Trial Outcomes & Findings for Allogenic Cord Blood Transfusion in Patients With Autism (NCT NCT03786744)
NCT ID: NCT03786744
Last Updated: 2020-11-19
Results Overview
Safety assessment. The adverse events rate will be assessed in all patients.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
20 participants
Primary outcome timeframe
24hrs post transfusion
Results posted on
2020-11-19
Participant Flow
Participant milestones
| Measure |
ASD CB-MNC Injection.
ASD CB-MNC injection from different donors and standard therapy.
ASD CB-MNC injection.: CB-MNC injection from different donors. One dose consist 20-50 mil MNC/kg.The protocol include 3 injection at monthly intervals.
Standard therapy.: The standard therapy can include drugs, special psychology training etc.
|
Standard Therapy.
Patients with standard therapy as control group.
Standard therapy.: The standard therapy can include drugs, special psychology training etc.
|
|---|---|---|
|
Overall Study
STARTED
|
10
|
10
|
|
Overall Study
COMPLETED
|
10
|
10
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
ASD CB-MNC Injection.
n=10 Participants
ASD CB-MNC injection from different donors and standard therapy.
ASD CB-MNC injection.: CB-MNC injection from different donors. One dose consist 20-50 mil MNC/kg.The protocol include 3 injection at monthly intervals.
Standard therapy.: The standard therapy can include drugs, special psychology training etc.
|
Standard Therapy.
n=10 Participants
Patients with standard therapy as control group.
Standard therapy.: The standard therapy can include drugs, special psychology training etc.
|
Total
n=20 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
10 Participants
n=10 Participants
|
10 Participants
n=10 Participants
|
20 Participants
n=20 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=10 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=20 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=10 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=20 Participants
|
|
Age, Continuous
|
7.95 years
n=10 Participants
|
7.80 years
n=10 Participants
|
7.87 years
n=20 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=10 Participants
|
2 Participants
n=10 Participants
|
3 Participants
n=20 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=10 Participants
|
8 Participants
n=10 Participants
|
17 Participants
n=20 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
Russia
|
10 participants
n=10 Participants
|
10 participants
n=10 Participants
|
20 participants
n=20 Participants
|
PRIMARY outcome
Timeframe: 24hrs post transfusionSafety assessment. The adverse events rate will be assessed in all patients.
Outcome measures
| Measure |
ASD CB-MNC Injection.
n=10 Participants
ASD CB-MNC injection from different donors and standard therapy.
ASD CB-MNC injection.: CB-MNC injection from different donors. One dose consist 20-50 mil MNC/kg.The protocol include 3 injection at monthly intervals.
Standard therapy.: The standard therapy can include drugs, special psychology training etc.
|
Control Group
n=10 Participants
The standard therapy can include drugs, special psychology training etc.
|
|---|---|---|
|
A Number of Participants With Non-serious and Serious Adverse Events 24 Hrs Post-transfusion
Anxiety
|
2 participants
|
0 participants
|
|
A Number of Participants With Non-serious and Serious Adverse Events 24 Hrs Post-transfusion
Increase in body temperature
|
0 participants
|
0 participants
|
|
A Number of Participants With Non-serious and Serious Adverse Events 24 Hrs Post-transfusion
Chill
|
0 participants
|
0 participants
|
|
A Number of Participants With Non-serious and Serious Adverse Events 24 Hrs Post-transfusion
Hypotension
|
0 participants
|
0 participants
|
|
A Number of Participants With Non-serious and Serious Adverse Events 24 Hrs Post-transfusion
Dyspnea
|
0 participants
|
0 participants
|
|
A Number of Participants With Non-serious and Serious Adverse Events 24 Hrs Post-transfusion
Skin itching
|
0 participants
|
0 participants
|
|
A Number of Participants With Non-serious and Serious Adverse Events 24 Hrs Post-transfusion
Hives
|
0 participants
|
