (twice a week for 4 weeks with the dosage of 500 IU/kg for 2 times intravenously and 250 IU/kg subcutaneously for 6 times),and active rehabilitation
|
Only Rehabilitation
n=32 Participants
Active rehabilitation
|
|---|---|---|---|
|
Changes in Cognitive Neurodevelopmental Outcome
BSID-II Mental Scale: Baseline
|
94.1 units on a scale
Standard Error 9.1
|
105.9 units on a scale
Standard Error 8.9
|
86.6 units on a scale
Standard Error 9.0
|
|
Changes in Cognitive Neurodevelopmental Outcome
BSID-II Mental Scale: 1 month - Baseline
|
8.2 units on a scale
Standard Error 1.3
|
3.4 units on a scale
Standard Error 0.5
|
3.3 units on a scale
Standard Error 0.6
|
|
Changes in Cognitive Neurodevelopmental Outcome
BSID-II Mental Scale: 3 months - Baseline
|
12.0 units on a scale
Standard Error 1.4
|
7.4 units on a scale
Standard Error 0.9
|
5.8 units on a scale
Standard Error 0.8
|
|
Changes in Cognitive Neurodevelopmental Outcome
BSID-II Mental Scale: 6 months - Baseline
|
17.6 units on a scale
Standard Error 1.8
|
11.5 units on a scale
Standard Error 1.3
|
9.9 units on a scale
Standard Error 1.6
|
|
Changes in Cognitive Neurodevelopmental Outcome
BSID-II Mental Scale: 3 months - 1 month
|
3.8 units on a scale
Standard Error 0.8
|
4.0 units on a scale
Standard Error 0.7
|
2.5 units on a scale
Standard Error 0.7
|
|
Changes in Cognitive Neurodevelopmental Outcome
BSID-II Mental Scale: 6 months - 1 month
|
9.4 units on a scale
Standard Error 1.4
|
8.1 units on a scale
Standard Error 1.3
|
6.6 units on a scale
Standard Error 1.4
|
|
Changes in Cognitive Neurodevelopmental Outcome
BSID-II Mental Scale: 6 months - 3 months
|
5.6 units on a scale
Standard Error 1.2
|
4.1 units on a scale
Standard Error 0.8
|
4.1 units on a scale
Standard Error 1.0
|
SECONDARY outcome
Timeframe: Baseline - 1 month - 3 months - 6 monthsPopulation: Intention to treat
Korean version of Bayley Scale of Infant Development-II (K-BSID-II) Motor Scales (higher value means better motor function: 0 - worst, 111 - best). We reported changes of BSID-II Motor Scale raw score between each assessment time points. Categories of outcome data are values of subtracting the latter scores from the former ones.
Outcome measures
| Measure |
Umbilical Cord Blood & Erythropoietin & Rehabilitation
n=31 Participants
Allogeneic umbilical cord blood infusion (total nucleated cells \> 3x10\^7/kg intravenously), Erythropoietin injection (twice a week for 4 weeks with the dosage of 500 IU/kg for 2 times intravenously and 250 IU/kg subcutaneously for 6 times), and active rehabilitation
|
Erythropoietin & Rehabilitation
n=33 Participants
Erythropoietin injection (twice a week for 4 weeks with the dosage of 500 IU/kg for 2 times intravenously and 250 IU/kg subcutaneously for 6 times),and active rehabilitation
|
Only Rehabilitation
n=32 Participants
Active rehabilitation
|
|---|---|---|---|
|
Changes in Motor Neurodevelopmental Outcome
BSID-II Motor Scale: Baseline
|
45.2 units on a scale
Standard Error 4.7
|
53.3 units on a scale
Standard Error 5.0
|
45.5 units on a scale
Standard Error 4.6
|
|
Changes in Motor Neurodevelopmental Outcome
BSID-II Motor Scale: 1 month - Baseline
|
5.0 units on a scale
Standard Error 1.5
|
5.2 units on a scale
Standard Error 2.1
|
2.7 units on a scale
Standard Error 0.6
|
|
Changes in Motor Neurodevelopmental Outcome
BSID-II Motor Scale: 3 months - Baseline
|
9.5 units on a scale
Standard Error 1.9
|
6.8 units on a scale
Standard Error 2.1
|
4.3 units on a scale
Standard Error 0.8
|
|
Changes in Motor Neurodevelopmental Outcome
BSID-II Motor Scale: 6 months - Baseline
|
11.7 units on a scale
Standard Error 2.0
|
7.6 units on a scale
Standard Error 2.2
|
5.2 units on a scale
Standard Error 0.9
|
|
Changes in Motor Neurodevelopmental Outcome
BSID-II Motor Scale: 3 months - 1 month
|
4.5 units on a scale
Standard Error 1.0
|
1.6 units on a scale
Standard Error 0.5
|
1.5 units on a scale
Standard Error 0.4
|
|
Changes in Motor Neurodevelopmental Outcome
BSID-II Motor Scale: 6 months - 1 month
|
6.7 units on a scale
Standard Error 1.3
|
2.5 units on a scale
Standard Error 0.6
|
2.5 units on a scale
Standard Error 0.5
|
|
Changes in Motor Neurodevelopmental Outcome
BSID-II Motor Scale: 6 months - 3 months
|
2.2 units on a scale
Standard Error 0.6
|
0.9 units on a scale
Standard Error 0.4
|
1.0 units on a scale
Standard Error 0.4
|
SECONDARY outcome
Timeframe: Baseline - 6 monthsChanges on brain Diffusion Tensor Image (DTI); DTI provides quantitative information about the microscopic integrity of white matter. White matter normally possesses a high degree of diffusion anisotropy than gray matter. We can measure fractional anisotropy (FA) value in DTI imaging and it ranges from 0 to 1. Higher FA value of a certain region of interest means the area has more integrity of white matter.
