Trial Outcomes & Findings for ASCEND GO-2: Study of RVT-1401 for the Treatment of Participants With Active, Moderate to Severe Graves' Ophthalmopathy ( GO ) (NCT NCT03938545)
NCT ID: NCT03938545
Last Updated: 2022-09-22
Results Overview
Proptosis was assessed using an exophthalmometer. A proptosis response was defined as having at least a 2 millimeter (mm) reduction in study eye proptosis without a deterioration (at least a 2 mm increase) in the fellow eye at the same visit. The study eye was defined as the most severely affected eye at the baseline visit.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
65 participants
Primary outcome timeframe
Baseline; Week 13
Results posted on
2022-09-22
Participant Flow
A total of 96 participants were screened, of which 65 participants were enrolled and randomized into the study. The total duration of the study was up to 20 weeks.
Participant milestones
| Measure |
RVT-1401 680 mg/Week
Participants received a RVT-1401 680 milligram (mg) subcutaneous (SC) injection weekly for 12 weeks.
|
RVT-1401 340 mg/Week
Participants received a RVT-1401 340 mg SC injection weekly for 12 weeks.
|
RVT-1401 255 mg/Week
Participants received a RVT-1401 255 mg SC injection weekly for 12 weeks.
|
Placebo
Participants received a matching placebo SC injection weekly for 12 weeks.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
18
|
19
|
10
|
18
|
|
Overall Study
COMPLETED
|
10
|
14
|
7
|
13
|
|
Overall Study
NOT COMPLETED
|
8
|
5
|
3
|
5
|
Reasons for withdrawal
| Measure |
RVT-1401 680 mg/Week
Participants received a RVT-1401 680 milligram (mg) subcutaneous (SC) injection weekly for 12 weeks.
|
RVT-1401 340 mg/Week
Participants received a RVT-1401 340 mg SC injection weekly for 12 weeks.
|
RVT-1401 255 mg/Week
Participants received a RVT-1401 255 mg SC injection weekly for 12 weeks.
|
Placebo
Participants received a matching placebo SC injection weekly for 12 weeks.
|
|---|---|---|---|---|
|
Overall Study
Adverse Event
|
1
|
0
|
0
|
0
|
|
Overall Study
Lost to Follow-up
|
0
|
0
|
0
|
1
|
|
Overall Study
Non-compliance with study drug
|
0
|
0
|
1
|
0
|
|
Overall Study
Pregnancy
|
1
|
0
|
0
|
0
|
|
Overall Study
Study terminated by sponsor
|
6
|
4
|
2
|
4
|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
0
|
0
|
Baseline Characteristics
ASCEND GO-2: Study of RVT-1401 for the Treatment of Participants With Active, Moderate to Severe Graves' Ophthalmopathy ( GO )
Baseline characteristics by cohort
| Measure |
RVT-1401 680 mg/Week
n=18 Participants
Participants received a RVT-1401 680 milligram (mg) subcutaneous (SC) injection weekly for 12 weeks.
|
RVT-1401 340 mg/Week
n=19 Participants
Participants received a RVT-1401 340 mg SC injection weekly for 12 weeks.
|
RVT-1401 255 mg/Week
n=10 Participants
Participants received a RVT-1401 255 mg SC injection weekly for 12 weeks.
|
Placebo
n=18 Participants
Participants received a matching placebo SC injection weekly for 12 weeks.
|
Total
n=65 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
46.6 Years
STANDARD_DEVIATION 9.03 • n=93 Participants
|
52.4 Years
STANDARD_DEVIATION 8.08 • n=4 Participants
|
44.3 Years
STANDARD_DEVIATION 12.61 • n=27 Participants
|
46.1 Years
STANDARD_DEVIATION 12.47 • n=483 Participants
|
47.8 Years
STANDARD_DEVIATION 10.64 • n=36 Participants
|
|
Sex: Female, Male
Female
|
15 Participants
n=93 Participants
|
13 Participants
n=4 Participants
|
8 Participants
n=27 Participants
|
14 Participants
n=483 Participants
|
50 Participants
n=36 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=93 Participants
|
6 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
4 Participants
n=483 Participants
|
15 Participants
n=36 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
3 Participants
n=36 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
17 Participants
n=93 Participants
|
17 Participants
n=4 Participants
|
10 Participants
n=27 Participants
|
18 Participants
n=483 Participants
|
62 Participants
n=36 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
|
Race (NIH/OMB)
White
|
17 Participants
n=93 Participants
|
18 Participants
n=4 Participants
|
10 Participants
n=27 Participants
|
18 Participants
n=483 Participants
|
63 Participants
n=36 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
2 Participants
n=36 Participants
|
|
Mean Proptosis
|
22.7 Millimeters (mm)
STANDARD_DEVIATION 3.10 • n=93 Participants
|
23.0 Millimeters (mm)
STANDARD_DEVIATION 3.97 • n=4 Participants
|
22.3 Millimeters (mm)
STANDARD_DEVIATION 2.95 • n=27 Participants
|
22.7 Millimeters (mm)
STANDARD_DEVIATION 2.70 • n=483 Participants
|
22.72 Millimeters (mm)
STANDARD_DEVIATION 3.19 • n=36 Participants
|
|
Mean Clinical Activity Score (CAS)
|
4.8 Units on a scale
STANDARD_DEVIATION 0.86 • n=93 Participants
|
5.1 Units on a scale
STANDARD_DEVIATION 0.94 • n=4 Participants
|
4.9 Units on a scale
STANDARD_DEVIATION 0.99 • n=27 Participants
|
5.2 Units on a scale
STANDARD_DEVIATION 1.04 • n=483 Participants
|
5.0 Units on a scale
STANDARD_DEVIATION 0.94 • n=36 Participants
|
PRIMARY outcome
Timeframe: Baseline; Week 13Population: Intent-to-Treat (ITT) Population: All randomized participants who received at least one dose of RVT-1401 or placebo and had 1 post-baseline visit. Participants with proptosis assessment at Week 13 were included in the analysis.
Proptosis was assessed using an exophthalmometer. A proptosis response was defined as having at least a 2 millimeter (mm) reduction in study eye proptosis without a deterioration (at least a 2 mm increase) in the fellow eye at the same visit. The study eye was defined as the most severely affected eye at the baseline visit.
