Trial Outcomes & Findings for Dose-Ranging Study of ST-920, an AAV2/6 Human Alpha Galactosidase A Gene Therapy in Subjects With Fabry Disease (STAAR) (NCT NCT04046224)
NCT ID: NCT04046224
Last Updated: 2026-04-14
Results Overview
All incidences of Treatment-Emergent Adverse Events (TEAEs) in subjects who receive ST-920 as assessed by Common Terminology Criteria for Adverse Events (CTCAE)
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
36 participants
Primary outcome timeframe
Up to 12 months after the ST-920 infusion
Results posted on
2026-04-14
Participant Flow
After participants completed screening and were deemed eligible, they moved into a baseline period with additional assessment and testing. Thirty-six participants completed screening but three participants were withdrawn during the baseline period and were never dosed with ST-920. One participant was withdrawn due to not completing baseline assessments while the other two participants were withdrawn but the site investigator due to results received during baseline.
Participant milestones
| Measure |
Dose Level 1 (0.26E + 13 vg/kg)
This is the lowest dose level with N of 2
|
Dose Level 2 (0.53E + 13 vg/kg)
This is 1 of 2 middle dose levels with N of 2
|
Dose Level 3 (1.58E + 13 vg/kg)
This is 1 of 2 middle dose levels with N of 3
|
Dose Level 4 (2.63E +13 vg/kg)
This is the highest dose level with N of 2.
|
Expansion - Cardiac Group (2.63E+13 vg/kg)
Expansion group with the selected dose level and N of 5
|
Expansion - Female Group (2.63E+13 vg/kg)
Expansion group with the selected dose level and N of 5
|
Expansion - Renal Group (2.63E+13 vg/kg)
Expansion group with the selected dose level and N of 2
|
Expansion - Anti Alpha Gal-A Negative (2.63E+13 vg/kg)
Expansion group with the selected dose level and N of 7
|
Expansion - Anti Alpha Gal-A Positive (2.63E+13 vg/kg)
Expansion group with the selected dose level and N of 5
|
|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
2
|
2
|
3
|
2
|
5
|
5
|
2
|
7
|
5
|
|
Overall Study
COMPLETED
|
2
|
2
|
3
|
2
|
4
|
5
|
2
|
7
|
5
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
Dose Level 1 (0.26E + 13 vg/kg)
This is the lowest dose level with N of 2
|
Dose Level 2 (0.53E + 13 vg/kg)
This is 1 of 2 middle dose levels with N of 2
|
Dose Level 3 (1.58E + 13 vg/kg)
This is 1 of 2 middle dose levels with N of 3
|
Dose Level 4 (2.63E +13 vg/kg)
This is the highest dose level with N of 2.
|
Expansion - Cardiac Group (2.63E+13 vg/kg)
Expansion group with the selected dose level and N of 5
|
Expansion - Female Group (2.63E+13 vg/kg)
Expansion group with the selected dose level and N of 5
|
Expansion - Renal Group (2.63E+13 vg/kg)
Expansion group with the selected dose level and N of 2
|
Expansion - Anti Alpha Gal-A Negative (2.63E+13 vg/kg)
Expansion group with the selected dose level and N of 7
|
Expansion - Anti Alpha Gal-A Positive (2.63E+13 vg/kg)
Expansion group with the selected dose level and N of 5
|
|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
Baseline Characteristics
The number of participants in each arm only includes the participants that were on Migalastat or previously on Migalastat and not the total dosed in each arm.
Baseline characteristics by cohort
| Measure |
Dose Level 1 (0.26E+13 vg/kg)
n=2 Participants
This is the lowest dose level with N of 2
|
Dose Level 2
n=2 Participants
Mid dose level with N of 2
|
Dose Level 3
n=3 Participants
Mid dose level with N of 3
|
Dose Level 4
n=2 Participants
Highest dose level with N of 2
|
Expansion - Cardiac Group (2.63E+13 vg/kg)
n=5 Participants
Expansion group with the selected dose level and N of 5
|
Expansion - Female Group (2.63E+13 vg/kg)
n=5 Participants
Expansion group with the selected dose level and N of 5
|
Expansion - Renal Group (2.63E+13 vg/kg)
n=2 Participants
Expansion group with the selected dose level and N of 2
|
Expansion - Anti Alpha Gal-A Negative (2.63E+13 vg/kg)
n=7 Participants
Expansion group with the selected dose level and N of 7
|
Expansion - Anti Alpha Gal-A Positive (2.63E+13 vg/kg)
n=5 Participants
Expansion group with the selected dose level and N of 5
|
Total
n=33 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Migalastat status at screening
Migalastat naive
|
2 Participants
n=2 Participants
|
2 Participants
n=2 Participants
|
3 Participants
n=3 Participants
|
2 Participants
n=2 Participants
|
5 Participants
n=5 Participants
|
4 Participants
n=5 Participants
|
2 Participants
n=2 Participants
|
6 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
29 Participants
n=33 Participants
|
|
Migalastat status at screening
Previously on Migalastat
|
0 Participants
n=2 Participants
|
0 Participants
n=2 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=2 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=2 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=33 Participants
|
|
Time (day) from Migalastat last dose to ST-920 infusion
|
—
|
—
|
—
|
—
|
—
|
55.0 Days
STANDARD_DEVIATION NA • n=1 Participants • The number of participants in each arm only includes the participants that were on Migalastat or previously on Migalastat and not the total dosed in each arm.
|
—
|
675.0 Days
STANDARD_DEVIATION NA • n=1 Participants • The number of participants in each arm only includes the participants that were on Migalastat or previously on Migalastat and not the total dosed in each arm.
|
165.0 Days
STANDARD_DEVIATION 100.41 • n=2 Participants • The number of participants in each arm only includes the participants that were on Migalastat or previously on Migalastat and not the total dosed in each arm.
|
265.0 Days
STANDARD_DEVIATION 284.18 • n=4 Participants • The number of participants in each arm only includes the participants that were on Migalastat or previously on Migalastat and not the total dosed in each arm.
|
|
Alpha Gal-A Activity in Plasma
|
0.769 nmol/h/mL
STANDARD_DEVIATION 1.0875 • n=2 Participants
|
1.221 nmol/h/mL
STANDARD_DEVIATION 1.7260 • n=2 Participants
|
0.302 nmol/h/mL
STANDARD_DEVIATION 0.5231 • n=3 Participants
|
0.482 nmol/h/mL
STANDARD_DEVIATION 0.6809 • n=2 Participants
|
2.778 nmol/h/mL
STANDARD_DEVIATION 2.2437 • n=5 Participants
|
3.166 nmol/h/mL
STANDARD_DEVIATION 1.0993 • n=5 Participants
|
1.317 nmol/h/mL
STANDARD_DEVIATION 0.27666 • n=2 Participants
|
0.140 nmol/h/mL
STANDARD_DEVIATION 0.2518 • n=7 Participants
|
0.179 nmol/h/mL
STANDARD_DEVIATION 0.2471 • n=5 Participants
|
1.214 nmol/h/mL
STANDARD_DEVIATION 1.5767 • n=33 Participants
|
|
Age, Categorical
<=18 years
|
0 Participants
n=2 Participants
|
0 Participants
n=2 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=2 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=2 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=33 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
2 Participants
n=2 Participants
|
2 Participants
n=2 Participants
|
3 Participants
n=3 Participants
|
2 Participants
n=2 Participants
|
5 Participants
n=5 Participants
|
5 Participants
n=5 Participants
|
2 Participants
n=2 Participants
|
7 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
33 Participants
n=33 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=2 Participants
|
0 Participants
n=2 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=2 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=2 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=33 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=2 Participants
|
0 Participants
n=2 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=2 Participants
|
4 Participants
n=5 Participants
|
5 Participants
n=5 Participants
|
1 Participants
n=2 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
10 Participants
n=33 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=2 Participants
|
2 Participants
n=2 Participants
|
3 Participants
n=3 Participants
|
2 Participants
n=2 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=2 Participants
|
7 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
23 Participants
n=33 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=2 Participants
|
0 Participants
n=2 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=2 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=2 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=33 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
1 Participants
n=2 Participants
|
2 Participants
n=2 Participants
|
3 Participants
n=3 Participants
|
2 Participants
n=2 Participants
|
5 Participants
n=5 Participants
|
5 Participants
n=5 Participants
|
2 Participants
n=2 Participants
|
6 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
31 Participants
n=33 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=2 Participants
|
0 Participants
n=2 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=2 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=2 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=33 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=2 Participants
|
0 Participants
n=2 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=2 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=2 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=33 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=2 Participants
|
0 Participants
n=2 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=2 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=2 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=33 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=2 Participants
|
0 Participants
n=2 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=2 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=2 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=33 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=2 Participants
|
0 Participants