Outcome measures
| Measure |
Umbilical Cord Blood & Erythropoietin & Rehabilitation
n=30 Participants
Allogeneic umbilical cord blood infusion (total nucleated cells \> 3x10\^7/kg intravenously), Erythropoietin injection (twice a week for 4 weeks with the dosage of 500 IU/kg for 2 times intravenously and 250 IU/kg subcutaneously for 6 times), and active rehabilitation
|
Erythropoietin & Rehabilitation
n=31 Participants
Erythropoietin injection (twice a week for 4 weeks with the dosage of 500 IU/kg for 2 times intravenously and 250 IU/kg subcutaneously for 6 times),and active rehabilitation
|
Only Rehabilitation
n=29 Participants
Active rehabilitation
|
|---|---|---|---|
|
Changes in Brain MRI
Posterior portion of Lt posterior Internal Capsule
|
0.05 units on a scale
Standard Error 0.02
|
0.04 units on a scale
Standard Error 0.02
|
0.05 units on a scale
Standard Error 0.02
|
|
Changes in Brain MRI
Anterior portion of Rt. posterior Internal Capsule
|
0.03 units on a scale
Standard Error 0.01
|
0.01 units on a scale
Standard Error 0.01
|
0.01 units on a scale
Standard Error 0.01
|
|
Changes in Brain MRI
Posterior portion of Rt posterior Internal Capsule
|
0.04 units on a scale
Standard Error 0.01
|
0.02 units on a scale
Standard Error 0.01
|
0.02 units on a scale
Standard Error 0.02
|
|
Changes in Brain MRI
Anterior portion of Lt. posterior Internal Capsule
|
0.03 units on a scale
Standard Error 0.01
|
0.02 units on a scale
Standard Error 0.01
|
0.04 units on a scale
Standard Error 0.02
|
SECONDARY outcome
Timeframe: Baseline - 2 weeksPopulation: Intention to treat
18F-FDG PET imaging was performed twice prior to and then 2 weeks post-treatment. Ninety slices of each emission image were obtained, and all scans were reviewed by a nuclear physician. Spatial pre-processing and statistical analyses were performed using SPM8 implanted in Matlab to compare differences in regional brain glucose metabolism between groups and differences between pre- and post-therapy imaging data. We reported increased areas and decreased areas of glucose metabolism in three groups. We defined that "1" refers to INCREASED areas, "-1", DECREASED areas and "0", just NO CHANGE.
Outcome measures
| Measure |
Umbilical Cord Blood & Erythropoietin & Rehabilitation
n=31 Participants
Allogeneic umbilical cord blood infusion (total nucleated cells \> 3x10\^7/kg intravenously), Erythropoietin injection (twice a week for 4 weeks with the dosage of 500 IU/kg for 2 times intravenously and 250 IU/kg subcutaneously for 6 times), and active rehabilitation
|
Erythropoietin & Rehabilitation
n=33 Participants
Erythropoietin injection (twice a week for 4 weeks with the dosage of 500 IU/kg for 2 times intravenously and 250 IU/kg subcutaneously for 6 times),and active rehabilitation
|
Only Rehabilitation
n=32 Participants
Active rehabilitation
|
|---|---|---|---|
|
Comparison of Changes in Brain Glucose Metabolism Using by Brain 18F-FDG PET: Increased and Decreased Areas of Brain Glucose Metabolism
Rt. Lentiform Nucleus, Gray Matter, Putamen
|
1 units on a scale
|
0 units on a scale
|
0 units on a scale
|
|
Comparison of Changes in Brain Glucose Metabolism Using by Brain 18F-FDG PET: Increased and Decreased Areas of Brain Glucose Metabolism
Lt. Frontal Lobe, Medial Frontal Gyrus
|
1 units on a scale
|
0 units on a scale
|
0 units on a scale
|
|
Comparison of Changes in Brain Glucose Metabolism Using by Brain 18F-FDG PET: Increased and Decreased Areas of Brain Glucose Metabolism
Lt. Sub-lobar, Insula
|
1 units on a scale
|
0 units on a scale
|
-1 units on a scale
|
|
Comparison of Changes in Brain Glucose Metabolism Using by Brain 18F-FDG PET: Increased and Decreased Areas of Brain Glucose Metabolism
Lt. Lentiform Nucleus, Gray Matter, Putamen
|
1 units on a scale
|
0 units on a scale
|
0 units on a scale
|
|
Comparison of Changes in Brain Glucose Metabolism Using by Brain 18F-FDG PET: Increased and Decreased Areas of Brain Glucose Metabolism
Lt.Lentiform Nucleus, Gray Matter, Globus Pallidus
|
1 units on a scale
|
0 units on a scale
|
0 units on a scale
|
|
Comparison of Changes in Brain Glucose Metabolism Using by Brain 18F-FDG PET: Increased and Decreased Areas of Brain Glucose Metabolism
Lt. Midbrain (Thalamus)
|
1 units on a scale
|
0 units on a scale
|
0 units on a scale
|
|
Comparison of Changes in Brain Glucose Metabolism Using by Brain 18F-FDG PET: Increased and Decreased Areas of Brain Glucose Metabolism
Rt. Parietal Lobe, Precuneus
|
1 units on a scale
|
0 units on a scale
|
0 units on a scale
|
|
Comparison of Changes in Brain Glucose Metabolism Using by Brain 18F-FDG PET: Increased and Decreased Areas of Brain Glucose Metabolism
Lt. Temporal Lobe, Middle Temporal Gyrus
|
1 units on a scale
|
0 units on a scale
|
-1 units on a scale
|
|
Comparison of Changes in Brain Glucose Metabolism Using by Brain 18F-FDG PET: Increased and Decreased Areas of Brain Glucose Metabolism
Rt. Parietal Lobe, Pre- and Post-central Gyrus
|
1 units on a scale
|
0 units on a scale
|
0 units on a scale
|
|
Comparison of Changes in Brain Glucose Metabolism Using by Brain 18F-FDG PET: Increased and Decreased Areas of Brain Glucose Metabolism