Outcome measures
| Measure |
RVT-1401 680 mg/Week
n=10 Participants
Participants received a RVT-1401 680 milligram (mg) subcutaneous (SC) injection weekly for 12 weeks.
|
RVT-1401 340 mg/Week
n=13 Participants
Participants received a RVT-1401 340 mg SC injection weekly for 12 weeks.
|
RVT-1401 255 mg/Week
n=6 Participants
Participants received a RVT-1401 255 mg SC injection weekly for 12 weeks.
|
Placebo
n=12 Participants
Participants received a matching placebo SC injection weekly for 12 weeks.
|
|---|---|---|---|---|
|
Percentage of Participants With Proptosis Response at Week 13
|
30.0 Percentage of participants
|
30.8 Percentage of participants
|
0 Percentage of participants
|
8.3 Percentage of participants
|
PRIMARY outcome
Timeframe: From Baseline up to Week 20Population: Safety Population: All randomized participants who received at least one dose of either RVT-1401 or placebo.
AEs - any untoward medical occurrences in a participant, temporally associated with use of a medicinal product, whether or not considered related to the product. Clinically significant changes determined by the Investigator such as vital signs, ECGs, and clinical laboratory values were also reported as AEs. TEAE is defined as an AE that starts on or after the first dose of the study drug and before 30 days after the last dose of the study drug. SAEs were defined as any untoward medical occurrences that: resulted in death; were life-threatening; required hospitalization or prolongation of existing hospitalization; resulted in disability/incapacity; were congenital anomaly/birth defects; were important medical events that may have jeopardized the participant or may have required medical or surgical intervention; invasive or malignant cancers; and development of drug dependency or drug abuse.
Outcome measures
| Measure |
RVT-1401 680 mg/Week
n=18 Participants
Participants received a RVT-1401 680 milligram (mg) subcutaneous (SC) injection weekly for 12 weeks.
|
RVT-1401 340 mg/Week
n=19 Participants
Participants received a RVT-1401 340 mg SC injection weekly for 12 weeks.
|
RVT-1401 255 mg/Week
n=10 Participants
Participants received a RVT-1401 255 mg SC injection weekly for 12 weeks.
|
Placebo
n=18 Participants
Participants received a matching placebo SC injection weekly for 12 weeks.
|
|---|---|---|---|---|
|
Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (SAEs)
TEAEs
|
16 Participants
|
16 Participants
|
8 Participants
|
16 Participants
|
|
Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (SAEs)
SAEs
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Baseline and Week 13Population: ITT Population. Participants with binding anti-TSHR serum assessments at Week 13 were included in the analysis.
Binding Anti-TSHR antibody serum levels are directly associated with GO clinical features. Baseline was the last available assessment prior to the time of the first dose unless it was specified otherwise and was identified as Day 1. A negative change from baseline in binding anti-TSHR antibody levels indicated therapeutic benefit.
Outcome measures
| Measure |
RVT-1401 680 mg/Week
n=10 Participants
Participants received a RVT-1401 680 milligram (mg) subcutaneous (SC) injection weekly for 12 weeks.
|
RVT-1401 340 mg/Week
n=13 Participants
Participants received a RVT-1401 340 mg SC injection weekly for 12 weeks.
|
RVT-1401 255 mg/Week
n=6 Participants
Participants received a RVT-1401 255 mg SC injection weekly for 12 weeks.
|
Placebo
n=12 Participants
Participants received a matching placebo SC injection weekly for 12 weeks.
|
|---|---|---|---|---|
|
Least Square Mean Percent Change From Baseline in Binding Anti-thyroid-stimulating Hormone Receptor (TSHR) Antibody Levels to Week 13
|
-64.605 Percent change
Interval -87.006 to -42.205
|
-69.663 Percent change
Interval -89.272 to -50.054
|
-41.843 Percent change
Interval -70.07 to -13.616
|
-4.520 Percent change
Interval -25.58 to 16.539
|
SECONDARY outcome
Timeframe: Baseline and Week 13Population: ITT Population: Participants with evaluable data were included for the analysis.
Blood samples we collected to determine total IgG levels. Baseline was the last available assessment prior to the time of the first dose unless it was specified otherwise and was identified as Day 1. A negative change from baseline in the IgG levels indicated therapeutic benefit.
Outcome measures
| Measure |
RVT-1401 680 mg/Week
n=10 Participants
Participants received a RVT-1401 680 milligram (mg) subcutaneous (SC) injection weekly for 12 weeks.
|
RVT-1401 340 mg/Week
n=13 Participants
Participants received a RVT-1401 340 mg SC injection weekly for 12 weeks.
|
RVT-1401 255 mg/Week
n=6 Participants
Participants received a RVT-1401 255 mg SC injection weekly for 12 weeks.
|
Placebo
n=12 Participants
Participants received a matching placebo SC injection weekly for 12 weeks.
|
|---|---|---|---|---|
|
Least Square Mean Percent Change From Baseline in Total IgG Levels
|
-79.101 Percent change
Interval -86.444 to -71.757
|
-65.103 Percent change
Interval -71.687 to -58.519
|
-57.934 Percent change
Interval -67.216 to -48.651
|
-6.098 Percent change
Interval -12.948 to 0.753
|
SECONDARY outcome
Timeframe: Baseline and Week 13Population: ITT Population. Participants with evaluable data were included for the analysis.
Blood samples were collected to determine IgG 1,2,3 and 4 levels. Baseline was the last available assessment prior to the time of the first dose unless it was specified otherwise and was identified as Day 1. A negative change from baseline in the IgG levels indicated therapeutic benefit.
Outcome measures
| Measure |
RVT-1401 680 mg/Week
n=9 Participants
Participants received a RVT-1401 680 milligram (mg) subcutaneous (SC) injection weekly for 12 weeks.
|
RVT-1401 340 mg/Week
n=12 Participants
Participants received a RVT-1401 340 mg SC injection weekly for 12 weeks.
|
RVT-1401 255 mg/Week
n=5 Participants
Participants received a RVT-1401 255 mg SC injection weekly for 12 weeks.
|
Placebo
n=9 Participants
Participants received a matching placebo SC injection weekly for 12 weeks.