n=2 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=2 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=2 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=33 Participants
|
|
Race (NIH/OMB)
White
|
2 Participants
n=2 Participants
|
2 Participants
n=2 Participants
|
3 Participants
n=3 Participants
|
2 Participants
n=2 Participants
|
5 Participants
n=5 Participants
|
5 Participants
n=5 Participants
|
2 Participants
n=2 Participants
|
7 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
33 Participants
n=33 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=2 Participants
|
0 Participants
n=2 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=2 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=2 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=33 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=2 Participants
|
0 Participants
n=2 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=2 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=2 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=33 Participants
|
|
Region of Enrollment
Canada
|
0 participants
n=2 Participants
|
0 participants
n=2 Participants
|
0 participants
n=3 Participants
|
0 participants
n=2 Participants
|
0 participants
n=5 Participants
|
0 participants
n=5 Participants
|
0 participants
n=2 Participants
|
1 participants
n=7 Participants
|
0 participants
n=5 Participants
|
1 participants
n=33 Participants
|
|
Region of Enrollment
United States
|
2 participants
n=2 Participants
|
2 participants
n=2 Participants
|
2 participants
n=3 Participants
|
2 participants
n=2 Participants
|
3 participants
n=5 Participants
|
5 participants
n=5 Participants
|
2 participants
n=2 Participants
|
3 participants
n=7 Participants
|
3 participants
n=5 Participants
|
24 participants
n=33 Participants
|
|
Region of Enrollment
United Kingdom
|
0 participants
n=2 Participants
|
0 participants
n=2 Participants
|
1 participants
n=3 Participants
|
0 participants
n=2 Participants
|
0 participants
n=5 Participants
|
0 participants
n=5 Participants
|
0 participants
n=2 Participants
|
0 participants
n=7 Participants
|
1 participants
n=5 Participants
|
2 participants
n=33 Participants
|
|
Region of Enrollment
Australia
|
0 participants
n=2 Participants
|
0 participants
n=2 Participants
|
0 participants
n=3 Participants
|
0 participants
n=2 Participants
|
2 participants
n=5 Participants
|
0 participants
n=5 Participants
|
0 participants
n=2 Participants
|
3 participants
n=7 Participants
|
0 participants
n=5 Participants
|
5 participants
n=33 Participants
|
|
Region of Enrollment
Germany
|
0 participants
n=2 Participants
|
0 participants
n=2 Participants
|
0 participants
n=3 Participants
|
0 participants
n=2 Participants
|
0 participants
n=5 Participants
|
0 participants
n=5 Participants
|
0 participants
n=2 Participants
|
0 participants
n=7 Participants
|
1 participants
n=5 Participants
|
1 participants
n=33 Participants
|
|
Height
|
172.0 centimeters
STANDARD_DEVIATION 16.97 • n=2 Participants
|
179.0 centimeters
STANDARD_DEVIATION 5.66 • n=2 Participants
|
177.7 centimeters
STANDARD_DEVIATION 6.11 • n=3 Participants
|
182.5 centimeters
STANDARD_DEVIATION 9.19 • n=2 Participants
|
169.4 centimeters
STANDARD_DEVIATION 13.13 • n=5 Participants
|
161.6 centimeters
STANDARD_DEVIATION 7.60 • n=5 Participants
|
168.5 centimeters
STANDARD_DEVIATION 9.19 • n=2 Participants
|
177.9 centimeters
STANDARD_DEVIATION 9.32 • n=7 Participants
|
176.6 centimeters
STANDARD_DEVIATION 4.34 • n=5 Participants
|
173.3 centimeters
STANDARD_DEVIATION 10.28 • n=33 Participants
|
|
Weight
|
64.05 kilograms
STANDARD_DEVIATION 6.293 • n=2 Participants
|
80.80 kilograms
STANDARD_DEVIATION 12.304 • n=2 Participants
|
98.43 kilograms
STANDARD_DEVIATION 25.599 • n=3 Participants
|
97.20 kilograms
STANDARD_DEVIATION 7.637 • n=2 Participants
|
73.94 kilograms
STANDARD_DEVIATION 4.999 • n=5 Participants
|
67.50 kilograms
STANDARD_DEVIATION 11.916 • n=5 Participants
|
82.85 kilograms
STANDARD_DEVIATION 2.616 • n=2 Participants
|
74.94 kilograms
STANDARD_DEVIATION 10.458 • n=7 Participants
|
73.60 kilograms
STANDARD_DEVIATION 13.499 • n=5 Participants
|
77.17 kilograms
STANDARD_DEVIATION 14.568 • n=33 Participants
|
|
Body Mass Index
|
22.03 kg/m^2
STANDARD_DEVIATION 2.209 • n=2 Participants
|
25.38 kg/m^2
STANDARD_DEVIATION 5.441 • n=2 Participants
|
30.89 kg/m^2
STANDARD_DEVIATION 6.063 • n=3 Participants
|
29.18 kg/m^2
STANDARD_DEVIATION 0.646 • n=2 Participants
|
26.07 kg/m^2
STANDARD_DEVIATION 4.000 • n=5 Participants
|
25.85 kg/m^2
STANDARD_DEVIATION 3.964 • n=5 Participants
|
29.26 kg/m^2
STANDARD_DEVIATION 2.268 • n=2 Participants
|
23.80 kg/m^2
STANDARD_DEVIATION 3.871 • n=7 Participants
|
23.56 kg/m^2
STANDARD_DEVIATION 4.041 • n=5 Participants
|
25.71 kg/m^2
STANDARD_DEVIATION 4.338 • n=33 Participants
|
|
Neutralizing antibodies to adeno-associated virus (AAV2/6)
Positive
|
0 Participants
n=2 Participants
|
0 Participants
n=2 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=2 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=2 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=33 Participants
|
|
Neutralizing antibodies to adeno-associated virus (AAV2/6)
Negative
|
2 Participants
n=2 Participants
|
2 Participants
n=2 Participants
|
3 Participants
n=3 Participants
|
2 Participants
n=2 Participants
|
5 Participants
n=5 Participants
|
5 Participants
n=5 Participants
|
2 Participants
n=2 Participants
|
7 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
33 Participants
n=33 Participants
|
|
alpha Gal-A antibodies
Positive
|
1 Participants
n=2 Participants
|
2 Participants
n=2 Participants
|
1 Participants
n=3 Participants
|
0 Participants
n=2 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=2 Participants
|
0 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
10 Participants
n=33 Participants
|
|
alpha Gal-A antibodies
Negative
|
1 Participants
n=2 Participants
|
0 Participants
n=2 Participants
|
2 Participants
n=3 Participants
|
2 Participants
n=2 Participants
|
5 Participants
n=5 Participants
|
5 Participants
n=5 Participants
|
1 Participants
n=2 Participants
|
7 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
23 Participants
n=33 Participants
|
|
Enzyme replacement therapy (ERT) status
on ERT
|
1 Participants
n=2 Participants
|
1 Participants
n=2 Participants
|
3 Participants
n=3 Participants
|
0 Participants
n=2 Participants
|
2 Participants
n=5 Participants
|
3 Participants
n=5 Participants
|
2 Participants
n=2 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
18 Participants
n=33 Participants
|
|
Enzyme replacement therapy (ERT) status
ERT naive
|
0 Participants
n=2 Participants
|
0 Participants
n=2 Participants
|
0 Participants
n=3 Participants
|
2 Participants
n=2 Participants
|
2 Participants
n=5 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=2 Participants
|
4 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
9 Participants
n=33 Participants
|
|
Enzyme replacement therapy (ERT) status
ERT pseudo-naive
|
1 Participants
n=2 Participants
|
1 Participants
n=2 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=2 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=2 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
6 Participants
n=33 Participants
|
|
Plasma Lyso-Gb3
|
20.50 ng/ml
STANDARD_DEVIATION 2.828 • n=2 Participants
|
47.58 ng/ml
STANDARD_DEVIATION 51.088 • n=2 Participants
|
17.54 ng/ml
STANDARD_DEVIATION 16.253 • n=3 Participants
|
91.78 ng/ml
STANDARD_DEVIATION 105.677 • n=2 Participants
|
17.13 ng/ml
STANDARD_DEVIATION 13.598 • n=5 Participants
|
7.96 ng/ml
STANDARD_DEVIATION 2.422 • n=5 Participants
|
13.34 ng/ml
STANDARD_DEVIATION 12.951 • n=2 Participants
|
75.63 ng/ml
STANDARD_DEVIATION 67.162 • n=7 Participants
|
70.52 ng/ml
STANDARD_DEVIATION 52.713 • n=5 Participants
|
42.62 ng/ml
STANDARD_DEVIATION 51.131 • n=33 Participants
|
|
Estimated glomerular filtration rate (eGFR)
|
109.70 mL/min/1.73m2
STANDARD_DEVIATION 11.738 • n=2 Participants
|
107.30 mL/min/1.73m2
STANDARD_DEVIATION 10.324 • n=2 Participants
|
75.72 mL/min/1.73m2
STANDARD_DEVIATION 10.455 • n=3 Participants
|
63.75 mL/min/1.73m2
STANDARD_DEVIATION 25.951 • n=2 Participants
|
76.64 mL/min/1.73m2
STANDARD_DEVIATION 9.565 • n=5 Participants
|
83.14 mL/min/1.73m2
STANDARD_DEVIATION 23.893 • n=5 Participants
|
73.65 mL/min/1.73m2
STANDARD_DEVIATION 38.133 • n=2 Participants
|
112.43 mL/min/1.73m2
STANDARD_DEVIATION 31.423 • n=7 Participants
|
115.84 mL/min/1.73m2
STANDARD_DEVIATION 16.959 • n=5 Participants
|
93.97 mL/min/1.73m2
STANDARD_DEVIATION 27.203 • n=33 Participants
|
|
Migalastat status at screening
On Migalastat
|
0 Participants
n=2 Participants
|
0 Participants
n=2 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=2 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=2 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=33 Participants
|
PRIMARY outcome
Timeframe: Up to 12 months after the ST-920 infusionPopulation: Safety population
All incidences of Treatment-Emergent Adverse Events (TEAEs) in subjects who receive ST-920 as assessed by Common Terminology Criteria for Adverse Events (CTCAE)
Outcome measures
| Measure |
Dose Level 1 (0.26E+13 vg/kg)
n=2 Participants
This is the lowest dose level with N of 2
|
Dose Level 2
n=2 Participants
Mid dose level with N of 2
|
Dose Level 3
n=3 Participants
Mid dose level with N of 3
|
Dose Level 4
n=2 Participants
Highest dose level with N of 2
|
Expansion - Cardiac Group (2.63E+13 vg/kg)
n=5 Participants
Expansion group with the selected dose level and N of 5
|
Expansion - Female Group (2.63E+13 vg/kg)
n=5 Participants
Expansion group with the selected dose level and N of 5
|
Expansion - Renal Group (2.63E+13 vg/kg)
n=2 Participants