Rt. Frontal Lobe, Paracentral Lobule
|
0 units on a scale
|
1 units on a scale
|
0 units on a scale
|
|
Comparison of Changes in Brain Glucose Metabolism Using by Brain 18F-FDG PET: Increased and Decreased Areas of Brain Glucose Metabolism
Rt. Limbic Lobe, Anterior Cingulate
|
0 units on a scale
|
1 units on a scale
|
0 units on a scale
|
|
Comparison of Changes in Brain Glucose Metabolism Using by Brain 18F-FDG PET: Increased and Decreased Areas of Brain Glucose Metabolism
Lt. Frontal Lobe, Precentral Gyrus
|
0 units on a scale
|
1 units on a scale
|
0 units on a scale
|
|
Comparison of Changes in Brain Glucose Metabolism Using by Brain 18F-FDG PET: Increased and Decreased Areas of Brain Glucose Metabolism
Lt. Lentiform Nucleus, Putamen
|
0 units on a scale
|
1 units on a scale
|
0 units on a scale
|
|
Comparison of Changes in Brain Glucose Metabolism Using by Brain 18F-FDG PET: Increased and Decreased Areas of Brain Glucose Metabolism
Rt. Cerebellar Anterior Lobe, Culmen
|
0 units on a scale
|
1 units on a scale
|
1 units on a scale
|
|
Comparison of Changes in Brain Glucose Metabolism Using by Brain 18F-FDG PET: Increased and Decreased Areas of Brain Glucose Metabolism
Lt. Cerebellar Posterior Lobe, Cerebellar Tonsil
|
0 units on a scale
|
1 units on a scale
|
1 units on a scale
|
|
Comparison of Changes in Brain Glucose Metabolism Using by Brain 18F-FDG PET: Increased and Decreased Areas of Brain Glucose Metabolism
Rt. Frontal Lobe, Orbital Gyrus
|
0 units on a scale
|
1 units on a scale
|
1 units on a scale
|
|
Comparison of Changes in Brain Glucose Metabolism Using by Brain 18F-FDG PET: Increased and Decreased Areas of Brain Glucose Metabolism
Rt. Occipital Lobe, Middle Occipital Gyrus
|
-1 units on a scale
|
0 units on a scale
|
0 units on a scale
|
|
Comparison of Changes in Brain Glucose Metabolism Using by Brain 18F-FDG PET: Increased and Decreased Areas of Brain Glucose Metabolism
Lt. Limbic Lobe, Parahippocampal Gyrus
|
-1 units on a scale
|
0 units on a scale
|
0 units on a scale
|
|
Comparison of Changes in Brain Glucose Metabolism Using by Brain 18F-FDG PET: Increased and Decreased Areas of Brain Glucose Metabolism
Rt. Limbic Lobe, Parahippocampal Gyrus
|
-1 units on a scale
|
0 units on a scale
|
-1 units on a scale
|
|
Comparison of Changes in Brain Glucose Metabolism Using by Brain 18F-FDG PET: Increased and Decreased Areas of Brain Glucose Metabolism
Rt Cerebellum, Posterior Lobe, Declive
|
0 units on a scale
|
-1 units on a scale
|
0 units on a scale
|
|
Comparison of Changes in Brain Glucose Metabolism Using by Brain 18F-FDG PET: Increased and Decreased Areas of Brain Glucose Metabolism
Rt Cerebellum, Anterior Lobe, Culmen, Occipital
|
0 units on a scale
|
-1 units on a scale
|
0 units on a scale
|
|
Comparison of Changes in Brain Glucose Metabolism Using by Brain 18F-FDG PET: Increased and Decreased Areas of Brain Glucose Metabolism
Lt Cerebellum, Posterior Lobe, Declive, Occipital
|
0 units on a scale
|
-1 units on a scale
|
0 units on a scale
|
|
Comparison of Changes in Brain Glucose Metabolism Using by Brain 18F-FDG PET: Increased and Decreased Areas of Brain Glucose Metabolism
Lt. Frontal Lobe, Middle Frontal Gyrus
|
0 units on a scale
|
0 units on a scale
|
-1 units on a scale
|
|
Comparison of Changes in Brain Glucose Metabolism Using by Brain 18F-FDG PET: Increased and Decreased Areas of Brain Glucose Metabolism
Rt. Frontal Lobe, Middle Frontal Gyrus
|
0 units on a scale
|
0 units on a scale
|
-1 units on a scale
|
|
Comparison of Changes in Brain Glucose Metabolism Using by Brain 18F-FDG PET: Increased and Decreased Areas of Brain Glucose Metabolism
Rt. Frontal Lobe, Sub-gyral
|
0 units on a scale
|
0 units on a scale
|
-1 units on a scale
|
|
Comparison of Changes in Brain Glucose Metabolism Using by Brain 18F-FDG PET: Increased and Decreased Areas of Brain Glucose Metabolism
Lt. Temporal Lobe, Fusiform Gyrus
|
0 units on a scale
|
0 units on a scale
|
-1 units on a scale
|
|
Comparison of Changes in Brain Glucose Metabolism Using by Brain 18F-FDG PET: Increased and Decreased Areas of Brain Glucose Metabolism
Lt. Temporal Lobe, Inferior Temporal Gyrus
|
0 units on a scale
|
0 units on a scale
|
-1 units on a scale
|
|
Comparison of Changes in Brain Glucose Metabolism Using by Brain 18F-FDG PET: Increased and Decreased Areas of Brain Glucose Metabolism
Rt. Temporal Lobe, Middle Temporal Gyrus
|
0 units on a scale
|
0 units on a scale
|
-1 units on a scale
|
SECONDARY outcome
Timeframe: Baseline -1 month - 3 months - 6 monthsPopulation: Intention to treat
Pediatric Evaluation of Disability Inventory (PEDI) for assessing functional performance in daily activities in children (All values are adjusted and higher value means better functional performance, 0 - worst, 100 - best). We reported here 2 scales and 3 domains of each scale: a Functional Skill Scale (FSS) and a Caregiver Assistance Scale (CAS) which are divided respectively into 3 domains: self care, mobility, and social function. Categories of outcome table are each domain scores measured at each assessment time point.
