Trial Outcomes & Findings for Dose-response Evaluation of the Cellavita HD Product in Patients With Huntington's Disease (NCT NCT03252535)
NCT ID: NCT03252535
Last Updated: 2025-09-19
Results Overview
The primary endpoint was the rate of change (slope) in Unified Huntington's Disease Rating Scale - Total Motor Score from V0 to V11 (minimum 0, the best; and maximum 124, the worst). For each participant, a regression line was fitted (Y = a + bx), where b represents the individual slope, reflecting the annualised rate of motor progression. A negative slope suggests improvement or slower decline; a positive slope indicates worsening. To compare treatment efficacy, the slopes were analysed using a Mixed Model for Repeated Measures (MMRM), which accounts for intra-subject variability and missing data. This approach allowed estimation and comparison of average slopes between each treated group and placebo, providing a robust measure of motor function trajectory over time.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
49 participants
Primary outcome timeframe
monthly for eleven months
Results posted on
2025-09-19
Participant Flow
Of 49 enrolled participants, 35 met the inclusion criteria and were randomized to treatment.
Participant milestones
| Measure |
Nestacell (Former Cellavita HD) Lower Dose
The participants randomized to this group will receive a total of 9 intravenous administrations of 1x10\^6 cells/weight range divided into three administrations per cycle. Each administration will occur every 30 days and cycle every 120 days (a total of 3 cycles).
NestaCell lower dose: The participants will receive a total of 9 intravenous administrations of 1x10\^6 cells/weight range divided into three administrations per cycle. Each administration will occur every 30 days and cycle every 120 days (a total of 3 cycles).
|
Nestacell (Former Cellavita HD) Higher Dose
The participants randomized to this group will receive a total of 9 intravenous administrations of 2 × 10\^6 cells/weight range, divided into three administrations per cycle. Each administration will occur every 30 days and cycle every 120 days (a total of 3 cycles).
NestaCell higher dose: The participants will receive a total of 9 intravenous administrations of 2x10\^6 cells/weight range divided into three administrations per cycle. Each administration will occur every 30 days and cycle every 120 days (a total of 3 cycles).
|
Placebo Group
The participants randomized to this group will receive a total of 9 intravenous administrations divided into three administrations per cycle. Each administration will occur every 30 days and cycles every 120 days (total of 3 cycles).
Placebo: The participants will receive a total of 9 intravenous administrations of placebo divided into three administrations per cycle. Each administration will occur every 30 days and cycles every 120 days (total of 3 cycles).
|
|---|---|---|---|
|
Overall Study
STARTED
|
14
|
14
|
7
|
|
Overall Study
COMPLETED
|
13
|
12
|
7
|
|
Overall Study
NOT COMPLETED
|
1
|
2
|
0
|
Reasons for withdrawal
| Measure |
Nestacell (Former Cellavita HD) Lower Dose
The participants randomized to this group will receive a total of 9 intravenous administrations of 1x10\^6 cells/weight range divided into three administrations per cycle. Each administration will occur every 30 days and cycle every 120 days (a total of 3 cycles).
NestaCell lower dose: The participants will receive a total of 9 intravenous administrations of 1x10\^6 cells/weight range divided into three administrations per cycle. Each administration will occur every 30 days and cycle every 120 days (a total of 3 cycles).
|
Nestacell (Former Cellavita HD) Higher Dose
The participants randomized to this group will receive a total of 9 intravenous administrations of 2 × 10\^6 cells/weight range, divided into three administrations per cycle. Each administration will occur every 30 days and cycle every 120 days (a total of 3 cycles).
NestaCell higher dose: The participants will receive a total of 9 intravenous administrations of 2x10\^6 cells/weight range divided into three administrations per cycle. Each administration will occur every 30 days and cycle every 120 days (a total of 3 cycles).
|
Placebo Group
The participants randomized to this group will receive a total of 9 intravenous administrations divided into three administrations per cycle. Each administration will occur every 30 days and cycles every 120 days (total of 3 cycles).