Expansion group with the selected dose level and N of 2
|
Expansion - Anti Alpha Gal-A Negative (2.63E+13 vg/kg)
n=7 Participants
Expansion group with the selected dose level and N of 7
|
Expansion - Anti Alpha Gal-A Positive (2.63E+13 vg/kg)
n=5 Participants
Expansion group with the selected dose level and N of 5
|
|---|---|---|---|---|---|---|---|---|---|
|
Incidence of Treatment-emergent Adverse Events (TEAEs) - All
|
2 Participants
|
2 Participants
|
3 Participants
|
2 Participants
|
5 Participants
|
5 Participants
|
2 Participants
|
7 Participants
|
5 Participants
|
PRIMARY outcome
Timeframe: Up to 12 months post ST-920 infusionPopulation: Safety population
Incidences of Treatment-Emergent Adverse Events (TEAEs) directly related to ST-920 in subjects who receive ST-920 as assessed by Common Terminology Criteria for Adverse Events (CTCAE)
Outcome measures
| Measure |
Dose Level 1 (0.26E+13 vg/kg)
n=2 Participants
This is the lowest dose level with N of 2
|
Dose Level 2
n=2 Participants
Mid dose level with N of 2
|
Dose Level 3
n=3 Participants
Mid dose level with N of 3
|
Dose Level 4
n=2 Participants
Highest dose level with N of 2
|
Expansion - Cardiac Group (2.63E+13 vg/kg)
n=5 Participants
Expansion group with the selected dose level and N of 5
|
Expansion - Female Group (2.63E+13 vg/kg)
n=5 Participants
Expansion group with the selected dose level and N of 5
|
Expansion - Renal Group (2.63E+13 vg/kg)
n=2 Participants
Expansion group with the selected dose level and N of 2
|
Expansion - Anti Alpha Gal-A Negative (2.63E+13 vg/kg)
n=7 Participants
Expansion group with the selected dose level and N of 7
|
Expansion - Anti Alpha Gal-A Positive (2.63E+13 vg/kg)
n=5 Participants
Expansion group with the selected dose level and N of 5
|
|---|---|---|---|---|---|---|---|---|---|
|
Incidence of Treatment-emergent Adverse Events (TEAEs) - Related to ST-920
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
5 Participants
|
4 Participants
|
2 Participants
|
7 Participants
|
5 Participants
|
PRIMARY outcome
Timeframe: Up to 12 month post ST-920 infusionPopulation: Safety population
All incidences of serious Treatment-Emergent Adverse Events (TEAEs) in subjects who receive ST-920 as assessed by Common Terminology Criteria for Adverse Events (CTCAE)
Outcome measures
| Measure |
Dose Level 1 (0.26E+13 vg/kg)
n=2 Participants
This is the lowest dose level with N of 2
|
Dose Level 2
n=2 Participants
Mid dose level with N of 2
|
Dose Level 3
n=3 Participants
Mid dose level with N of 3
|
Dose Level 4
n=2 Participants
Highest dose level with N of 2
|
Expansion - Cardiac Group (2.63E+13 vg/kg)
n=5 Participants
Expansion group with the selected dose level and N of 5
|
Expansion - Female Group (2.63E+13 vg/kg)
n=5 Participants
Expansion group with the selected dose level and N of 5
|
Expansion - Renal Group (2.63E+13 vg/kg)
n=2 Participants
Expansion group with the selected dose level and N of 2
|
Expansion - Anti Alpha Gal-A Negative (2.63E+13 vg/kg)
n=7 Participants
Expansion group with the selected dose level and N of 7
|
Expansion - Anti Alpha Gal-A Positive (2.63E+13 vg/kg)
n=5 Participants
Expansion group with the selected dose level and N of 5
|
|---|---|---|---|---|---|---|---|---|---|
|
Incidence of Treatment-emergent Adverse Events (TEAEs) - Serious
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
PRIMARY outcome
Timeframe: Up to 12 month post ST-920 infusionPopulation: Safety population
All incidences of Treatment-Emergent Adverse Events (TEAEs) that lead to study discontinuation or withdrawal in subjects who receive ST-920 as assessed by Common Terminology Criteria for Adverse Events (CTCAE)
Outcome measures
| Measure |
Dose Level 1 (0.26E+13 vg/kg)
n=2 Participants
This is the lowest dose level with N of 2
|
Dose Level 2
n=2 Participants
Mid dose level with N of 2
|
Dose Level 3
n=3 Participants
Mid dose level with N of 3
|
Dose Level 4
n=2 Participants
Highest dose level with N of 2
|
Expansion - Cardiac Group (2.63E+13 vg/kg)
n=5 Participants
Expansion group with the selected dose level and N of 5
|
Expansion - Female Group (2.63E+13 vg/kg)
n=5 Participants
Expansion group with the selected dose level and N of 5
|
Expansion - Renal Group (2.63E+13 vg/kg)
n=2 Participants
Expansion group with the selected dose level and N of 2
|
Expansion - Anti Alpha Gal-A Negative (2.63E+13 vg/kg)
n=7 Participants
Expansion group with the selected dose level and N of 7
|
Expansion - Anti Alpha Gal-A Positive (2.63E+13 vg/kg)
n=5 Participants
Expansion group with the selected dose level and N of 5
|
|---|---|---|---|---|---|---|---|---|---|
|
Incidence of Treatment-emergent Adverse Events (TEAEs) - Any TEAEs Leading to Study Discontinuation or Withdrawal
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: up to 12 months post ST-920 infusionChange in alpha Gal-A activity in plasma from baseline at specific time points over the 1-year study period. Two collections occurred during the baseline period and the latter of the two collections was used for the baseline value. The specific time points are Week 24 and Week 52/End of Study (EOS). Plasma α-Gal A activity was measured using a validated fluorometric enzyme activity assay.
Outcome measures
| Measure |
Dose Level 1 (0.26E+13 vg/kg)
n=2 Participants
This is the lowest dose level with N of 2
|
Dose Level 2
n=2 Participants
Mid dose level with N of 2
|
Dose Level 3
n=3 Participants
Mid dose level with N of 3
|
Dose Level 4
n=2 Participants
Highest dose level with N of 2
|
Expansion - Cardiac Group (2.63E+13 vg/kg)
n=5 Participants
Expansion group with the selected dose level and N of 5
|
Expansion - Female Group (2.63E+13 vg/kg)
n=5 Participants
Expansion group with the selected dose level and N of 5
|
Expansion - Renal Group (2.63E+13 vg/kg)
n=2 Participants
Expansion group with the selected dose level and N of 2
|
Expansion - Anti Alpha Gal-A Negative (2.63E+13 vg/kg)
n=7 Participants
Expansion group with the selected dose level and N of 7
|
Expansion - Anti Alpha Gal-A Positive (2.63E+13 vg/kg)
n=5 Participants
Expansion group with the selected dose level and N of 5
|
|---|---|---|---|---|---|---|---|---|---|
|
To Assess Alpha Gal-A Activity in Plasma Over Time
Week 24
|
43.596 nmol/h/mL
Standard Deviation 36.0808
|
38.549 nmol/h/mL
Standard Deviation 35.6530
|
75.534 nmol/h/mL
Standard Deviation 40.7195
|
60.062 nmol/h/mL
Standard Deviation 19.9864
|
16.244 nmol/h/mL
Standard Deviation 9.1279
|
24.098 nmol/h/mL
Standard Deviation 12.8699
|
29.323 nmol/h/mL
Standard Deviation 22.4825
|
24.944 nmol/h/mL
Standard Deviation 16.5362
|
50.358 nmol/h/mL
Standard Deviation 39.0512
|
|
To Assess Alpha Gal-A Activity in Plasma Over Time
Week 52/EOS
|
49.567 nmol/h/mL
Standard Deviation 49.8266
|
31.098 nmol/h/mL
Standard Deviation 16.4770
|
162.561 nmol/h/mL
Standard Deviation 194.2052
|
52.295 nmol/h/mL
Standard Deviation 29.3329
|
14.699 nmol/h/mL
Standard Deviation 6.0089
|
29.402 nmol/h/mL
Standard Deviation 11.313
|
26.987 nmol/h/mL
Standard Deviation 18.2342
|
28.615 nmol/h/mL
Standard Deviation 13.0885
|
47.625 nmol/h/mL
Standard Deviation 46.6933
|
Adverse Events
Dose Level 1 (0.26E +13 vg/kg)
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Dose Level 2 (0.53E + 13 vg/kg)
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Dose Level 3 (1.58E + 13 vg/kg)
Serious events: 1 serious events
Other events: 3 other events
Deaths: 0 deaths
Dose Level 4 (2.63E +13 vg/kg)
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Expansion - Cardiac Group (2.63E+13 vg/kg)
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Expansion - Female Group (2.63E+13 vg/kg)
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Expansion - Renal Group (2.63E+13 vg/kg)
Serious events: 1 serious events
Other events: 2 other events
Deaths: 0 deaths
Expansion - Anti Alpha Gal-A Negative (2.63E+13 vg/kg)
Serious events: 1 serious events
Other events: 7 other events
Deaths: 0 deaths
Expansion - Anti Alpha Gal-A Positive (2.63E+13 vg/kg)
Serious events: 1 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Dose Level 1 (0.26E +13 vg/kg)
n=2 participants at risk
This is the lowest dose level with N of 2
|
Dose Level 2 (0.53E + 13 vg/kg)
n=2 participants at risk
This is 1 of 2 middle dose levels with N of 2
|
Dose Level 3 (1.58E + 13 vg/kg)
n=3 participants at risk
This is 1 of 2 middle dose levels with N of 3
|
Dose Level 4 (2.63E +13 vg/kg)
n=2 participants at risk
This is the highest dose level with N of 2.
|
Expansion - Cardiac Group (2.63E+13 vg/kg)
n=5 participants at risk
Expansion group with the selected dose level and N of 5
|
Expansion - Female Group (2.63E+13 vg/kg)
n=5 participants at risk
Expansion group with the selected dose level and N of 5
|
Expansion - Renal Group (2.63E+13 vg/kg)
n=2 participants at risk
Expansion group with the selected dose level and N of 2
|
Expansion - Anti Alpha Gal-A Negative (2.63E+13 vg/kg)
n=7 participants at risk
Expansion group with the selected dose level and N of 7
|
Expansion - Anti Alpha Gal-A Positive (2.63E+13 vg/kg)
n=5 participants at risk
Expansion group with the selected dose level and N of 5
|
|---|---|---|---|---|---|---|---|---|---|
|
Infections and infestations
Sepsis
|
0.00%
0/2 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/2 • Adverse events were collected for a period of 1 year post dose.
|
33.3%
1/3 • Number of events 1 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/2 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/5 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/5 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/2 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/7 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/5 • Adverse events were collected for a period of 1 year post dose.