Outcome measures
| Measure |
Umbilical Cord Blood & Erythropoietin & Rehabilitation
n=31 Participants
Allogeneic umbilical cord blood infusion (total nucleated cells \> 3x10\^7/kg intravenously), Erythropoietin injection (twice a week for 4 weeks with the dosage of 500 IU/kg for 2 times intravenously and 250 IU/kg subcutaneously for 6 times), and active rehabilitation
|
Erythropoietin & Rehabilitation
n=33 Participants
Erythropoietin injection (twice a week for 4 weeks with the dosage of 500 IU/kg for 2 times intravenously and 250 IU/kg subcutaneously for 6 times),and active rehabilitation
|
Only Rehabilitation
n=32 Participants
Active rehabilitation
|
|---|---|---|---|
|
Changes in Functional Performance in Daily Activities
Mobility of CAS: 6 months
|
24.9 units on a scale
Standard Error 5.5
|
29.2 units on a scale
Standard Error 5.4
|
24.0 units on a scale
Standard Error 4.8
|
|
Changes in Functional Performance in Daily Activities
Social function of CAS: Baseline
|
23.0 units on a scale
Standard Error 5.2
|
24.7 units on a scale
Standard Error 3.9
|
18.2 units on a scale
Standard Error 4.4
|
|
Changes in Functional Performance in Daily Activities
Social function of CAS: 1 month
|
28.5 units on a scale
Standard Error 5.6
|
30.0 units on a scale
Standard Error 4.5
|
21.1 units on a scale
Standard Error 4.8
|
|
Changes in Functional Performance in Daily Activities
Social function of CAS: 3 months
|
34.8 units on a scale
Standard Error 6.0
|
34.2 units on a scale
Standard Error 4.8
|
24.2 units on a scale
Standard Error 5.0
|
|
Changes in Functional Performance in Daily Activities
Social function of CAS: 6 months
|
38.4 units on a scale
Standard Error 6.2
|
36.2 units on a scale
Standard Error 4.6
|
27.6 units on a scale
Standard Error 5.3
|
|
Changes in Functional Performance in Daily Activities
Self care of FSS: Baseline
|
39.1 units on a scale
Standard Error 2.5
|
38.2 units on a scale
Standard Error 2.7
|
37.4 units on a scale
Standard Error 2.2
|
|
Changes in Functional Performance in Daily Activities
Self care of FSS: 1 month
|
42.2 units on a scale
Standard Error 2.2
|
40.4 units on a scale
Standard Error 2.9
|
40.0 units on a scale
Standard Error 2.2
|
|
Changes in Functional Performance in Daily Activities
Self care of FSS: 3 months
|
44.7 units on a scale
Standard Error 2.4
|
43.5 units on a scale
Standard Error 2.9
|
41.7 units on a scale
Standard Error 2.3
|
|
Changes in Functional Performance in Daily Activities
Self care of FSS: 6 months
|
46.5 units on a scale
Standard Error 2.5
|
45.0 units on a scale
Standard Error 2.8
|
42.8 units on a scale
Standard Error 2.3
|
|
Changes in Functional Performance in Daily Activities
Mobility of FSS: Baseline
|
24.8 units on a scale
Standard Error 3.7
|
29.2 units on a scale
Standard Error 4.3
|
24.9 units on a scale
Standard Error 3.7
|
|
Changes in Functional Performance in Daily Activities
Mobility of FSS: 1 month
|
28.1 units on a scale
Standard Error 3.9
|
32.4 units on a scale
Standard Error 4.3
|
27.9 units on a scale
Standard Error 3.8
|
|
Changes in Functional Performance in Daily Activities
Mobility of FSS: 3 months
|
31.7 units on a scale
Standard Error 4.3
|
34.6 units on a scale
Standard Error 4.3
|
29.3 units on a scale
Standard Error 3.9
|
|
Changes in Functional Performance in Daily Activities
Mobility of FSS: 6 months
|
34.6 units on a scale
Standard Error 4.3
|
36.6 units on a scale
Standard Error 4.4
|
31.4 units on a scale
Standard Error 3.9
|
|
Changes in Functional Performance in Daily Activities
Social function of FSS: Baseline
|
40.0 units on a scale
Standard Error 3.5
|
40.1 units on a scale
Standard Error 3.3
|
34.8 units on a scale
Standard Error 3.5
|
|
Changes in Functional Performance in Daily Activities
Social function of FSS: 1 month
|
42.8 units on a scale
Standard Error 3.6
|
42.5 units on a scale
Standard Error 3.3
|
37.5 units on a scale
Standard Error 3.6
|
|
Changes in Functional Performance in Daily Activities
Social function of FSS: 3 months
|
46.4 units on a scale
Standard Error 3.9
|
45.8 units on a scale
Standard Error 3.3
|
40.0 units on a scale
Standard Error 3.5
|
|
Changes in Functional Performance in Daily Activities
Social function of FSS: 6 months