|
|---|---|---|---|---|
|
Least Square Mean Percent Change From Baseline in IgG Subclasses 1, 2, 3 and 4
IgG1
|
-82.040 Percent change
Interval -90.757 to -73.323
|
-68.141 Percent change
Interval -75.721 to -60.561
|
-67.784 Percent change
Interval -79.273 to -56.294
|
-0.550 Percent change
Interval -9.307 to 8.207
|
|
Least Square Mean Percent Change From Baseline in IgG Subclasses 1, 2, 3 and 4
IgG2
|
-75.346 Percent change
Interval -84.395 to -66.297
|
-53.678 Percent change
Interval -62.077 to -45.28
|
-53.879 Percent change
Interval -65.648 to -42.11
|
-0.481 Percent change
Interval -9.392 to 8.431
|
|
Least Square Mean Percent Change From Baseline in IgG Subclasses 1, 2, 3 and 4
IgG3
|
-88.260 Percent change
Interval -98.901 to -77.619
|
-65.211 Percent change
Interval -74.336 to -56.085
|
-66.182 Percent change
Interval -79.856 to -52.508
|
0.503 Percent change
Interval -9.907 to 10.914
|
|
Least Square Mean Percent Change From Baseline in IgG Subclasses 1, 2, 3 and 4
IgG4
|
-68.559 Percent change
Interval -77.456 to -59.663
|
-55.391 Percent change
Interval -63.131 to -47.651
|
-52.916 Percent change
Interval -64.774 to -41.059
|
0.163 Percent change
Interval -9.167 to 9.493
|
Adverse Events
RVT-1401 680 mg/Week
Serious events: 0 serious events
Other events: 16 other events
Deaths: 0 deaths
RVT-1401 340 mg/Week
Serious events: 0 serious events
Other events: 16 other events
Deaths: 0 deaths
RVT-1401 255 mg/Week
Serious events: 1 serious events
Other events: 8 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 16 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
RVT-1401 680 mg/Week
n=18 participants at risk
Participants received a RVT-1401 680 milligram (mg) subcutaneous (SC) injection weekly for 12 weeks.
|
RVT-1401 340 mg/Week
n=19 participants at risk
Participants received a RVT-1401 340 mg SC injection weekly for 12 weeks.
|
RVT-1401 255 mg/Week
n=10 participants at risk
Participants received a RVT-1401 255 mg SC injection weekly for 12 weeks.
|
Placebo
n=18 participants at risk
Participants received a matching placebo SC injection weekly for 12 weeks.
|
|---|---|---|---|---|
|
Eye disorders
Optic neuropathy
|
0.00%
0/18 • From Baseline up to Week 20
TEAE is defined as an AE that starts on or after the first dose of the study drug and before 30 days after the last dose of the study drug.
|
0.00%
0/19 • From Baseline up to Week 20
TEAE is defined as an AE that starts on or after the first dose of the study drug and before 30 days after the last dose of the study drug.
|
10.0%
1/10 • Number of events 1 • From Baseline up to Week 20
TEAE is defined as an AE that starts on or after the first dose of the study drug and before 30 days after the last dose of the study drug.
|
0.00%
0/18 • From Baseline up to Week 20
TEAE is defined as an AE that starts on or after the first dose of the study drug and before 30 days after the last dose of the study drug.
|
Other adverse events
| Measure |
RVT-1401 680 mg/Week
n=18 participants at risk
Participants received a RVT-1401 680 milligram (mg) subcutaneous (SC) injection weekly for 12 weeks.
|
RVT-1401 340 mg/Week
n=19 participants at risk
Participants received a RVT-1401 340 mg SC injection weekly for 12 weeks.
|
RVT-1401 255 mg/Week
n=10 participants at risk
Participants received a RVT-1401 255 mg SC injection weekly for 12 weeks.
|
Placebo
n=18 participants at risk
Participants received a matching placebo SC injection weekly for 12 weeks.
|
|---|---|---|---|---|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
0.00%
0/18 • From Baseline up to Week 20
TEAE is defined as an AE that starts on or after the first dose of the study drug and before 30 days after the last dose of the study drug.
|
0.00%
0/19 • From Baseline up to Week 20
TEAE is defined as an AE that starts on or after the first dose of the study drug and before 30 days after the last dose of the study drug.
|
10.0%
1/10 • Number of events 1 • From Baseline up to Week 20
TEAE is defined as an AE that starts on or after the first dose of the study drug and before 30 days after the last dose of the study drug.
|
0.00%
0/18 • From Baseline up to Week 20
TEAE is defined as an AE that starts on or after the first dose of the study drug and before 30 days after the last dose of the study drug.
|
|
Cardiac disorders
Palpitations
|
5.6%
1/18 • Number of events 1 • From Baseline up to Week 20
TEAE is defined as an AE that starts on or after the first dose of the study drug and before 30 days after the last dose of the study drug.
|
0.00%
0/19 • From Baseline up to Week 20
TEAE is defined as an AE that starts on or after the first dose of the study drug and before 30 days after the last dose of the study drug.
|
0.00%
0/10 • From Baseline up to Week 20
TEAE is defined as an AE that starts on or after the first dose of the study drug and before 30 days after the last dose of the study drug.
|
0.00%
0/18 • From Baseline up to Week 20
TEAE is defined as an AE that starts on or after the first dose of the study drug and before 30 days after the last dose of the study drug.
|
|
Ear and labyrinth disorders
Ear pain
|
0.00%
0/18 • From Baseline up to Week 20
TEAE is defined as an AE that starts on or after the first dose of the study drug and before 30 days after the last dose of the study drug.
|
0.00%
0/19 • From Baseline up to Week 20
TEAE is defined as an AE that starts on or after the first dose of the study drug and before 30 days after the last dose of the study drug.
|
10.0%
1/10 • Number of events 1 • From Baseline up to Week 20
TEAE is defined as an AE that starts on or after the first dose of the study drug and before 30 days after the last dose of the study drug.
|
0.00%
0/18 • From Baseline up to Week 20
TEAE is defined as an AE that starts on or after the first dose of the study drug and before 30 days after the last dose of the study drug.
|
|
Endocrine disorders
Hypothyroidism
|
5.6%
1/18 • Number of events 1 • From Baseline up to Week 20
TEAE is defined as an AE that starts on or after the first dose of the study drug and before 30 days after the last dose of the study drug.
|
0.00%
0/19 • From Baseline up to Week 20
TEAE is defined as an AE that starts on or after the first dose of the study drug and before 30 days after the last dose of the study drug.
|
0.00%
0/10 • From Baseline up to Week 20
TEAE is defined as an AE that starts on or after the first dose of the study drug and before 30 days after the last dose of the study drug.
|
0.00%
0/18 • From Baseline up to Week 20
TEAE is defined as an AE that starts on or after the first dose of the study drug and before 30 days after the last dose of the study drug.