|
|
Nervous system disorders
Brain Stem Stroke
|
0.00%
0/2 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/2 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/3 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/2 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/5 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/5 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/2 • Adverse events were collected for a period of 1 year post dose.
|
14.3%
1/7 • Number of events 1 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/5 • Adverse events were collected for a period of 1 year post dose.
|
|
Nervous system disorders
Cerebro Vascular Accident
|
0.00%
0/2 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/2 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/3 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/2 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/5 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/5 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/2 • Adverse events were collected for a period of 1 year post dose.
|
14.3%
1/7 • Number of events 1 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/5 • Adverse events were collected for a period of 1 year post dose.
|
|
General disorders
Chest Pain
|
0.00%
0/2 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/2 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/3 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/2 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/5 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/5 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/2 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/7 • Adverse events were collected for a period of 1 year post dose.
|
20.0%
1/5 • Number of events 1 • Adverse events were collected for a period of 1 year post dose.
|
|
Musculoskeletal and connective tissue disorders
Enthesopathy
|
0.00%
0/2 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/2 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/3 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/2 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/5 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/5 • Adverse events were collected for a period of 1 year post dose.
|
50.0%
1/2 • Number of events 1 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/7 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/5 • Adverse events were collected for a period of 1 year post dose.
|
Other adverse events
| Measure |
Dose Level 1 (0.26E +13 vg/kg)
n=2 participants at risk
This is the lowest dose level with N of 2
|
Dose Level 2 (0.53E + 13 vg/kg)
n=2 participants at risk
This is 1 of 2 middle dose levels with N of 2
|
Dose Level 3 (1.58E + 13 vg/kg)
n=3 participants at risk
This is 1 of 2 middle dose levels with N of 3
|
Dose Level 4 (2.63E +13 vg/kg)
n=2 participants at risk
This is the highest dose level with N of 2.
|
Expansion - Cardiac Group (2.63E+13 vg/kg)
n=5 participants at risk
Expansion group with the selected dose level and N of 5
|
Expansion - Female Group (2.63E+13 vg/kg)
n=5 participants at risk
Expansion group with the selected dose level and N of 5
|
Expansion - Renal Group (2.63E+13 vg/kg)
n=2 participants at risk
Expansion group with the selected dose level and N of 2
|
Expansion - Anti Alpha Gal-A Negative (2.63E+13 vg/kg)
n=7 participants at risk
Expansion group with the selected dose level and N of 7
|
Expansion - Anti Alpha Gal-A Positive (2.63E+13 vg/kg)
n=5 participants at risk
Expansion group with the selected dose level and N of 5
|
|---|---|---|---|---|---|---|---|---|---|
|
Infections and infestations
Nasopharyngitis
|
50.0%
1/2 • Number of events 1 • Adverse events were collected for a period of 1 year post dose.
|
50.0%
1/2 • Number of events 2 • Adverse events were collected for a period of 1 year post dose.
|
33.3%
1/3 • Number of events 1 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/2 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/5 • Adverse events were collected for a period of 1 year post dose.
|
40.0%
2/5 • Number of events 3 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/2 • Adverse events were collected for a period of 1 year post dose.
|
28.6%
2/7 • Number of events 2 • Adverse events were collected for a period of 1 year post dose.
|
40.0%
2/5 • Number of events 4 • Adverse events were collected for a period of 1 year post dose.
|
|
Infections and infestations
COVID-19
|
0.00%
0/2 • Adverse events were collected for a period of 1 year post dose.
|
50.0%
1/2 • Number of events 1 • Adverse events were collected for a period of 1 year post dose.
|
33.3%
1/3 • Number of events 1 • Adverse events were collected for a period of 1 year post dose.
|
50.0%
1/2 • Number of events 1 • Adverse events were collected for a period of 1 year post dose.
|
60.0%
3/5 • Number of events 3 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/5 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/2 • Adverse events were collected for a period of 1 year post dose.
|
14.3%
1/7 • Number of events 1 • Adverse events were collected for a period of 1 year post dose.
|
20.0%
1/5 • Number of events 1 • Adverse events were collected for a period of 1 year post dose.
|
|
Infections and infestations
Tooth Infection
|
50.0%
1/2 • Number of events 3 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/2 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/3 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/2 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/5 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/5 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/2 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/7 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/5 • Adverse events were collected for a period of 1 year post dose.
|
|
Infections and infestations
Gastroenteritis Viral
|
50.0%
1/2 • Number of events 1 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/2 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/3 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/2 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/5 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/5 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/2 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/7 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/5 • Adverse events were collected for a period of 1 year post dose.
|
|
Infections and infestations
Helicobacter Infection
|
50.0%
1/2 • Number of events 1 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/2 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/3 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/2 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/5 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/5 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/2 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/7 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/5 • Adverse events were collected for a period of 1 year post dose.
|
|
Infections and infestations
Influenza
|
0.00%
0/2 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/2 • Adverse events were collected for a period of 1 year post dose.
|
33.3%
1/3 • Number of events 1 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/2 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/5 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/5 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/2 • Adverse events were collected for a period of 1 year post dose.
|
14.3%
1/7 • Number of events 1 • Adverse events were collected for a period of 1 year post dose.
|
20.0%
1/5 • Number of events 1 • Adverse events were collected for a period of 1 year post dose.
|
|
Infections and infestations
Oral Herpes
|
0.00%
0/2 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/2 • Adverse events were collected for a period of 1 year post dose.
|
33.3%
1/3 • Number of events 1 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/2 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/5 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/5 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/2 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/7 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/5 • Adverse events were collected for a period of 1 year post dose.
|
|
Infections and infestations
Rhinitis
|
0.00%
0/2 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/2 • Adverse events were collected for a period of 1 year post dose.
|
33.3%
1/3 • Number of events 1 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/2 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/5 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/5 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/2 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/7 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/5 • Adverse events were collected for a period of 1 year post dose.
|
|
Infections and infestations
Sepsis
|
0.00%
0/2 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/2 • Adverse events were collected for a period of 1 year post dose.
|
33.3%
1/3 • Number of events 1 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/2 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/5 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/5 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/2 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/7 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/5 • Adverse events were collected for a period of 1 year post dose.
|
|
Infections and infestations
Suspected COVID-19
|
0.00%
0/2 • Adverse events were collected for a period of 1 year post dose.
|
50.0%
1/2 • Number of events 1 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/3 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/2 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/5 • Adverse events were collected for a period of 1 year post dose.
|
20.0%
1/5 • Number of events 1 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/2 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/7 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/5 • Adverse events were collected for a period of 1 year post dose.
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
0.00%
0/2 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/2 • Adverse events were collected for a period of 1 year post dose.
|
33.3%
1/3 • Number of events 1 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/2 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/5 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/5 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/2 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/7 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/5 • Adverse events were collected for a period of 1 year post dose.
|
|
Infections and infestations
Viral Infection
|
0.00%
0/2 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/2 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/3 • Adverse events were collected for a period of 1 year post dose.
|
50.0%
1/2 • Number of events 1 • Adverse events were collected for a period of 1 year post dose.
|
20.0%
1/5 • Number of events 1 • Adverse events were collected for a period of 1 year post dose.
|
20.0%
1/5 • Number of events 1 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/2 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/7 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/5 • Adverse events were collected for a period of 1 year post dose.
|
|
Infections and infestations
Skin Infection
|
0.00%
0/2 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/2 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/3 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/2 • Adverse events were collected for a period of 1 year post dose.
|
20.0%
1/5 • Number of events 1 • Adverse events were collected for a period of 1 year post dose.
|
20.0%
1/5 • Number of events 1 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/2 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/7 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/5 • Adverse events were collected for a period of 1 year post dose.
|
|
Infections and infestations
Abscess Neck
|
0.00%
0/2 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/2 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/3 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/2 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/5 • Adverse events were collected for a period of 1 year post dose.
|
20.0%
1/5 • Number of events 1 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/2 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/7 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/5 • Adverse events were collected for a period of 1 year post dose.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/2 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/2 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/3 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/2 • Adverse events were collected for a period of 1 year post dose.
|
20.0%
1/5 • Number of events 1 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/5 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/2 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/7 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/5 • Adverse events were collected for a period of 1 year post dose.
|
|
Infections and infestations
Conjunctivitis
|
0.00%
0/2 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/2 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/3 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/2 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/5 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/5 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/2 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/7 • Adverse events were collected for a period of 1 year post dose.
|
20.0%
1/5 • Number of events 1 • Adverse events were collected for a period of 1 year post dose.
|
|
Infections and infestations
Infection
|
0.00%
0/2 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/2 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/3 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/2 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/5 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/5 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/2 • Adverse events were collected for a period of 1 year post dose.
|
14.3%
1/7 • Number of events 1 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/5 • Adverse events were collected for a period of 1 year post dose.