Placebo: The participants will receive a total of 9 intravenous administrations of placebo divided into three administrations per cycle. Each administration will occur every 30 days and cycles every 120 days (total of 3 cycles).
|
|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
0
|
|
Overall Study
Physician Decision
|
0
|
1
|
0
|
|
Overall Study
Met discontinuation criteria
|
0
|
1
|
0
|
Baseline Characteristics
Dose-response Evaluation of the Cellavita HD Product in Patients With Huntington's Disease
Baseline characteristics by cohort
| Measure |
Nestacell (Former Cellavita HD) Lower Dose
n=14 Participants
The participants randomized to this group will receive a total of 9 intravenous administrations of 1x10\^6 cells/weight range divided into three administrations per cycle. Each administration will occur every 30 days and cycle every 120 days (a total of 3 cycles).
NestaCell lower dose: The participants will receive a total of 9 intravenous administrations of 1x10\^6 cells/weight range divided into three administrations per cycle. Each administration will occur every 30 days and cycle every 120 days (a total of 3 cycles).
|
Nestacell (Former Cellavita HD) Higher Dose
n=14 Participants
The participants randomized to this group will receive a total of 9 intravenous administrations of 2 × 10\^6 cells/weight range, divided into three administrations per cycle. Each administration will occur every 30 days and cycle every 120 days (a total of 3 cycles).
NestaCell higher dose: The participants will receive a total of 9 intravenous administrations of 2x10\^6 cells/weight range divided into three administrations per cycle. Each administration will occur every 30 days and cycle every 120 days (a total of 3 cycles).
|
Placebo Group
n=7 Participants
The participants randomized to this group will receive a total of 9 intravenous administrations divided into three administrations per cycle. Each administration will occur every 30 days and cycles every 120 days (total of 3 cycles).
Placebo: The participants will receive a total of 9 intravenous administrations of placebo divided into three administrations per cycle. Each administration will occur every 30 days and cycles every 120 days (total of 3 cycles).
|
Total
n=35 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
51.6 years
STANDARD_DEVIATION 9.4 • n=99 Participants
|
43.7 years
STANDARD_DEVIATION 8.5 • n=107 Participants
|
50.9 years
STANDARD_DEVIATION 9.7 • n=206 Participants
|
48.7 years
STANDARD_DEVIATION 9.2 • n=7 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=99 Participants
|
9 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
18 Participants
n=7 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
17 Participants
n=7 Participants
|
|
Race/Ethnicity, Customized
Black
|
2 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
3 Participants
n=7 Participants
|
|
Race/Ethnicity, Customized
Multiracial
|
3 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
9 Participants
n=7 Participants
|
|
Race/Ethnicity, Customized
White
|
9 Participants
n=99 Participants
|
9 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
22 Participants
n=7 Participants
|
|
Race/Ethnicity, Customized
Other
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
|
Region of Enrollment
Brazil
|
14 participants
n=99 Participants
|
14 participants
n=107 Participants
|
7 participants
n=206 Participants
|
35 participants
n=7 Participants
|
|
Height
|
1.63 meters
STANDARD_DEVIATION 0.08 • n=99 Participants
|
1.61 meters
STANDARD_DEVIATION 0.1 • n=107 Participants
|
1.66 meters
STANDARD_DEVIATION 0.06 • n=206 Participants
|
1.63 meters
STANDARD_DEVIATION 0.08 • n=7 Participants
|
|
Weight
|
65.5 Kg
STANDARD_DEVIATION 14.0 • n=99 Participants
|
68.7 Kg
STANDARD_DEVIATION 14.5 • n=107 Participants
|
69.3 Kg
STANDARD_DEVIATION 14.0 • n=206 Participants
|
67.8 Kg
STANDARD_DEVIATION 14.2 • n=7 Participants
|
|
BMI
|
24.4 Kg/m^2
STANDARD_DEVIATION 4.5 • n=99 Participants
|
26.4 Kg/m^2
STANDARD_DEVIATION 5.5 • n=107 Participants
|
25.0 Kg/m^2
STANDARD_DEVIATION 4.4 • n=206 Participants
|
25.3 Kg/m^2
STANDARD_DEVIATION 4.8 • n=7 Participants
|
|
CAG repeat
<44
|
9 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
20 Participants
n=7 Participants
|
|
CAG repeat
>=44
|
5 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
15 Participants
n=7 Participants
|
|
CAP scale
|
106.7 units on a scale
STANDARD_DEVIATION 18.6 • n=99 Participants
|
97.5 units on a scale
STANDARD_DEVIATION 11.5 • n=107 Participants
|
110.7 units on a scale
