Trial Outcomes & Findings for Ascending Dose Study of Genome Editing by the Zinc Finger Nuclease (ZFN) Therapeutic SB-913 in Subjects With MPS II (NCT NCT03041324)
NCT ID: NCT03041324
Last Updated: 2022-10-25
Results Overview
Number of participants with Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) in subjects who receive SB-913 as assessed by Common Terminology Criteria for Adverse Events (CTCAE)
Recruitment status
TERMINATED
Study phase
PHASE1/PHASE2
Target enrollment
9 participants
Primary outcome timeframe
Up to 36 months after the SB-913 infusion
Results posted on
2022-10-25
Participant Flow
The original enrollment goal was 32 subjects: Subjects with MPS II disease sequentially enrolled in age cohorts: age \>18 (adult cohorts 1 through 4), age 12-17 (pediatric cohorts 5 and 6), and age 5-11 (pediatric cohorts 7 and 8). Due to the lack of observed clinical benefit, Sangamo Therapeutics, Inc. decided to stop enrollment in this study at 9 subjects, all adults in 3 cohorts. We continue to monitor the subjects in a 10-year, long-term follow-up study ST-IVPRP-LT01 (NCT04628871).
Participant milestones
| Measure |
Experimental: Cohort 1 SB-913 Starting Dose 5.00E+12 vg/kg
A single dose of each of the three components of SB-913 \[zinc finger nucleases (ZFN1, ZFN2, and hIDUA Donor)\] administered via intravenous (IV) infusion.
|
Experimental: Cohort 2 SB-913 at Next Ascending Dose 1.00E+13 vg/kg
A single dose of each of the three components of SB-913 \[zinc finger nucleases (ZFN1, ZFN2, and hIDUA Donor)\] administered via intravenous (IV) infusion.
|
Experimental: Cohort 3 SB-913 at Next Ascending Dose 5.00E+13 vg/kg
A single dose of each of the three components of SB-913 \[zinc finger nucleases (ZFN1, ZFN2, and hIDUA Donor)\] administered via intravenous (IV) infusion.
|
|---|---|---|---|
|
Overall Study
STARTED
|
2
|
2
|
5
|
|
Overall Study
COMPLETED
|
2
|
2
|
5
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Ascending Dose Study of Genome Editing by the Zinc Finger Nuclease (ZFN) Therapeutic SB-913 in Subjects With MPS II
Baseline characteristics by cohort
| Measure |
Experimental: Cohort 1 SB-913 Starting Dose 5.00E+12 vg/kg
n=2 Participants
A single dose of each of the three components of SB-913 \[zinc finger nucleases (ZFN1, ZFN2, and hIDUA Donor)\] administered via intravenous (IV) infusion.
|
Experimental: Cohort 2 SB-913 at Next Ascending Dose 1.00E+13 vg/kg
n=2 Participants
A single dose of each of the three components of SB-913 \[zinc finger nucleases (ZFN1, ZFN2, and hIDUA Donor)\] administered via intravenous (IV) infusion.
|
Experimental: Cohort 3 SB-913 at Next Ascending Dose 5.00E+13 vg/kg
n=5 Participants
A single dose of each of the three components of SB-913 \[zinc finger nucleases (ZFN1, ZFN2, and hIDUA Donor)\] administered via intravenous (IV) infusion.
|
Total
n=9 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
9 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
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (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
|
|
Region of Enrollment
United States
|
2 participants
n=5 Participants
|
2 participants
n=7 Participants
|
5 participants
n=5 Participants
|
9 participants
n=4 Participants
|
|
Baseline Iduronate 2 Sulfatase (IDS) Results
|
4.93 nmol/mL/hr
STANDARD_DEVIATION 1.79605 • n=5 Participants
|
1.21 nmol/mL/hr
STANDARD_DEVIATION 0.55154 • n=7 Participants
|
7.054 nmol/mL/hr
STANDARD_DEVIATION 3.74949 • n=5 Participants
|
5.2833 nmol/mL/hr
STANDARD_DEVIATION 3.68909 • n=4 Participants
|
|
Baseline Urine Glycosaminoglycans (GAG) Levels
Dermatan Sulfate, Urine (g/mol creatinine)
|
4.255 (g/mol creatinine)
STANDARD_DEVIATION 1.70413 • n=5 Participants
|
5.165 (g/mol creatinine)
STANDARD_DEVIATION 1.83141 • n=7 Participants
|
4.094 (g/mol creatinine)
STANDARD_DEVIATION 0.79563 • n=5 Participants
|
4.3678 (g/mol creatinine)
STANDARD_DEVIATION 1.14354 • n=4 Participants
|
|
Baseline Urine Glycosaminoglycans (GAG) Levels
Heparan Sulfate, Urine (g/mol creatinine)
|
4.955 (g/mol creatinine)
STANDARD_DEVIATION 0.24749 • n=5 Participants
|
9.795 (g/mol creatinine)
STANDARD_DEVIATION 4.16486 • n=7 Participants
|
5.074 (g/mol creatinine)
STANDARD_DEVIATION 0.76843 • n=5 Participants
|
6.0967 (g/mol creatinine)
STANDARD_DEVIATION 2.62108 • n=4 Participants
|
|
Baseline Urine Glycosaminoglycans (GAG) Levels
Total GAG (g/mol creatinine)
|
4.785 (g/mol creatinine)
STANDARD_DEVIATION 1.44957 • n=5 Participants
|
6.88 (g/mol creatinine)
STANDARD_DEVIATION 0.9051 • n=7 Participants
|
4.816 (g/mol creatinine)
STANDARD_DEVIATION 2.96001 • n=5 Participants
|
5.2678 (g/mol creatinine)
STANDARD_DEVIATION 2.36252 • n=4 Participants
|
PRIMARY outcome
Timeframe: Up to 36 months after the SB-913 infusionPopulation: All subjects in this study who received any portion of the SB-913 infusion
Number of participants with Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) in subjects who receive SB-913 as assessed by Common Terminology Criteria for Adverse Events (CTCAE)
Outcome measures
| Measure |
Experimental: Cohort 1 SB-913 Starting Dose 5.00E+12 vg/kg
n=2 Participants
A single dose of each of the three components of SB-913 \[zinc finger nucleases (ZFN1, ZFN2, and hIDUA Donor)\] administered via intravenous (IV) infusion.
SB-913: Single dose of each of the 3 components of SB-913: ZFN1, ZFN2 and hIDS Donor
|
Experimental: Cohort 2 SB-913 at Next Ascending Dose 1.00E+13 vg/kg
n=2 Participants
A single dose of each of the three components of SB-913 \[zinc finger nucleases (ZFN1, ZFN2, and hIDUA Donor)\] administered via intravenous (IV) infusion.
SB-913: Single dose of each of the 3 components of SB-913: ZFN1, ZFN2 and hIDS Donor
|
Experimental: Cohort 3 SB-913 at Next Ascending Dose 5.00E+13 vg/kg
n=5 Participants
A single dose of each of the three components of SB-913 \[zinc finger nucleases (ZFN1, ZFN2, and hIDUA Donor)\] administered via intravenous (IV) infusion.
SB-913: Single dose of each of the 3 components of SB-913: ZFN1, ZFN2 and hIDS Donor
|
|---|---|---|---|
|
Number of Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) [ Time Frame: Up to 36 Months After the SB-913 Infusion
|
2 participants
|
2 participants
|
5 participants
|
SECONDARY outcome
Timeframe: Baseline and Month 33 after the SB-913 infusionPopulation: All subjects in this study who received any dose of the SB-913 infusion
Change from baseline in clinical laboratory measurement of IDS activity measured in blood, at Month 33.
Outcome measures
| Measure |
Experimental: Cohort 1 SB-913 Starting Dose 5.00E+12 vg/kg
n=2 Participants
A single dose of each of the three components of SB-913 \[zinc finger nucleases (ZFN1, ZFN2, and hIDUA Donor)\] administered via intravenous (IV) infusion.
SB-913: Single dose of each of the 3 components of SB-913: ZFN1, ZFN2 and hIDS Donor
|
Experimental: Cohort 2 SB-913 at Next Ascending Dose 1.00E+13 vg/kg
A single dose of each of the three components of SB-913 \[zinc finger nucleases (ZFN1, ZFN2, and hIDUA Donor)\] administered via intravenous (IV) infusion.
SB-913: Single dose of each of the 3 components of SB-913: ZFN1, ZFN2 and hIDS Donor
|
Experimental: Cohort 3 SB-913 at Next Ascending Dose 5.00E+13 vg/kg
A single dose of each of the three components of SB-913 \[zinc finger nucleases (ZFN1, ZFN2, and hIDUA Donor)\] administered via intravenous (IV) infusion.
SB-913: Single dose of each of the 3 components of SB-913: ZFN1, ZFN2 and hIDS Donor
|
|---|---|---|---|
|
Effect of SB-913 on IDS Activity
|
-2.6600 nmol/mL/hr
Standard Deviation 3.5213
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline and 36 months after the SB-913 infusionPopulation: All subjects in this study who received any dose of the SB-913 infusion
Change from baseline in total GAG, Dermatan Sulfate GAG, and Heparan Sulfate GAG measured in urine at Month 36
Outcome measures
| Measure |
Experimental: Cohort 1 SB-913 Starting Dose 5.00E+12 vg/kg
n=2 Participants
A single dose of each of the three components of SB-913 \[zinc finger nucleases (ZFN1, ZFN2, and hIDUA Donor)\] administered via intravenous (IV) infusion.
SB-913: Single dose of each of the 3 components of SB-913: ZFN1, ZFN2 and hIDS Donor
|
Experimental: Cohort 2 SB-913 at Next Ascending Dose 1.00E+13 vg/kg
n=1 Participants
A single dose of each of the three components of SB-913 \[zinc finger nucleases (ZFN1, ZFN2, and hIDUA Donor)\] administered via intravenous (IV) infusion.
SB-913: Single dose of each of the 3 components of SB-913: ZFN1, ZFN2 and hIDS Donor
|
Experimental: Cohort 3 SB-913 at Next Ascending Dose 5.00E+13 vg/kg
n=5 Participants
A single dose of each of the three components of SB-913 \[zinc finger nucleases (ZFN1, ZFN2, and hIDUA Donor)\] administered via intravenous (IV) infusion.
SB-913: Single dose of each of the 3 components of SB-913: ZFN1, ZFN2 and hIDS Donor
|
|---|---|---|---|
|
Effect of SB-913 on Urine Glycosaminoglycans (GAG) Levels
Total GAG
|
1.035 g/mol creatinine
Standard Deviation 0.03536
|
-2.6 g/mol creatinine
Standard Deviation NA
For total GAG, at month 36, only one patient in cohort 2 had a sample tested for total GAG, so no standard deviation was available.
|
1.734 g/mol creatinine
Standard Deviation 1.58357
|
|
Effect of SB-913 on Urine Glycosaminoglycans (GAG) Levels
Dermatan Sulfate Urine
|
-0.025 g/mol creatinine
Standard Deviation 1.18087
|
-3.39 g/mol creatinine
Standard Deviation NA
For DS GAG, at month 36, only one patient in cohort 2 had a sample tested for DS GAG, so no standard deviation was available.
|
0.262 g/mol creatinine
Standard Deviation 0.6985
|
|
Effect of SB-913 on Urine Glycosaminoglycans (GAG) Levels
Heparan Sulfate Urine
|
1.895 g/mol creatinine
Standard Deviation 2.39709
|
-7.6 g/mol creatinine
Standard Deviation NA
For HS GAG, at month 36, only one patient in cohort 2 had a sample tested for HS GAG, so no standard deviation was available.
|
2.880 g/mol creatinine
Standard Deviation 2.91261
|
SECONDARY outcome
Timeframe: Up to 36 months after the SB-913 infusionPopulation: All subjects in this study who received any dose of the SB-913 infusion
Change from baseline in annualized frequency of idursulfase (or equivalent ERT)
Outcome measures
| Measure |
Experimental: Cohort 1 SB-913 Starting Dose 5.00E+12 vg/kg
n=1 Participants
A single dose of each of the three components of SB-913 \[zinc finger nucleases (ZFN1, ZFN2, and hIDUA Donor)\] administered via intravenous (IV) infusion.