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/2 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/2 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/3 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/2 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/5 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/5 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/2 • Adverse events were collected for a period of 1 year post dose.
|
14.3%
1/7 • Number of events 1 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/5 • Adverse events were collected for a period of 1 year post dose.
|
|
Infections and infestations
Sinusitis
|
0.00%
0/2 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/2 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/3 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/2 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/5 • Adverse events were collected for a period of 1 year post dose.
|
20.0%
1/5 • Number of events 1 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/2 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/7 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/5 • Adverse events were collected for a period of 1 year post dose.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/2 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/2 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/3 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/2 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/5 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/5 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/2 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/7 • Adverse events were collected for a period of 1 year post dose.
|
20.0%
1/5 • Number of events 1 • Adverse events were collected for a period of 1 year post dose.
|
|
Infections and infestations
Viral Upper Respiratory Tract Infection
|
0.00%
0/2 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/2 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/3 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/2 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/5 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/5 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/2 • Adverse events were collected for a period of 1 year post dose.
|
14.3%
1/7 • Number of events 1 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/5 • Adverse events were collected for a period of 1 year post dose.
|
|
Infections and infestations
Wound infection staphylococcal
|
0.00%
0/2 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/2 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/3 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/2 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/5 • Adverse events were collected for a period of 1 year post dose.
|
20.0%
1/5 • Number of events 1 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/2 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/7 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/5 • Adverse events were collected for a period of 1 year post dose.
|
|
General disorders
Pyrexia
|
50.0%
1/2 • Number of events 1 • Adverse events were collected for a period of 1 year post dose.
|
50.0%
1/2 • Number of events 1 • Adverse events were collected for a period of 1 year post dose.
|
33.3%
1/3 • Number of events 1 • Adverse events were collected for a period of 1 year post dose.
|
50.0%
1/2 • Number of events 1 • Adverse events were collected for a period of 1 year post dose.
|
80.0%
4/5 • Number of events 6 • Adverse events were collected for a period of 1 year post dose.
|
80.0%
4/5 • Number of events 7 • Adverse events were collected for a period of 1 year post dose.
|
100.0%
2/2 • Number of events 2 • Adverse events were collected for a period of 1 year post dose.
|
28.6%
2/7 • Number of events 2 • Adverse events were collected for a period of 1 year post dose.
|
80.0%
4/5 • Number of events 4 • Adverse events were collected for a period of 1 year post dose.
|
|
General disorders
Fatigue
|
0.00%
0/2 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/2 • Adverse events were collected for a period of 1 year post dose.
|
33.3%
1/3 • Number of events 1 • Adverse events were collected for a period of 1 year post dose.
|
50.0%
1/2 • Number of events 1 • Adverse events were collected for a period of 1 year post dose.
|
60.0%
3/5 • Number of events 4 • Adverse events were collected for a period of 1 year post dose.
|
20.0%
1/5 • Number of events 1 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/2 • Adverse events were collected for a period of 1 year post dose.
|
28.6%
2/7 • Number of events 2 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/5 • Adverse events were collected for a period of 1 year post dose.
|
|
General disorders
Pain
|
0.00%
0/2 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/2 • Adverse events were collected for a period of 1 year post dose.
|
33.3%
1/3 • Number of events 2 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/2 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/5 • Adverse events were collected for a period of 1 year post dose.
|
20.0%
1/5 • Number of events 1 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/2 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/7 • Adverse events were collected for a period of 1 year post dose.
|
20.0%
1/5 • Number of events 1 • Adverse events were collected for a period of 1 year post dose.
|
|
General disorders
Influenza Like Illness
|
0.00%
0/2 • Adverse events were collected for a period of 1 year post dose.
|
50.0%
1/2 • Number of events 1 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/3 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/2 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/5 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/5 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/2 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/7 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/5 • Adverse events were collected for a period of 1 year post dose.
|
|
General disorders
Vaccination Site Pain
|
0.00%
0/2 • Adverse events were collected for a period of 1 year post dose.
|
50.0%
1/2 • Number of events 1 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/3 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/2 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/5 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/5 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/2 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/7 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/5 • Adverse events were collected for a period of 1 year post dose.
|
|
General disorders
Chills
|
0.00%
0/2 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/2 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/3 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/2 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/5 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/5 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/2 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/7 • Adverse events were collected for a period of 1 year post dose.
|
60.0%
3/5 • Number of events 3 • Adverse events were collected for a period of 1 year post dose.
|
|
General disorders
Drug Intolerance
|
0.00%
0/2 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/2 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/3 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/2 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/5 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/5 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/2 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/7 • Adverse events were collected for a period of 1 year post dose.
|
20.0%
1/5 • Number of events 4 • Adverse events were collected for a period of 1 year post dose.
|
|
General disorders
Asthenia
|
0.00%
0/2 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/2 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/3 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/2 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/5 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/5 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/2 • Adverse events were collected for a period of 1 year post dose.
|
14.3%
1/7 • Number of events 1 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/5 • Adverse events were collected for a period of 1 year post dose.
|
|
General disorders
Chest Pain
|
0.00%
0/2 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/2 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/3 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/2 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/5 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/5 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/2 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/7 • Adverse events were collected for a period of 1 year post dose.
|
20.0%
1/5 • Number of events 1 • Adverse events were collected for a period of 1 year post dose.
|
|
General disorders
Exercise Tolerance Decreased
|
0.00%
0/2 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/2 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/3 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/2 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/5 • Adverse events were collected for a period of 1 year post dose.
|
20.0%
1/5 • Number of events 1 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/2 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/7 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/5 • Adverse events were collected for a period of 1 year post dose.
|
|
General disorders
Feeling Jittery
|
0.00%
0/2 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/2 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/3 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/2 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/5 • Adverse events were collected for a period of 1 year post dose.
|
20.0%
1/5 • Number of events 1 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/2 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/7 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/5 • Adverse events were collected for a period of 1 year post dose.
|
|
General disorders
Infusion Site Oedema
|
0.00%
0/2 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/2 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/3 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/2 • Adverse events were collected for a period of 1 year post dose.
|
20.0%
1/5 • Number of events 1 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/5 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/2 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/7 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/5 • Adverse events were collected for a period of 1 year post dose.
|
|
General disorders
Malaise
|
0.00%
0/2 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/2 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/3 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/2 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/5 • Adverse events were collected for a period of 1 year post dose.
|
20.0%
1/5 • Number of events 1 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/2 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/7 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/5 • Adverse events were collected for a period of 1 year post dose.
|
|
General disorders
Non-Cardiac Chest Pain
|
0.00%
0/2 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/2 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/3 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/2 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/5 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/5 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/2 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/7 • Adverse events were collected for a period of 1 year post dose.
|
20.0%
1/5 • Number of events 1 • Adverse events were collected for a period of 1 year post dose.
|
|
Injury, poisoning and procedural complications
Infusion Related Reactions
|
0.00%
0/2 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/2 • Adverse events were collected for a period of 1 year post dose.
|
33.3%
1/3 • Number of events 1 • Adverse events were collected for a period of 1 year post dose.
|
50.0%
1/2 • Number of events 1 • Adverse events were collected for a period of 1 year post dose.
|
20.0%
1/5 • Number of events 1 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/5 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/2 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/7 • Adverse events were collected for a period of 1 year post dose.
|
20.0%
1/5 • Number of events 1 • Adverse events were collected for a period of 1 year post dose.
|
|
Injury, poisoning and procedural complications
Immunization Reaction
|
0.00%
0/2 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/2 • Adverse events were collected for a period of 1 year post dose.
|
33.3%
1/3 • Number of events 2 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/2 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/5 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/5 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/2 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/7 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/5 • Adverse events were collected for a period of 1 year post dose.
|
|
Injury, poisoning and procedural complications
Arthropod Bites
|
0.00%
0/2 • Adverse events were collected for a period of 1 year post dose.
|
50.0%
1/2 • Number of events 1 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/3 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/2 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/5 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/5 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/2 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/7 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/5 • Adverse events were collected for a period of 1 year post dose.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/2 • Adverse events were collected for a period of 1 year post dose.
|
50.0%
1/2 • Number of events 1 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/3 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/2 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/5 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/5 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/2 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/7 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/5 • Adverse events were collected for a period of 1 year post dose.
|
|
Injury, poisoning and procedural complications
Ligament Sprain
|
0.00%
0/2 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/2 • Adverse events were collected for a period of 1 year post dose.
|
33.3%
1/3 • Number of events 1 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/2 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/5 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/5 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/2 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/7 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/5 • Adverse events were collected for a period of 1 year post dose.
|
|
Injury, poisoning and procedural complications
Skin Abrasion
|
0.00%
0/2 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/2 • Adverse events were collected for a period of 1 year post dose.
|
33.3%
1/3 • Number of events 1 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/2 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/5 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/5 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/2 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/7 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/5 • Adverse events were collected for a period of 1 year post dose.
|
|
Injury, poisoning and procedural complications
Traumatic Pain
|
0.00%
0/2 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/2 • Adverse events were collected for a period of 1 year post dose.
|
33.3%
1/3 • Number of events 1 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/2 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/5 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/5 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/2 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/7 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/5 • Adverse events were collected for a period of 1 year post dose.
|
|
Injury, poisoning and procedural complications
Wound
|
0.00%
0/2 • Adverse events were collected for a period of 1 year post dose.
|
50.0%
1/2 • Number of events 1 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/3 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/2 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/5 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/5 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/2 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/7 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/5 • Adverse events were collected for a period of 1 year post dose.
|
|
Injury, poisoning and procedural complications
Hand Fracture
|
0.00%
0/2 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/2 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/3 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/2 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/5 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/5 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/2 • Adverse events were collected for a period of 1 year post dose.
|
14.3%
1/7 • Number of events 1 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/5 • Adverse events were collected for a period of 1 year post dose.
|
|
Injury, poisoning and procedural complications
Post-procedural Pruritus
|
0.00%
0/2 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/2 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/3 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/2 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/5 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/5 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/2 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/7 • Adverse events were collected for a period of 1 year post dose.
|
20.0%
1/5 • Number of events 1 • Adverse events were collected for a period of 1 year post dose.
|
|
Injury, poisoning and procedural complications
Thermal Burn
|
0.00%
0/2 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/2 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/3 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/2 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/5 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/5 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/2 • Adverse events were collected for a period of 1 year post dose.
|
14.3%
1/7 • Number of events 1 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/5 • Adverse events were collected for a period of 1 year post dose.
|
|
Investigations
Haemoglobin Decreased
|
50.0%
1/2 • Number of events 1 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/2 • Adverse events were collected for a period of 1 year post dose.
|
33.3%
1/3 • Number of events 1 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/2 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/5 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/5 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/2 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/7 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/5 • Adverse events were collected for a period of 1 year post dose.
|
|
Investigations
Blood Lactate Dehydrogenase Increased
|
0.00%
0/2 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/2 • Adverse events were collected for a period of 1 year post dose.
|
33.3%
1/3 • Number of events 1 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/2 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/5 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/5 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/2 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/7 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/5 • Adverse events were collected for a period of 1 year post dose.
|
|
Investigations
Platelet Count Increased
|
50.0%
1/2 • Number of events 1 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/2 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/3 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/2 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/5 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/5 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/2 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/7 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/5 • Adverse events were collected for a period of 1 year post dose.
|
|
Investigations
SARS-CoV-2 Test Positive
|
0.00%
0/2 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/2 • Adverse events were collected for a period of 1 year post dose.