STANDARD_DEVIATION 12.0 • n=206 Participants
|
105.0 units on a scale
STANDARD_DEVIATION 14.0 • n=7 Participants
|
|
Years of symptoms
|
10.1 years
STANDARD_DEVIATION 3.6 • n=99 Participants
|
7.4 years
STANDARD_DEVIATION 2.1 • n=107 Participants
|
10.1 years
STANDARD_DEVIATION 3.2 • n=206 Participants
|
9.2 years
STANDARD_DEVIATION 3.0 • n=7 Participants
|
|
UHDRS Total Motor Score
|
43.6 units on a scale
STANDARD_DEVIATION 23.8 • n=99 Participants
|
20.7 units on a scale
STANDARD_DEVIATION 11.8 • n=107 Participants
|
38.0 units on a scale
STANDARD_DEVIATION 7.5 • n=206 Participants
|
34.1 units on a scale
STANDARD_DEVIATION 14.4 • n=7 Participants
|
|
UHDRS Total Functional Capacity
|
8.1 units on a scale
STANDARD_DEVIATION 2.1 • n=99 Participants
|
8.4 units on a scale
STANDARD_DEVIATION 2.6 • n=107 Participants
|
6.7 units on a scale
STANDARD_DEVIATION 1.4 • n=206 Participants
|
7.7 units on a scale
STANDARD_DEVIATION 2.0 • n=7 Participants
|
PRIMARY outcome
Timeframe: monthly for eleven monthsThe primary endpoint was the rate of change (slope) in Unified Huntington's Disease Rating Scale - Total Motor Score from V0 to V11 (minimum 0, the best; and maximum 124, the worst). For each participant, a regression line was fitted (Y = a + bx), where b represents the individual slope, reflecting the annualised rate of motor progression. A negative slope suggests improvement or slower decline; a positive slope indicates worsening. To compare treatment efficacy, the slopes were analysed using a Mixed Model for Repeated Measures (MMRM), which accounts for intra-subject variability and missing data. This approach allowed estimation and comparison of average slopes between each treated group and placebo, providing a robust measure of motor function trajectory over time.
Outcome measures
| Measure |
Nestacell (Former Cellavita HD) Lower Dose
n=14 Participants
The participants randomized to this group will receive a total of 9 intravenous administrations of 1x10\^6 cells/weight range divided into three administrations per cycle. Each administration will occur every 30 days and cycle every 120 days (a total of 3 cycles).
NestaCell lower dose: The participants will receive a total of 9 intravenous administrations of 1x10\^6 cells/weight range divided into three administrations per cycle. Each administration will occur every 30 days and cycle every 120 days (a total of 3 cycles).
|
Nestacell (Former Cellavita HD) Higher Dose
n=14 Participants
The participants randomized to this group will receive a total of 9 intravenous administrations of 2 × 10\^6 cells/weight range, divided into three administrations per cycle. Each administration will occur every 30 days and cycle every 120 days (a total of 3 cycles).
NestaCell higher dose: The participants will receive a total of 9 intravenous administrations of 2x10\^6 cells/weight range divided into three administrations per cycle. Each administration will occur every 30 days and cycle every 120 days (a total of 3 cycles).
|
Placebo Group
n=7 Participants
The participants randomized to this group will receive a total of 9 intravenous administrations divided into three administrations per cycle. Each administration will occur every 30 days and cycles every 120 days (total of 3 cycles).
Placebo: The participants will receive a total of 9 intravenous administrations of placebo divided into three administrations per cycle. Each administration will occur every 30 days and cycles every 120 days (total of 3 cycles).
|
|---|---|---|---|
|
Efficacy by UHDRS-TMS
|
-1.23 score on a scale/year
Standard Error 0.84
|
0.84 score on a scale/year
Standard Error 0.90
|
8.91 score on a scale/year
Standard Error 1.11
|
SECONDARY outcome
Timeframe: monthly for eleven monthsAssessed by the rate of change (slope) from V0 to V11 in the UHDRS-TFC. The response of each participant or means of all participants was evaluated by the slopes of each regression line of UHDRS-TFC determined as follows: The equation describes the regression line: Y = a + bx, where: * "Y" is the dependent variable. * "a" is the constant that represents the intersection of the line with the vertical axis. * "b" is the angular coefficient, that is, the slope. * "x" is the independent variable. Therefore, the 'b' value represents the slope of the straight line that best fits the values collected from the baseline (V0) to the value of V11, using the least squares method. This slope corresponds to the estimated annualized individual variation of UHDRS-TFC during the given period.
