Trial Outcomes & Findings for A Study of UCB and MSCs in Children With CP: ACCeNT-CP (NCT NCT03473301)
NCT ID: NCT03473301
Last Updated: 2021-08-19
Results Overview
GMFM-66 is used to evaluate gross motor function in children with cerebral palsy and is scored using a propriety software program called the Gross Motor Ability Estimator that produces an interval level continuous score ranging from 0 to 100. Higher scores indicate better motor function. The primary endpoint in this study was computed from the GMFM-66 score in three steps: 1) The "observed" change in motor function from Baseline to Month 12 was calculated (positive values indicate improvement, negative values indicate reduction, and zero indicates no change) for each participant; and 2) The expected change in motor function was determined for each participant based on published growth curves; and 3) The expected change in GMFM-66 was subtracted from the observed change to yield the final primary outcome. Positive values indicate a greater change than would be expected, zero indicates change as expected, and negative values indicate a smaller amount of change than would be expected.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
91 participants
Primary outcome timeframe
Baseline to 12 months
Results posted on
2021-08-19
Participant Flow
First participant randomized on April 10, 2018. Last participant randomized May 30, 2019. Single center study.
Participant milestones
| Measure |
Allogeneic Umbilical Cord Blood (AlloCB)
Subjects will receive a single intravenous infusion of a maximum of 10x107/kg allogeneic umbilical cord blood (CB) cells
Infusion of allogeneic umbilical cord blood: Subjects will receive a single infusion of allogeneic umbilical cord blood at the baseline visit.
|
Cord Tissue Mesenchymal Stromal Cells (MSC)
Subjects will receive three intravenous infusions of 2x106/kg human umbilical cord tissue cells (hCT-MSC), manufactured from allogeneic umbilical cord donors
Infusion of MSCs: Subjects will receive 3 infusions of MSCs (baseline, 3 months and 6 months).
|
Natural History, Then AlloCB
Subjects will not receive any study product infusion until after the 12 month assessment. At the 12 month visit, they will receive an infusion of allogeneic umbilical cord blood cells so that all study participants will receive some type of cellular therapy.
Infusion of allogeneic umbilical cord blood: Subjects will receive a single infusion of allogeneic umbilical cord blood at the baseline visit.
|
|---|---|---|---|
|
Overall Study
STARTED
|
31
|
29
|
31
|
|
Overall Study
COMPLETED
|
20
|
23
|
25
|
|
Overall Study
NOT COMPLETED
|
11
|
6
|
6
|
Reasons for withdrawal
| Measure |
Allogeneic Umbilical Cord Blood (AlloCB)
Subjects will receive a single intravenous infusion of a maximum of 10x107/kg allogeneic umbilical cord blood (CB) cells
Infusion of allogeneic umbilical cord blood: Subjects will receive a single infusion of allogeneic umbilical cord blood at the baseline visit.
|
Cord Tissue Mesenchymal Stromal Cells (MSC)
Subjects will receive three intravenous infusions of 2x106/kg human umbilical cord tissue cells (hCT-MSC), manufactured from allogeneic umbilical cord donors
Infusion of MSCs: Subjects will receive 3 infusions of MSCs (baseline, 3 months and 6 months).
|
Natural History, Then AlloCB
Subjects will not receive any study product infusion until after the 12 month assessment. At the 12 month visit, they will receive an infusion of allogeneic umbilical cord blood cells so that all study participants will receive some type of cellular therapy.