0 participants
|
|
A Number of Participants With Non-serious and Serious Adverse Events 24 Hrs Post-transfusion
Post-transfusion purple
|
0 participants
|
0 participants
|
|
A Number of Participants With Non-serious and Serious Adverse Events 24 Hrs Post-transfusion
Oedema Quinque
|
0 participants
|
0 participants
|
|
A Number of Participants With Non-serious and Serious Adverse Events 24 Hrs Post-transfusion
Oliguria
|
0 participants
|
0 participants
|
|
A Number of Participants With Non-serious and Serious Adverse Events 24 Hrs Post-transfusion
Hematuria
|
0 participants
|
0 participants
|
|
A Number of Participants With Non-serious and Serious Adverse Events 24 Hrs Post-transfusion
Jaundice
|
0 participants
|
0 participants
|
|
A Number of Participants With Non-serious and Serious Adverse Events 24 Hrs Post-transfusion
Nausea
|
0 participants
|
0 participants
|
|
A Number of Participants With Non-serious and Serious Adverse Events 24 Hrs Post-transfusion
Vomiting
|
0 participants
|
0 participants
|
|
A Number of Participants With Non-serious and Serious Adverse Events 24 Hrs Post-transfusion
Dizziness
|
0 participants
|
0 participants
|
|
A Number of Participants With Non-serious and Serious Adverse Events 24 Hrs Post-transfusion
Pain at injection site
|
1 participants
|
0 participants
|
PRIMARY outcome
Timeframe: score at baseline, 1, 2, 6, 12 monthsThe ATEC is designed to measure changes in the severity of ASD in response to treatment. A total score and 4 subscale scores are reported. Questions in the first 3 subscales are scored using a 0-3 scale (not true/partially true/absolutely true). The 4 subscale, Health/Physical/Behavior, is scored using a 0-4 point scale (Not a problem/Minor problem/Moderate problem/Serious problem). The first subscale, Speech/Language/Communication, contains 14 items where the score ranges from 0-28 points. The Sociability subscale contains 20 items and participants can score from 0-40. The third subscale, Sensory/Cognitive awareness, has 18 items and scores range from 0-36. Finally, the Health/Physical/Behavior subscale contains 25 items and scores range from 0-75. The scores from each subscale are combined in order to calculate a Total Score, which ranges from 0 to179 points. A lower score indicates less severe symptoms of ASD and a higher score correlates with more severe symptoms of ASD.
Outcome measures
| Measure |
ASD CB-MNC Injection.
n=10 Participants
ASD CB-MNC injection from different donors and standard therapy.
ASD CB-MNC injection.: CB-MNC injection from different donors. One dose consist 20-50 mil MNC/kg.The protocol include 3 injection at monthly intervals.
Standard therapy.: The standard therapy can include drugs, special psychology training etc.
|
Control Group
n=10 Participants
The standard therapy can include drugs, special psychology training etc.
|
|---|---|---|
|
Autism Treatment Evaluation Checklist (ATEC).
Speech/Language/Communication at baseline
|
14 score on a scale
Interval 10.0 to 20.0
|
14 score on a scale
Interval 13.0 to 21.0
|
|
Autism Treatment Evaluation Checklist (ATEC).
Sociability at 12 months
|
12 score on a scale
Interval 8.0 to 14.0
|
14 score on a scale
Interval 11.0 to 14.0
|
|
Autism Treatment Evaluation Checklist (ATEC).
Sensory/Cognitive Awareness at baseline
|
13 score on a scale
Interval 9.0 to 14.0
|
12 score on a scale
Interval 10.0 to 15.0
|
|
Autism Treatment Evaluation Checklist (ATEC).
Sensory/Cognitive Awareness at 1 months
|
10 score on a scale
Interval 6.0 to 15.0
|
11 score on a scale
Interval 10.0 to 17.0
|
|
Autism Treatment Evaluation Checklist (ATEC).
Sensory/Cognitive Awareness at 2 months
|
10 score on a scale
Interval 5.0 to 11.0
|
11 score on a scale
Interval 11.0 to 16.0
|
|
Autism Treatment Evaluation Checklist (ATEC).
Sensory/Cognitive Awareness at 6 months
|
12 score on a scale
Interval 8.0 to 14.0
|
14 score on a scale
Interval 11.0 to 16.0
|
|
Autism Treatment Evaluation Checklist (ATEC).
Sensory/Cognitive Awareness at 12 months
|
12 score on a scale
Interval 7.0 to 13.0
|
13 score on a scale
Interval 11.0 to 17.0
|
|
Autism Treatment Evaluation Checklist (ATEC).