Outcome measures
| Measure |
Nestacell (Former Cellavita HD) Lower Dose
n=14 Participants
The participants randomized to this group will receive a total of 9 intravenous administrations of 1x10\^6 cells/weight range divided into three administrations per cycle. Each administration will occur every 30 days and cycle every 120 days (a total of 3 cycles).
NestaCell lower dose: The participants will receive a total of 9 intravenous administrations of 1x10\^6 cells/weight range divided into three administrations per cycle. Each administration will occur every 30 days and cycle every 120 days (a total of 3 cycles).
|
Nestacell (Former Cellavita HD) Higher Dose
n=14 Participants
The participants randomized to this group will receive a total of 9 intravenous administrations of 2 × 10\^6 cells/weight range, divided into three administrations per cycle. Each administration will occur every 30 days and cycle every 120 days (a total of 3 cycles).
NestaCell higher dose: The participants will receive a total of 9 intravenous administrations of 2x10\^6 cells/weight range divided into three administrations per cycle. Each administration will occur every 30 days and cycle every 120 days (a total of 3 cycles).
|
Placebo Group
n=7 Participants
The participants randomized to this group will receive a total of 9 intravenous administrations divided into three administrations per cycle. Each administration will occur every 30 days and cycles every 120 days (total of 3 cycles).
Placebo: The participants will receive a total of 9 intravenous administrations of placebo divided into three administrations per cycle. Each administration will occur every 30 days and cycles every 120 days (total of 3 cycles).
|
|---|---|---|---|
|
Efficacy by UHDRS-TFC
|
-0.29 score on a scale/year
Standard Error 0.18
|
0.73 score on a scale/year
Standard Error 0.18
|
-0.89 score on a scale/year
Standard Error 0.26
|
OTHER_PRE_SPECIFIED outcome
Timeframe: eleven monthsNumber of administrations of NestaCell (Former Cellavita HD) and Placebo
Outcome measures
| Measure |
Nestacell (Former Cellavita HD) Lower Dose
n=14 Participants
The participants randomized to this group will receive a total of 9 intravenous administrations of 1x10\^6 cells/weight range divided into three administrations per cycle. Each administration will occur every 30 days and cycle every 120 days (a total of 3 cycles).
NestaCell lower dose: The participants will receive a total of 9 intravenous administrations of 1x10\^6 cells/weight range divided into three administrations per cycle. Each administration will occur every 30 days and cycle every 120 days (a total of 3 cycles).
|
Nestacell (Former Cellavita HD) Higher Dose
n=14 Participants
The participants randomized to this group will receive a total of 9 intravenous administrations of 2 × 10\^6 cells/weight range, divided into three administrations per cycle. Each administration will occur every 30 days and cycle every 120 days (a total of 3 cycles).
NestaCell higher dose: The participants will receive a total of 9 intravenous administrations of 2x10\^6 cells/weight range divided into three administrations per cycle. Each administration will occur every 30 days and cycle every 120 days (a total of 3 cycles).
|
Placebo Group
n=7 Participants
The participants randomized to this group will receive a total of 9 intravenous administrations divided into three administrations per cycle. Each administration will occur every 30 days and cycles every 120 days (total of 3 cycles).
Placebo: The participants will receive a total of 9 intravenous administrations of placebo divided into three administrations per cycle. Each administration will occur every 30 days and cycles every 120 days (total of 3 cycles).
|
|---|---|---|---|
|
Exposure to NestaCell (Former Cellavita HD) Product
|
9.0 number os adminstrations
Standard Deviation 0.0
|
8.4 number os adminstrations
Standard Deviation 1.5
|
9.0 number os adminstrations
Standard Deviation 0.0
|
Adverse Events
Nestacell (Former Cellavita HD) Lower Dose
Serious events: 1 serious events
Other events: 12 other events
Deaths: 0 deaths
Nestacell (Former Cellavita HD) Higher Dose
Serious events: 0 serious events
Other events: 12 other events
Deaths: 0 deaths
Placebo Group
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Nestacell (Former Cellavita HD) Lower Dose
n=14 participants at risk
The participants randomized to this group will receive a total of 9 intravenous administrations of 1x10\^6 cells/weight range divided into three administrations per cycle. Each administration will occur every 30 days and cycle every 120 days (a total of 3 cycles).