|
33.3%
1/3 • Number of events 1 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/2 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/5 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/5 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/2 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/7 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/5 • Adverse events were collected for a period of 1 year post dose.
|
|
Investigations
Troponin Increased
|
0.00%
0/2 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/2 • Adverse events were collected for a period of 1 year post dose.
|
33.3%
1/3 • Number of events 1 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/2 • Adverse events were collected for a period of 1 year post dose.
|
20.0%
1/5 • Number of events 1 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/5 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/2 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/7 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/5 • Adverse events were collected for a period of 1 year post dose.
|
|
Investigations
Urine Albumin/Creatinine Ratio Increased
|
0.00%
0/2 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/2 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/3 • Adverse events were collected for a period of 1 year post dose.
|
50.0%
1/2 • Number of events 1 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/5 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/5 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/2 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/7 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/5 • Adverse events were collected for a period of 1 year post dose.
|
|
Investigations
Weight Increased
|
0.00%
0/2 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/2 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/3 • Adverse events were collected for a period of 1 year post dose.
|
50.0%
1/2 • Number of events 1 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/5 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/5 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/2 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/7 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/5 • Adverse events were collected for a period of 1 year post dose.
|
|
Investigations
White Blood Cells Urine
|
0.00%
0/2 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/2 • Adverse events were collected for a period of 1 year post dose.
|
33.3%
1/3 • Number of events 1 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/2 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/5 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/5 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/2 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/7 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/5 • Adverse events were collected for a period of 1 year post dose.
|
|
Investigations
Lymphocyte Count Decreased
|
0.00%
0/2 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/2 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/3 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/2 • Adverse events were collected for a period of 1 year post dose.
|
40.0%
2/5 • Number of events 2 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/5 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/2 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/7 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/5 • Adverse events were collected for a period of 1 year post dose.
|
|
Investigations
Liver Function Test Increased
|
0.00%
0/2 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/2 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/3 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/2 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/5 • Adverse events were collected for a period of 1 year post dose.
|
20.0%
1/5 • Number of events 2 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/2 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/7 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/5 • Adverse events were collected for a period of 1 year post dose.
|
|
Investigations
Aspartate Aminotransferase Increased
|
0.00%
0/2 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/2 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/3 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/2 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/5 • Adverse events were collected for a period of 1 year post dose.
|
20.0%
1/5 • Number of events 1 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/2 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/7 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/5 • Adverse events were collected for a period of 1 year post dose.
|
|
Investigations
Electrocardiogram ST Segment Depression
|
0.00%
0/2 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/2 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/3 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/2 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/5 • Adverse events were collected for a period of 1 year post dose.
|
20.0%
1/5 • Number of events 1 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/2 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/7 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/5 • Adverse events were collected for a period of 1 year post dose.
|
|
Investigations
Gamma-Glutamyltransferase Increased
|
0.00%
0/2 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/2 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/3 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/2 • Adverse events were collected for a period of 1 year post dose.
|
20.0%
1/5 • Number of events 1 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/5 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/2 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/7 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/5 • Adverse events were collected for a period of 1 year post dose.
|
|
Investigations
Liver Function Tests Abnormal
|
0.00%
0/2 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/2 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/3 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/2 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/5 • Adverse events were collected for a period of 1 year post dose.
|
20.0%
1/5 • Number of events 1 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/2 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/7 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/5 • Adverse events were collected for a period of 1 year post dose.
|
|
Investigations
Lymphocyte Count Abnormal
|
0.00%
0/2 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/2 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/3 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/2 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/5 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/5 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/2 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/7 • Adverse events were collected for a period of 1 year post dose.
|
20.0%
1/5 • Number of events 1 • Adverse events were collected for a period of 1 year post dose.
|
|
Investigations
N-Terminal Prohormone Brain Natriuretic Peptide Increased
|
0.00%
0/2 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/2 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/3 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/2 • Adverse events were collected for a period of 1 year post dose.
|
20.0%
1/5 • Number of events 1 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/5 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/2 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/7 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/5 • Adverse events were collected for a period of 1 year post dose.
|
|
Musculoskeletal and connective tissue disorders
Tendonitis
|
0.00%
0/2 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/2 • Adverse events were collected for a period of 1 year post dose.
|
33.3%
1/3 • Number of events 2 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/2 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/5 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/5 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/2 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/7 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/5 • Adverse events were collected for a period of 1 year post dose.
|
|
Investigations
Spleen palpable
|
0.00%
0/2 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/2 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/3 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/2 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/5 • Adverse events were collected for a period of 1 year post dose.
|
20.0%
1/5 • Number of events 1 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/2 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/7 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/5 • Adverse events were collected for a period of 1 year post dose.
|
|
Investigations
Transaminases increased
|
0.00%
0/2 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/2 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/3 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/2 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/5 • Adverse events were collected for a period of 1 year post dose.
|
20.0%
1/5 • Number of events 1 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/2 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/7 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/5 • Adverse events were collected for a period of 1 year post dose.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/2 • Adverse events were collected for a period of 1 year post dose.
|
50.0%
1/2 • Number of events 1 • Adverse events were collected for a period of 1 year post dose.
|
33.3%
1/3 • Number of events 2 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/2 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/5 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/5 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/2 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/7 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/5 • Adverse events were collected for a period of 1 year post dose.
|
|
Gastrointestinal disorders
Frequent Bowel Movements
|
0.00%
0/2 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/2 • Adverse events were collected for a period of 1 year post dose.
|
33.3%
1/3 • Number of events 1 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/2 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/5 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/5 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/2 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/7 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/5 • Adverse events were collected for a period of 1 year post dose.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/2 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/2 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/3 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/2 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/5 • Adverse events were collected for a period of 1 year post dose.
|
20.0%
1/5 • Number of events 1 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/2 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/7 • Adverse events were collected for a period of 1 year post dose.
|
20.0%
1/5 • Number of events 1 • Adverse events were collected for a period of 1 year post dose.
|
|
Gastrointestinal disorders
Oral Pain
|
0.00%
0/2 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/2 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/3 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/2 • Adverse events were collected for a period of 1 year post dose.
|
20.0%
1/5 • Number of events 2 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/5 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/2 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/7 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/5 • Adverse events were collected for a period of 1 year post dose.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/2 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/2 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/3 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/2 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/5 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/5 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/2 • Adverse events were collected for a period of 1 year post dose.
|
14.3%
1/7 • Number of events 1 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/5 • Adverse events were collected for a period of 1 year post dose.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/2 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/2 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/3 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/2 • Adverse events were collected for a period of 1 year post dose.
|
20.0%
1/5 • Number of events 1 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/5 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/2 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/7 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/5 • Adverse events were collected for a period of 1 year post dose.
|
|
Gastrointestinal disorders
Food Poisoning
|
0.00%
0/2 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/2 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/3 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/2 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/5 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/5 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/2 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/7 • Adverse events were collected for a period of 1 year post dose.
|
20.0%
1/5 • Number of events 1 • Adverse events were collected for a period of 1 year post dose.
|
|
Gastrointestinal disorders
Gastrooesophageal Reflux Disease
|
0.00%
0/2 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/2 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/3 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/2 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/5 • Adverse events were collected for a period of 1 year post dose.
|
20.0%
1/5 • Number of events 1 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/2 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/7 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/5 • Adverse events were collected for a period of 1 year post dose.
|
|
Gastrointestinal disorders
Lip Swelling
|
0.00%
0/2 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/2 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/3 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/2 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/5 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/5 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/2 • Adverse events were collected for a period of 1 year post dose.
|
14.3%
1/7 • Number of events 1 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/5 • Adverse events were collected for a period of 1 year post dose.
|
|
Gastrointestinal disorders
Swollen Tongue
|
0.00%
0/2 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/2 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/3 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/2 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/5 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/5 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/2 • Adverse events were collected for a period of 1 year post dose.
|
14.3%
1/7 • Number of events 1 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/5 • Adverse events were collected for a period of 1 year post dose.
|
|
Skin and subcutaneous tissue disorders
Rash
|
50.0%
1/2 • Number of events 1 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/2 • Adverse events were collected for a period of 1 year post dose.
|
33.3%
1/3 • Number of events 1 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/2 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/5 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/5 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/2 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/7 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/5 • Adverse events were collected for a period of 1 year post dose.
|
|
Skin and subcutaneous tissue disorders
Leukonychia
|
50.0%
1/2 • Number of events 1 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/2 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/3 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/2 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/5 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/5 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/2 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/7 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/5 • Adverse events were collected for a period of 1 year post dose.
|
|
Skin and subcutaneous tissue disorders
Rash Erythematous
|
0.00%
0/2 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/2 • Adverse events were collected for a period of 1 year post dose.
|
33.3%
1/3 • Number of events 1 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/2 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/5 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/5 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/2 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/7 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/5 • Adverse events were collected for a period of 1 year post dose.
|
|
Skin and subcutaneous tissue disorders
Rosacea
|
0.00%
0/2 • Adverse events were collected for a period of 1 year post dose.
|
50.0%
1/2 • Number of events 1 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/3 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/2 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/5 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/5 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/2 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/7 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/5 • Adverse events were collected for a period of 1 year post dose.
|
|
Skin and subcutaneous tissue disorders
Skin Exfoliation
|
0.00%
0/2 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/2 • Adverse events were collected for a period of 1 year post dose.
|
33.3%
1/3 • Number of events 1 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/2 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/5 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/5 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/2 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/7 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/5 • Adverse events were collected for a period of 1 year post dose.
|
|
Skin and subcutaneous tissue disorders
Angioedema
|
0.00%
0/2 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/2 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/3 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/2 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/5 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/5 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/2 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/7 • Adverse events were collected for a period of 1 year post dose.
|
20.0%
1/5 • Number of events 2 • Adverse events were collected for a period of 1 year post dose.