Infusion of allogeneic umbilical cord blood: Subjects will receive a single infusion of allogeneic umbilical cord blood at the baseline visit.
|
|---|---|---|---|
|
Overall Study
Protocol Violation
|
4
|
0
|
0
|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
0
|
|
Overall Study
Missed study visit due to pandemic restrictions
|
7
|
5
|
6
|
Baseline Characteristics
A Study of UCB and MSCs in Children With CP: ACCeNT-CP
Baseline characteristics by cohort
| Measure |
Allogeneic Umbilical Cord Blood (AlloCB)
n=31 Participants
Subjects will receive a single intravenous infusion of a maximum of 10x107/kg allogeneic umbilical cord blood (CB) cells
Infusion of allogeneic umbilical cord blood: Subjects will receive a single infusion of allogeneic umbilical cord blood at the baseline visit.
|
Cord Tissue Mesenchymal Stromal Cells (MSC)
n=29 Participants
Subjects will receive three intravenous infusions of 2x106/kg human umbilical cord tissue cells (hCT-MSC), manufactured from allogeneic umbilical cord donors
Infusion of MSCs: Subjects will receive 3 infusions of MSCs (baseline, 3 months and 6 months).
|
Natural History, Then AlloCB
n=31 Participants
Subjects will not receive any study product infusion until after the 12 month assessment. At the 12 month visit, they will receive an infusion of allogeneic umbilical cord blood cells so that all study participants will receive some type of cellular therapy.
Infusion of allogeneic umbilical cord blood: Subjects will receive a single infusion of allogeneic umbilical cord blood at the baseline visit.
|
Total
n=91 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Asian
|
0 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
British Indian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Italian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
White
|
30 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
79 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
More than one race
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
31 Participants
n=5 Participants
|
29 Participants
n=7 Participants
|
31 Participants
n=5 Participants
|
91 Participants
n=4 Participants
|
|
Age, Continuous
|
3.47 years
STANDARD_DEVIATION 0.96 • n=5 Participants
|
3.53 years
STANDARD_DEVIATION 0.88 • n=7 Participants
|
3.55 years
STANDARD_DEVIATION 0.84 • n=5 Participants
|
3.52 years
STANDARD_DEVIATION 0.89 • n=4 Participants
|
|
Sex: Female, Male
Female
|
16 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
39 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
15 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
52 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
4 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
12 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
27 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
79 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Baseline to 12 monthsPopulation: Efficacy data not collected on Natural History participants after receiving allogeneic umbilical cord blood. Participants who did not complete the Month 12 visit are excluded.
GMFM-66 is used to evaluate gross motor function in children with cerebral palsy and is scored using a propriety software program called the Gross Motor Ability Estimator that produces an interval level continuous score ranging from 0 to 100. Higher scores indicate better motor function. The primary endpoint in this study was computed from the GMFM-66 score in three steps: 1) The "observed" change in motor function from Baseline to Month 12 was calculated (positive values indicate improvement, negative values indicate reduction, and zero indicates no change) for each participant; and 2) The expected change in motor function was determined for each participant based on published growth curves; and 3) The expected change in GMFM-66 was subtracted from the observed change to yield the final primary outcome. Positive values indicate a greater change than would be expected, zero indicates change as expected, and negative values indicate a smaller amount of change than would be expected.
Outcome measures
| Measure |
Allogeneic Umbilical Cord Blood (AlloCB)
n=20 Participants
Subjects will receive a single intravenous infusion of a maximum of 10x107/kg allogeneic umbilical cord blood (CB) cells
Infusion of allogeneic umbilical cord blood: Subjects will receive a single infusion of allogeneic umbilical cord blood at the baseline visit.
|
Cord Tissue Mesenchymal Stromal Cells (MSC)
n=23 Participants
Subjects will receive three intravenous infusions of 2x106/kg human umbilical cord tissue cells (hCT-MSC), manufactured from allogeneic umbilical cord donors
Infusion of MSCs: Subjects will receive 3 infusions of MSCs (baseline, 3 months and 6 months).
|
Natural History
n=25 Participants
Subjects will not receive any study product infusion until after the 12 month assessment. At the 12 month visit, they will receive an infusion of allogeneic umbilical cord blood cells so that all study participants will receive some type of cellular therapy.
Infusion of allogeneic umbilical cord blood: Subjects will receive a single infusion of allogeneic umbilical cord blood at the baseline visit.
|
AlloCB After Natural History
Subjects will not receive any study product infusion until after the 12 month assessment. At the 12 month visit, they will receive an infusion of allogeneic umbilical cord blood cells so that all study participants will receive some type of cellular therapy.