|
49.1 units on a scale
Standard Error 3.6
|
47.8 units on a scale
Standard Error 3.4
|
42.3 units on a scale
Standard Error 3.9
|
|
Changes in Functional Performance in Daily Activities
Self care of CAS: Baseline
|
18.0 units on a scale
Standard Error 4.1
|
17.9 units on a scale
Standard Error 3.7
|
15.3 units on a scale
Standard Error 3.2
|
|
Changes in Functional Performance in Daily Activities
Self care of CAS: 1 month
|
20.1 units on a scale
Standard Error 4.0
|
21.1 units on a scale
Standard Error 3.8
|
19.0 units on a scale
Standard Error 3.7
|
|
Changes in Functional Performance in Daily Activities
Self care of CAS: 3 months
|
27.0 units on a scale
Standard Error 4.3
|
24.2 units on a scale
Standard Error 3.9
|
21.5 units on a scale
Standard Error 3.7
|
|
Changes in Functional Performance in Daily Activities
Self care of CAS: 6 months
|
29.4 units on a scale
Standard Error 4.0
|
26.0 units on a scale
Standard Error 4.1
|
23.1 units on a scale
Standard Error 3.9
|
|
Changes in Functional Performance in Daily Activities
Mobility of CAS: Baseline
|
14.6 units on a scale
Standard Error 4.1
|
19.7 units on a scale
Standard Error 4.8
|
13.5 units on a scale
Standard Error 4.0
|
|
Changes in Functional Performance in Daily Activities
Mobility of CAS: 1 month
|
19.6 units on a scale
Standard Error 4.5
|
22.6 units on a scale
Standard Error 4.9
|
15.6 units on a scale
Standard Error 4.2
|
|
Changes in Functional Performance in Daily Activities
Moblity of CAS: 3 months
|
22.5 units on a scale
Standard Error 5.1
|
26.0 units on a scale
Standard Error 5.3
|
19.3 units on a scale
Standard Error 4.5
|
SECONDARY outcome
Timeframe: Baseline - 1 month - 3 months - 6 monthsPopulation: Intention to treat
WeeFIM (Functional Independence Measure for Children) measures functional independence in daily activities. WeeFIM contains 18 items and each item is ranked from complete dependence (scored as 1) to complete independence (scored as 7). The range is from 18 to 126 and higher scores mean more independent performance in daily activities. Categories of outcome table are total WeeFIM scores measured at each assessment time point.
Outcome measures
| Measure |
Umbilical Cord Blood & Erythropoietin & Rehabilitation
n=31 Participants
Allogeneic umbilical cord blood infusion (total nucleated cells \> 3x10\^7/kg intravenously), Erythropoietin injection (twice a week for 4 weeks with the dosage of 500 IU/kg for 2 times intravenously and 250 IU/kg subcutaneously for 6 times), and active rehabilitation
|
Erythropoietin & Rehabilitation
n=33 Participants
Erythropoietin injection (twice a week for 4 weeks with the dosage of 500 IU/kg for 2 times intravenously and 250 IU/kg subcutaneously for 6 times),and active rehabilitation
|
Only Rehabilitation
n=32 Participants
Active rehabilitation
|
|---|---|---|---|
|
Changes in Functional Independence in Daily Activities
Baseline
|
34.1 units on a scale
Standard Error 3.8
|
36.6 units on a scale
Standard Error 3.7
|
31.4 units on a scale
Standard Error 2.9
|
|
Changes in Functional Independence in Daily Activities
1 month
|
35.6 units on a scale
Standard Error 4.1
|
37.5 units on a scale
Standard Error 3.8
|
33.2 units on a scale
Standard Error 3.1
|
|
Changes in Functional Independence in Daily Activities
3 months
|
38.7 units on a scale
Standard Error 4.7
|
38.5 units on a scale
Standard Error 4.1
|
37.1 units on a scale
Standard Error 3.8
|
|
Changes in Functional Independence in Daily Activities
6 months
|
41.1 units on a scale
Standard Error 4.8
|
40.3 units on a scale
Standard Error 4.2
|
37.7 units on a scale
Standard Error 4.1
|
SECONDARY outcome
Timeframe: Baseline - 1 month - 3 months - 6 monthsPopulation: Intention to treat
Summation of MMT (manual muscle strength test score): summated scores of the manual muscle strength test (zero=0, trace=1, poor=2, fair=3, good=4, normal=5) for flexors, extensors, abductors, and adductors of bilateral shoulder and hip joints; flexors and extensors of bilateral elbow, wrist, and knee; dorsiflexors and plantar flexors of the ankles (range: 0 \~ 160) Higher score means better muscle strength. Categories of outcome table are summation of MMT scores measured at each assessment time point.