NestaCell lower dose: The participants will receive a total of 9 intravenous administrations of 1x10\^6 cells/weight range divided into three administrations per cycle. Each administration will occur every 30 days and cycle every 120 days (a total of 3 cycles).
|
Nestacell (Former Cellavita HD) Higher Dose
n=14 participants at risk
The participants randomized to this group will receive a total of 9 intravenous administrations of 2 × 10\^6 cells/weight range, divided into three administrations per cycle. Each administration will occur every 30 days and cycle every 120 days (a total of 3 cycles).
NestaCell higher dose: The participants will receive a total of 9 intravenous administrations of 2x10\^6 cells/weight range divided into three administrations per cycle. Each administration will occur every 30 days and cycle every 120 days (a total of 3 cycles).
|
Placebo Group
n=7 participants at risk
The participants randomized to this group will receive a total of 9 intravenous administrations divided into three administrations per cycle. Each administration will occur every 30 days and cycles every 120 days (total of 3 cycles).
Placebo: The participants will receive a total of 9 intravenous administrations of placebo divided into three administrations per cycle. Each administration will occur every 30 days and cycles every 120 days (total of 3 cycles).
|
|---|---|---|---|
|
Infections and infestations
hospitalized for sinusitis
|
7.1%
1/14 • Number of events 1 • 11 months
|
0.00%
0/14 • 11 months
|
0.00%
0/7 • 11 months
|
Other adverse events
| Measure |
Nestacell (Former Cellavita HD) Lower Dose
n=14 participants at risk
The participants randomized to this group will receive a total of 9 intravenous administrations of 1x10\^6 cells/weight range divided into three administrations per cycle. Each administration will occur every 30 days and cycle every 120 days (a total of 3 cycles).
NestaCell lower dose: The participants will receive a total of 9 intravenous administrations of 1x10\^6 cells/weight range divided into three administrations per cycle. Each administration will occur every 30 days and cycle every 120 days (a total of 3 cycles).
|
Nestacell (Former Cellavita HD) Higher Dose
n=14 participants at risk
The participants randomized to this group will receive a total of 9 intravenous administrations of 2 × 10\^6 cells/weight range, divided into three administrations per cycle. Each administration will occur every 30 days and cycle every 120 days (a total of 3 cycles).
NestaCell higher dose: The participants will receive a total of 9 intravenous administrations of 2x10\^6 cells/weight range divided into three administrations per cycle. Each administration will occur every 30 days and cycle every 120 days (a total of 3 cycles).
|
Placebo Group
n=7 participants at risk
The participants randomized to this group will receive a total of 9 intravenous administrations divided into three administrations per cycle. Each administration will occur every 30 days and cycles every 120 days (total of 3 cycles).
Placebo: The participants will receive a total of 9 intravenous administrations of placebo divided into three administrations per cycle. Each administration will occur every 30 days and cycles every 120 days (total of 3 cycles).