Infusion of allogeneic umbilical cord blood: Subjects will receive a single infusion of allogeneic umbilical cord blood at the baseline visit.
|
|---|---|---|---|---|
|
Change in Gross Motor Function Measure (GMFM-66) in Excess of Expected Change
|
5.83 score on a scale
Interval 3.44 to 8.21
|
4.27 score on a scale
Interval 2.17 to 6.36
|
3.15 score on a scale
Interval 1.31 to 4.99
|
—
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: Four participants randomized to the Natural History arm did not receive an infusion of AlloCB at Month12.
The secondary endpoint of this study is the number of adverse events occurring over a 12-month period post-treatment with hCT-MSC or AlloCB.
Outcome measures
| Measure |
Allogeneic Umbilical Cord Blood (AlloCB)
n=31 Participants
Subjects will receive a single intravenous infusion of a maximum of 10x107/kg allogeneic umbilical cord blood (CB) cells
Infusion of allogeneic umbilical cord blood: Subjects will receive a single infusion of allogeneic umbilical cord blood at the baseline visit.
|
Cord Tissue Mesenchymal Stromal Cells (MSC)
n=29 Participants
Subjects will receive three intravenous infusions of 2x106/kg human umbilical cord tissue cells (hCT-MSC), manufactured from allogeneic umbilical cord donors
Infusion of MSCs: Subjects will receive 3 infusions of MSCs (baseline, 3 months and 6 months).
|
Natural History
n=31 Participants
Subjects will not receive any study product infusion until after the 12 month assessment. At the 12 month visit, they will receive an infusion of allogeneic umbilical cord blood cells so that all study participants will receive some type of cellular therapy.
Infusion of allogeneic umbilical cord blood: Subjects will receive a single infusion of allogeneic umbilical cord blood at the baseline visit.
|
AlloCB After Natural History
n=27 Participants
Subjects will not receive any study product infusion until after the 12 month assessment. At the 12 month visit, they will receive an infusion of allogeneic umbilical cord blood cells so that all study participants will receive some type of cellular therapy.
Infusion of allogeneic umbilical cord blood: Subjects will receive a single infusion of allogeneic umbilical cord blood at the baseline visit.
|
|---|---|---|---|---|
|
Number of Adverse Events
|
30 adverse events
|
48 adverse events
|
16 adverse events
|
9 adverse events
|
Adverse Events
Allogeneic Umbilical Cord Blood (AlloCB)
Serious events: 9 serious events
Other events: 18 other events
Deaths: 0 deaths
Cord Tissue Mesenchymal Stromal Cells (MSC)
Serious events: 3 serious events
Other events: 22 other events
Deaths: 0 deaths
Natural History
Serious events: 9 serious events
Other events: 12 other events
Deaths: 0 deaths
AlloCB After Natural History
Serious events: 3 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Allogeneic Umbilical Cord Blood (AlloCB)
n=31 participants at risk
Subjects will receive a single intravenous infusion of a maximum of 10x107/kg allogeneic umbilical cord blood (CB) cells
Infusion of allogeneic umbilical cord blood: Subjects will receive a single infusion of allogeneic umbilical cord blood at the baseline visit.
|
Cord Tissue Mesenchymal Stromal Cells (MSC)
n=29 participants at risk
Subjects will receive three intravenous infusions of 2x106/kg human umbilical cord tissue cells (hCT-MSC), manufactured from allogeneic umbilical cord donors
Infusion of MSCs: Subjects will receive 3 infusions of MSCs (baseline, 3 months and 6 months).
|
Natural History
n=31 participants at risk
Subjects will not receive any study product infusion until after the 12 month assessment. At the 12 month visit, they will receive an infusion of allogeneic umbilical cord blood cells so that all study participants will receive some type of cellular therapy.