Outcome measures
| Measure |
Umbilical Cord Blood & Erythropoietin & Rehabilitation
n=31 Participants
Allogeneic umbilical cord blood infusion (total nucleated cells \> 3x10\^7/kg intravenously), Erythropoietin injection (twice a week for 4 weeks with the dosage of 500 IU/kg for 2 times intravenously and 250 IU/kg subcutaneously for 6 times), and active rehabilitation
|
Erythropoietin & Rehabilitation
n=33 Participants
Erythropoietin injection (twice a week for 4 weeks with the dosage of 500 IU/kg for 2 times intravenously and 250 IU/kg subcutaneously for 6 times),and active rehabilitation
|
Only Rehabilitation
n=32 Participants
Active rehabilitation
|
|---|---|---|---|
|
Changes in Muscle Strength
Baseline
|
100.7 units on a scale
Standard Error 5.5
|
104.8 units on a scale
Standard Error 4.4
|
100.3 units on a scale
Standard Error 4.6
|
|
Changes in Muscle Strength
1 month
|
105.0 units on a scale
Standard Error 4.9
|
106.8 units on a scale
Standard Error 4.5
|
101.8 units on a scale
Standard Error 4.6
|
|
Changes in Muscle Strength
3 months
|
107.8 units on a scale
Standard Error 4.4
|
107.7 units on a scale
Standard Error 4.5
|
103.6 units on a scale
Standard Error 4.6
|
|
Changes in Muscle Strength
6 months
|
109.9 units on a scale
Standard Error 4.6
|
109.3 units on a scale
Standard Error 4.5
|
104.3 units on a scale
Standard Error 4.6
|
SECONDARY outcome
Timeframe: Baseline - 1 month - 3 months - 6 monthsPopulation: Intention to treat
QUEST (Quality of Upper Extremity Skills Test) as a standardized measurement tool for assessing hand function consisting of sub-scales; dissociated movement, grasps, weight bearing, and protective extension. These are standardized to range from zero (or below zero in grasp section) to 100 and higher values mean better hand function. We reported QUEST differences between each assessment times.
Outcome measures
| Measure |
Umbilical Cord Blood & Erythropoietin & Rehabilitation
n=31 Participants
Allogeneic umbilical cord blood infusion (total nucleated cells \> 3x10\^7/kg intravenously), Erythropoietin injection (twice a week for 4 weeks with the dosage of 500 IU/kg for 2 times intravenously and 250 IU/kg subcutaneously for 6 times), and active rehabilitation
|
Erythropoietin & Rehabilitation
n=33 Participants
Erythropoietin injection (twice a week for 4 weeks with the dosage of 500 IU/kg for 2 times intravenously and 250 IU/kg subcutaneously for 6 times),and active rehabilitation
|
Only Rehabilitation
n=32 Participants
Active rehabilitation
|
|---|---|---|---|
|
Changes in Hand Function
Baseline
|
36.0 units on a scale
Standard Error 6.4
|
52.8 units on a scale
Standard Error 4.9
|
43.0 units on a scale
Standard Error 5.5
|
|
Changes in Hand Function
1 month - Baseline
|
5.0 units on a scale
Standard Error 1.4
|
5.7 units on a scale
Standard Error 1.7
|
6.6 units on a scale
Standard Error 1.4
|
|
Changes in Hand Function
3 months - Baseline
|
11.1 units on a scale
Standard Error 2.2
|
8.8 units on a scale
Standard Error 2.0
|
10.5 units on a scale
Standard Error 1.8
|
|
Changes in Hand Function
6 months - Baseline
|
13.9 units on a scale
Standard Error 2.6
|
10.7 units on a scale
Standard Error 2.2
|
13.0 units on a scale
Standard Error 2.4
|
|
Changes in Hand Function
3 months - 1 month
|
5.7 units on a scale
Standard Error 1.6
|
3.1 units on a scale
Standard Error 1.0
|
3.5 units on a scale
Standard Error 1.7
|
|
Changes in Hand Function
6 months - 1 month
|
8.4 units on a scale
Standard Error 2.0
|
5.1 units on a scale
Standard Error 1.3
|
6.4 units on a scale
Standard Error 2.1
|
|
Changes in Hand Function
6 months - 3 months
|
2.8 units on a scale
Standard Error 0.8
|
2.4 units on a scale
Standard Error 0.8
|
3.1 units on a scale
Standard Error 1.2
|
SECONDARY outcome
Timeframe: 6 monthsThe number of patients with serious adverse events within each group; Serious adverse events were defined as any event that resulted in death, was life-threatening, required hospitalization or prolonged the hospital stay, or was otherwise serious in the judgment of the investigator.