|
|
Eye disorders
Dry eye
|
0.00%
0/18 • From Baseline up to Week 20
TEAE is defined as an AE that starts on or after the first dose of the study drug and before 30 days after the last dose of the study drug.
|
5.3%
1/19 • Number of events 1 • From Baseline up to Week 20
TEAE is defined as an AE that starts on or after the first dose of the study drug and before 30 days after the last dose of the study drug.
|
0.00%
0/10 • From Baseline up to Week 20
TEAE is defined as an AE that starts on or after the first dose of the study drug and before 30 days after the last dose of the study drug.
|
0.00%
0/18 • From Baseline up to Week 20
TEAE is defined as an AE that starts on or after the first dose of the study drug and before 30 days after the last dose of the study drug.
|
|
Eye disorders
Blepharitis
|
0.00%
0/18 • From Baseline up to Week 20
TEAE is defined as an AE that starts on or after the first dose of the study drug and before 30 days after the last dose of the study drug.
|
0.00%
0/19 • From Baseline up to Week 20
TEAE is defined as an AE that starts on or after the first dose of the study drug and before 30 days after the last dose of the study drug.
|
10.0%
1/10 • Number of events 1 • From Baseline up to Week 20
TEAE is defined as an AE that starts on or after the first dose of the study drug and before 30 days after the last dose of the study drug.
|
0.00%
0/18 • From Baseline up to Week 20
TEAE is defined as an AE that starts on or after the first dose of the study drug and before 30 days after the last dose of the study drug.
|
|
Eye disorders
Optic neuropathy
|
5.6%
1/18 • Number of events 1 • From Baseline up to Week 20
TEAE is defined as an AE that starts on or after the first dose of the study drug and before 30 days after the last dose of the study drug.
|
0.00%
0/19 • From Baseline up to Week 20
TEAE is defined as an AE that starts on or after the first dose of the study drug and before 30 days after the last dose of the study drug.
|
0.00%
0/10 • From Baseline up to Week 20
TEAE is defined as an AE that starts on or after the first dose of the study drug and before 30 days after the last dose of the study drug.
|
0.00%
0/18 • From Baseline up to Week 20
TEAE is defined as an AE that starts on or after the first dose of the study drug and before 30 days after the last dose of the study drug.
|
|
Gastrointestinal disorders
Constipation
|
5.6%
1/18 • Number of events 1 • From Baseline up to Week 20
TEAE is defined as an AE that starts on or after the first dose of the study drug and before 30 days after the last dose of the study drug.
|
0.00%
0/19 • From Baseline up to Week 20
TEAE is defined as an AE that starts on or after the first dose of the study drug and before 30 days after the last dose of the study drug.
|
0.00%
0/10 • From Baseline up to Week 20
TEAE is defined as an AE that starts on or after the first dose of the study drug and before 30 days after the last dose of the study drug.
|
0.00%
0/18 • From Baseline up to Week 20
TEAE is defined as an AE that starts on or after the first dose of the study drug and before 30 days after the last dose of the study drug.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/18 • From Baseline up to Week 20
TEAE is defined as an AE that starts on or after the first dose of the study drug and before 30 days after the last dose of the study drug.
|
5.3%
1/19 • Number of events 1 • From Baseline up to Week 20
TEAE is defined as an AE that starts on or after the first dose of the study drug and before 30 days after the last dose of the study drug.
|
0.00%
0/10 • From Baseline up to Week 20
TEAE is defined as an AE that starts on or after the first dose of the study drug and before 30 days after the last dose of the study drug.
|
0.00%
0/18 • From Baseline up to Week 20
TEAE is defined as an AE that starts on or after the first dose of the study drug and before 30 days after the last dose of the study drug.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
5.6%
1/18 • Number of events 1 • From Baseline up to Week 20
TEAE is defined as an AE that starts on or after the first dose of the study drug and before 30 days after the last dose of the study drug.
|
10.5%
2/19 • Number of events 2 • From Baseline up to Week 20
TEAE is defined as an AE that starts on or after the first dose of the study drug and before 30 days after the last dose of the study drug.
|
0.00%
0/10 • From Baseline up to Week 20
TEAE is defined as an AE that starts on or after the first dose of the study drug and before 30 days after the last dose of the study drug.
|
0.00%
0/18 • From Baseline up to Week 20
TEAE is defined as an AE that starts on or after the first dose of the study drug and before 30 days after the last dose of the study drug.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/18 • From Baseline up to Week 20
TEAE is defined as an AE that starts on or after the first dose of the study drug and before 30 days after the last dose of the study drug.
|
0.00%
0/19 • From Baseline up to Week 20
TEAE is defined as an AE that starts on or after the first dose of the study drug and before 30 days after the last dose of the study drug.
|
0.00%
0/10 • From Baseline up to Week 20
TEAE is defined as an AE that starts on or after the first dose of the study drug and before 30 days after the last dose of the study drug.
|
5.6%
1/18 • Number of events 1 • From Baseline up to Week 20
TEAE is defined as an AE that starts on or after the first dose of the study drug and before 30 days after the last dose of the study drug.
|
|
Gastrointestinal disorders
Aphthous ulcer
|
0.00%
0/18 • From Baseline up to Week 20
TEAE is defined as an AE that starts on or after the first dose of the study drug and before 30 days after the last dose of the study drug.
|
0.00%
0/19 • From Baseline up to Week 20
TEAE is defined as an AE that starts on or after the first dose of the study drug and before 30 days after the last dose of the study drug.
|
0.00%
0/10 • From Baseline up to Week 20
TEAE is defined as an AE that starts on or after the first dose of the study drug and before 30 days after the last dose of the study drug.
|
5.6%
1/18 • Number of events 1 • From Baseline up to Week 20
TEAE is defined as an AE that starts on or after the first dose of the study drug and before 30 days after the last dose of the study drug.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/18 • From Baseline up to Week 20
TEAE is defined as an AE that starts on or after the first dose of the study drug and before 30 days after the last dose of the study drug.
|
10.5%
2/19 • Number of events 2 • From Baseline up to Week 20
TEAE is defined as an AE that starts on or after the first dose of the study drug and before 30 days after the last dose of the study drug.
|
0.00%
0/10 • From Baseline up to Week 20
TEAE is defined as an AE that starts on or after the first dose of the study drug and before 30 days after the last dose of the study drug.