SB-913: Single dose of each of the 3 components of SB-913: ZFN1, ZFN2 and hIDS Donor
|
Experimental: Cohort 2 SB-913 at Next Ascending Dose 1.00E+13 vg/kg
n=2 Participants
A single dose of each of the three components of SB-913 \[zinc finger nucleases (ZFN1, ZFN2, and hIDUA Donor)\] administered via intravenous (IV) infusion.
SB-913: Single dose of each of the 3 components of SB-913: ZFN1, ZFN2 and hIDS Donor
|
Experimental: Cohort 3 SB-913 at Next Ascending Dose 5.00E+13 vg/kg
n=5 Participants
A single dose of each of the three components of SB-913 \[zinc finger nucleases (ZFN1, ZFN2, and hIDUA Donor)\] administered via intravenous (IV) infusion.
SB-913: Single dose of each of the 3 components of SB-913: ZFN1, ZFN2 and hIDS Donor
|
|---|---|---|---|
|
Annualized Frequency of Idursulfase (or Equivalent ERT) Administration.
|
-2.8 Number of Infusions
Standard Deviation NA
Only one subject in this cohort had ERT withdrawal, so no standard deviation is available.
|
9.9 Number of Infusions
Standard Deviation 25.5
|
-0.5 Number of Infusions
Standard Deviation 6.13
|
SECONDARY outcome
Timeframe: Up to 36 months after the SB-913 infusionPopulation: All subjects in this study who received any portion of the SB-913 infusion
Subjects with AAV2/6 clearance in plasma, saliva, urine, stool, and semen by PCR by Week 24. All the subjects had AAV2/6 clearance in all the samples assessed (i.e., plasma, saliva, urine, stool, and semen) by week 24. Subjects were only tested until Week 24 because, by that time, they all had 3 consecutive negative tests in all body fluids.
Outcome measures
| Measure |
Experimental: Cohort 1 SB-913 Starting Dose 5.00E+12 vg/kg
n=2 Participants
A single dose of each of the three components of SB-913 \[zinc finger nucleases (ZFN1, ZFN2, and hIDUA Donor)\] administered via intravenous (IV) infusion.
SB-913: Single dose of each of the 3 components of SB-913: ZFN1, ZFN2 and hIDS Donor
|
Experimental: Cohort 2 SB-913 at Next Ascending Dose 1.00E+13 vg/kg
n=2 Participants
A single dose of each of the three components of SB-913 \[zinc finger nucleases (ZFN1, ZFN2, and hIDUA Donor)\] administered via intravenous (IV) infusion.
SB-913: Single dose of each of the 3 components of SB-913: ZFN1, ZFN2 and hIDS Donor
|
Experimental: Cohort 3 SB-913 at Next Ascending Dose 5.00E+13 vg/kg
n=5 Participants
A single dose of each of the three components of SB-913 \[zinc finger nucleases (ZFN1, ZFN2, and hIDUA Donor)\] administered via intravenous (IV) infusion.
SB-913: Single dose of each of the 3 components of SB-913: ZFN1, ZFN2 and hIDS Donor
|
|---|---|---|---|
|
AAV2/6 Clearance in Plasma, Saliva, Urine, Stool, and Semen
|
2 Participants
|
2 Participants
|
5 Participants
|
Adverse Events
Experimental: Cohort 1 SB-913 Starting Dose 5.00E+12 vg/kg
Serious events: 1 serious events
Other events: 2 other events
Deaths: 0 deaths
Experimental: Cohort 2 SB-913 at Next Ascending Dose 1.00E+13 vg/kg
Serious events: 1 serious events
Other events: 2 other events
Deaths: 0 deaths
Experimental: Cohort 3 SB-913 at Next Ascending Dose 5.00E+13 vg/kg
Serious events: 3 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Experimental: Cohort 1 SB-913 Starting Dose 5.00E+12 vg/kg
n=2 participants at risk
A single dose of each of the three components of SB-913 \[zinc finger nucleases (ZFN1, ZFN2, and hIDUA Donor)\] administered via intravenous (IV) infusion.
|
Experimental: Cohort 2 SB-913 at Next Ascending Dose 1.00E+13 vg/kg
n=2 participants at risk
A single dose of each of the three components of SB-913 \[zinc finger nucleases (ZFN1, ZFN2, and hIDUA Donor)\] administered via intravenous (IV) infusion.
|
Experimental: Cohort 3 SB-913 at Next Ascending Dose 5.00E+13 vg/kg
n=5 participants at risk
A single dose of each of the three components of SB-913 \[zinc finger nucleases (ZFN1, ZFN2, and hIDUA Donor)\] administered via intravenous (IV) infusion.
|
|---|---|---|---|
|
Cardiac disorders
Atrial Fibrillation
|
0.00%
0/2 • Adverse event data was collected from the subject's date of screening until their end of study visit which ranged from 24 to 36 months.
|
50.0%
1/2 • Number of events 1 • Adverse event data was collected from the subject's date of screening until their end of study visit which ranged from 24 to 36 months.
|
0.00%
0/5 • Adverse event data was collected from the subject's date of screening until their end of study visit which ranged from 24 to 36 months.
|
|
Gastrointestinal disorders
Incarcerated Umbilical Hernia
|
0.00%
0/2 • Adverse event data was collected from the subject's date of screening until their end of study visit which ranged from 24 to 36 months.
|
0.00%
0/2 • Adverse event data was collected from the subject's date of screening until their end of study visit which ranged from 24 to 36 months.
|
20.0%
1/5 • Number of events 1 • Adverse event data was collected from the subject's date of screening until their end of study visit which ranged from 24 to 36 months.
|
|
Gastrointestinal disorders
Intestinal Obstruction
|
0.00%
0/2 • Adverse event data was collected from the subject's date of screening until their end of study visit which ranged from 24 to 36 months.
|
0.00%
0/2 • Adverse event data was collected from the subject's date of screening until their end of study visit which ranged from 24 to 36 months.
|
20.0%
1/5 • Number of events 1 • Adverse event data was collected from the subject's date of screening until their end of study visit which ranged from 24 to 36 months.
|
|
General disorders
Pyrexia
|
0.00%
0/2 • Adverse event data was collected from the subject's date of screening until their end of study visit which ranged from 24 to 36 months.
|
0.00%
0/2 • Adverse event data was collected from the subject's date of screening until their end of study visit which ranged from 24 to 36 months.
|
20.0%
1/5 • Number of events 1 • Adverse event data was collected from the subject's date of screening until their end of study visit which ranged from 24 to 36 months.
|
|
Infections and infestations
Bronchitis
|
50.0%
1/2 • Number of events 1 • Adverse event data was collected from the subject's date of screening until their end of study visit which ranged from 24 to 36 months.
|
0.00%
0/2 • Adverse event data was collected from the subject's date of screening until their end of study visit which ranged from 24 to 36 months.
|
0.00%
0/5 • Adverse event data was collected from the subject's date of screening until their end of study visit which ranged from 24 to 36 months.
|
|
Infections and infestations
Influenza
|
50.0%
1/2 • Number of events 1 • Adverse event data was collected from the subject's date of screening until their end of study visit which ranged from 24 to 36 months.
|
0.00%
0/2 • Adverse event data was collected from the subject's date of screening until their end of study visit which ranged from 24 to 36 months.
|
0.00%
0/5 • Adverse event data was collected from the subject's date of screening until their end of study visit which ranged from 24 to 36 months.
|
|
Musculoskeletal and connective tissue disorders
Spinal Stenosis
|
0.00%
0/2 • Adverse event data was collected from the subject's date of screening until their end of study visit which ranged from 24 to 36 months.
|
0.00%
0/2 • Adverse event data was collected from the subject's date of screening until their end of study visit which ranged from 24 to 36 months.
|
20.0%
1/5 • Number of events 1 • Adverse event data was collected from the subject's date of screening until their end of study visit which ranged from 24 to 36 months.
|
|
Nervous system disorders
Lacunar Stroke
|
0.00%
0/2 • Adverse event data was collected from the subject's date of screening until their end of study visit which ranged from 24 to 36 months.
|
0.00%
0/2 • Adverse event data was collected from the subject's date of screening until their end of study visit which ranged from 24 to 36 months.
|
20.0%
1/5 • Number of events 1 • Adverse event data was collected from the subject's date of screening until their end of study visit which ranged from 24 to 36 months.
|
|
Product Issues
Device Dislocation
|
0.00%
0/2 • Adverse event data was collected from the subject's date of screening until their end of study visit which ranged from 24 to 36 months.
|
0.00%
0/2 • Adverse event data was collected from the subject's date of screening until their end of study visit which ranged from 24 to 36 months.
|
20.0%
1/5 • Number of events 1 • Adverse event data was collected from the subject's date of screening until their end of study visit which ranged from 24 to 36 months.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Failure
|
0.00%
0/2 • Adverse event data was collected from the subject's date of screening until their end of study visit which ranged from 24 to 36 months.
|
0.00%
0/2 • Adverse event data was collected from the subject's date of screening until their end of study visit which ranged from 24 to 36 months.
|
20.0%
1/5 • Number of events 1 • Adverse event data was collected from the subject's date of screening until their end of study visit which ranged from 24 to 36 months.
|
Other adverse events
| Measure |
Experimental: Cohort 1 SB-913 Starting Dose 5.00E+12 vg/kg
n=2 participants at risk
A single dose of each of the three components of SB-913 \[zinc finger nucleases (ZFN1, ZFN2, and hIDUA Donor)\] administered via intravenous (IV) infusion.
|
Experimental: Cohort 2 SB-913 at Next Ascending Dose 1.00E+13 vg/kg
n=2 participants at risk
A single dose of each of the three components of SB-913 \[zinc finger nucleases (ZFN1, ZFN2, and hIDUA Donor)\] administered via intravenous (IV) infusion.
|
Experimental: Cohort 3 SB-913 at Next Ascending Dose 5.00E+13 vg/kg
n=5 participants at risk
A single dose of each of the three components of SB-913 \[zinc finger nucleases (ZFN1, ZFN2, and hIDUA Donor)\] administered via intravenous (IV) infusion.
|
|---|---|---|---|
|
Vascular disorders
Deep Vein Thrombosis
|
0.00%
0/2 • Adverse event data was collected from the subject's date of screening until their end of study visit which ranged from 24 to 36 months.
|
0.00%
0/2 • Adverse event data was collected from the subject's date of screening until their end of study visit which ranged from 24 to 36 months.
|
20.0%
1/5 • Number of events 1 • Adverse event data was collected from the subject's date of screening until their end of study visit which ranged from 24 to 36 months.
|
|
Vascular disorders
Flushing
|
0.00%
0/2 • Adverse event data was collected from the subject's date of screening until their end of study visit which ranged from 24 to 36 months.
|
50.0%
1/2 • Number of events 2 • Adverse event data was collected from the subject's date of screening until their end of study visit which ranged from 24 to 36 months.