Speech/Language/Communication at 1 months
|
11 score on a scale
Interval 5.0 to 18.0
|
14 score on a scale
Interval 11.0 to 21.0
|
|
Autism Treatment Evaluation Checklist (ATEC).
Speech/Language/Communication at 2 months
|
7 score on a scale
Interval 2.0 to 17.0
|
16 score on a scale
Interval 14.0 to 22.0
|
|
Autism Treatment Evaluation Checklist (ATEC).
Speech/Language/Communication at 6 months
|
11 score on a scale
Interval 5.0 to 22.0
|
14 score on a scale
Interval 12.0 to 20.0
|
|
Autism Treatment Evaluation Checklist (ATEC).
Speech/Language/Communication at 12 months
|
12 score on a scale
Interval 6.0 to 17.0
|
15 score on a scale
Interval 13.0 to 20.0
|
|
Autism Treatment Evaluation Checklist (ATEC).
Sociability at baseline
|
11 score on a scale
Interval 9.0 to 17.0
|
11 score on a scale
Interval 9.0 to 15.0
|
|
Autism Treatment Evaluation Checklist (ATEC).
Sociability at 1 months
|
11 score on a scale
Interval 9.0 to 13.0
|
12 score on a scale
Interval 9.0 to 15.0
|
|
Autism Treatment Evaluation Checklist (ATEC).
Sociability at 2 months
|
9 score on a scale
Interval 6.0 to 14.0
|
11 score on a scale
Interval 10.0 to 14.0
|
|
Autism Treatment Evaluation Checklist (ATEC).
Sociability at 6 months
|
11 score on a scale
Interval 8.0 to 14.0
|
13 score on a scale
Interval 10.0 to 15.0
|
|
Autism Treatment Evaluation Checklist (ATEC).
Health/ Physical Development/Behaviour at 2 months
|
14 score on a scale
Interval 7.0 to 18.0
|
23 score on a scale
Interval 19.0 to 30.0
|
|
Autism Treatment Evaluation Checklist (ATEC).
Health/ Physical Development/Behaviour at baseline
|
24 score on a scale
Interval 19.0 to 30.0
|
24 score on a scale
Interval 19.0 to 30.0
|
|
Autism Treatment Evaluation Checklist (ATEC).
Health/ Physical Development/Behaviour at 1 months
|
16 score on a scale
Interval 13.0 to 21.0
|
24 score on a scale
Interval 19.0 to 30.0
|
|
Autism Treatment Evaluation Checklist (ATEC).
Health/ Physical Development/Behaviour at 6 months
|
16 score on a scale
Interval 13.0 to 25.0
|
24 score on a scale
Interval 19.0 to 30.0
|
|
Autism Treatment Evaluation Checklist (ATEC).
Health/ Physical Development/Behaviour at 12months
|
13 score on a scale
Interval 10.0 to 17.0
|
22 score on a scale
Interval 19.0 to 30.0
|
|
Autism Treatment Evaluation Checklist (ATEC).
Total score at baseline
|
63 score on a scale
Interval 56.0 to 66.0
|
62 score on a scale
Interval 59.0 to 73.0
|
|
Autism Treatment Evaluation Checklist (ATEC).
Total score at 1 months
|
55 score on a scale
Interval 43.0 to 60.0
|
65 score on a scale
Interval 60.0 to 72.0
|
|
Autism Treatment Evaluation Checklist (ATEC).
Total score at 2 months
|
44 score on a scale
Interval 31.0 to 57.0
|
68 score on a scale
Interval 59.0 to 76.0
|
|
Autism Treatment Evaluation Checklist (ATEC).
Total score at 6 months
|
55 score on a scale
Interval 49.0 to 65.0
|
70 score on a scale
Interval 60.0 to 82.0
|
|
Autism Treatment Evaluation Checklist (ATEC).
Total score at 12 months
|
55 score on a scale
Interval 38.0 to 61.0
|
71 score on a scale
Interval 60.0 to 81.0
|
SECONDARY outcome
Timeframe: score at baseline, 1, 2, 6 monthsIL1b, IL6, TNF-alpha, IL8, y-IFN measure in patient peripheral blood
Outcome measures
| Measure |
ASD CB-MNC Injection.
n=10 Participants
ASD CB-MNC injection from different donors and standard therapy.