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
0.00%
0/2 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/2 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/3 • Adverse events were collected for a period of 1 year post dose.
|
50.0%
1/2 • Number of events 1 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/5 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/5 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/2 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/7 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/5 • Adverse events were collected for a period of 1 year post dose.
|
|
Musculoskeletal and connective tissue disorders
Flank Pain
|
0.00%
0/2 • Adverse events were collected for a period of 1 year post dose.
|
50.0%
1/2 • Number of events 1 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/3 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/2 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/5 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/5 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/2 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/7 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/5 • Adverse events were collected for a period of 1 year post dose.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/2 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/2 • Adverse events were collected for a period of 1 year post dose.
|
33.3%
1/3 • Number of events 1 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/2 • Adverse events were collected for a period of 1 year post dose.
|
20.0%
1/5 • Number of events 1 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/5 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/2 • Adverse events were collected for a period of 1 year post dose.
|
28.6%
2/7 • Number of events 2 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/5 • Adverse events were collected for a period of 1 year post dose.
|
|
Musculoskeletal and connective tissue disorders
Neck Pain
|
0.00%
0/2 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/2 • Adverse events were collected for a period of 1 year post dose.
|
33.3%
1/3 • Number of events 1 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/2 • Adverse events were collected for a period of 1 year post dose.
|
20.0%
1/5 • Number of events 1 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/5 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/2 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/7 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/5 • Adverse events were collected for a period of 1 year post dose.
|
|
Musculoskeletal and connective tissue disorders
Pain in Extremity
|
0.00%
0/2 • Adverse events were collected for a period of 1 year post dose.
|
50.0%
1/2 • Number of events 1 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/3 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/2 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/5 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/5 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/2 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/7 • Adverse events were collected for a period of 1 year post dose.
|
20.0%
1/5 • Number of events 4 • Adverse events were collected for a period of 1 year post dose.
|
|
Musculoskeletal and connective tissue disorders
Enthesopathy
|
0.00%
0/2 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/2 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/3 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/2 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/5 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/5 • Adverse events were collected for a period of 1 year post dose.
|
50.0%
1/2 • Number of events 1 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/7 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/5 • Adverse events were collected for a period of 1 year post dose.
|
|
Musculoskeletal and connective tissue disorders
Tenosynovitis Stenosans
|
0.00%
0/2 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/2 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/3 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/2 • Adverse events were collected for a period of 1 year post dose.
|
20.0%
1/5 • Number of events 1 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/5 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/2 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/7 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/5 • Adverse events were collected for a period of 1 year post dose.
|
|
Gastrointestinal disorders
Diarrhoea
|
100.0%
2/2 • Number of events 2 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/2 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/3 • Adverse events were collected for a period of 1 year post dose.
|
50.0%
1/2 • Number of events 1 • Adverse events were collected for a period of 1 year post dose.
|
20.0%
1/5 • Number of events 2 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/5 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/2 • Adverse events were collected for a period of 1 year post dose.
|
14.3%
1/7 • Number of events 1 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/5 • Adverse events were collected for a period of 1 year post dose.
|
|
Gastrointestinal disorders
Abdominal Pain
|
0.00%
0/2 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/2 • Adverse events were collected for a period of 1 year post dose.
|
33.3%
1/3 • Number of events 2 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/2 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/5 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/5 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/2 • Adverse events were collected for a period of 1 year post dose.
|
14.3%
1/7 • Number of events 1 • Adverse events were collected for a period of 1 year post dose.
|
20.0%
1/5 • Number of events 1 • Adverse events were collected for a period of 1 year post dose.
|
|
Nervous system disorders
Lethargy
|
0.00%
0/2 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/2 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/3 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/2 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/5 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/5 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/2 • Adverse events were collected for a period of 1 year post dose.
|
14.3%
1/7 • Number of events 1 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/5 • Adverse events were collected for a period of 1 year post dose.
|
|
Nervous system disorders
Migraine
|
0.00%
0/2 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/2 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/3 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/2 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/5 • Adverse events were collected for a period of 1 year post dose.
|
20.0%
1/5 • Number of events 1 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/2 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/7 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/5 • Adverse events were collected for a period of 1 year post dose.
|
|
Nervous system disorders
Neuralgia
|
0.00%
0/2 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/2 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/3 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/2 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/5 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/5 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/2 • Adverse events were collected for a period of 1 year post dose.
|
14.3%
1/7 • Number of events 1 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/5 • Adverse events were collected for a period of 1 year post dose.
|
|
Nervous system disorders
Tension Headache
|
0.00%
0/2 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/2 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/3 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/2 • Adverse events were collected for a period of 1 year post dose.
|
20.0%
1/5 • Number of events 1 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/5 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/2 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/7 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/5 • Adverse events were collected for a period of 1 year post dose.
|
|
Nervous system disorders
Transient Ischaemic Attack
|
0.00%
0/2 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/2 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/3 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/2 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/5 • Adverse events were collected for a period of 1 year post dose.
|
20.0%
1/5 • Number of events 1 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/2 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/7 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/5 • Adverse events were collected for a period of 1 year post dose.
|
|
Blood and lymphatic system disorders
Anemia
|
50.0%
1/2 • Number of events 1 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/2 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/3 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/2 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/5 • Adverse events were collected for a period of 1 year post dose.
|
20.0%
1/5 • Number of events 1 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/2 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/7 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/5 • Adverse events were collected for a period of 1 year post dose.
|
|
Blood and lymphatic system disorders
Lymphopenia
|
50.0%
1/2 • Number of events 1 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/2 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/3 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/2 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/5 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/5 • Adverse events were collected for a period of 1 year post dose.
|
50.0%
1/2 • Number of events 1 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/7 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/5 • Adverse events were collected for a period of 1 year post dose.
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
0.00%
0/2 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/2 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/3 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/2 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/5 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/5 • Adverse events were collected for a period of 1 year post dose.
|
50.0%
1/2 • Number of events 1 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/7 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/5 • Adverse events were collected for a period of 1 year post dose.
|
|
Blood and lymphatic system disorders
Splenic Cyst
|
0.00%
0/2 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/2 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/3 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/2 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/5 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/5 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/2 • Adverse events were collected for a period of 1 year post dose.
|
14.3%
1/7 • Number of events 1 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/5 • Adverse events were collected for a period of 1 year post dose.
|
|
Ear and labyrinth disorders
Ear Pain
|
0.00%
0/2 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/2 • Adverse events were collected for a period of 1 year post dose.
|
33.3%
1/3 • Number of events 1 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/2 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/5 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/5 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/2 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/7 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/5 • Adverse events were collected for a period of 1 year post dose.
|
|
Ear and labyrinth disorders
Deafness
|
0.00%
0/2 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/2 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/3 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/2 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/5 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/5 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/2 • Adverse events were collected for a period of 1 year post dose.
|
14.3%
1/7 • Number of events 1 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/5 • Adverse events were collected for a period of 1 year post dose.
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/2 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/2 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/3 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/2 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/5 • Adverse events were collected for a period of 1 year post dose.
|
20.0%
1/5 • Number of events 1 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/2 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/7 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/5 • Adverse events were collected for a period of 1 year post dose.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous Cell Carcinoma
|
0.00%
0/2 • Adverse events were collected for a period of 1 year post dose.
|
50.0%
1/2 • Number of events 1 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/3 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/2 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/5 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/5 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/2 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/7 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/5 • Adverse events were collected for a period of 1 year post dose.
|
|
Renal and urinary disorders
Proteinuria
|
0.00%
0/2 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/2 • Adverse events were collected for a period of 1 year post dose.
|
33.3%
1/3 • Number of events 1 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/2 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/5 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/5 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/2 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/7 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/5 • Adverse events were collected for a period of 1 year post dose.
|
|
Cardiac disorders
Palpitations
|
0.00%
0/2 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/2 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/3 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/2 • Adverse events were collected for a period of 1 year post dose.
|
20.0%
1/5 • Number of events 1 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/5 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/2 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/7 • Adverse events were collected for a period of 1 year post dose.
|
20.0%
1/5 • Number of events 2 • Adverse events were collected for a period of 1 year post dose.
|
|
Cardiac disorders
Bundle Branch Block Left
|
0.00%
0/2 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/2 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/3 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/2 • Adverse events were collected for a period of 1 year post dose.
|
20.0%
1/5 • Number of events 1 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/5 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/2 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/7 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/5 • Adverse events were collected for a period of 1 year post dose.
|
|
Cardiac disorders
Dilatation ventricular
|
0.00%
0/2 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/2 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/3 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/2 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/5 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/5 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/2 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/7 • Adverse events were collected for a period of 1 year post dose.
|
20.0%
1/5 • Number of events 1 • Adverse events were collected for a period of 1 year post dose.
|
|
Cardiac disorders
Left Ventricular Dilatation
|
0.00%
0/2 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/2 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/3 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/2 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/5 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/5 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/2 • Adverse events were collected for a period of 1 year post dose.
|
14.3%
1/7 • Number of events 1 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/5 • Adverse events were collected for a period of 1 year post dose.
|
|
Cardiac disorders
Right Ventricular Dysfunction
|
0.00%
0/2 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/2 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/3 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/2 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/5 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/5 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/2 • Adverse events were collected for a period of 1 year post dose.
|
14.3%
1/7 • Number of events 1 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/5 • Adverse events were collected for a period of 1 year post dose.
|
|
Cardiac disorders
Supraventricular Tachycardia
|
0.00%
0/2 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/2 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/3 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/2 • Adverse events were collected for a period of 1 year post dose.
|
20.0%
1/5 • Number of events 1 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/5 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/2 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/7 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/5 • Adverse events were collected for a period of 1 year post dose.
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/2 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/2 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/3 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/2 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/5 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/5 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/2 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/7 • Adverse events were collected for a period of 1 year post dose.
|
20.0%
1/5 • Number of events 1 • Adverse events were collected for a period of 1 year post dose.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/2 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/2 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/3 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/2 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/5 • Adverse events were collected for a period of 1 year post dose.
|
20.0%
1/5 • Number of events 1 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/2 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/7 • Adverse events were collected for a period of 1 year post dose.
|
20.0%
1/5 • Number of events 1 • Adverse events were collected for a period of 1 year post dose.
|
|
Respiratory, thoracic and mediastinal disorders
Tachypnoea
|
0.00%
0/2 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/2 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/3 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/2 • Adverse events were collected for a period of 1 year post dose.
|
20.0%
1/5 • Number of events 1 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/5 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/2 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/7 • Adverse events were collected for a period of 1 year post dose.
|
20.0%
1/5 • Number of events 1 • Adverse events were collected for a period of 1 year post dose.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal Congestion
|
0.00%
0/2 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/2 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/3 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/2 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/5 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/5 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/2 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/7 • Adverse events were collected for a period of 1 year post dose.
|
20.0%
1/5 • Number of events 2 • Adverse events were collected for a period of 1 year post dose.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/2 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/2 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/3 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/2 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/5 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/5 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/2 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/7 • Adverse events were collected for a period of 1 year post dose.
|
20.0%
1/5 • Number of events 1 • Adverse events were collected for a period of 1 year post dose.
|
|
Respiratory, thoracic and mediastinal disorders
Lung Opacity
|
0.00%
0/2 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/2 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/3 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/2 • Adverse events were collected for a period of 1 year post dose.
|
20.0%
1/5 • Number of events 1 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/5 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/2 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/7 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/5 • Adverse events were collected for a period of 1 year post dose.