|
40.0%
2/5 • Number of events 2 • Adverse event data was collected from the subject's date of screening until their end of study visit which ranged from 24 to 36 months.
|
|
Vascular disorders
Hypertension
|
0.00%
0/2 • Adverse event data was collected from the subject's date of screening until their end of study visit which ranged from 24 to 36 months.
|
50.0%
1/2 • Number of events 1 • Adverse event data was collected from the subject's date of screening until their end of study visit which ranged from 24 to 36 months.
|
20.0%
1/5 • Number of events 1 • Adverse event data was collected from the subject's date of screening until their end of study visit which ranged from 24 to 36 months.
|
|
Vascular disorders
Hypotension
|
0.00%
0/2 • Adverse event data was collected from the subject's date of screening until their end of study visit which ranged from 24 to 36 months.
|
50.0%
1/2 • Number of events 1 • Adverse event data was collected from the subject's date of screening until their end of study visit which ranged from 24 to 36 months.
|
20.0%
1/5 • Number of events 1 • Adverse event data was collected from the subject's date of screening until their end of study visit which ranged from 24 to 36 months.
|
|
Vascular disorders
Lymphoedema
|
0.00%
0/2 • Adverse event data was collected from the subject's date of screening until their end of study visit which ranged from 24 to 36 months.
|
0.00%
0/2 • Adverse event data was collected from the subject's date of screening until their end of study visit which ranged from 24 to 36 months.
|
20.0%
1/5 • Number of events 1 • Adverse event data was collected from the subject's date of screening until their end of study visit which ranged from 24 to 36 months.
|
|
General disorders
Infusion Site Extravasation
|
0.00%
0/2 • Adverse event data was collected from the subject's date of screening until their end of study visit which ranged from 24 to 36 months.
|
0.00%
0/2 • Adverse event data was collected from the subject's date of screening until their end of study visit which ranged from 24 to 36 months.
|
20.0%
1/5 • Number of events 1 • Adverse event data was collected from the subject's date of screening until their end of study visit which ranged from 24 to 36 months.
|
|
General disorders
Swelling
|
0.00%
0/2 • Adverse event data was collected from the subject's date of screening until their end of study visit which ranged from 24 to 36 months.
|
0.00%
0/2 • Adverse event data was collected from the subject's date of screening until their end of study visit which ranged from 24 to 36 months.
|
20.0%
1/5 • Number of events 1 • Adverse event data was collected from the subject's date of screening until their end of study visit which ranged from 24 to 36 months.
|
|
Respiratory, thoracic and mediastinal disorders
Lower Respiratory Infection
|
0.00%
0/2 • Adverse event data was collected from the subject's date of screening until their end of study visit which ranged from 24 to 36 months.
|
0.00%
0/2 • Adverse event data was collected from the subject's date of screening until their end of study visit which ranged from 24 to 36 months.
|
20.0%
1/5 • Number of events 1 • Adverse event data was collected from the subject's date of screening until their end of study visit which ranged from 24 to 36 months.
|
|
Investigations
Blood Lactate Dehydrogenase Increased
|
0.00%
0/2 • Adverse event data was collected from the subject's date of screening until their end of study visit which ranged from 24 to 36 months.
|
0.00%
0/2 • Adverse event data was collected from the subject's date of screening until their end of study visit which ranged from 24 to 36 months.
|
20.0%
1/5 • Number of events 1 • Adverse event data was collected from the subject's date of screening until their end of study visit which ranged from 24 to 36 months.
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/2 • Adverse event data was collected from the subject's date of screening until their end of study visit which ranged from 24 to 36 months.
|
0.00%
0/2 • Adverse event data was collected from the subject's date of screening until their end of study visit which ranged from 24 to 36 months.
|
40.0%
2/5 • Number of events 2 • Adverse event data was collected from the subject's date of screening until their end of study visit which ranged from 24 to 36 months.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
50.0%
1/2 • Number of events 1 • Adverse event data was collected from the subject's date of screening until their end of study visit which ranged from 24 to 36 months.
|
0.00%
0/2 • Adverse event data was collected from the subject's date of screening until their end of study visit which ranged from 24 to 36 months.
|
20.0%
1/5 • Number of events 1 • Adverse event data was collected from the subject's date of screening until their end of study visit which ranged from 24 to 36 months.
|
|
Product Issues
Device Loosening
|
0.00%
0/2 • Adverse event data was collected from the subject's date of screening until their end of study visit which ranged from 24 to 36 months.
|
0.00%
0/2 • Adverse event data was collected from the subject's date of screening until their end of study visit which ranged from 24 to 36 months.
|
20.0%
1/5 • Number of events 1 • Adverse event data was collected from the subject's date of screening until their end of study visit which ranged from 24 to 36 months.
|
|
Infections and infestations
Bronchitis
|
50.0%
1/2 • Number of events 1 • Adverse event data was collected from the subject's date of screening until their end of study visit which ranged from 24 to 36 months.
|
0.00%
0/2 • Adverse event data was collected from the subject's date of screening until their end of study visit which ranged from 24 to 36 months.
|
20.0%
1/5 • Number of events 1 • Adverse event data was collected from the subject's date of screening until their end of study visit which ranged from 24 to 36 months.
|
|
Cardiac disorders
Atrial Fibrillation
|
0.00%
0/2 • Adverse event data was collected from the subject's date of screening until their end of study visit which ranged from 24 to 36 months.
|
50.0%
1/2 • Number of events 1 • Adverse event data was collected from the subject's date of screening until their end of study visit which ranged from 24 to 36 months.
|
0.00%
0/5 • Adverse event data was collected from the subject's date of screening until their end of study visit which ranged from 24 to 36 months.
|
|
Gastrointestinal disorders
Incarcerated Umbilical Hernia
|
0.00%
0/2 • Adverse event data was collected from the subject's date of screening until their end of study visit which ranged from 24 to 36 months.
|
0.00%
0/2 • Adverse event data was collected from the subject's date of screening until their end of study visit which ranged from 24 to 36 months.
|
20.0%
1/5 • Number of events 1 • Adverse event data was collected from the subject's date of screening until their end of study visit which ranged from 24 to 36 months.
|
|
General disorders
Pyrexia
|
0.00%
0/2 • Adverse event data was collected from the subject's date of screening until their end of study visit which ranged from 24 to 36 months.
|
0.00%
0/2 • Adverse event data was collected from the subject's date of screening until their end of study visit which ranged from 24 to 36 months.
|
20.0%
1/5 • Number of events 1 • Adverse event data was collected from the subject's date of screening until their end of study visit which ranged from 24 to 36 months.
|
|
Musculoskeletal and connective tissue disorders
Spinal Stenosis
|
0.00%
0/2 • Adverse event data was collected from the subject's date of screening until their end of study visit which ranged from 24 to 36 months.
|
0.00%
0/2 • Adverse event data was collected from the subject's date of screening until their end of study visit which ranged from 24 to 36 months.
|
20.0%
1/5 • Number of events 1 • Adverse event data was collected from the subject's date of screening until their end of study visit which ranged from 24 to 36 months.
|
|
Blood and lymphatic system disorders
Anemia
|
0.00%
0/2 • Adverse event data was collected from the subject's date of screening until their end of study visit which ranged from 24 to 36 months.
|
50.0%
1/2 • Number of events 1 • Adverse event data was collected from the subject's date of screening until their end of study visit which ranged from 24 to 36 months.
|
0.00%
0/5 • Adverse event data was collected from the subject's date of screening until their end of study visit which ranged from 24 to 36 months.
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.00%
0/2 • Adverse event data was collected from the subject's date of screening until their end of study visit which ranged from 24 to 36 months.
|
0.00%
0/2 • Adverse event data was collected from the subject's date of screening until their end of study visit which ranged from 24 to 36 months.
|
20.0%
1/5 • Number of events 1 • Adverse event data was collected from the subject's date of screening until their end of study visit which ranged from 24 to 36 months.
|
|
Blood and lymphatic system disorders
Splenomegaly
|
0.00%
0/2 • Adverse event data was collected from the subject's date of screening until their end of study visit which ranged from 24 to 36 months.
|
0.00%
0/2 • Adverse event data was collected from the subject's date of screening until their end of study visit which ranged from 24 to 36 months.
|
20.0%
1/5 • Number of events 1 • Adverse event data was collected from the subject's date of screening until their end of study visit which ranged from 24 to 36 months.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/2 • Adverse event data was collected from the subject's date of screening until their end of study visit which ranged from 24 to 36 months.
|
0.00%
0/2 • Adverse event data was collected from the subject's date of screening until their end of study visit which ranged from 24 to 36 months.
|
20.0%
1/5 • Number of events 1 • Adverse event data was collected from the subject's date of screening until their end of study visit which ranged from 24 to 36 months.
|
|
Vascular disorders
Aortic Stenosis
|
50.0%
1/2 • Number of events 1 • Adverse event data was collected from the subject's date of screening until their end of study visit which ranged from 24 to 36 months.
|
0.00%
0/2 • Adverse event data was collected from the subject's date of screening until their end of study visit which ranged from 24 to 36 months.
|
0.00%
0/5 • Adverse event data was collected from the subject's date of screening until their end of study visit which ranged from 24 to 36 months.
|
|
Cardiac disorders
Cardiomegaly
|
0.00%
0/2 • Adverse event data was collected from the subject's date of screening until their end of study visit which ranged from 24 to 36 months.
|
0.00%
0/2 • Adverse event data was collected from the subject's date of screening until their end of study visit which ranged from 24 to 36 months.
|
20.0%
1/5 • Number of events 1 • Adverse event data was collected from the subject's date of screening until their end of study visit which ranged from 24 to 36 months.
|
|
Cardiac disorders
Left Atrial Dilatation
|
0.00%
0/2 • Adverse event data was collected from the subject's date of screening until their end of study visit which ranged from 24 to 36 months.
|
50.0%
1/2 • Number of events 1 • Adverse event data was collected from the subject's date of screening until their end of study visit which ranged from 24 to 36 months.
|
0.00%
0/5 • Adverse event data was collected from the subject's date of screening until their end of study visit which ranged from 24 to 36 months.
|
|
Musculoskeletal and connective tissue disorders
Lumbar Spinal Stenosis
|
0.00%
0/2 • Adverse event data was collected from the subject's date of screening until their end of study visit which ranged from 24 to 36 months.
|
0.00%
0/2 • Adverse event data was collected from the subject's date of screening until their end of study visit which ranged from 24 to 36 months.
|
20.0%
1/5 • Number of events 1 • Adverse event data was collected from the subject's date of screening until their end of study visit which ranged from 24 to 36 months.
|
|
Cardiac disorders
Mitral Spinal Stenosis
|
0.00%
0/2 • Adverse event data was collected from the subject's date of screening until their end of study visit which ranged from 24 to 36 months.
|
50.0%
1/2 • Number of events 1 • Adverse event data was collected from the subject's date of screening until their end of study visit which ranged from 24 to 36 months.
|
0.00%
0/5 • Adverse event data was collected from the subject's date of screening until their end of study visit which ranged from 24 to 36 months.
|
|
Cardiac disorders
Palpatations
|
0.00%
0/2 • Adverse event data was collected from the subject's date of screening until their end of study visit which ranged from 24 to 36 months.
|
50.0%
1/2 • Number of events 4 • Adverse event data was collected from the subject's date of screening until their end of study visit which ranged from 24 to 36 months.
|
0.00%
0/5 • Adverse event data was collected from the subject's date of screening until their end of study visit which ranged from 24 to 36 months.