ASD CB-MNC injection.: CB-MNC injection from different donors. One dose consist 20-50 mil MNC/kg.The protocol include 3 injection at monthly intervals.
Standard therapy.: The standard therapy can include drugs, special psychology training etc.
|
Control Group
The standard therapy can include drugs, special psychology training etc.
|
|---|---|---|
|
Cytokine Analysis.
y-IFN pg/ml at baseline
|
0 pg/mL
Interval 0.0 to 0.0
|
—
|
|
Cytokine Analysis.
y-IFN pg/ml at 1 months
|
0 pg/mL
Interval 0.0 to 0.0
|
—
|
|
Cytokine Analysis.
y-IFN pg/ml at 2 months
|
0 pg/mL
Interval 0.0 to 0.0
|
—
|
|
Cytokine Analysis.
y-IFN pg/ml at 6 months
|
0 pg/mL
Interval 0.0 to 0.0
|
—
|
|
Cytokine Analysis.
IL1b pg/ml at baseline
|
1.228 pg/mL
Interval 0.0 to 2.62
|
—
|
|
Cytokine Analysis.
IL1b pg/ml at 1 months
|
1.279 pg/mL
Interval 0.0 to 3.117
|
—
|
|
Cytokine Analysis.
IL1b pg/ml at 2 months
|
1.9675 pg/mL
Interval 0.095 to 3.251
|
—
|
|
Cytokine Analysis.
IL1b pg/ml at 6 months
|
2.794 pg/mL
Interval 0.396 to 3.103
|
—
|
|
Cytokine Analysis.
IL6 pg/ml at baseline
|
1.0225 pg/mL
Interval 0.43 to 2.168
|
—
|
|
Cytokine Analysis.
IL6 pg/ml at 1 months
|
0.673 pg/mL
Interval 0.392 to 2.076
|
—
|
|
Cytokine Analysis.
IL6 pg/ml at 2 months
|
0.5625 pg/mL
Interval 0.195 to 0.753
|
—
|
|
Cytokine Analysis.
IL6pg/ml at 6 months
|
0.7455 pg/mL
Interval 0.494 to 0.863
|
—
|
|
Cytokine Analysis.
IL8 pg/ml at baseline
|
3.9175 pg/mL
Interval 1.913 to 9.822
|
—
|
|
Cytokine Analysis.
IL8 pg/ml at 1 months
|
2.7985 pg/mL
Interval 2.157 to 5.341
|
—
|
|
Cytokine Analysis.
IL8 pg/ml at 2 months
|
2.7485 pg/mL
Interval 1.197 to 3.348
|
—
|
|
Cytokine Analysis.
IL8 pg/ml at 6 months
|
4.7975 pg/mL
Interval 3.507 to 38.388
|
—
|
|
Cytokine Analysis.
TNF-alpha pg/ml at baseline
|
0 pg/mL
Interval 0.0 to 0.0
|
—
|
|
Cytokine Analysis.
TNF-alpha pg/ml at 1 months
|
0 pg/mL
Interval 0.0 to 0.0
|
—
|
|
Cytokine Analysis.
TNF-alpha pg/ml at 2 months
|
0 pg/mL
Interval 0.0 to 0.0
|
—
|
|
Cytokine Analysis.
TNF-alpha pg/ml at 6 months
|
0.0 pg/mL
Interval 0.0 to 0.0
|
—
|
SECONDARY outcome
Timeframe: score at baseline, 6 monthPeripheral blood flow cytometry cell count for CD3; CD4; CD8; CD19; CD16-56 (%)
Outcome measures
| Measure |
ASD CB-MNC Injection.
n=10 Participants
ASD CB-MNC injection from different donors and standard therapy.
ASD CB-MNC injection.: CB-MNC injection from different donors. One dose consist 20-50 mil MNC/kg.The protocol include 3 injection at monthly intervals.