|
5.6%
1/18 • Number of events 1 • From Baseline up to Week 20
TEAE is defined as an AE that starts on or after the first dose of the study drug and before 30 days after the last dose of the study drug.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/18 • From Baseline up to Week 20
TEAE is defined as an AE that starts on or after the first dose of the study drug and before 30 days after the last dose of the study drug.
|
5.3%
1/19 • Number of events 1 • From Baseline up to Week 20
TEAE is defined as an AE that starts on or after the first dose of the study drug and before 30 days after the last dose of the study drug.
|
10.0%
1/10 • Number of events 1 • From Baseline up to Week 20
TEAE is defined as an AE that starts on or after the first dose of the study drug and before 30 days after the last dose of the study drug.
|
5.6%
1/18 • Number of events 1 • From Baseline up to Week 20
TEAE is defined as an AE that starts on or after the first dose of the study drug and before 30 days after the last dose of the study drug.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/18 • From Baseline up to Week 20
TEAE is defined as an AE that starts on or after the first dose of the study drug and before 30 days after the last dose of the study drug.
|
21.1%
4/19 • Number of events 4 • From Baseline up to Week 20
TEAE is defined as an AE that starts on or after the first dose of the study drug and before 30 days after the last dose of the study drug.
|
0.00%
0/10 • From Baseline up to Week 20
TEAE is defined as an AE that starts on or after the first dose of the study drug and before 30 days after the last dose of the study drug.
|
11.1%
2/18 • Number of events 2 • From Baseline up to Week 20
TEAE is defined as an AE that starts on or after the first dose of the study drug and before 30 days after the last dose of the study drug.
|
|
General disorders
Oedema peripheral
|
27.8%
5/18 • Number of events 5 • From Baseline up to Week 20
TEAE is defined as an AE that starts on or after the first dose of the study drug and before 30 days after the last dose of the study drug.
|
0.00%
0/19 • From Baseline up to Week 20
TEAE is defined as an AE that starts on or after the first dose of the study drug and before 30 days after the last dose of the study drug.
|
0.00%
0/10 • From Baseline up to Week 20
TEAE is defined as an AE that starts on or after the first dose of the study drug and before 30 days after the last dose of the study drug.
|
0.00%
0/18 • From Baseline up to Week 20
TEAE is defined as an AE that starts on or after the first dose of the study drug and before 30 days after the last dose of the study drug.
|
|
General disorders
Influenza like illness
|
0.00%
0/18 • From Baseline up to Week 20
TEAE is defined as an AE that starts on or after the first dose of the study drug and before 30 days after the last dose of the study drug.
|
5.3%
1/19 • Number of events 1 • From Baseline up to Week 20
TEAE is defined as an AE that starts on or after the first dose of the study drug and before 30 days after the last dose of the study drug.
|
0.00%
0/10 • From Baseline up to Week 20
TEAE is defined as an AE that starts on or after the first dose of the study drug and before 30 days after the last dose of the study drug.
|
0.00%
0/18 • From Baseline up to Week 20
TEAE is defined as an AE that starts on or after the first dose of the study drug and before 30 days after the last dose of the study drug.
|
|
General disorders
Injection site urticaria
|
0.00%
0/18 • From Baseline up to Week 20
TEAE is defined as an AE that starts on or after the first dose of the study drug and before 30 days after the last dose of the study drug.
|
5.3%
1/19 • Number of events 1 • From Baseline up to Week 20
TEAE is defined as an AE that starts on or after the first dose of the study drug and before 30 days after the last dose of the study drug.
|
0.00%
0/10 • From Baseline up to Week 20
TEAE is defined as an AE that starts on or after the first dose of the study drug and before 30 days after the last dose of the study drug.
|
0.00%
0/18 • From Baseline up to Week 20
TEAE is defined as an AE that starts on or after the first dose of the study drug and before 30 days after the last dose of the study drug.
|
|
General disorders
Nodule
|
0.00%
0/18 • From Baseline up to Week 20
TEAE is defined as an AE that starts on or after the first dose of the study drug and before 30 days after the last dose of the study drug.
|
5.3%
1/19 • Number of events 1 • From Baseline up to Week 20
TEAE is defined as an AE that starts on or after the first dose of the study drug and before 30 days after the last dose of the study drug.
|
0.00%
0/10 • From Baseline up to Week 20
TEAE is defined as an AE that starts on or after the first dose of the study drug and before 30 days after the last dose of the study drug.
|
0.00%
0/18 • From Baseline up to Week 20
TEAE is defined as an AE that starts on or after the first dose of the study drug and before 30 days after the last dose of the study drug.
|
|
General disorders
Pain
|
0.00%
0/18 • From Baseline up to Week 20
TEAE is defined as an AE that starts on or after the first dose of the study drug and before 30 days after the last dose of the study drug.
|
5.3%
1/19 • Number of events 1 • From Baseline up to Week 20
TEAE is defined as an AE that starts on or after the first dose of the study drug and before 30 days after the last dose of the study drug.
|
0.00%
0/10 • From Baseline up to Week 20
TEAE is defined as an AE that starts on or after the first dose of the study drug and before 30 days after the last dose of the study drug.
|
0.00%
0/18 • From Baseline up to Week 20
TEAE is defined as an AE that starts on or after the first dose of the study drug and before 30 days after the last dose of the study drug.
|
|
General disorders
Pyrexia
|
0.00%
0/18 • From Baseline up to Week 20
TEAE is defined as an AE that starts on or after the first dose of the study drug and before 30 days after the last dose of the study drug.
|
5.3%
1/19 • Number of events 1 • From Baseline up to Week 20
TEAE is defined as an AE that starts on or after the first dose of the study drug and before 30 days after the last dose of the study drug.
|
0.00%
0/10 • From Baseline up to Week 20
TEAE is defined as an AE that starts on or after the first dose of the study drug and before 30 days after the last dose of the study drug.
|
0.00%
0/18 • From Baseline up to Week 20
TEAE is defined as an AE that starts on or after the first dose of the study drug and before 30 days after the last dose of the study drug.
|
|
General disorders
Injection site pain
|
5.6%
1/18 • Number of events 1 • From Baseline up to Week 20
TEAE is defined as an AE that starts on or after the first dose of the study drug and before 30 days after the last dose of the study drug.
|
15.8%
3/19 • Number of events 3 • From Baseline up to Week 20
TEAE is defined as an AE that starts on or after the first dose of the study drug and before 30 days after the last dose of the study drug.