Infusion of allogeneic umbilical cord blood: Subjects will receive a single infusion of allogeneic umbilical cord blood at the baseline visit.
|
AlloCB After Natural History
n=27 participants at risk
Subjects will not receive any study product infusion until after the 12 month assessment. At the 12 month visit, they will receive an infusion of allogeneic umbilical cord blood cells so that all study participants will receive some type of cellular therapy.
Infusion of allogeneic umbilical cord blood: Subjects will receive a single infusion of allogeneic umbilical cord blood at the baseline visit.
|
|---|---|---|---|---|
|
Infections and infestations
Bronchitis viral
|
3.2%
1/31 • 12 months
|
0.00%
0/29 • 12 months
|
0.00%
0/31 • 12 months
|
0.00%
0/27 • 12 months
|
|
Metabolism and nutrition disorders
Dehydration
|
3.2%
1/31 • 12 months
|
0.00%
0/29 • 12 months
|
0.00%
0/31 • 12 months
|
0.00%
0/27 • 12 months
|
|
Gastrointestinal disorders
Gastritis
|
3.2%
1/31 • 12 months
|
0.00%
0/29 • 12 months
|
0.00%
0/31 • 12 months
|
0.00%
0/27 • 12 months
|
|
Surgical and medical procedures
Hospitalisation
|
0.00%
0/31 • 12 months
|
6.9%
2/29 • 12 months
|
6.5%
2/31 • 12 months
|
7.4%
2/27 • 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/31 • 12 months
|
0.00%
0/29 • 12 months
|
3.2%
1/31 • 12 months
|
0.00%
0/27 • 12 months
|
|
Infections and infestations
Respiratory syncytial virus infection
|
3.2%
1/31 • 12 months
|
0.00%
0/29 • 12 months
|
0.00%
0/31 • 12 months
|
0.00%
0/27 • 12 months
|
|
Infections and infestations
Respiratory tract infection viral
|
0.00%
0/31 • 12 months
|
0.00%
0/29 • 12 months
|
3.2%
1/31 • 12 months
|
0.00%
0/27 • 12 months
|
|
Infections and infestations
Rhinovirus infection
|
3.2%
1/31 • 12 months
|
0.00%
0/29 • 12 months
|
0.00%
0/31 • 12 months
|
0.00%
0/27 • 12 months
|
|
Nervous system disorders
Seizure
|
6.5%
2/31 • 12 months
|
0.00%
0/29 • 12 months
|
16.1%
5/31 • 12 months
|
3.7%
1/27 • 12 months
|
|
Psychiatric disorders
Sleep disorder
|
0.00%
0/31 • 12 months
|
3.4%
1/29 • 12 months
|
0.00%
0/31 • 12 months
|
0.00%
0/27 • 12 months
|
|
Surgical and medical procedures
Surgery
|
9.7%
3/31 • 12 months
|
0.00%
0/29 • 12 months
|
3.2%
1/31 • 12 months
|
0.00%
0/27 • 12 months
|
|
Surgical and medical procedures
Tonsillectomy
|
0.00%
0/31 • 12 months
|
0.00%
0/29 • 12 months
|
3.2%
1/31 • 12 months
|
0.00%
0/27 • 12 months
|
Other adverse events
| Measure |
Allogeneic Umbilical Cord Blood (AlloCB)
n=31 participants at risk
Subjects will receive a single intravenous infusion of a maximum of 10x107/kg allogeneic umbilical cord blood (CB) cells
Infusion of allogeneic umbilical cord blood: Subjects will receive a single infusion of allogeneic umbilical cord blood at the baseline visit.
|
Cord Tissue Mesenchymal Stromal Cells (MSC)
n=29 participants at risk
Subjects will receive three intravenous infusions of 2x106/kg human umbilical cord tissue cells (hCT-MSC), manufactured from allogeneic umbilical cord donors
Infusion of MSCs: Subjects will receive 3 infusions of MSCs (baseline, 3 months and 6 months).
|
Natural History
n=31 participants at risk
Subjects will not receive any study product infusion until after the 12 month assessment. At the 12 month visit, they will receive an infusion of allogeneic umbilical cord blood cells so that all study participants will receive some type of cellular therapy.