Standard therapy.: The standard therapy can include drugs, special psychology training etc.
|
Control Group
The standard therapy can include drugs, special psychology training etc.
|
|---|---|---|
|
Immune Status as Determined by Percentage of Peripheral Blood Cells
CD 3+(%) at baseline
|
61.24 percentage of cells
Interval 58.55 to 66.59
|
—
|
|
Immune Status as Determined by Percentage of Peripheral Blood Cells
CD 3+(%) at 6 months
|
63.71 percentage of cells
Interval 58.56 to 67.83
|
—
|
|
Immune Status as Determined by Percentage of Peripheral Blood Cells
СD3+СD8+ (%) at baseline
|
24.33 percentage of cells
Interval 22.36 to 25.58
|
—
|
|
Immune Status as Determined by Percentage of Peripheral Blood Cells
СD3+СD8+(%) at 6 months
|
25.345 percentage of cells
Interval 20.19 to 26.15
|
—
|
|
Immune Status as Determined by Percentage of Peripheral Blood Cells
СD3+СD4+ (%) at baseline
|
32.835 percentage of cells
Interval 29.14 to 36.3
|
—
|
|
Immune Status as Determined by Percentage of Peripheral Blood Cells
СD3+СD4+(%) at 6 months
|
32.55 percentage of cells
Interval 30.26 to 35.46
|
—
|
|
Immune Status as Determined by Percentage of Peripheral Blood Cells
СD3+СD4+СD8+ (%) at baseline
|
0.215 percentage of cells
Interval 0.19 to 0.25
|
—
|
|
Immune Status as Determined by Percentage of Peripheral Blood Cells
СD3+СD4+СD8+(%) at 6 months
|
0.31 percentage of cells
Interval 0.25 to 0.42
|
—
|
|
Immune Status as Determined by Percentage of Peripheral Blood Cells
СD16+СD56+(%) at baseline
|
15.19 percentage of cells
Interval 7.29 to 21.08
|
—
|
|
Immune Status as Determined by Percentage of Peripheral Blood Cells
СD16+СD56+(%) at 6 months
|
16.05 percentage of cells
Interval 11.47 to 21.0
|
—
|
|
Immune Status as Determined by Percentage of Peripheral Blood Cells
СD19+(%) at baseline
|
19.29 percentage of cells
Interval 17.46 to 21.67
|
—
|
|
Immune Status as Determined by Percentage of Peripheral Blood Cells
СD19+ (%) at 6 months
|
17.255 percentage of cells
Interval 16.25 to 18.68
|
—
|
SECONDARY outcome
Timeframe: score at baseline, 6 monthPeripheral blood flow cytometry cell count for CD3; CD4; CD8; CD19; CD16-56 (absolute v.)
Outcome measures
| Measure |
ASD CB-MNC Injection.
n=10 Participants
ASD CB-MNC injection from different donors and standard therapy.
ASD CB-MNC injection.: CB-MNC injection from different donors. One dose consist 20-50 mil MNC/kg.The protocol include 3 injection at monthly intervals.
Standard therapy.: The standard therapy can include drugs, special psychology training etc.
|
Control Group
The standard therapy can include drugs, special psychology training etc.
|
|---|---|---|
|
Immune Status as Determined by Absolute Cell Count of Peripheral Blood Cells
CD 3+ at baseline
|
1450.355 cells/µl
Interval 1364.77 to 2163.81
|
—
|
|
Immune Status as Determined by Absolute Cell Count of Peripheral Blood Cells
CD 3+at 6 months
|
1829.11 cells/µl
Interval 1507.34 to 2312.87
|
—
|
|
Immune Status as Determined by Absolute Cell Count of Peripheral Blood Cells
CD 3+CD8+ at baseline
|
598.48 cells/µl
Interval 481.48 to 790.19
|
—
|
|
Immune Status as Determined by Absolute Cell Count of Peripheral Blood Cells
CD 3+CD8+ at 6 months
|
654.385 cells/µl
Interval 600.56 to 819.81
|
—
|
|
Immune Status as Determined by Absolute Cell Count of Peripheral Blood Cells
CD 3+CD4+ at baseline
|
750.08 cells/µl
Interval 649.35 to 1197.94
|
—
|
|
Immune Status as Determined by Absolute Cell Count of Peripheral Blood Cells
CD 3+CD4+ at 6 months
|
877.095 cells/µl
Interval 752.35 to 1197.99
|
—
|
|
Immune Status as Determined by Absolute Cell Count of Peripheral Blood Cells
CD 3+ CD4+CD8+ at baseline
|
5.555 cells/µl
Interval 3.59 to 7.09
|
—
|
|
Immune Status as Determined by Absolute Cell Count of Peripheral Blood Cells
CD 3+ CD4+CD8+ at 6 months
|
8.656 cells/µl
Interval 7.46 to 10.93
|
—
|
|
Immune Status as Determined by Absolute Cell Count of Peripheral Blood Cells
CD 16+CD56+ at baseline
|
321.89 cells/µl
Interval 188.46 to 550.36
|
—
|
|
Immune Status as Determined by Absolute Cell Count of Peripheral Blood Cells
CD 16+CD56+ at 6 months
|
476.055 cells/µl
Interval 306.37 to 607.71
|
—
|
|
Immune Status as Determined by Absolute Cell Count of Peripheral Blood Cells
СD19+ at baseline
|
457.505 cells/µl
Interval 431.81 to 839.35
|
—
|
|
Immune Status as Determined by Absolute Cell Count of Peripheral Blood Cells
СD19+ at 6 months
|
506.365 cells/µl
Interval 392.8 to 650.88
|
—
|
Adverse Events
ASD CB-MNC Injection.