|
0.00%
0/10 • From Baseline up to Week 20
TEAE is defined as an AE that starts on or after the first dose of the study drug and before 30 days after the last dose of the study drug.
|
0.00%
0/18 • From Baseline up to Week 20
TEAE is defined as an AE that starts on or after the first dose of the study drug and before 30 days after the last dose of the study drug.
|
|
General disorders
Chills
|
0.00%
0/18 • From Baseline up to Week 20
TEAE is defined as an AE that starts on or after the first dose of the study drug and before 30 days after the last dose of the study drug.
|
0.00%
0/19 • From Baseline up to Week 20
TEAE is defined as an AE that starts on or after the first dose of the study drug and before 30 days after the last dose of the study drug.
|
10.0%
1/10 • Number of events 1 • From Baseline up to Week 20
TEAE is defined as an AE that starts on or after the first dose of the study drug and before 30 days after the last dose of the study drug.
|
0.00%
0/18 • From Baseline up to Week 20
TEAE is defined as an AE that starts on or after the first dose of the study drug and before 30 days after the last dose of the study drug.
|
|
General disorders
Injection site bruising
|
0.00%
0/18 • From Baseline up to Week 20
TEAE is defined as an AE that starts on or after the first dose of the study drug and before 30 days after the last dose of the study drug.
|
5.3%
1/19 • Number of events 1 • From Baseline up to Week 20
TEAE is defined as an AE that starts on or after the first dose of the study drug and before 30 days after the last dose of the study drug.
|
10.0%
1/10 • Number of events 1 • From Baseline up to Week 20
TEAE is defined as an AE that starts on or after the first dose of the study drug and before 30 days after the last dose of the study drug.
|
0.00%
0/18 • From Baseline up to Week 20
TEAE is defined as an AE that starts on or after the first dose of the study drug and before 30 days after the last dose of the study drug.
|
|
General disorders
Injection site pruritus
|
0.00%
0/18 • From Baseline up to Week 20
TEAE is defined as an AE that starts on or after the first dose of the study drug and before 30 days after the last dose of the study drug.
|
5.3%
1/19 • Number of events 1 • From Baseline up to Week 20
TEAE is defined as an AE that starts on or after the first dose of the study drug and before 30 days after the last dose of the study drug.
|
10.0%
1/10 • Number of events 1 • From Baseline up to Week 20
TEAE is defined as an AE that starts on or after the first dose of the study drug and before 30 days after the last dose of the study drug.
|
0.00%
0/18 • From Baseline up to Week 20
TEAE is defined as an AE that starts on or after the first dose of the study drug and before 30 days after the last dose of the study drug.
|
|
General disorders
Fatigue
|
0.00%
0/18 • From Baseline up to Week 20
TEAE is defined as an AE that starts on or after the first dose of the study drug and before 30 days after the last dose of the study drug.
|
10.5%
2/19 • Number of events 2 • From Baseline up to Week 20
TEAE is defined as an AE that starts on or after the first dose of the study drug and before 30 days after the last dose of the study drug.
|
10.0%
1/10 • Number of events 1 • From Baseline up to Week 20
TEAE is defined as an AE that starts on or after the first dose of the study drug and before 30 days after the last dose of the study drug.
|
0.00%
0/18 • From Baseline up to Week 20
TEAE is defined as an AE that starts on or after the first dose of the study drug and before 30 days after the last dose of the study drug.
|
|
General disorders
Injection site swelling
|
5.6%
1/18 • Number of events 1 • From Baseline up to Week 20
TEAE is defined as an AE that starts on or after the first dose of the study drug and before 30 days after the last dose of the study drug.
|
21.1%
4/19 • Number of events 4 • From Baseline up to Week 20
TEAE is defined as an AE that starts on or after the first dose of the study drug and before 30 days after the last dose of the study drug.
|
10.0%
1/10 • Number of events 1 • From Baseline up to Week 20
TEAE is defined as an AE that starts on or after the first dose of the study drug and before 30 days after the last dose of the study drug.
|
5.6%
1/18 • Number of events 1 • From Baseline up to Week 20
TEAE is defined as an AE that starts on or after the first dose of the study drug and before 30 days after the last dose of the study drug.
|
|
General disorders
Injection site erythema
|
50.0%
9/18 • Number of events 9 • From Baseline up to Week 20
TEAE is defined as an AE that starts on or after the first dose of the study drug and before 30 days after the last dose of the study drug.
|
47.4%
9/19 • Number of events 9 • From Baseline up to Week 20
TEAE is defined as an AE that starts on or after the first dose of the study drug and before 30 days after the last dose of the study drug.
|
30.0%
3/10 • Number of events 3 • From Baseline up to Week 20
TEAE is defined as an AE that starts on or after the first dose of the study drug and before 30 days after the last dose of the study drug.
|
16.7%
3/18 • Number of events 3 • From Baseline up to Week 20
TEAE is defined as an AE that starts on or after the first dose of the study drug and before 30 days after the last dose of the study drug.
|
|
Infections and infestations
Gastrointestinal viral infection
|
5.6%
1/18 • Number of events 1 • From Baseline up to Week 20
TEAE is defined as an AE that starts on or after the first dose of the study drug and before 30 days after the last dose of the study drug.
|
0.00%
0/19 • From Baseline up to Week 20
TEAE is defined as an AE that starts on or after the first dose of the study drug and before 30 days after the last dose of the study drug.
|
0.00%
0/10 • From Baseline up to Week 20
TEAE is defined as an AE that starts on or after the first dose of the study drug and before 30 days after the last dose of the study drug.
|
0.00%
0/18 • From Baseline up to Week 20
TEAE is defined as an AE that starts on or after the first dose of the study drug and before 30 days after the last dose of the study drug.
|
|
Infections and infestations
Groin abscess
|
5.6%
1/18 • Number of events 1 • From Baseline up to Week 20
TEAE is defined as an AE that starts on or after the first dose of the study drug and before 30 days after the last dose of the study drug.
|
0.00%
0/19 • From Baseline up to Week 20
TEAE is defined as an AE that starts on or after the first dose of the study drug and before 30 days after the last dose of the study drug.
|
0.00%
0/10 • From Baseline up to Week 20
TEAE is defined as an AE that starts on or after the first dose of the study drug and before 30 days after the last dose of the study drug.