|
|---|---|---|---|
|
Skin and subcutaneous tissue disorders
Alopecia
|
35.7%
5/14 • Number of events 7 • 11 months
|
14.3%
2/14 • Number of events 3 • 11 months
|
0.00%
0/7 • 11 months
|
|
Skin and subcutaneous tissue disorders
Dermal cyst
|
7.1%
1/14 • Number of events 1 • 11 months
|
0.00%
0/14 • 11 months
|
0.00%
0/7 • 11 months
|
|
Skin and subcutaneous tissue disorders
Abnormal hair growth
|
14.3%
2/14 • Number of events 2 • 11 months
|
0.00%
0/14 • 11 months
|
0.00%
0/7 • 11 months
|
|
Skin and subcutaneous tissue disorders
Wound
|
14.3%
2/14 • Number of events 2 • 11 months
|
0.00%
0/14 • 11 months
|
0.00%
0/7 • 11 months
|
|
Skin and subcutaneous tissue disorders
Subcutaneous hemorrhage
|
0.00%
0/14 • 11 months
|
7.1%
1/14 • Number of events 1 • 11 months
|
0.00%
0/7 • 11 months
|
|
Skin and subcutaneous tissue disorders
Change in hair color
|
7.1%
1/14 • Number of events 1 • 11 months
|
7.1%
1/14 • Number of events 1 • 11 months
|
0.00%
0/7 • 11 months
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
7.1%
1/14 • Number of events 1 • 11 months
|
0.00%
0/14 • 11 months
|
0.00%
0/7 • 11 months
|
|
Immune system disorders
Atopic dermatitis
|
0.00%
0/14 • 11 months
|
0.00%
0/14 • 11 months
|
14.3%
1/7 • Number of events 2 • 11 months
|
|
Metabolism and nutrition disorders
Dyslipidemia
|
21.4%
3/14 • Number of events 3 • 11 months
|
7.1%
1/14 • Number of events 2 • 11 months
|
14.3%
1/7 • Number of events 1 • 11 months
|
|
Metabolism and nutrition disorders
Hypertriglyceridemia
|
7.1%
1/14 • Number of events 1 • 11 months
|
0.00%
0/14 • 11 months
|
0.00%
0/7 • 11 months
|
|
Metabolism and nutrition disorders
Overweight
|
0.00%
0/14 • 11 months
|
14.3%
2/14 • Number of events 2 • 11 months
|
0.00%
0/7 • 11 months
|
|
Nervous system disorders
Akathisia
|
7.1%
1/14 • Number of events 1 • 11 months
|
0.00%
0/14 • 11 months
|
0.00%
0/7 • 11 months
|
|
Nervous system disorders
Headache
|
7.1%
1/14 • Number of events 1 • 11 months
|
0.00%
0/14 • 11 months
|
0.00%
0/7 • 11 months
|
|
Nervous system disorders
Cervicogenic gourd pain
|
0.00%
0/14 • 11 months
|
7.1%
1/14 • Number of events 1 • 11 months
|
0.00%
0/7 • 11 months
|
|
Nervous system disorders
Insomnia
|
0.00%
0/14 • 11 months
|
7.1%
1/14 • Number of events 3 • 11 months
|
0.00%
0/7 • 11 months
|
|
Nervous system disorders
Somnolence
|
7.1%
1/14 • Number of events 2 • 11 months
|
0.00%
0/14 • 11 months
|
0.00%
0/7 • 11 months
|
|
Nervous system disorders
Dizziness
|
7.1%
1/14 • Number of events 1 • 11 months
|
0.00%
0/14 • 11 months
|
0.00%
0/7 • 11 months
|
|
Nervous system disorders
Essential tremor
|
0.00%
0/14 • 11 months
|
7.1%
1/14 • Number of events 1 • 11 months
|
0.00%
0/7 • 11 months
|
|
Nervous system disorders
Vertigo
|
0.00%
0/14 • 11 months
|
7.1%
1/14 • Number of events 1 • 11 months
|
0.00%
0/7 • 11 months
|
|
Blood and lymphatic system disorders
Normochromic and normocytic anemia
|
0.00%
0/14 • 11 months
|
7.1%
1/14 • Number of events 1 • 11 months
|
0.00%
0/7 • 11 months
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/14 • 11 months
|
7.1%
1/14 • Number of events 1 • 11 months
|
0.00%
0/7 • 11 months
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
14.3%
2/14 • Number of events 2 • 11 months
|
0.00%
0/14 • 11 months
|
14.3%
1/7 • Number of events 1 • 11 months
|
|
Musculoskeletal and connective tissue disorders
Pain in extremities
|