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Standard Therapy.
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
ASD CB-MNC Injection.
n=10 participants at risk
ASD CB-MNC injection from different donors and standard therapy.
ASD CB-MNC injection.: CB-MNC injection from different donors. One dose consist 20-50 mil MNC/kg.The protocol include 3 injection at monthly intervals.
Standard therapy.: The standard therapy can include drugs, special psychology training etc.
|
Standard Therapy.
n=10 participants at risk
Patients with standard therapy as control group.
Standard therapy.: The standard therapy can include drugs, special psychology training etc.
|
|---|---|---|
|
Cardiac disorders
Infectious nature
|
0.00%
0/10 • 12 months
|
0.00%
0/10 • 12 months
|
|
Cardiac disorders
Non Infectious nature
|
0.00%
0/10 • 12 months
|
0.00%
0/10 • 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Infectious nature
|
50.0%
5/10 • Number of events 6 • 12 months
|
40.0%
4/10 • Number of events 7 • 12 months
|
|
Respiratory, thoracic and mediastinal disorders
NON Infectious nature
|
10.0%
1/10 • Number of events 1 • 12 months
|
10.0%
1/10 • Number of events 1 • 12 months
|
|
Musculoskeletal and connective tissue disorders
Infectious nature
|
0.00%
0/10 • 12 months
|
0.00%
0/10 • 12 months
|
|
Musculoskeletal and connective tissue disorders
NON Infectious nature
|
0.00%
0/10 • 12 months
|
10.0%
1/10 • Number of events 2 • 12 months
|
|
Renal and urinary disorders
Infectious nature
|
0.00%
0/10 • 12 months
|
0.00%
0/10 • 12 months
|
|
Renal and urinary disorders
NON Infectious nature
|
10.0%
1/10 • Number of events 1 • 12 months
|
0.00%
0/10 • 12 months
|
|
Gastrointestinal disorders
Infectious nature
|
20.0%
2/10 • Number of events 2 • 12 months
|
10.0%
1/10 • Number of events 1 • 12 months
|
|
Gastrointestinal disorders
NON Infectious nature
|
10.0%
1/10 • Number of events 1 • 12 months
|
20.0%
2/10 • Number of events 2 • 12 months
|
|
Skin and subcutaneous tissue disorders
Infectious nature
|
0.00%
0/10 • 12 months
|
0.00%
0/10 • 12 months
|
|
Skin and subcutaneous tissue disorders
NON Infectious nature
|
0.00%
0/10 • 12 months
|
0.00%
0/10 • 12 months
|
|
Nervous system disorders
Infectious nature
|
0.00%
0/10 • 12 months
|
0.00%
0/10 • 12 months
|
|
Nervous system disorders
NON Infectious nature
|
20.0%
2/10 • Number of events 3 • 12 months
|
10.0%
1/10 • Number of events 1 • 12 months
|
|
Psychiatric disorders
Psychiatric symptoms
|
10.0%
1/10 • Number of events 1 • 12 months
|
10.0%
1/10 • Number of events 1 • 12 months
|
|
Immune system disorders
Hypersensitivity
|
10.0%
1/10 • Number of events 1 • 12 months
|
20.0%
2/10 • Number of events 3 • 12 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place