Outcome measures
| Measure |
Umbilical Cord Blood & Erythropoietin & Rehabilitation
n=31 Participants
Allogeneic umbilical cord blood infusion (total nucleated cells \> 3x10\^7/kg intravenously), Erythropoietin injection (twice a week for 4 weeks with the dosage of 500 IU/kg for 2 times intravenously and 250 IU/kg subcutaneously for 6 times), and active rehabilitation
|
Erythropoietin & Rehabilitation
n=33 Participants
Erythropoietin injection (twice a week for 4 weeks with the dosage of 500 IU/kg for 2 times intravenously and 250 IU/kg subcutaneously for 6 times),and active rehabilitation
|
Only Rehabilitation
n=32 Participants
Active rehabilitation
|
|---|---|---|---|
|
Number of Participants With Serious Adverse Events as a Measure of Safety,Which Are Related to Umbilical Cord Blood, Erythropoietin, or Immunosuppressant
|
3 participants
|
3 participants
|
3 participants
|
Adverse Events
Umbilical Cord Blood & Erythropoietin & Rehabilitation
Serious events: 3 serious events
Other events: 30 other events
Deaths: 0 deaths
Erythropoietin & Rehabilitation
Serious events: 3 serious events
Other events: 29 other events
Deaths: 0 deaths
Only Rehabilitation
Serious events: 3 serious events
Other events: 32 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Umbilical Cord Blood & Erythropoietin & Rehabilitation
n=35 participants at risk
Allogeneic umbilical cord blood infusion (total nucleated cells \> 3x10\^7/kg intravenously), Erythropoietin injection (twice a week for 4 weeks with the dosage of 500 IU/kg for 2 times intravenously and 250 IU/kg subcutaneously for 6 times), and active rehabilitation
|
Erythropoietin & Rehabilitation
n=36 participants at risk；n=6 participants at risk
Erythropoietin injection (twice a week for 4 weeks with the dosage of 500 IU/kg for 2 times intravenously and 250 IU/kg subcutaneously for 6 times),and active rehabilitation
|
Only Rehabilitation
n=34 participants at risk；n=8 participants at risk
Active rehabilitation
|
|---|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia
|
2.9%
1/35 • Number of events 1 • Baseline - 1 month - 3 months - 6 months
|
33.3%
2/6 • Number of events 3 • Baseline - 1 month - 3 months - 6 months
|
12.5%
1/8 • Number of events 1 • Baseline - 1 month - 3 months - 6 months
|
|
Nervous system disorders
Seizure
|
0.00%
0/35 • Baseline - 1 month - 3 months - 6 months
|
16.7%
1/6 • Number of events 1 • Baseline - 1 month - 3 months - 6 months
|
0.00%
0/8 • Baseline - 1 month - 3 months - 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Influenza
|
2.9%
1/35 • Number of events 1 • Baseline - 1 month - 3 months - 6 months
|
0.00%
0/6 • Baseline - 1 month - 3 months - 6 months
|
12.5%
1/8 • Number of events 1 • Baseline - 1 month - 3 months - 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Death
|
2.9%
1/35 • Number of events 1 • Baseline - 1 month - 3 months - 6 months
|
0.00%
0/6 • Baseline - 1 month - 3 months - 6 months
|
0.00%
0/8 • Baseline - 1 month - 3 months - 6 months
|
|
Renal and urinary disorders
Urinary tract infection
|
0.00%
0/35 • Baseline - 1 month - 3 months - 6 months
|
0.00%
0/6 • Baseline - 1 month - 3 months - 6 months
|
12.5%
1/8 • Number of events 1 • Baseline - 1 month - 3 months - 6 months
|
Other adverse events
| Measure |
Umbilical Cord Blood & Erythropoietin & Rehabilitation
n=35 participants at risk
Allogeneic umbilical cord blood infusion (total nucleated cells \> 3x10\^7/kg intravenously), Erythropoietin injection (twice a week for 4 weeks with the dosage of 500 IU/kg for 2 times intravenously and 250 IU/kg subcutaneously for 6 times), and active rehabilitation
|
Erythropoietin & Rehabilitation
n=36 participants at risk；n=6 participants at risk
Erythropoietin injection (twice a week for 4 weeks with the dosage of 500 IU/kg for 2 times intravenously and 250 IU/kg subcutaneously for 6 times),and active rehabilitation
|
Only Rehabilitation
n=34 participants at risk；n=8 participants at risk
Active rehabilitation
|
|---|---|---|---|
|
Nervous system disorders
Seizure
|
2.9%
1/35 • Number of events 1 • Baseline - 1 month - 3 months - 6 months
|
8.3%
3/36 • Number of events 6 • Baseline - 1 month - 3 months - 6 months
|
16.7%
3/18 • Number of events 7 • Baseline - 1 month - 3 months - 6 months
|
|
Nervous system disorders
Febrile convulsioin
|
5.7%
2/35 • Number of events 3 • Baseline - 1 month - 3 months - 6 months
|
7.1%
1/14 • Number of events 1 • Baseline - 1 month - 3 months - 6 months
|
0.00%
0/18 • Baseline - 1 month - 3 months - 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Bronchitis
|
11.4%
4/35 • Number of events 4 • Baseline - 1 month - 3 months - 6 months
|
28.6%
4/14 • Number of events 4 • Baseline - 1 month - 3 months - 6 months
|
16.7%
3/18 • Number of events 3 • Baseline - 1 month - 3 months - 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia
|
17.1%
6/35 • Number of events 6 • Baseline - 1 month - 3 months - 6 months
|
0.00%
0/14 • Baseline - 1 month - 3 months - 6 months
|
0.00%
0/18 • Baseline - 1 month - 3 months - 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory tract infection