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/2 • Adverse event data was collected from the subject's date of screening until their end of study visit which ranged from 24 to 36 months.
|
0.00%
0/2 • Adverse event data was collected from the subject's date of screening until their end of study visit which ranged from 24 to 36 months.
|
20.0%
1/5 • Number of events 1 • Adverse event data was collected from the subject's date of screening until their end of study visit which ranged from 24 to 36 months.
|
|
Cardiac disorders
Tachypnea
|
0.00%
0/2 • Adverse event data was collected from the subject's date of screening until their end of study visit which ranged from 24 to 36 months.
|
0.00%
0/2 • Adverse event data was collected from the subject's date of screening until their end of study visit which ranged from 24 to 36 months.
|
20.0%
1/5 • Number of events 1 • Adverse event data was collected from the subject's date of screening until their end of study visit which ranged from 24 to 36 months.
|
|
Ear and labyrinth disorders
Ear Congestion
|
0.00%
0/2 • Adverse event data was collected from the subject's date of screening until their end of study visit which ranged from 24 to 36 months.
|
0.00%
0/2 • Adverse event data was collected from the subject's date of screening until their end of study visit which ranged from 24 to 36 months.
|
40.0%
2/5 • Number of events 2 • Adverse event data was collected from the subject's date of screening until their end of study visit which ranged from 24 to 36 months.
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/2 • Adverse event data was collected from the subject's date of screening until their end of study visit which ranged from 24 to 36 months.
|
0.00%
0/2 • Adverse event data was collected from the subject's date of screening until their end of study visit which ranged from 24 to 36 months.
|
20.0%
1/5 • Number of events 1 • Adverse event data was collected from the subject's date of screening until their end of study visit which ranged from 24 to 36 months.
|
|
Eye disorders
Vision Blurred
|
0.00%
0/2 • Adverse event data was collected from the subject's date of screening until their end of study visit which ranged from 24 to 36 months.
|
0.00%
0/2 • Adverse event data was collected from the subject's date of screening until their end of study visit which ranged from 24 to 36 months.
|
20.0%
1/5 • Number of events 1 • Adverse event data was collected from the subject's date of screening until their end of study visit which ranged from 24 to 36 months.
|
|
Eye disorders
Visual Impairment
|
0.00%
0/2 • Adverse event data was collected from the subject's date of screening until their end of study visit which ranged from 24 to 36 months.
|
0.00%
0/2 • Adverse event data was collected from the subject's date of screening until their end of study visit which ranged from 24 to 36 months.
|
20.0%
1/5 • Number of events 1 • Adverse event data was collected from the subject's date of screening until their end of study visit which ranged from 24 to 36 months.
|
|
Gastrointestinal disorders
Abdomen Pain, Upper
|
0.00%
0/2 • Adverse event data was collected from the subject's date of screening until their end of study visit which ranged from 24 to 36 months.
|
50.0%
1/2 • Number of events 1 • Adverse event data was collected from the subject's date of screening until their end of study visit which ranged from 24 to 36 months.
|
20.0%
1/5 • Number of events 1 • Adverse event data was collected from the subject's date of screening until their end of study visit which ranged from 24 to 36 months.
|
|
Gastrointestinal disorders
Abdominal Discomfort
|
0.00%
0/2 • Adverse event data was collected from the subject's date of screening until their end of study visit which ranged from 24 to 36 months.
|
50.0%
1/2 • Number of events 1 • Adverse event data was collected from the subject's date of screening until their end of study visit which ranged from 24 to 36 months.
|
0.00%
0/5 • Adverse event data was collected from the subject's date of screening until their end of study visit which ranged from 24 to 36 months.
|
|
Gastrointestinal disorders
Abdominal Pain
|
0.00%
0/2 • Adverse event data was collected from the subject's date of screening until their end of study visit which ranged from 24 to 36 months.
|
50.0%
1/2 • Number of events 1 • Adverse event data was collected from the subject's date of screening until their end of study visit which ranged from 24 to 36 months.
|
20.0%
1/5 • Number of events 1 • Adverse event data was collected from the subject's date of screening until their end of study visit which ranged from 24 to 36 months.
|
|
Gastrointestinal disorders
Abdominal Pain, Lower
|
0.00%
0/2 • Adverse event data was collected from the subject's date of screening until their end of study visit which ranged from 24 to 36 months.
|
50.0%
1/2 • Number of events 1 • Adverse event data was collected from the subject's date of screening until their end of study visit which ranged from 24 to 36 months.
|
0.00%
0/5 • Adverse event data was collected from the subject's date of screening until their end of study visit which ranged from 24 to 36 months.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/2 • Adverse event data was collected from the subject's date of screening until their end of study visit which ranged from 24 to 36 months.
|
50.0%
1/2 • Number of events 1 • Adverse event data was collected from the subject's date of screening until their end of study visit which ranged from 24 to 36 months.
|
20.0%
1/5 • Number of events 1 • Adverse event data was collected from the subject's date of screening until their end of study visit which ranged from 24 to 36 months.
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/2 • Adverse event data was collected from the subject's date of screening until their end of study visit which ranged from 24 to 36 months.
|
0.00%
0/2 • Adverse event data was collected from the subject's date of screening until their end of study visit which ranged from 24 to 36 months.
|
20.0%
1/5 • Number of events 1 • Adverse event data was collected from the subject's date of screening until their end of study visit which ranged from 24 to 36 months.
|
|
Gastrointestinal disorders
Dyspepsia
|
50.0%
1/2 • Number of events 2 • Adverse event data was collected from the subject's date of screening until their end of study visit which ranged from 24 to 36 months.
|
0.00%
0/2 • Adverse event data was collected from the subject's date of screening until their end of study visit which ranged from 24 to 36 months.
|
20.0%
1/5 • Number of events 2 • Adverse event data was collected from the subject's date of screening until their end of study visit which ranged from 24 to 36 months.
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/2 • Adverse event data was collected from the subject's date of screening until their end of study visit which ranged from 24 to 36 months.
|
0.00%
0/2 • Adverse event data was collected from the subject's date of screening until their end of study visit which ranged from 24 to 36 months.
|
20.0%
1/5 • Number of events 1 • Adverse event data was collected from the subject's date of screening until their end of study visit which ranged from 24 to 36 months.
|
|
Gastrointestinal disorders
Food Poisoning
|
0.00%
0/2 • Adverse event data was collected from the subject's date of screening until their end of study visit which ranged from 24 to 36 months.
|
0.00%
0/2 • Adverse event data was collected from the subject's date of screening until their end of study visit which ranged from 24 to 36 months.
|
20.0%
1/5 • Number of events 1 • Adverse event data was collected from the subject's date of screening until their end of study visit which ranged from 24 to 36 months.
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/2 • Adverse event data was collected from the subject's date of screening until their end of study visit which ranged from 24 to 36 months.
|
0.00%
0/2 • Adverse event data was collected from the subject's date of screening until their end of study visit which ranged from 24 to 36 months.
|
20.0%
1/5 • Number of events 1 • Adverse event data was collected from the subject's date of screening until their end of study visit which ranged from 24 to 36 months.
|
|
Gastrointestinal disorders
Gastroesophageal Reflux Disease
|
50.0%
1/2 • Number of events 4 • Adverse event data was collected from the subject's date of screening until their end of study visit which ranged from 24 to 36 months.
|
0.00%
0/2 • Adverse event data was collected from the subject's date of screening until their end of study visit which ranged from 24 to 36 months.
|
20.0%
1/5 • Number of events 1 • Adverse event data was collected from the subject's date of screening until their end of study visit which ranged from 24 to 36 months.
|
|
Gastrointestinal disorders
Jejunal Stenosis
|
0.00%
0/2 • Adverse event data was collected from the subject's date of screening until their end of study visit which ranged from 24 to 36 months.
|
0.00%
0/2 • Adverse event data was collected from the subject's date of screening until their end of study visit which ranged from 24 to 36 months.
|
20.0%
1/5 • Number of events 1 • Adverse event data was collected from the subject's date of screening until their end of study visit which ranged from 24 to 36 months.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/2 • Adverse event data was collected from the subject's date of screening until their end of study visit which ranged from 24 to 36 months.
|
50.0%
1/2 • Number of events 1 • Adverse event data was collected from the subject's date of screening until their end of study visit which ranged from 24 to 36 months.
|
40.0%
2/5 • Number of events 2 • Adverse event data was collected from the subject's date of screening until their end of study visit which ranged from 24 to 36 months.
|
|
Gastrointestinal disorders
Oesophageal Stenosis
|
0.00%
0/2 • Adverse event data was collected from the subject's date of screening until their end of study visit which ranged from 24 to 36 months.
|
0.00%
0/2 • Adverse event data was collected from the subject's date of screening until their end of study visit which ranged from 24 to 36 months.
|
20.0%
1/5 • Number of events 1 • Adverse event data was collected from the subject's date of screening until their end of study visit which ranged from 24 to 36 months.
|
|
Gastrointestinal disorders
Pancreatic Cyst
|
0.00%
0/2 • Adverse event data was collected from the subject's date of screening until their end of study visit which ranged from 24 to 36 months.
|
0.00%
0/2 • Adverse event data was collected from the subject's date of screening until their end of study visit which ranged from 24 to 36 months.
|
20.0%
1/5 • Number of events 1 • Adverse event data was collected from the subject's date of screening until their end of study visit which ranged from 24 to 36 months.
|
|
General disorders
Chest Pain
|
50.0%
1/2 • Number of events 1 • Adverse event data was collected from the subject's date of screening until their end of study visit which ranged from 24 to 36 months.
|
0.00%
0/2 • Adverse event data was collected from the subject's date of screening until their end of study visit which ranged from 24 to 36 months.
|
0.00%
0/5 • Adverse event data was collected from the subject's date of screening until their end of study visit which ranged from 24 to 36 months.
|
|
General disorders
Fatigue
|
0.00%
0/2 • Adverse event data was collected from the subject's date of screening until their end of study visit which ranged from 24 to 36 months.
|
50.0%
1/2 • Number of events 1 • Adverse event data was collected from the subject's date of screening until their end of study visit which ranged from 24 to 36 months.
|
20.0%
1/5 • Number of events 2 • Adverse event data was collected from the subject's date of screening until their end of study visit which ranged from 24 to 36 months.
|
|
General disorders
Impaired Healing
|
0.00%
0/2 • Adverse event data was collected from the subject's date of screening until their end of study visit which ranged from 24 to 36 months.
|
0.00%
0/2 • Adverse event data was collected from the subject's date of screening until their end of study visit which ranged from 24 to 36 months.
|
20.0%
1/5 • Number of events 1 • Adverse event data was collected from the subject's date of screening until their end of study visit which ranged from 24 to 36 months.
|
|
General disorders
Influenza like Illness
|
0.00%
0/2 • Adverse event data was collected from the subject's date of screening until their end of study visit which ranged from 24 to 36 months.
|
0.00%
0/2 • Adverse event data was collected from the subject's date of screening until their end of study visit which ranged from 24 to 36 months.
|
20.0%
1/5 • Number of events 1 • Adverse event data was collected from the subject's date of screening until their end of study visit which ranged from 24 to 36 months.
|
|
General disorders
Non-Cardiac Chest Pain
|
0.00%
0/2 • Adverse event data was collected from the subject's date of screening until their end of study visit which ranged from 24 to 36 months.
|
0.00%
0/2 • Adverse event data was collected from the subject's date of screening until their end of study visit which ranged from 24 to 36 months.
|
20.0%
1/5 • Number of events 1 • Adverse event data was collected from the subject's date of screening until their end of study visit which ranged from 24 to 36 months.