Infusion of allogeneic umbilical cord blood: Subjects will receive a single infusion of allogeneic umbilical cord blood at the baseline visit.
|
AlloCB After Natural History
n=27 participants at risk
Subjects will not receive any study product infusion until after the 12 month assessment. At the 12 month visit, they will receive an infusion of allogeneic umbilical cord blood cells so that all study participants will receive some type of cellular therapy.
Infusion of allogeneic umbilical cord blood: Subjects will receive a single infusion of allogeneic umbilical cord blood at the baseline visit.
|
|---|---|---|---|---|
|
Psychiatric disorders
Insomnia
|
0.00%
0/31 • 12 months
|
3.4%
1/29 • 12 months
|
0.00%
0/31 • 12 months
|
0.00%
0/27 • 12 months
|
|
Surgical and medical procedures
Adenoidectomy
|
0.00%
0/31 • 12 months
|
3.4%
1/29 • 12 months
|
0.00%
0/31 • 12 months
|
0.00%
0/27 • 12 months
|
|
Skin and subcutaneous tissue disorders
Henoch-Schonlein purpura
|
0.00%
0/31 • 12 months
|
3.4%
1/29 • 12 months
|
0.00%
0/31 • 12 months
|
0.00%
0/27 • 12 months
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/31 • 12 months
|
6.9%
2/29 • 12 months
|
0.00%
0/31 • 12 months
|
0.00%
0/27 • 12 months
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/31 • 12 months
|
3.4%
1/29 • 12 months
|
0.00%
0/31 • 12 months
|
0.00%
0/27 • 12 months
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/31 • 12 months
|
0.00%
0/29 • 12 months
|
3.2%
1/31 • 12 months
|
0.00%
0/27 • 12 months
|
|
Cardiac disorders
Bradycardia
|
0.00%
0/31 • 12 months
|
0.00%
0/29 • 12 months
|
3.2%
1/31 • 12 months
|
0.00%
0/27 • 12 months
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
0.00%
0/31 • 12 months
|
0.00%
0/29 • 12 months
|
3.2%
1/31 • 12 months
|
0.00%
0/27 • 12 months
|
|
General disorders
Pyrexia
|
6.5%
2/31 • 12 months
|
10.3%
3/29 • 12 months
|
6.5%
2/31 • 12 months
|
3.7%
1/27 • 12 months
|
|
Infections and infestations
Bronchitis
|
0.00%
0/31 • 12 months
|
0.00%
0/29 • 12 months
|
3.2%
1/31 • 12 months
|
0.00%
0/27 • 12 months
|
|
Infections and infestations
Enterocolitis infectious
|
0.00%
0/31 • 12 months
|
0.00%
0/29 • 12 months
|
3.2%
1/31 • 12 months
|
0.00%
0/27 • 12 months
|
|
Infections and infestations
Otitis media
|
6.5%
2/31 • 12 months
|
6.9%
2/29 • 12 months
|
3.2%
1/31 • 12 months
|
0.00%
0/27 • 12 months
|
|
Injury, poisoning and procedural complications
Fall
|
6.5%
2/31 • 12 months
|
3.4%
1/29 • 12 months
|
3.2%
1/31 • 12 months
|
0.00%
0/27 • 12 months
|
|
Injury, poisoning and procedural complications
Fracture
|
0.00%
0/31 • 12 months
|
0.00%
0/29 • 12 months
|
3.2%
1/31 • 12 months
|
0.00%
0/27 • 12 months
|
|
Nervous system disorders
Nervous system disorder
|
0.00%
0/31 • 12 months
|
0.00%
0/29 • 12 months