|
0.00%
0/18 • From Baseline up to Week 20
TEAE is defined as an AE that starts on or after the first dose of the study drug and before 30 days after the last dose of the study drug.
|
|
Infections and infestations
Influenza
|
5.6%
1/18 • Number of events 1 • From Baseline up to Week 20
TEAE is defined as an AE that starts on or after the first dose of the study drug and before 30 days after the last dose of the study drug.
|
0.00%
0/19 • From Baseline up to Week 20
TEAE is defined as an AE that starts on or after the first dose of the study drug and before 30 days after the last dose of the study drug.
|
0.00%
0/10 • From Baseline up to Week 20
TEAE is defined as an AE that starts on or after the first dose of the study drug and before 30 days after the last dose of the study drug.
|
0.00%
0/18 • From Baseline up to Week 20
TEAE is defined as an AE that starts on or after the first dose of the study drug and before 30 days after the last dose of the study drug.
|
|
Infections and infestations
Erythema migrans
|
0.00%
0/18 • From Baseline up to Week 20
TEAE is defined as an AE that starts on or after the first dose of the study drug and before 30 days after the last dose of the study drug.
|
5.3%
1/19 • Number of events 1 • From Baseline up to Week 20
TEAE is defined as an AE that starts on or after the first dose of the study drug and before 30 days after the last dose of the study drug.
|
0.00%
0/10 • From Baseline up to Week 20
TEAE is defined as an AE that starts on or after the first dose of the study drug and before 30 days after the last dose of the study drug.
|
0.00%
0/18 • From Baseline up to Week 20
TEAE is defined as an AE that starts on or after the first dose of the study drug and before 30 days after the last dose of the study drug.
|
|
Infections and infestations
Fungal skin infection
|
0.00%
0/18 • From Baseline up to Week 20
TEAE is defined as an AE that starts on or after the first dose of the study drug and before 30 days after the last dose of the study drug.
|
5.3%
1/19 • Number of events 1 • From Baseline up to Week 20
TEAE is defined as an AE that starts on or after the first dose of the study drug and before 30 days after the last dose of the study drug.
|
0.00%
0/10 • From Baseline up to Week 20
TEAE is defined as an AE that starts on or after the first dose of the study drug and before 30 days after the last dose of the study drug.
|
0.00%
0/18 • From Baseline up to Week 20
TEAE is defined as an AE that starts on or after the first dose of the study drug and before 30 days after the last dose of the study drug.
|
|
Infections and infestations
Herpes zoster
|
0.00%
0/18 • From Baseline up to Week 20
TEAE is defined as an AE that starts on or after the first dose of the study drug and before 30 days after the last dose of the study drug.
|
5.3%
1/19 • Number of events 1 • From Baseline up to Week 20
TEAE is defined as an AE that starts on or after the first dose of the study drug and before 30 days after the last dose of the study drug.
|
0.00%
0/10 • From Baseline up to Week 20
TEAE is defined as an AE that starts on or after the first dose of the study drug and before 30 days after the last dose of the study drug.
|
0.00%
0/18 • From Baseline up to Week 20
TEAE is defined as an AE that starts on or after the first dose of the study drug and before 30 days after the last dose of the study drug.
|
|
Infections and infestations
Vulvovaginal mycotic infection
|
0.00%
0/18 • From Baseline up to Week 20
TEAE is defined as an AE that starts on or after the first dose of the study drug and before 30 days after the last dose of the study drug.
|
5.3%
1/19 • Number of events 1 • From Baseline up to Week 20
TEAE is defined as an AE that starts on or after the first dose of the study drug and before 30 days after the last dose of the study drug.
|
0.00%
0/10 • From Baseline up to Week 20
TEAE is defined as an AE that starts on or after the first dose of the study drug and before 30 days after the last dose of the study drug.
|
0.00%
0/18 • From Baseline up to Week 20
TEAE is defined as an AE that starts on or after the first dose of the study drug and before 30 days after the last dose of the study drug.
|
|
Infections and infestations
Corona virus infection
|
5.6%
1/18 • Number of events 1 • From Baseline up to Week 20
TEAE is defined as an AE that starts on or after the first dose of the study drug and before 30 days after the last dose of the study drug.
|
5.3%
1/19 • Number of events 1 • From Baseline up to Week 20
TEAE is defined as an AE that starts on or after the first dose of the study drug and before 30 days after the last dose of the study drug.
|
0.00%
0/10 • From Baseline up to Week 20
TEAE is defined as an AE that starts on or after the first dose of the study drug and before 30 days after the last dose of the study drug.
|
0.00%
0/18 • From Baseline up to Week 20
TEAE is defined as an AE that starts on or after the first dose of the study drug and before 30 days after the last dose of the study drug.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/18 • From Baseline up to Week 20
TEAE is defined as an AE that starts on or after the first dose of the study drug and before 30 days after the last dose of the study drug.
|
0.00%
0/19 • From Baseline up to Week 20
TEAE is defined as an AE that starts on or after the first dose of the study drug and before 30 days after the last dose of the study drug.
|
10.0%
1/10 • Number of events 1 • From Baseline up to Week 20
TEAE is defined as an AE that starts on or after the first dose of the study drug and before 30 days after the last dose of the study drug.
|
0.00%
0/18 • From Baseline up to Week 20
TEAE is defined as an AE that starts on or after the first dose of the study drug and before 30 days after the last dose of the study drug.
|
|
Infections and infestations
Hordeolum
|
0.00%
0/18 • From Baseline up to Week 20
TEAE is defined as an AE that starts on or after the first dose of the study drug and before 30 days after the last dose of the study drug.
|
0.00%
0/19 • From Baseline up to Week 20
TEAE is defined as an AE that starts on or after the first dose of the study drug and before 30 days after the last dose of the study drug.
|
0.00%
0/10 • From Baseline up to Week 20
TEAE is defined as an AE that starts on or after the first dose of the study drug and before 30 days after the last dose of the study drug.
|
5.6%
1/18 • Number of events 1 • From Baseline up to Week 20
TEAE is defined as an AE that starts on or after the first dose of the study drug and before 30 days after the last dose of the study drug.
|
|
Infections and infestations
Sinusitis
|
0.00%
0/18 • From Baseline up to Week 20
TEAE is defined as an AE that starts on or after the first dose of the study drug and before 30 days after the last dose of the study drug.
|
0.00%
0/19 • From Baseline up to Week 20
TEAE is defined as an AE that starts on or after the first dose of the study drug and before 30 days after the last dose of the study drug.