|
|
General disorders
Prosthetic Cardiac Valve Stenosis
|
0.00%
0/2 • Adverse event data was collected from the subject's date of screening until their end of study visit which ranged from 24 to 36 months.
|
0.00%
0/2 • Adverse event data was collected from the subject's date of screening until their end of study visit which ranged from 24 to 36 months.
|
20.0%
1/5 • Number of events 1 • Adverse event data was collected from the subject's date of screening until their end of study visit which ranged from 24 to 36 months.
|
|
General disorders
Thirst
|
0.00%
0/2 • Adverse event data was collected from the subject's date of screening until their end of study visit which ranged from 24 to 36 months.
|
50.0%
1/2 • Number of events 1 • Adverse event data was collected from the subject's date of screening until their end of study visit which ranged from 24 to 36 months.
|
0.00%
0/5 • Adverse event data was collected from the subject's date of screening until their end of study visit which ranged from 24 to 36 months.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/2 • Adverse event data was collected from the subject's date of screening until their end of study visit which ranged from 24 to 36 months.
|
0.00%
0/2 • Adverse event data was collected from the subject's date of screening until their end of study visit which ranged from 24 to 36 months.
|
20.0%
1/5 • Number of events 1 • Adverse event data was collected from the subject's date of screening until their end of study visit which ranged from 24 to 36 months.
|
|
Infections and infestations
Gastroenteritis Viral
|
0.00%
0/2 • Adverse event data was collected from the subject's date of screening until their end of study visit which ranged from 24 to 36 months.
|
50.0%
1/2 • Number of events 1 • Adverse event data was collected from the subject's date of screening until their end of study visit which ranged from 24 to 36 months.
|
0.00%
0/5 • Adverse event data was collected from the subject's date of screening until their end of study visit which ranged from 24 to 36 months.
|
|
Hepatobiliary disorders
Hepatocellular Injury
|
0.00%
0/2 • Adverse event data was collected from the subject's date of screening until their end of study visit which ranged from 24 to 36 months.
|
50.0%
1/2 • Number of events 1 • Adverse event data was collected from the subject's date of screening until their end of study visit which ranged from 24 to 36 months.
|
0.00%
0/5 • Adverse event data was collected from the subject's date of screening until their end of study visit which ranged from 24 to 36 months.
|
|
Hepatobiliary disorders
Hepatomegaly
|
0.00%
0/2 • Adverse event data was collected from the subject's date of screening until their end of study visit which ranged from 24 to 36 months.
|
0.00%
0/2 • Adverse event data was collected from the subject's date of screening until their end of study visit which ranged from 24 to 36 months.
|
40.0%
2/5 • Number of events 2 • Adverse event data was collected from the subject's date of screening until their end of study visit which ranged from 24 to 36 months.
|
|
Hepatobiliary disorders
Mild Fibrosis in few portal tracts
|
0.00%
0/2 • Adverse event data was collected from the subject's date of screening until their end of study visit which ranged from 24 to 36 months.
|
0.00%
0/2 • Adverse event data was collected from the subject's date of screening until their end of study visit which ranged from 24 to 36 months.
|
20.0%
1/5 • Number of events 1 • Adverse event data was collected from the subject's date of screening until their end of study visit which ranged from 24 to 36 months.
|
|
Hepatobiliary disorders
Portal Fibrosis
|
0.00%
0/2 • Adverse event data was collected from the subject's date of screening until their end of study visit which ranged from 24 to 36 months.
|
0.00%
0/2 • Adverse event data was collected from the subject's date of screening until their end of study visit which ranged from 24 to 36 months.
|
20.0%
1/5 • Number of events 1 • Adverse event data was collected from the subject's date of screening until their end of study visit which ranged from 24 to 36 months.
|
|
Immune system disorders
Seasonal Allergy
|
0.00%
0/2 • Adverse event data was collected from the subject's date of screening until their end of study visit which ranged from 24 to 36 months.
|
0.00%
0/2 • Adverse event data was collected from the subject's date of screening until their end of study visit which ranged from 24 to 36 months.
|
20.0%
1/5 • Number of events 1 • Adverse event data was collected from the subject's date of screening until their end of study visit which ranged from 24 to 36 months.
|
|
Infections and infestations
Bacterial Test Positive
|
0.00%
0/2 • Adverse event data was collected from the subject's date of screening until their end of study visit which ranged from 24 to 36 months.
|
0.00%
0/2 • Adverse event data was collected from the subject's date of screening until their end of study visit which ranged from 24 to 36 months.
|
20.0%
1/5 • Number of events 1 • Adverse event data was collected from the subject's date of screening until their end of study visit which ranged from 24 to 36 months.
|
|
Investigations
Blood Urine Present
|
0.00%
0/2 • Adverse event data was collected from the subject's date of screening until their end of study visit which ranged from 24 to 36 months.
|
0.00%
0/2 • Adverse event data was collected from the subject's date of screening until their end of study visit which ranged from 24 to 36 months.
|
20.0%
1/5 • Number of events 1 • Adverse event data was collected from the subject's date of screening until their end of study visit which ranged from 24 to 36 months.
|
|
Infections and infestations
Ear Infection
|
50.0%
1/2 • Number of events 1 • Adverse event data was collected from the subject's date of screening until their end of study visit which ranged from 24 to 36 months.
|
0.00%
0/2 • Adverse event data was collected from the subject's date of screening until their end of study visit which ranged from 24 to 36 months.
|
20.0%
1/5 • Number of events 1 • Adverse event data was collected from the subject's date of screening until their end of study visit which ranged from 24 to 36 months.
|
|
Infections and infestations
Sinusitis
|
0.00%
0/2 • Adverse event data was collected from the subject's date of screening until their end of study visit which ranged from 24 to 36 months.
|
0.00%
0/2 • Adverse event data was collected from the subject's date of screening until their end of study visit which ranged from 24 to 36 months.
|
20.0%
1/5 • Number of events 1 • Adverse event data was collected from the subject's date of screening until their end of study visit which ranged from 24 to 36 months.
|
|
Infections and infestations
Skin Candida
|
0.00%
0/2 • Adverse event data was collected from the subject's date of screening until their end of study visit which ranged from 24 to 36 months.
|
0.00%
0/2 • Adverse event data was collected from the subject's date of screening until their end of study visit which ranged from 24 to 36 months.
|
20.0%
1/5 • Number of events 1 • Adverse event data was collected from the subject's date of screening until their end of study visit which ranged from 24 to 36 months.
|
|
Respiratory, thoracic and mediastinal disorders
Upper Respiratory Tract Congestion
|
0.00%
0/2 • Adverse event data was collected from the subject's date of screening until their end of study visit which ranged from 24 to 36 months.
|
50.0%
1/2 • Number of events 1 • Adverse event data was collected from the subject's date of screening until their end of study visit which ranged from 24 to 36 months.
|
20.0%
1/5 • Number of events 1 • Adverse event data was collected from the subject's date of screening until their end of study visit which ranged from 24 to 36 months.
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
100.0%
2/2 • Number of events 8 • Adverse event data was collected from the subject's date of screening until their end of study visit which ranged from 24 to 36 months.
|
0.00%
0/2 • Adverse event data was collected from the subject's date of screening until their end of study visit which ranged from 24 to 36 months.
|
0.00%
0/5 • Adverse event data was collected from the subject's date of screening until their end of study visit which ranged from 24 to 36 months.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/2 • Adverse event data was collected from the subject's date of screening until their end of study visit which ranged from 24 to 36 months.
|
50.0%
1/2 • Number of events 2 • Adverse event data was collected from the subject's date of screening until their end of study visit which ranged from 24 to 36 months.
|
20.0%
1/5 • Number of events 2 • Adverse event data was collected from the subject's date of screening until their end of study visit which ranged from 24 to 36 months.
|
|
Injury, poisoning and procedural complications
Incision Site Pain
|
0.00%
0/2 • Adverse event data was collected from the subject's date of screening until their end of study visit which ranged from 24 to 36 months.
|
0.00%
0/2 • Adverse event data was collected from the subject's date of screening until their end of study visit which ranged from 24 to 36 months.
|
20.0%
1/5 • Number of events 1 • Adverse event data was collected from the subject's date of screening until their end of study visit which ranged from 24 to 36 months.
|
|
Injury, poisoning and procedural complications
Infusion Related Reaction
|
0.00%
0/2 • Adverse event data was collected from the subject's date of screening until their end of study visit which ranged from 24 to 36 months.
|
50.0%
1/2 • Number of events 1 • Adverse event data was collected from the subject's date of screening until their end of study visit which ranged from 24 to 36 months.
|
20.0%
1/5 • Number of events 1 • Adverse event data was collected from the subject's date of screening until their end of study visit which ranged from 24 to 36 months.
|
|
Injury, poisoning and procedural complications
Post Procedural Discharge
|
0.00%
0/2 • Adverse event data was collected from the subject's date of screening until their end of study visit which ranged from 24 to 36 months.
|
0.00%
0/2 • Adverse event data was collected from the subject's date of screening until their end of study visit which ranged from 24 to 36 months.
|
20.0%
1/5 • Number of events 2 • Adverse event data was collected from the subject's date of screening until their end of study visit which ranged from 24 to 36 months.
|
|
Injury, poisoning and procedural complications
Post Procedural Hematoma
|
0.00%
0/2 • Adverse event data was collected from the subject's date of screening until their end of study visit which ranged from 24 to 36 months.
|
0.00%
0/2 • Adverse event data was collected from the subject's date of screening until their end of study visit which ranged from 24 to 36 months.
|
20.0%
1/5 • Number of events 1 • Adverse event data was collected from the subject's date of screening until their end of study visit which ranged from 24 to 36 months.
|
|
Injury, poisoning and procedural complications
Post Procedural Vomiting
|
0.00%
0/2 • Adverse event data was collected from the subject's date of screening until their end of study visit which ranged from 24 to 36 months.
|
0.00%
0/2 • Adverse event data was collected from the subject's date of screening until their end of study visit which ranged from 24 to 36 months.
|
20.0%
1/5 • Number of events 1 • Adverse event data was collected from the subject's date of screening until their end of study visit which ranged from 24 to 36 months.
|
|
Injury, poisoning and procedural complications
Procedural Pain
|
50.0%
1/2 • Number of events 2 • Adverse event data was collected from the subject's date of screening until their end of study visit which ranged from 24 to 36 months.
|
100.0%
2/2 • Number of events 3 • Adverse event data was collected from the subject's date of screening until their end of study visit which ranged from 24 to 36 months.
|
40.0%
2/5 • Number of events 3 • Adverse event data was collected from the subject's date of screening until their end of study visit which ranged from 24 to 36 months.
|
|
Injury, poisoning and procedural complications
Skin Abrasion
|
0.00%
0/2 • Adverse event data was collected from the subject's date of screening until their end of study visit which ranged from 24 to 36 months.
|
0.00%
0/2 • Adverse event data was collected from the subject's date of screening until their end of study visit which ranged from 24 to 36 months.
|
20.0%
1/5 • Number of events 1 • Adverse event data was collected from the subject's date of screening until their end of study visit which ranged from 24 to 36 months.
|
|
Injury, poisoning and procedural complications
Sunburn
|
0.00%
0/2 • Adverse event data was collected from the subject's date of screening until their end of study visit which ranged from 24 to 36 months.
|
50.0%
1/2 • Number of events 1 • Adverse event data was collected from the subject's date of screening until their end of study visit which ranged from 24 to 36 months.
|
0.00%
0/5 • Adverse event data was collected from the subject's date of screening until their end of study visit which ranged from 24 to 36 months.