|
3.2%
1/31 • 12 months
|
0.00%
0/27 • 12 months
|
|
Nervous system disorders
Seizure
|
0.00%
0/31 • 12 months
|
20.7%
6/29 • 12 months
|
6.5%
2/31 • 12 months
|
0.00%
0/27 • 12 months
|
|
Surgical and medical procedures
Adenotonsillectomy
|
0.00%
0/31 • 12 months
|
0.00%
0/29 • 12 months
|
3.2%
1/31 • 12 months
|
0.00%
0/27 • 12 months
|
|
Surgical and medical procedures
Strabismus correction
|
3.2%
1/31 • 12 months
|
0.00%
0/29 • 12 months
|
6.5%
2/31 • 12 months
|
0.00%
0/27 • 12 months
|
|
Gastrointestinal disorders
Cyclic vomiting syndrome
|
0.00%
0/31 • 12 months
|
0.00%
0/29 • 12 months
|
0.00%
0/31 • 12 months
|
3.7%
1/27 • 12 months
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/31 • 12 months
|
0.00%
0/29 • 12 months
|
0.00%
0/31 • 12 months
|
3.7%
1/27 • 12 months
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
3.2%
1/31 • 12 months
|
13.8%
4/29 • 12 months
|
0.00%
0/31 • 12 months
|
7.4%
2/27 • 12 months
|
|
Nervous system disorders
Headache
|
0.00%
0/31 • 12 months
|
6.9%
2/29 • 12 months
|
0.00%
0/31 • 12 months
|
3.7%
1/27 • 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/31 • 12 months
|
0.00%
0/29 • 12 months
|
0.00%
0/31 • 12 months
|
3.7%
1/27 • 12 months
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/31 • 12 months
|
13.8%
4/29 • 12 months
|
0.00%
0/31 • 12 months
|
3.7%
1/27 • 12 months
|
|
Ear and labyrinth disorders
Hypoacusis
|
3.2%
1/31 • 12 months
|
0.00%
0/29 • 12 months
|
0.00%
0/31 • 12 months
|
0.00%
0/27 • 12 months
|
|
Gastrointestinal disorders
Constipation
|
3.2%
1/31 • 12 months
|
0.00%
0/29 • 12 months
|
0.00%
0/31 • 12 months
|
0.00%
0/27 • 12 months
|
|
Gastrointestinal disorders
Diarrhoea
|
3.2%
1/31 • 12 months
|
3.4%
1/29 • 12 months
|
0.00%
0/31 • 12 months
|
0.00%
0/27 • 12 months
|
|
Gastrointestinal disorders
Vomiting
|
3.2%
1/31 • 12 months
|
6.9%
2/29 • 12 months
|
0.00%
0/31 • 12 months
|
0.00%
0/27 • 12 months
|
|
General disorders
Fatigue
|
3.2%
1/31 • 12 months
|
0.00%
0/29 • 12 months
|
0.00%
0/31 • 12 months
|
0.00%
0/27 • 12 months
|
|
Immune system disorders
Anaphylactic reaction
|
3.2%
1/31 • 12 months
|
0.00%
0/29 • 12 months
|
0.00%
0/31 • 12 months
|
0.00%
0/27 • 12 months
|
|
Infections and infestations
Hand-foot-and-mouth disease
|
6.5%
2/31 • 12 months
|
0.00%
0/29 • 12 months
|
0.00%
0/31 • 12 months
|
0.00%
0/27 • 12 months
|
|
Infections and infestations
Influenza
|
3.2%
1/31 • 12 months
|
0.00%
0/29 • 12 months
|
0.00%
0/31 • 12 months
|
0.00%
0/27 • 12 months
|
|
Infections and infestations
Pneumonia
|
3.2%
1/31 • 12 months
|
0.00%
0/29 • 12 months
|
0.00%
0/31 • 12 months
|
0.00%
0/27 • 12 months
|
|
Infections and infestations
Upper respiratory tract infection
|
3.2%
1/31 • 12 months
|
27.6%
8/29 • 12 months
|
0.00%