7.1%
1/14 • Number of events 1 • 11 months
|
14.3%
2/14 • Number of events 2 • 11 months
|
0.00%
0/7 • 11 months
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
7.1%
1/14 • Number of events 1 • 11 months
|
0.00%
0/14 • 11 months
|
0.00%
0/7 • 11 months
|
|
Gastrointestinal disorders
Diarrhea
|
7.1%
1/14 • Number of events 1 • 11 months
|
7.1%
1/14 • Number of events 3 • 11 months
|
28.6%
2/7 • Number of events 4 • 11 months
|
|
Gastrointestinal disorders
Dyspepsia
|
7.1%
1/14 • Number of events 1 • 11 months
|
0.00%
0/14 • 11 months
|
0.00%
0/7 • 11 months
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
0.00%
0/14 • 11 months
|
0.00%
0/14 • 11 months
|
14.3%
1/7 • Number of events 1 • 11 months
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/14 • 11 months
|
14.3%
2/14 • Number of events 2 • 11 months
|
0.00%
0/7 • 11 months
|
|
Gastrointestinal disorders
Odynophagia
|
0.00%
0/14 • 11 months
|
0.00%
0/14 • 11 months
|
14.3%
1/7 • Number of events 1 • 11 months
|
|
Gastrointestinal disorders
Vomit
|
0.00%
0/14 • 11 months
|
0.00%
0/14 • 11 months
|
28.6%
2/7 • Number of events 2 • 11 months
|
|
Gastrointestinal disorders
Aphthous ulcer
|
0.00%
0/14 • 11 months
|
7.1%
1/14 • Number of events 1 • 11 months
|
0.00%
0/7 • 11 months
|
|
General disorders
Chest pain
|
7.1%
1/14 • Number of events 1 • 11 months
|
0.00%
0/14 • 11 months
|
0.00%
0/7 • 11 months
|
|
General disorders
Phlebitis at the administration site
|
0.00%
0/14 • 11 months
|
7.1%
1/14 • Number of events 1 • 11 months
|
0.00%
0/7 • 11 months
|
|
General disorders
Malaise
|
0.00%
0/14 • 11 months
|
7.1%
1/14 • Number of events 1 • 11 months
|
0.00%
0/7 • 11 months
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/14 • 11 months
|
14.3%
2/14 • Number of events 2 • 11 months
|
0.00%
0/7 • 11 months
|
|
Psychiatric disorders
Compulsion
|
0.00%
0/14 • 11 months
|
7.1%
1/14 • Number of events 1 • 11 months
|
0.00%
0/7 • 11 months
|
|
Psychiatric disorders
Depression
|
7.1%
1/14 • Number of events 1 • 11 months
|
14.3%
2/14 • Number of events 3 • 11 months
|
0.00%
0/7 • 11 months
|
|
Psychiatric disorders
Anxiety disorder
|
0.00%
0/14 • 11 months
|
0.00%
0/14 • 11 months
|
14.3%
1/7 • Number of events 1 • 11 months
|
|
Psychiatric disorders
Obsessive-compulsive disorder
|
0.00%
0/14 • 11 months
|
7.1%
1/14 • Number of events 1 • 11 months
|
0.00%
0/7 • 11 months
|
|
Psychiatric disorders
Hypomania
|
0.00%
0/14 • 11 months
|
7.1%
1/14 • Number of events 1 • 11 months
|
0.00%
0/7 • 11 months
|
|
Psychiatric disorders
Altered mood
|
0.00%
0/14 • 11 months
|
14.3%
2/14 • Number of events 2 • 11 months
|
14.3%
1/7 • Number of events 1 • 11 months
|
|
Psychiatric disorders
Depressed mood
|
7.1%
1/14 • Number of events 1 • 11 months
|
14.3%
2/14 • Number of events 2 • 11 months
|
14.3%
1/7 • Number of events 1 • 11 months
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/14 • 11 months
|
7.1%
1/14 • Number of events 1 • 11 months
|
28.6%
2/7 • Number of events 2 • 11 months
|
|
Renal and urinary disorders
Urinary incontinence
|
7.1%
1/14 • Number of events 1 • 11 months
|
0.00%
0/14 • 11 months
|
0.00%
0/7 • 11 months
|
|
Renal and urinary disorders
Urinary tract infection
|
0.00%
0/14 • 11 months
|
14.3%
2/14 • Number of events 2 • 11 months
|
0.00%
0/7 • 11 months
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.00%
0/14 • 11 months
|
0.00%