|
|
Investigations
Alanine Aminotransferase Increased
|
50.0%
1/2 • Number of events 1 • Adverse event data was collected from the subject's date of screening until their end of study visit which ranged from 24 to 36 months.
|
50.0%
1/2 • Number of events 1 • Adverse event data was collected from the subject's date of screening until their end of study visit which ranged from 24 to 36 months.
|
40.0%
2/5 • Number of events 2 • Adverse event data was collected from the subject's date of screening until their end of study visit which ranged from 24 to 36 months.
|
|
Investigations
Aspartate Aminotransferase Increased
|
50.0%
1/2 • Number of events 1 • Adverse event data was collected from the subject's date of screening until their end of study visit which ranged from 24 to 36 months.
|
50.0%
1/2 • Number of events 2 • Adverse event data was collected from the subject's date of screening until their end of study visit which ranged from 24 to 36 months.
|
40.0%
2/5 • Number of events 2 • Adverse event data was collected from the subject's date of screening until their end of study visit which ranged from 24 to 36 months.
|
|
Investigations
Blood Phosphorus Decreased
|
0.00%
0/2 • Adverse event data was collected from the subject's date of screening until their end of study visit which ranged from 24 to 36 months.
|
0.00%
0/2 • Adverse event data was collected from the subject's date of screening until their end of study visit which ranged from 24 to 36 months.
|
20.0%
1/5 • Number of events 1 • Adverse event data was collected from the subject's date of screening until their end of study visit which ranged from 24 to 36 months.
|
|
Investigations
Blood Pressure Systolic Increased
|
0.00%
0/2 • Adverse event data was collected from the subject's date of screening until their end of study visit which ranged from 24 to 36 months.
|
0.00%
0/2 • Adverse event data was collected from the subject's date of screening until their end of study visit which ranged from 24 to 36 months.
|
20.0%
1/5 • Number of events 4 • Adverse event data was collected from the subject's date of screening until their end of study visit which ranged from 24 to 36 months.
|
|
Investigations
Blood Thyroid Stimulating Hormone Increased
|
0.00%
0/2 • Adverse event data was collected from the subject's date of screening until their end of study visit which ranged from 24 to 36 months.
|
0.00%
0/2 • Adverse event data was collected from the subject's date of screening until their end of study visit which ranged from 24 to 36 months.
|
20.0%
1/5 • Number of events 1 • Adverse event data was collected from the subject's date of screening until their end of study visit which ranged from 24 to 36 months.
|
|
Investigations
CSF Glucose Decreased
|
0.00%
0/2 • Adverse event data was collected from the subject's date of screening until their end of study visit which ranged from 24 to 36 months.
|
50.0%
1/2 • Number of events 1 • Adverse event data was collected from the subject's date of screening until their end of study visit which ranged from 24 to 36 months.
|
0.00%
0/5 • Adverse event data was collected from the subject's date of screening until their end of study visit which ranged from 24 to 36 months.
|
|
Investigations
Crystals Urine Present
|
0.00%
0/2 • Adverse event data was collected from the subject's date of screening until their end of study visit which ranged from 24 to 36 months.
|
0.00%
0/2 • Adverse event data was collected from the subject's date of screening until their end of study visit which ranged from 24 to 36 months.
|
40.0%
2/5 • Number of events 2 • Adverse event data was collected from the subject's date of screening until their end of study visit which ranged from 24 to 36 months.
|
|
Investigations
Decreased Phosphorous
|
0.00%
0/2 • Adverse event data was collected from the subject's date of screening until their end of study visit which ranged from 24 to 36 months.
|
0.00%
0/2 • Adverse event data was collected from the subject's date of screening until their end of study visit which ranged from 24 to 36 months.
|
20.0%
1/5 • Number of events 1 • Adverse event data was collected from the subject's date of screening until their end of study visit which ranged from 24 to 36 months.
|
|
Investigations
Lmphocyte Count Decreased
|
0.00%
0/2 • Adverse event data was collected from the subject's date of screening until their end of study visit which ranged from 24 to 36 months.
|
0.00%
0/2 • Adverse event data was collected from the subject's date of screening until their end of study visit which ranged from 24 to 36 months.
|
20.0%
1/5 • Number of events 1 • Adverse event data was collected from the subject's date of screening until their end of study visit which ranged from 24 to 36 months.
|
|
Investigations
Neutrophils Count Increased
|
0.00%
0/2 • Adverse event data was collected from the subject's date of screening until their end of study visit which ranged from 24 to 36 months.
|
0.00%
0/2 • Adverse event data was collected from the subject's date of screening until their end of study visit which ranged from 24 to 36 months.
|
20.0%
1/5 • Number of events 1 • Adverse event data was collected from the subject's date of screening until their end of study visit which ranged from 24 to 36 months.
|
|
Investigations
Prothrombin Time Prolonged
|
0.00%
0/2 • Adverse event data was collected from the subject's date of screening until their end of study visit which ranged from 24 to 36 months.
|
50.0%
1/2 • Number of events 1 • Adverse event data was collected from the subject's date of screening until their end of study visit which ranged from 24 to 36 months.
|
0.00%
0/5 • Adverse event data was collected from the subject's date of screening until their end of study visit which ranged from 24 to 36 months.
|
|
Investigations
Red Cell Distribution Width Increased
|
0.00%
0/2 • Adverse event data was collected from the subject's date of screening until their end of study visit which ranged from 24 to 36 months.
|
0.00%
0/2 • Adverse event data was collected from the subject's date of screening until their end of study visit which ranged from 24 to 36 months.
|
20.0%
1/5 • Number of events 1 • Adverse event data was collected from the subject's date of screening until their end of study visit which ranged from 24 to 36 months.
|
|
Investigations
Urinary Glycosaminoglycans Increased
|
50.0%
1/2 • Number of events 1 • Adverse event data was collected from the subject's date of screening until their end of study visit which ranged from 24 to 36 months.
|
0.00%
0/2 • Adverse event data was collected from the subject's date of screening until their end of study visit which ranged from 24 to 36 months.
|
20.0%
1/5 • Number of events 1 • Adverse event data was collected from the subject's date of screening until their end of study visit which ranged from 24 to 36 months.
|
|
Investigations
White Blood Cell Count Increased
|
0.00%
0/2 • Adverse event data was collected from the subject's date of screening until their end of study visit which ranged from 24 to 36 months.
|
0.00%
0/2 • Adverse event data was collected from the subject's date of screening until their end of study visit which ranged from 24 to 36 months.
|
20.0%
1/5 • Number of events 1 • Adverse event data was collected from the subject's date of screening until their end of study visit which ranged from 24 to 36 months.
|
|
Metabolism and nutrition disorders
Obesity
|
50.0%
1/2 • Number of events 1 • Adverse event data was collected from the subject's date of screening until their end of study visit which ranged from 24 to 36 months.
|
0.00%
0/2 • Adverse event data was collected from the subject's date of screening until their end of study visit which ranged from 24 to 36 months.
|
0.00%
0/5 • Adverse event data was collected from the subject's date of screening until their end of study visit which ranged from 24 to 36 months.
|
|
Investigations
Weight Decreased.
|
0.00%
0/2 • Adverse event data was collected from the subject's date of screening until their end of study visit which ranged from 24 to 36 months.
|
0.00%
0/2 • Adverse event data was collected from the subject's date of screening until their end of study visit which ranged from 24 to 36 months.
|
20.0%
1/5 • Number of events 1 • Adverse event data was collected from the subject's date of screening until their end of study visit which ranged from 24 to 36 months.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/2 • Adverse event data was collected from the subject's date of screening until their end of study visit which ranged from 24 to 36 months.
|
0.00%
0/2 • Adverse event data was collected from the subject's date of screening until their end of study visit which ranged from 24 to 36 months.
|
40.0%
2/5 • Number of events 2 • Adverse event data was collected from the subject's date of screening until their end of study visit which ranged from 24 to 36 months.
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
50.0%
1/2 • Number of events 1 • Adverse event data was collected from the subject's date of screening until their end of study visit which ranged from 24 to 36 months.
|
50.0%
1/2 • Number of events 2 • Adverse event data was collected from the subject's date of screening until their end of study visit which ranged from 24 to 36 months.
|
20.0%
1/5 • Number of events 1 • Adverse event data was collected from the subject's date of screening until their end of study visit which ranged from 24 to 36 months.
|
|
Musculoskeletal and connective tissue disorders
Bursitis
|
0.00%
0/2 • Adverse event data was collected from the subject's date of screening until their end of study visit which ranged from 24 to 36 months.
|
0.00%
0/2 • Adverse event data was collected from the subject's date of screening until their end of study visit which ranged from 24 to 36 months.
|
20.0%
1/5 • Number of events 1 • Adverse event data was collected from the subject's date of screening until their end of study visit which ranged from 24 to 36 months.
|
|
Musculoskeletal and connective tissue disorders
Cervical Spinal Stenosis
|
0.00%
0/2 • Adverse event data was collected from the subject's date of screening until their end of study visit which ranged from 24 to 36 months.
|
0.00%
0/2 • Adverse event data was collected from the subject's date of screening until their end of study visit which ranged from 24 to 36 months.
|
20.0%
1/5 • Number of events 1 • Adverse event data was collected from the subject's date of screening until their end of study visit which ranged from 24 to 36 months.
|
|
Injury, poisoning and procedural complications
Cervical Vertebral Fracture
|
0.00%
0/2 • Adverse event data was collected from the subject's date of screening until their end of study visit which ranged from 24 to 36 months.
|
0.00%
0/2 • Adverse event data was collected from the subject's date of screening until their end of study visit which ranged from 24 to 36 months.
|
20.0%
1/5 • Number of events 1 • Adverse event data was collected from the subject's date of screening until their end of study visit which ranged from 24 to 36 months.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral Disc Degeneration
|
0.00%
0/2 • Adverse event data was collected from the subject's date of screening until their end of study visit which ranged from 24 to 36 months.
|
0.00%
0/2 • Adverse event data was collected from the subject's date of screening until their end of study visit which ranged from 24 to 36 months.
|
20.0%
1/5 • Number of events 1 • Adverse event data was collected from the subject's date of screening until their end of study visit which ranged from 24 to 36 months.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral Disc Protrusion
|
0.00%
0/2 • Adverse event data was collected from the subject's date of screening until their end of study visit which ranged from 24 to 36 months.
|
0.00%
0/2 • Adverse event data was collected from the subject's date of screening until their end of study visit which ranged from 24 to 36 months.
|
20.0%
1/5 • Number of events 1 • Adverse event data was collected from the subject's date of screening until their end of study visit which ranged from 24 to 36 months.
|
|
Musculoskeletal and connective tissue disorders
Mobility Decreased
|
0.00%
0/2 • Adverse event data was collected from the subject's date of screening until their end of study visit which ranged from 24 to 36 months.
|
50.0%
1/2 • Number of events 1 • Adverse event data was collected from the subject's date of screening until their end of study visit which ranged from 24 to 36 months.
|
0.00%
0/5 • Adverse event data was collected from the subject's date of screening until their end of study visit which ranged from 24 to 36 months.
|
|
Musculoskeletal and connective tissue disorders
Muscle Spasms Musculoskeletal Stiffness
|
0.00%
0/2 • Adverse event data was collected from the subject's date of screening until their end of study visit which ranged from 24 to 36 months.
|
0.00%
0/2 • Adverse event data was collected from the subject's date of screening until their end of study visit which ranged from 24 to 36 months.
|
20.0%
1/5 • Number of events 1 • Adverse event data was collected from the subject's date of screening until their end of study visit which ranged from 24 to 36 months.