|
51.4%
18/35 • Number of events 20 • Baseline - 1 month - 3 months - 6 months
|
52.8%
19/36 • Number of events 23 • Baseline - 1 month - 3 months - 6 months
|
61.8%
21/34 • Number of events 24 • Baseline - 1 month - 3 months - 6 months
|
|
Infections and infestations
Herpangina
|
0.00%
0/35 • Baseline - 1 month - 3 months - 6 months
|
14.3%
2/14 • Number of events 2 • Baseline - 1 month - 3 months - 6 months
|
5.6%
1/18 • Number of events 1 • Baseline - 1 month - 3 months - 6 months
|
|
Gastrointestinal disorders
Constipation
|
14.3%
5/35 • Number of events 5 • Baseline - 1 month - 3 months - 6 months
|
28.6%
4/14 • Number of events 4 • Baseline - 1 month - 3 months - 6 months
|
27.8%
5/18 • Number of events 5 • Baseline - 1 month - 3 months - 6 months
|
|
Gastrointestinal disorders
Dyspepsia
|
14.3%
5/35 • Number of events 5 • Baseline - 1 month - 3 months - 6 months
|
5.6%
2/36 • Number of events 2 • Baseline - 1 month - 3 months - 6 months
|
11.1%
2/18 • Number of events 2 • Baseline - 1 month - 3 months - 6 months
|
|
Gastrointestinal disorders
Nausea, vomiting
|
17.1%
6/35 • Number of events 6 • Baseline - 1 month - 3 months - 6 months
|
13.9%
5/36 • Number of events 5 • Baseline - 1 month - 3 months - 6 months
|
11.1%
2/18 • Number of events 2 • Baseline - 1 month - 3 months - 6 months
|
|
Gastrointestinal disorders
Diarrhea
|
17.1%
6/35 • Number of events 6 • Baseline - 1 month - 3 months - 6 months
|
5.6%
2/36 • Number of events 2 • Baseline - 1 month - 3 months - 6 months
|
11.1%
2/18 • Number of events 2 • Baseline - 1 month - 3 months - 6 months
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/35 • Baseline - 1 month - 3 months - 6 months
|
7.1%
1/14 • Number of events 1 • Baseline - 1 month - 3 months - 6 months
|
11.1%
2/18 • Number of events 2 • Baseline - 1 month - 3 months - 6 months
|
|
Gastrointestinal disorders
Anorexia
|
14.3%
5/35 • Number of events 5 • Baseline - 1 month - 3 months - 6 months
|
5.6%
2/36 • Number of events 2 • Baseline - 1 month - 3 months - 6 months
|
5.6%
1/18 • Number of events 1 • Baseline - 1 month - 3 months - 6 months
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
0.00%
0/35 • Baseline - 1 month - 3 months - 6 months
|
5.6%
2/36 • Number of events 2 • Baseline - 1 month - 3 months - 6 months
|
11.1%
2/18 • Number of events 2 • Baseline - 1 month - 3 months - 6 months
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
5.7%
2/35 • Number of events 2 • Baseline - 1 month - 3 months - 6 months
|
7.1%
1/14 • Number of events 1 • Baseline - 1 month - 3 months - 6 months
|
22.2%
4/18 • Number of events 4 • Baseline - 1 month - 3 months - 6 months
|
|
Skin and subcutaneous tissue disorders
Hirsuitism
|
5.7%
2/35 • Number of events 2 • Baseline - 1 month - 3 months - 6 months
|
—
0/0 • Baseline - 1 month - 3 months - 6 months
|
—
0/0 • Baseline - 1 month - 3 months - 6 months
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
2.9%
1/35 • Number of events 1 • Baseline - 1 month - 3 months - 6 months
|
—
0/0 • Baseline - 1 month - 3 months - 6 months
|
—
0/0 • Baseline - 1 month - 3 months - 6 months
|
|
Psychiatric disorders
Irritability
|
11.4%
4/35 • Number of events 4 • Baseline - 1 month - 3 months - 6 months
|
0.00%
0/14 • Baseline - 1 month - 3 months - 6 months
|
0.00%
0/18 • Baseline - 1 month - 3 months - 6 months
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/35 • Baseline - 1 month - 3 months - 6 months
|
2.8%
1/36 • Number of events 1 • Baseline - 1 month - 3 months - 6 months
|
5.6%
1/18 • Number of events 1 • Baseline - 1 month - 3 months - 6 months
|
|
Ear and labyrinth disorders
Otitis media acute
|
2.9%
1/35 • Number of events 1 • Baseline - 1 month - 3 months - 6 months
|
7.1%
1/14 • Number of events 1 • Baseline - 1 month - 3 months - 6 months
|
0.00%
0/18 • Baseline - 1 month - 3 months - 6 months
|
|
Eye disorders
Conjunctival irritations
|
0.00%
0/35 • Baseline - 1 month - 3 months - 6 months
|
7.1%
1/14 • Number of events 1 • Baseline - 1 month - 3 months - 6 months
|
5.6%
1/18 • Number of events 2 • Baseline - 1 month - 3 months - 6 months
|
|
Blood and lymphatic system disorders
Anemia
|
2.9%
1/35 • Number of events 1 • Baseline - 1 month - 3 months - 6 months
|
—
0/0 • Baseline - 1 month - 3 months - 6 months
|
0.00%
0/18 • Baseline - 1 month - 3 months - 6 months
|
|
Infections and infestations
Fever
|
34.3%
12/35 • Number of events 12 • Baseline - 1 month - 3 months - 6 months
|
11.1%
4/36 • Number of events 4 • Baseline - 1 month - 3 months - 6 months
|
44.4%
8/18 • Number of events 8 • Baseline - 1 month - 3 months - 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
8.6%
3/35 • Number of events 3 • Baseline - 1 month - 3 months - 6 months
|
2.8%
1/36 • Number of events 1 • Baseline - 1 month - 3 months - 6 months
|
5.6%
1/18 • Number of events 1 • Baseline - 1 month - 3 months - 6 months
|
Additional Information
Minyoung Kim, MD, PhD
CHA Bundang Medical Center, CHA University
Phone: 82-31-780-1872
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place