0/31 • 12 months
|
0.00%
0/27 • 12 months
|
|
Injury, poisoning and procedural complications
Arthropod bite
|
3.2%
1/31 • 12 months
|
0.00%
0/29 • 12 months
|
0.00%
0/31 • 12 months
|
0.00%
0/27 • 12 months
|
|
Injury, poisoning and procedural complications
Tooth avulsion
|
3.2%
1/31 • 12 months
|
0.00%
0/29 • 12 months
|
0.00%
0/31 • 12 months
|
0.00%
0/27 • 12 months
|
|
Investigations
Laboratory test abnormal
|
6.5%
2/31 • 12 months
|
0.00%
0/29 • 12 months
|
0.00%
0/31 • 12 months
|
0.00%
0/27 • 12 months
|
|
Metabolism and nutrition disorders
Dehydration
|
3.2%
1/31 • 12 months
|
0.00%
0/29 • 12 months
|
0.00%
0/31 • 12 months
|
0.00%
0/27 • 12 months
|
|
Nervous system disorders
Facial paresis
|
3.2%
1/31 • 12 months
|
0.00%
0/29 • 12 months
|
0.00%
0/31 • 12 months
|
0.00%
0/27 • 12 months
|
|
Nervous system disorders
Partial seizures
|
3.2%
1/31 • 12 months
|
0.00%
0/29 • 12 months
|
0.00%
0/31 • 12 months
|
0.00%
0/27 • 12 months
|
|
Surgical and medical procedures
Dental operation
|
3.2%
1/31 • 12 months
|
0.00%
0/29 • 12 months
|
0.00%
0/31 • 12 months
|
0.00%
0/27 • 12 months
|
|
Surgical and medical procedures
Orchidopexy
|
3.2%
1/31 • 12 months
|
3.4%
1/29 • 12 months
|
0.00%
0/31 • 12 months
|
0.00%
0/27 • 12 months
|
|
Surgical and medical procedures
Suture insertion
|
3.2%
1/31 • 12 months
|
0.00%
0/29 • 12 months
|
0.00%
0/31 • 12 months
|
0.00%
0/27 • 12 months
|
|
Surgical and medical procedures
Tongue tie operation
|
3.2%
1/31 • 12 months
|
0.00%
0/29 • 12 months
|
0.00%
0/31 • 12 months
|
0.00%
0/27 • 12 months
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/31 • 12 months
|
3.4%
1/29 • 12 months
|
0.00%
0/31 • 12 months
|
0.00%
0/27 • 12 months
|
|
General disorders
Influenza like illness
|
0.00%
0/31 • 12 months
|
3.4%
1/29 • 12 months
|
0.00%
0/31 • 12 months
|
0.00%
0/27 • 12 months
|
|
General disorders
Infusion site rash
|
0.00%
0/31 • 12 months
|
3.4%
1/29 • 12 months
|
0.00%
0/31 • 12 months
|
0.00%
0/27 • 12 months
|
|
Immune system disorders
Drug hypersensitivity
|
0.00%
0/31 • 12 months
|
3.4%
1/29 • 12 months
|
0.00%
0/31 • 12 months
|
0.00%
0/27 • 12 months
|
|
Infections and infestations
Tonsillitis
|
0.00%
0/31 • 12 months
|
3.4%
1/29 • 12 months
|
0.00%
0/31 • 12 months
|
0.00%
0/27 • 12 months
|
|
Infections and infestations
Varicella
|
0.00%
0/31 • 12 months
|
3.4%
1/29 • 12 months
|
0.00%
0/31 • 12 months
|
0.00%
0/27 • 12 months
|
|
General disorders
Injection site reaction
|
0.00%
0/31 • 12 months
|
3.4%
1/29 • 12 months
|
0.00%
0/31 • 12 months
|
0.00%
0/27 • 12 months
|
|
Nervous system disorders
Disturbance in attention
|
0.00%
0/31 • 12 months
|
3.4%
1/29 • 12 months
|
0.00%
0/31 • 12 months
|
0.00%
0/27 • 12 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place