0/14 • 11 months
|
14.3%
1/7 • Number of events 1 • 11 months
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/14 • 11 months
|
7.1%
1/14 • Number of events 1 • 11 months
|
0.00%
0/7 • 11 months
|
|
Respiratory, thoracic and mediastinal disorders
Influenza
|
7.1%
1/14 • Number of events 1 • 11 months
|
21.4%
3/14 • Number of events 3 • 11 months
|
0.00%
0/7 • 11 months
|
|
Vascular disorders
Hypertension
|
0.00%
0/14 • 11 months
|
0.00%
0/14 • 11 months
|
14.3%
1/7 • Number of events 1 • 11 months
|
|
Infections and infestations
Viral conjunctivitis
|
7.1%
1/14 • Number of events 1 • 11 months
|
0.00%
0/14 • 11 months
|
0.00%
0/7 • 11 months
|
|
Infections and infestations
Dengue Fever
|
0.00%
0/14 • 11 months
|
0.00%
0/14 • 11 months
|
14.3%
1/7 • Number of events 1 • 11 months
|
|
Infections and infestations
Tooth infection
|
0.00%
0/14 • 11 months
|
7.1%
1/14 • Number of events 1 • 11 months
|
0.00%
0/7 • 11 months
|
|
Infections and infestations
Influenza
|
7.1%
1/14 • Number of events 2 • 11 months
|
7.1%
1/14 • Number of events 1 • 11 months
|
0.00%
0/7 • 11 months
|
|
Infections and infestations
Tonsillitis
|
7.1%
1/14 • Number of events 1 • 11 months
|
0.00%
0/14 • 11 months
|
0.00%
0/7 • 11 months
|
|
Infections and infestations
Sinusitis
|
0.00%
0/14 • 11 months
|
7.1%
1/14 • Number of events 1 • 11 months
|
0.00%
0/7 • 11 months
|
|
Investigations
Increased blood creatinine
|
0.00%
0/14 • 11 months
|
0.00%
0/14 • 11 months
|
14.3%
1/7 • Number of events 1 • 11 months
|
|
Investigations
Weight gain
|
0.00%
0/14 • 11 months
|
0.00%
0/14 • 11 months
|
14.3%
1/7 • Number of events 1 • 11 months
|
|
Investigations
Positive salmonella test
|
0.00%
0/14 • 11 months
|
0.00%
0/14 • 11 months
|
14.3%
1/7 • Number of events 1 • 11 months
|
|
Investigations
Abnormal temperature perception test
|
0.00%
0/14 • 11 months
|
0.00%
0/14 • 11 months
|
14.3%
1/7 • Number of events 1 • 11 months
|
|
Injury, poisoning and procedural complications
Hand fracture
|
0.00%
0/14 • 11 months
|
7.1%
1/14 • Number of events 1 • 11 months
|
0.00%
0/7 • 11 months
|
|
Injury, poisoning and procedural complications
Limb fracture
|
7.1%
1/14 • Number of events 2 • 11 months
|
0.00%
0/14 • 11 months
|
0.00%
0/7 • 11 months
|
|
Injury, poisoning and procedural complications
Subdural hematoma
|
7.1%
1/14 • Number of events 1 • 11 months
|
0.00%
0/14 • 11 months
|
0.00%
0/7 • 11 months
|
|
Injury, poisoning and procedural complications
Joint injury
|
0.00%
0/14 • 11 months
|
7.1%
1/14 • Number of events 1 • 11 months
|
0.00%
0/7 • 11 months
|
|
Injury, poisoning and procedural complications
Face injury
|
0.00%
0/14 • 11 months
|
0.00%
0/14 • 11 months
|
14.3%
1/7 • Number of events 1 • 11 months
|
|
Injury, poisoning and procedural complications
Fall
|
35.7%
5/14 • Number of events 7 • 11 months
|
0.00%
0/14 • 11 months
|
14.3%
1/7 • Number of events 1 • 11 months
|
|
Surgical and medical procedures
Tooth extraction
|
7.1%
1/14 • Number of events 1 • 11 months
|
0.00%
0/14 • 11 months
|
0.00%
0/7 • 11 months
|
|
Surgical and medical procedures
Tooth implant
|
0.00%
0/14 • 11 months
|
0.00%
0/14 • 11 months
|
14.3%
1/7 • Number of events 1 • 11 months
|
|
Surgical and medical procedures
Cataract operation
|
0.00%
0/14 • 11 months
|
0.00%
0/14 • 11 months
|
14.3%
1/7 • Number of events 2 • 11 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place