|
|
Injury, poisoning and procedural complications
Muscle Strain
|
0.00%
0/2 • Adverse event data was collected from the subject's date of screening until their end of study visit which ranged from 24 to 36 months.
|
50.0%
1/2 • Number of events 1 • Adverse event data was collected from the subject's date of screening until their end of study visit which ranged from 24 to 36 months.
|
0.00%
0/5 • Adverse event data was collected from the subject's date of screening until their end of study visit which ranged from 24 to 36 months.
|
|
Musculoskeletal and connective tissue disorders
Muscular Weakness
|
50.0%
1/2 • Number of events 1 • Adverse event data was collected from the subject's date of screening until their end of study visit which ranged from 24 to 36 months.
|
0.00%
0/2 • Adverse event data was collected from the subject's date of screening until their end of study visit which ranged from 24 to 36 months.
|
20.0%
1/5 • Number of events 1 • Adverse event data was collected from the subject's date of screening until their end of study visit which ranged from 24 to 36 months.
|
|
Musculoskeletal and connective tissue disorders
Pain in Extremity
|
0.00%
0/2 • Adverse event data was collected from the subject's date of screening until their end of study visit which ranged from 24 to 36 months.
|
0.00%
0/2 • Adverse event data was collected from the subject's date of screening until their end of study visit which ranged from 24 to 36 months.
|
20.0%
1/5 • Number of events 1 • Adverse event data was collected from the subject's date of screening until their end of study visit which ranged from 24 to 36 months.
|
|
Nervous system disorders
Cerebral Atrophy
|
0.00%
0/2 • Adverse event data was collected from the subject's date of screening until their end of study visit which ranged from 24 to 36 months.
|
0.00%
0/2 • Adverse event data was collected from the subject's date of screening until their end of study visit which ranged from 24 to 36 months.
|
20.0%
1/5 • Number of events 1 • Adverse event data was collected from the subject's date of screening until their end of study visit which ranged from 24 to 36 months.
|
|
Nervous system disorders
Dizziness
|
50.0%
1/2 • Number of events 1 • Adverse event data was collected from the subject's date of screening until their end of study visit which ranged from 24 to 36 months.
|
0.00%
0/2 • Adverse event data was collected from the subject's date of screening until their end of study visit which ranged from 24 to 36 months.
|
20.0%
1/5 • Number of events 1 • Adverse event data was collected from the subject's date of screening until their end of study visit which ranged from 24 to 36 months.
|
|
Nervous system disorders
Dysarthria
|
0.00%
0/2 • Adverse event data was collected from the subject's date of screening until their end of study visit which ranged from 24 to 36 months.
|
0.00%
0/2 • Adverse event data was collected from the subject's date of screening until their end of study visit which ranged from 24 to 36 months.
|
20.0%
1/5 • Number of events 1 • Adverse event data was collected from the subject's date of screening until their end of study visit which ranged from 24 to 36 months.
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/2 • Adverse event data was collected from the subject's date of screening until their end of study visit which ranged from 24 to 36 months.
|
0.00%
0/2 • Adverse event data was collected from the subject's date of screening until their end of study visit which ranged from 24 to 36 months.
|
20.0%
1/5 • Number of events 1 • Adverse event data was collected from the subject's date of screening until their end of study visit which ranged from 24 to 36 months.
|
|
Nervous system disorders
Hemiparesis
|
0.00%
0/2 • Adverse event data was collected from the subject's date of screening until their end of study visit which ranged from 24 to 36 months.
|
0.00%
0/2 • Adverse event data was collected from the subject's date of screening until their end of study visit which ranged from 24 to 36 months.
|
20.0%
1/5 • Number of events 1 • Adverse event data was collected from the subject's date of screening until their end of study visit which ranged from 24 to 36 months.
|
|
Nervous system disorders
Hypaesthesia
|
0.00%
0/2 • Adverse event data was collected from the subject's date of screening until their end of study visit which ranged from 24 to 36 months.
|
0.00%
0/2 • Adverse event data was collected from the subject's date of screening until their end of study visit which ranged from 24 to 36 months.
|
40.0%
2/5 • Number of events 2 • Adverse event data was collected from the subject's date of screening until their end of study visit which ranged from 24 to 36 months.
|
|
Nervous system disorders
White Matter Lesion
|
0.00%
0/2 • Adverse event data was collected from the subject's date of screening until their end of study visit which ranged from 24 to 36 months.
|
50.0%
1/2 • Number of events 1 • Adverse event data was collected from the subject's date of screening until their end of study visit which ranged from 24 to 36 months.
|
0.00%
0/5 • Adverse event data was collected from the subject's date of screening until their end of study visit which ranged from 24 to 36 months.
|
|
Nervous system disorders
Headache
|
0.00%
0/2 • Adverse event data was collected from the subject's date of screening until their end of study visit which ranged from 24 to 36 months.
|
50.0%
1/2 • Number of events 3 • Adverse event data was collected from the subject's date of screening until their end of study visit which ranged from 24 to 36 months.
|
20.0%
1/5 • Number of events 2 • Adverse event data was collected from the subject's date of screening until their end of study visit which ranged from 24 to 36 months.
|
|
Product Issues
Devise Dislocation
|
0.00%
0/2 • Adverse event data was collected from the subject's date of screening until their end of study visit which ranged from 24 to 36 months.
|
0.00%
0/2 • Adverse event data was collected from the subject's date of screening until their end of study visit which ranged from 24 to 36 months.
|
20.0%
1/5 • Number of events 1 • Adverse event data was collected from the subject's date of screening until their end of study visit which ranged from 24 to 36 months.
|
|
Injury, poisoning and procedural complications
Foreign Body Aspiration
|
50.0%
1/2 • Number of events 1 • Adverse event data was collected from the subject's date of screening until their end of study visit which ranged from 24 to 36 months.
|
0.00%
0/2 • Adverse event data was collected from the subject's date of screening until their end of study visit which ranged from 24 to 36 months.
|
0.00%
0/5 • Adverse event data was collected from the subject's date of screening until their end of study visit which ranged from 24 to 36 months.
|
|
Psychiatric disorders
Agitation
|
0.00%
0/2 • Adverse event data was collected from the subject's date of screening until their end of study visit which ranged from 24 to 36 months.
|
50.0%
1/2 • Number of events 1 • Adverse event data was collected from the subject's date of screening until their end of study visit which ranged from 24 to 36 months.
|
0.00%
0/5 • Adverse event data was collected from the subject's date of screening until their end of study visit which ranged from 24 to 36 months.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/2 • Adverse event data was collected from the subject's date of screening until their end of study visit which ranged from 24 to 36 months.
|
50.0%
1/2 • Number of events 1 • Adverse event data was collected from the subject's date of screening until their end of study visit which ranged from 24 to 36 months.
|
0.00%
0/5 • Adverse event data was collected from the subject's date of screening until their end of study visit which ranged from 24 to 36 months.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/2 • Adverse event data was collected from the subject's date of screening until their end of study visit which ranged from 24 to 36 months.
|
50.0%
1/2 • Number of events 2 • Adverse event data was collected from the subject's date of screening until their end of study visit which ranged from 24 to 36 months.
|
20.0%
1/5 • Number of events 1 • Adverse event data was collected from the subject's date of screening until their end of study visit which ranged from 24 to 36 months.
|
|
Psychiatric disorders
Irritability
|
0.00%
0/2 • Adverse event data was collected from the subject's date of screening until their end of study visit which ranged from 24 to 36 months.
|
0.00%
0/2 • Adverse event data was collected from the subject's date of screening until their end of study visit which ranged from 24 to 36 months.
|
20.0%
1/5 • Number of events 1 • Adverse event data was collected from the subject's date of screening until their end of study visit which ranged from 24 to 36 months.
|
|
Psychiatric disorders
Suicidal Ideation
|
0.00%
0/2 • Adverse event data was collected from the subject's date of screening until their end of study visit which ranged from 24 to 36 months.
|
50.0%
1/2 • Number of events 1 • Adverse event data was collected from the subject's date of screening until their end of study visit which ranged from 24 to 36 months.
|
0.00%
0/5 • Adverse event data was collected from the subject's date of screening until their end of study visit which ranged from 24 to 36 months.
|
|
Infections and infestations
Bacteriuria
|
0.00%
0/2 • Adverse event data was collected from the subject's date of screening until their end of study visit which ranged from 24 to 36 months.
|
0.00%
0/2 • Adverse event data was collected from the subject's date of screening until their end of study visit which ranged from 24 to 36 months.
|
20.0%
1/5 • Number of events 1 • Adverse event data was collected from the subject's date of screening until their end of study visit which ranged from 24 to 36 months.
|
|
Renal and urinary disorders
Hematuria
|
0.00%
0/2 • Adverse event data was collected from the subject's date of screening until their end of study visit which ranged from 24 to 36 months.
|
0.00%
0/2 • Adverse event data was collected from the subject's date of screening until their end of study visit which ranged from 24 to 36 months.
|
20.0%
1/5 • Number of events 1 • Adverse event data was collected from the subject's date of screening until their end of study visit which ranged from 24 to 36 months.
|
|
Renal and urinary disorders
Hepatic Lesion
|
0.00%
0/2 • Adverse event data was collected from the subject's date of screening until their end of study visit which ranged from 24 to 36 months.
|
50.0%
1/2 • Number of events 1 • Adverse event data was collected from the subject's date of screening until their end of study visit which ranged from 24 to 36 months.
|
0.00%
0/5 • Adverse event data was collected from the subject's date of screening until their end of study visit which ranged from 24 to 36 months.
|
|
Renal and urinary disorders
Pollakiuria
|
50.0%
1/2 • Number of events 1 • Adverse event data was collected from the subject's date of screening until their end of study visit which ranged from 24 to 36 months.
|
0.00%
0/2 • Adverse event data was collected from the subject's date of screening until their end of study visit which ranged from 24 to 36 months.
|
0.00%
0/5 • Adverse event data was collected from the subject's date of screening until their end of study visit which ranged from 24 to 36 months.
|
|
Renal and urinary disorders
Proteinuria
|
0.00%
0/2 • Adverse event data was collected from the subject's date of screening until their end of study visit which ranged from 24 to 36 months.
|
0.00%
0/2 • Adverse event data was collected from the subject's date of screening until their end of study visit which ranged from 24 to 36 months.
|
20.0%
1/5 • Number of events 1 • Adverse event data was collected from the subject's date of screening until their end of study visit which ranged from 24 to 36 months.
|
|
Renal and urinary disorders
Renal Cyst
|
50.0%
1/2 • Number of events 1 • Adverse event data was collected from the subject's date of screening until their end of study visit which ranged from 24 to 36 months.
|
0.00%
0/2 • Adverse event data was collected from the subject's date of screening until their end of study visit which ranged from 24 to 36 months.
|
0.00%
0/5 • Adverse event data was collected from the subject's date of screening until their end of study visit which ranged from 24 to 36 months.
|
|
Renal and urinary disorders
Urinary Incontinence
|
0.00%
0/2 • Adverse event data was collected from the subject's date of screening until their end of study visit which ranged from 24 to 36 months.
|
0.00%
0/2 • Adverse event data was collected from the subject's date of screening until their end of study visit which ranged from 24 to 36 months.
|
20.0%
1/5 • Number of events 1 • Adverse event data was collected from the subject's date of screening until their end of study visit which ranged from 24 to 36 months.
|
|
Infections and infestations
Urinary Tract Infection
|
0.00%
0/2 • Adverse event data was collected from the subject's date of screening until their end of study visit which ranged from 24 to 36 months.
|
50.0%
1/2 • Number of events 1 • Adverse event data was collected from the subject's date of screening until their end of study visit which ranged from 24 to 36 months.
|
20.0%
1/5 • Number of events 1 • Adverse event data was collected from the subject's date of screening until their end of study visit which ranged from 24 to 36 months.
|
|
Reproductive system and breast disorders
Scrotal Swelling
|
0.00%
0/2 • Adverse event data was collected from the subject's date of screening until their end of study visit which ranged from 24 to 36 months.
|
0.00%
0/2 • Adverse event data was collected from the subject's date of screening until their end of study visit which ranged from 24 to 36 months.
|
20.0%
1/5 • Number of events 1 • Adverse event data was collected from the subject's date of screening until their end of study visit which ranged from 24 to 36 months.