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
0.00%
0/2 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/2 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/3 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/2 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/5 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/5 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/2 • Adverse events were collected for a period of 1 year post dose.
|
14.3%
1/7 • Number of events 1 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/5 • Adverse events were collected for a period of 1 year post dose.
|
|
Vascular disorders
Hypotension
|
0.00%
0/2 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/2 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/3 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/2 • Adverse events were collected for a period of 1 year post dose.
|
20.0%
1/5 • Number of events 1 • Adverse events were collected for a period of 1 year post dose.
|
40.0%
2/5 • Number of events 2 • Adverse events were collected for a period of 1 year post dose.
|
50.0%
1/2 • Number of events 1 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/7 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/5 • Adverse events were collected for a period of 1 year post dose.
|
|
Vascular disorders
Hypertension
|
0.00%
0/2 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/2 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/3 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/2 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/5 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/5 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/2 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/7 • Adverse events were collected for a period of 1 year post dose.
|
20.0%
1/5 • Number of events 1 • Adverse events were collected for a period of 1 year post dose.
|
|
Vascular disorders
Superficial Vein Thrombosis
|
0.00%
0/2 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/2 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/3 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/2 • Adverse events were collected for a period of 1 year post dose.
|
20.0%
1/5 • Number of events 1 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/5 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/2 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/7 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/5 • Adverse events were collected for a period of 1 year post dose.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/2 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/2 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/3 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/2 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/5 • Adverse events were collected for a period of 1 year post dose.
|
20.0%
1/5 • Number of events 1 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/2 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/7 • Adverse events were collected for a period of 1 year post dose.
|
20.0%
1/5 • Number of events 1 • Adverse events were collected for a period of 1 year post dose.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/2 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/2 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/3 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/2 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/5 • Adverse events were collected for a period of 1 year post dose.
|
20.0%
1/5 • Number of events 1 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/2 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/7 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/5 • Adverse events were collected for a period of 1 year post dose.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
0.00%
0/2 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/2 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/3 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/2 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/5 • Adverse events were collected for a period of 1 year post dose.
|
20.0%
1/5 • Number of events 1 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/2 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/7 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/5 • Adverse events were collected for a period of 1 year post dose.
|
|
Metabolism and nutrition disorders
Increased Appetite
|
0.00%
0/2 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/2 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/3 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/2 • Adverse events were collected for a period of 1 year post dose.
|
20.0%
1/5 • Number of events 1 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/5 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/2 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/7 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/5 • Adverse events were collected for a period of 1 year post dose.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/2 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/2 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/3 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/2 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/5 • Adverse events were collected for a period of 1 year post dose.
|
20.0%
1/5 • Number of events 1 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/2 • Adverse events were collected for a period of 1 year post dose.
|
14.3%
1/7 • Number of events 1 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/5 • Adverse events were collected for a period of 1 year post dose.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/2 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/2 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/3 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/2 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/5 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/5 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/2 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/7 • Adverse events were collected for a period of 1 year post dose.
|
20.0%
1/5 • Number of events 1 • Adverse events were collected for a period of 1 year post dose.
|
|
Congenital, familial and genetic disorders
Fabry Disease
|
0.00%
0/2 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/2 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/3 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/2 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/5 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/5 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/2 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/7 • Adverse events were collected for a period of 1 year post dose.
|
20.0%
1/5 • Number of events 2 • Adverse events were collected for a period of 1 year post dose.
|
|
Congenital, familial and genetic disorders
Left Ventricle Outflow Tract Obstruction
|
0.00%
0/2 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/2 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/3 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/2 • Adverse events were collected for a period of 1 year post dose.
|
20.0%
1/5 • Number of events 1 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/5 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/2 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/7 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/5 • Adverse events were collected for a period of 1 year post dose.
|
|
Eye disorders
Eyelid Function Disorder
|
0.00%
0/2 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/2 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/3 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/2 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/5 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/5 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/2 • Adverse events were collected for a period of 1 year post dose.
|
14.3%
1/7 • Number of events 1 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/5 • Adverse events were collected for a period of 1 year post dose.
|
|
Eye disorders
Periorbital Oedema
|
0.00%
0/2 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/2 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/3 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/2 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/5 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/5 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/2 • Adverse events were collected for a period of 1 year post dose.
|
14.3%
1/7 • Number of events 1 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/5 • Adverse events were collected for a period of 1 year post dose.
|
|
Eye disorders
Vision Blurred
|
0.00%
0/2 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/2 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/3 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/2 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/5 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/5 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/2 • Adverse events were collected for a period of 1 year post dose.
|
14.3%
1/7 • Number of events 1 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/5 • Adverse events were collected for a period of 1 year post dose.
|
|
Endocrine disorders
Goitre
|
0.00%
0/2 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/2 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/3 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/2 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/5 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/5 • Adverse events were collected for a period of 1 year post dose.
|
50.0%
1/2 • Number of events 1 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/7 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/5 • Adverse events were collected for a period of 1 year post dose.
|
|
Reproductive system and breast disorders
Benign Prostatic Hyperplasia
|
0.00%
0/2 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/2 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/3 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/2 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/5 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/5 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/2 • Adverse events were collected for a period of 1 year post dose.
|
14.3%
1/7 • Number of events 1 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/5 • Adverse events were collected for a period of 1 year post dose.
|
|
Skin and subcutaneous tissue disorders
Dry Skin
|
0.00%
0/2 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/2 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/3 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/2 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/5 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/5 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/2 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/7 • Adverse events were collected for a period of 1 year post dose.
|
20.0%
1/5 • Number of events 2 • Adverse events were collected for a period of 1 year post dose.
|
|
Skin and subcutaneous tissue disorders
Angiokeratoma
|
0.00%
0/2 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/2 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/3 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/2 • Adverse events were collected for a period of 1 year post dose.
|
20.0%
1/5 • Number of events 1 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/5 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/2 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/7 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/5 • Adverse events were collected for a period of 1 year post dose.
|
|
Skin and subcutaneous tissue disorders
Eczema Nummular
|
0.00%
0/2 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/2 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/3 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/2 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/5 • Adverse events were collected for a period of 1 year post dose.
|
20.0%
1/5 • Number of events 1 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/2 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/7 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/5 • Adverse events were collected for a period of 1 year post dose.
|
|
Nervous system disorders
Headache
|
50.0%
1/2 • Number of events 1 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/2 • Adverse events were collected for a period of 1 year post dose.
|
33.3%
1/3 • Number of events 1 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/2 • Adverse events were collected for a period of 1 year post dose.
|
60.0%
3/5 • Number of events 4 • Adverse events were collected for a period of 1 year post dose.
|
40.0%
2/5 • Number of events 2 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/2 • Adverse events were collected for a period of 1 year post dose.
|
14.3%
1/7 • Number of events 1 • Adverse events were collected for a period of 1 year post dose.
|
40.0%
2/5 • Number of events 3 • Adverse events were collected for a period of 1 year post dose.
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/2 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/2 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/3 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/2 • Adverse events were collected for a period of 1 year post dose.
|
20.0%
1/5 • Number of events 1 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/5 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/2 • Adverse events were collected for a period of 1 year post dose.
|
28.6%
2/7 • Number of events 3 • Adverse events were collected for a period of 1 year post dose.
|
40.0%
2/5 • Number of events 4 • Adverse events were collected for a period of 1 year post dose.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/2 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/2 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/3 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/2 • Adverse events were collected for a period of 1 year post dose.
|
40.0%
2/5 • Number of events 2 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/5 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/2 • Adverse events were collected for a period of 1 year post dose.
|
14.3%
1/7 • Number of events 1 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/5 • Adverse events were collected for a period of 1 year post dose.
|
|
Nervous system disorders
Ataxia
|
0.00%
0/2 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/2 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/3 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/2 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/5 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/5 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/2 • Adverse events were collected for a period of 1 year post dose.
|
14.3%
1/7 • Number of events 1 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/5 • Adverse events were collected for a period of 1 year post dose.
|
|
Nervous system disorders
Brain Stem Stroke
|
0.00%
0/2 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/2 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/3 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/2 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/5 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/5 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/2 • Adverse events were collected for a period of 1 year post dose.
|
14.3%
1/7 • Number of events 1 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/5 • Adverse events were collected for a period of 1 year post dose.
|
|
Nervous system disorders
Cerebrovascular Accident
|
0.00%
0/2 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/2 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/3 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/2 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/5 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/5 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/2 • Adverse events were collected for a period of 1 year post dose.
|
14.3%
1/7 • Number of events 1 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/5 • Adverse events were collected for a period of 1 year post dose.
|
|
Nervous system disorders
Disturbance in Attention
|
0.00%
0/2 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/2 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/3 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/2 • Adverse events were collected for a period of 1 year post dose.
|
20.0%
1/5 • Number of events 1 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/5 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/2 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/7 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/5 • Adverse events were collected for a period of 1 year post dose.
|
|
Nervous system disorders
Ischaemic Cerebral Infarction
|
0.00%
0/2 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/2 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/3 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/2 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/5 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/5 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/2 • Adverse events were collected for a period of 1 year post dose.
|
14.3%
1/7 • Number of events 1 • Adverse events were collected for a period of 1 year post dose.
|
0.00%
0/5 • Adverse events were collected for a period of 1 year post dose.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60