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
0.00%
0/2 • Adverse event data was collected from the subject's date of screening until their end of study visit which ranged from 24 to 36 months.
|
0.00%
0/2 • Adverse event data was collected from the subject's date of screening until their end of study visit which ranged from 24 to 36 months.
|
20.0%
1/5 • Number of events 1 • Adverse event data was collected from the subject's date of screening until their end of study visit which ranged from 24 to 36 months.
|
|
Infections and infestations
COVID-19
|
0.00%
0/2 • Adverse event data was collected from the subject's date of screening until their end of study visit which ranged from 24 to 36 months.
|
0.00%
0/2 • Adverse event data was collected from the subject's date of screening until their end of study visit which ranged from 24 to 36 months.
|
20.0%
1/5 • Number of events 1 • Adverse event data was collected from the subject's date of screening until their end of study visit which ranged from 24 to 36 months.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
50.0%
1/2 • Number of events 1 • Adverse event data was collected from the subject's date of screening until their end of study visit which ranged from 24 to 36 months.
|
0.00%
0/2 • Adverse event data was collected from the subject's date of screening until their end of study visit which ranged from 24 to 36 months.
|
20.0%
1/5 • Number of events 1 • Adverse event data was collected from the subject's date of screening until their end of study visit which ranged from 24 to 36 months.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/2 • Adverse event data was collected from the subject's date of screening until their end of study visit which ranged from 24 to 36 months.
|
50.0%
1/2 • Number of events 2 • Adverse event data was collected from the subject's date of screening until their end of study visit which ranged from 24 to 36 months.
|
20.0%
1/5 • Number of events 2 • Adverse event data was collected from the subject's date of screening until their end of study visit which ranged from 24 to 36 months.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/2 • Adverse event data was collected from the subject's date of screening until their end of study visit which ranged from 24 to 36 months.
|
0.00%
0/2 • Adverse event data was collected from the subject's date of screening until their end of study visit which ranged from 24 to 36 months.
|
20.0%
1/5 • Number of events 1 • Adverse event data was collected from the subject's date of screening until their end of study visit which ranged from 24 to 36 months.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/2 • Adverse event data was collected from the subject's date of screening until their end of study visit which ranged from 24 to 36 months.
|
0.00%
0/2 • Adverse event data was collected from the subject's date of screening until their end of study visit which ranged from 24 to 36 months.
|
20.0%
1/5 • Number of events 1 • Adverse event data was collected from the subject's date of screening until their end of study visit which ranged from 24 to 36 months.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal Congestion
|
0.00%
0/2 • Adverse event data was collected from the subject's date of screening until their end of study visit which ranged from 24 to 36 months.
|
0.00%
0/2 • Adverse event data was collected from the subject's date of screening until their end of study visit which ranged from 24 to 36 months.
|
40.0%
2/5 • Number of events 2 • Adverse event data was collected from the subject's date of screening until their end of study visit which ranged from 24 to 36 months.
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/2 • Adverse event data was collected from the subject's date of screening until their end of study visit which ranged from 24 to 36 months.
|
50.0%
1/2 • Number of events 1 • Adverse event data was collected from the subject's date of screening until their end of study visit which ranged from 24 to 36 months.
|
0.00%
0/5 • Adverse event data was collected from the subject's date of screening until their end of study visit which ranged from 24 to 36 months.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal Pain
|
0.00%
0/2 • Adverse event data was collected from the subject's date of screening until their end of study visit which ranged from 24 to 36 months.
|
0.00%
0/2 • Adverse event data was collected from the subject's date of screening until their end of study visit which ranged from 24 to 36 months.
|
20.0%
1/5 • Number of events 1 • Adverse event data was collected from the subject's date of screening until their end of study visit which ranged from 24 to 36 months.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/2 • Adverse event data was collected from the subject's date of screening until their end of study visit which ranged from 24 to 36 months.
|
0.00%
0/2 • Adverse event data was collected from the subject's date of screening until their end of study visit which ranged from 24 to 36 months.
|
20.0%
1/5 • Number of events 1 • Adverse event data was collected from the subject's date of screening until their end of study visit which ranged from 24 to 36 months.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
50.0%
1/2 • Number of events 1 • Adverse event data was collected from the subject's date of screening until their end of study visit which ranged from 24 to 36 months.
|
0.00%
0/2 • Adverse event data was collected from the subject's date of screening until their end of study visit which ranged from 24 to 36 months.
|
0.00%
0/5 • Adverse event data was collected from the subject's date of screening until their end of study visit which ranged from 24 to 36 months.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhea
|
0.00%
0/2 • Adverse event data was collected from the subject's date of screening until their end of study visit which ranged from 24 to 36 months.
|
0.00%
0/2 • Adverse event data was collected from the subject's date of screening until their end of study visit which ranged from 24 to 36 months.
|
20.0%
1/5 • Number of events 2 • Adverse event data was collected from the subject's date of screening until their end of study visit which ranged from 24 to 36 months.
|
|
Respiratory, thoracic and mediastinal disorders
Sore Throat
|
0.00%
0/2 • Adverse event data was collected from the subject's date of screening until their end of study visit which ranged from 24 to 36 months.
|
0.00%
0/2 • Adverse event data was collected from the subject's date of screening until their end of study visit which ranged from 24 to 36 months.
|
20.0%
1/5 • Number of events 1 • Adverse event data was collected from the subject's date of screening until their end of study visit which ranged from 24 to 36 months.
|
|
Respiratory, thoracic and mediastinal disorders
Tracheal Disorder
|
0.00%
0/2 • Adverse event data was collected from the subject's date of screening until their end of study visit which ranged from 24 to 36 months.
|
0.00%
0/2 • Adverse event data was collected from the subject's date of screening until their end of study visit which ranged from 24 to 36 months.
|
20.0%
1/5 • Number of events 1 • Adverse event data was collected from the subject's date of screening until their end of study visit which ranged from 24 to 36 months.
|
|
Skin and subcutaneous tissue disorders
Acne
|
50.0%
1/2 • Number of events 1 • Adverse event data was collected from the subject's date of screening until their end of study visit which ranged from 24 to 36 months.
|
0.00%
0/2 • Adverse event data was collected from the subject's date of screening until their end of study visit which ranged from 24 to 36 months.
|
0.00%
0/5 • Adverse event data was collected from the subject's date of screening until their end of study visit which ranged from 24 to 36 months.
|
|
General disorders
Application Site Rash
|
0.00%
0/2 • Adverse event data was collected from the subject's date of screening until their end of study visit which ranged from 24 to 36 months.
|
50.0%
1/2 • Number of events 1 • Adverse event data was collected from the subject's date of screening until their end of study visit which ranged from 24 to 36 months.
|
0.00%
0/5 • Adverse event data was collected from the subject's date of screening until their end of study visit which ranged from 24 to 36 months.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal Cell Carcinoma
|
0.00%
0/2 • Adverse event data was collected from the subject's date of screening until their end of study visit which ranged from 24 to 36 months.
|
0.00%
0/2 • Adverse event data was collected from the subject's date of screening until their end of study visit which ranged from 24 to 36 months.
|
20.0%
1/5 • Number of events 1 • Adverse event data was collected from the subject's date of screening until their end of study visit which ranged from 24 to 36 months.
|
|
Skin and subcutaneous tissue disorders
Cold Sweat
|
50.0%
1/2 • Number of events 1 • Adverse event data was collected from the subject's date of screening until their end of study visit which ranged from 24 to 36 months.
|
0.00%
0/2 • Adverse event data was collected from the subject's date of screening until their end of study visit which ranged from 24 to 36 months.
|
0.00%
0/5 • Adverse event data was collected from the subject's date of screening until their end of study visit which ranged from 24 to 36 months.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/2 • Adverse event data was collected from the subject's date of screening until their end of study visit which ranged from 24 to 36 months.
|
50.0%
1/2 • Number of events 1 • Adverse event data was collected from the subject's date of screening until their end of study visit which ranged from 24 to 36 months.
|
0.00%
0/5 • Adverse event data was collected from the subject's date of screening until their end of study visit which ranged from 24 to 36 months.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
50.0%
1/2 • Number of events 1 • Adverse event data was collected from the subject's date of screening until their end of study visit which ranged from 24 to 36 months.
|
0.00%
0/2 • Adverse event data was collected from the subject's date of screening until their end of study visit which ranged from 24 to 36 months.
|
20.0%
1/5 • Number of events 1 • Adverse event data was collected from the subject's date of screening until their end of study visit which ranged from 24 to 36 months.
|
|
Skin and subcutaneous tissue disorders
Rash on wrists, bilaterally
|
50.0%
1/2 • Number of events 1 • Adverse event data was collected from the subject's date of screening until their end of study visit which ranged from 24 to 36 months.
|
0.00%
0/2 • Adverse event data was collected from the subject's date of screening until their end of study visit which ranged from 24 to 36 months.
|
0.00%
0/5 • Adverse event data was collected from the subject's date of screening until their end of study visit which ranged from 24 to 36 months.
|
|
Skin and subcutaneous tissue disorders
Skin Abrasion
|
0.00%
0/2 • Adverse event data was collected from the subject's date of screening until their end of study visit which ranged from 24 to 36 months.
|
0.00%
0/2 • Adverse event data was collected from the subject's date of screening until their end of study visit which ranged from 24 to 36 months.
|
20.0%
1/5 • Number of events 1 • Adverse event data was collected from the subject's date of screening until their end of study visit which ranged from 24 to 36 months.
|
|
Injury, poisoning and procedural complications
Skin Irritation
|
50.0%
1/2 • Number of events 1 • Adverse event data was collected from the subject's date of screening until their end of study visit which ranged from 24 to 36 months.
|
0.00%
0/2 • Adverse event data was collected from the subject's date of screening until their end of study visit which ranged from 24 to 36 months.
|
0.00%
0/5 • Adverse event data was collected from the subject's date of screening until their end of study visit which ranged from 24 to 36 months.
|
|
Social circumstances
Loss Of Personal Independence In Daily Activities
|
0.00%
0/2 • Adverse event data was collected from the subject's date of screening until their end of study visit which ranged from 24 to 36 months.
|
0.00%
0/2 • Adverse event data was collected from the subject's date of screening until their end of study visit which ranged from 24 to 36 months.
|
20.0%
1/5 • Number of events 1 • Adverse event data was collected from the subject's date of screening until their end of study visit which ranged from 24 to 36 months.
|
|
Vascular disorders
Aortic Dilatation
|
0.00%
0/2 • Adverse event data was collected from the subject's date of screening until their end of study visit which ranged from 24 to 36 months.
|
0.00%
0/2 • Adverse event data was collected from the subject's date of screening until their end of study visit which ranged from 24 to 36 months.
|
20.0%
1/5 • Number of events 1 • Adverse event data was collected from the subject's date of screening until their end of study visit which ranged from 24 to 36 months.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place