|
0.00%
0/10 • From Baseline up to Week 20
TEAE is defined as an AE that starts on or after the first dose of the study drug and before 30 days after the last dose of the study drug.
|
5.6%
1/18 • Number of events 1 • From Baseline up to Week 20
TEAE is defined as an AE that starts on or after the first dose of the study drug and before 30 days after the last dose of the study drug.
|
|
Infections and infestations
Herpes simplex
|
5.6%
1/18 • Number of events 1 • From Baseline up to Week 20
TEAE is defined as an AE that starts on or after the first dose of the study drug and before 30 days after the last dose of the study drug.
|
0.00%
0/19 • From Baseline up to Week 20
TEAE is defined as an AE that starts on or after the first dose of the study drug and before 30 days after the last dose of the study drug.
|
0.00%
0/10 • From Baseline up to Week 20
TEAE is defined as an AE that starts on or after the first dose of the study drug and before 30 days after the last dose of the study drug.
|
5.6%
1/18 • Number of events 1 • From Baseline up to Week 20
TEAE is defined as an AE that starts on or after the first dose of the study drug and before 30 days after the last dose of the study drug.
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/18 • From Baseline up to Week 20
TEAE is defined as an AE that starts on or after the first dose of the study drug and before 30 days after the last dose of the study drug.
|
5.3%
1/19 • Number of events 1 • From Baseline up to Week 20
TEAE is defined as an AE that starts on or after the first dose of the study drug and before 30 days after the last dose of the study drug.
|
10.0%
1/10 • Number of events 1 • From Baseline up to Week 20
TEAE is defined as an AE that starts on or after the first dose of the study drug and before 30 days after the last dose of the study drug.
|
5.6%
1/18 • Number of events 1 • From Baseline up to Week 20
TEAE is defined as an AE that starts on or after the first dose of the study drug and before 30 days after the last dose of the study drug.
|
|
Injury, poisoning and procedural complications
Accident
|
5.6%
1/18 • Number of events 1 • From Baseline up to Week 20
TEAE is defined as an AE that starts on or after the first dose of the study drug and before 30 days after the last dose of the study drug.
|
0.00%
0/19 • From Baseline up to Week 20
TEAE is defined as an AE that starts on or after the first dose of the study drug and before 30 days after the last dose of the study drug.
|
0.00%
0/10 • From Baseline up to Week 20
TEAE is defined as an AE that starts on or after the first dose of the study drug and before 30 days after the last dose of the study drug.
|
0.00%
0/18 • From Baseline up to Week 20
TEAE is defined as an AE that starts on or after the first dose of the study drug and before 30 days after the last dose of the study drug.
|
|
Injury, poisoning and procedural complications
Back injury
|
5.6%
1/18 • Number of events 1 • From Baseline up to Week 20
TEAE is defined as an AE that starts on or after the first dose of the study drug and before 30 days after the last dose of the study drug.
|
0.00%
0/19 • From Baseline up to Week 20
TEAE is defined as an AE that starts on or after the first dose of the study drug and before 30 days after the last dose of the study drug.
|
0.00%
0/10 • From Baseline up to Week 20
TEAE is defined as an AE that starts on or after the first dose of the study drug and before 30 days after the last dose of the study drug.
|
0.00%
0/18 • From Baseline up to Week 20
TEAE is defined as an AE that starts on or after the first dose of the study drug and before 30 days after the last dose of the study drug.
|
|
Injury, poisoning and procedural complications
Tooth fracture
|
0.00%
0/18 • From Baseline up to Week 20
TEAE is defined as an AE that starts on or after the first dose of the study drug and before 30 days after the last dose of the study drug.
|
5.3%
1/19 • Number of events 1 • From Baseline up to Week 20
TEAE is defined as an AE that starts on or after the first dose of the study drug and before 30 days after the last dose of the study drug.
|
0.00%
0/10 • From Baseline up to Week 20
TEAE is defined as an AE that starts on or after the first dose of the study drug and before 30 days after the last dose of the study drug.
|
0.00%
0/18 • From Baseline up to Week 20
TEAE is defined as an AE that starts on or after the first dose of the study drug and before 30 days after the last dose of the study drug.
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
0.00%
0/18 • From Baseline up to Week 20
TEAE is defined as an AE that starts on or after the first dose of the study drug and before 30 days after the last dose of the study drug.
|
0.00%
0/19 • From Baseline up to Week 20
TEAE is defined as an AE that starts on or after the first dose of the study drug and before 30 days after the last dose of the study drug.
|
0.00%
0/10 • From Baseline up to Week 20
TEAE is defined as an AE that starts on or after the first dose of the study drug and before 30 days after the last dose of the study drug.
|
5.6%
1/18 • Number of events 1 • From Baseline up to Week 20
TEAE is defined as an AE that starts on or after the first dose of the study drug and before 30 days after the last dose of the study drug.
|
|
Investigations
Blood thyroid stimulating hormone decreased
|
5.6%
1/18 • Number of events 1 • From Baseline up to Week 20
TEAE is defined as an AE that starts on or after the first dose of the study drug and before 30 days after the last dose of the study drug.
|
0.00%
0/19 • From Baseline up to Week 20
TEAE is defined as an AE that starts on or after the first dose of the study drug and before 30 days after the last dose of the study drug.
|
0.00%
0/10 • From Baseline up to Week 20
TEAE is defined as an AE that starts on or after the first dose of the study drug and before 30 days after the last dose of the study drug.
|
0.00%
0/18 • From Baseline up to Week 20
TEAE is defined as an AE that starts on or after the first dose of the study drug and before 30 days after the last dose of the study drug.
|
|
Investigations
Blood thyroid stimulating hormone increased
|
5.6%
1/18 • Number of events 1 • From Baseline up to Week 20
TEAE is defined as an AE that starts on or after the first dose of the study drug and before 30 days after the last dose of the study drug.
|
0.00%
0/19 • From Baseline up to Week 20
TEAE is defined as an AE that starts on or after the first dose of the study drug and before 30 days after the last dose of the study drug.
|
0.00%
0/10 • From Baseline up to Week 20
TEAE is defined as an AE that starts on or after the first dose of the study drug and before 30 days after the last dose of the study drug.
|
0.00%
0/18 • From Baseline up to Week 20
TEAE is defined as an AE that starts on or after the first dose of the study drug and before 30 days after the last dose of the study drug.
|
|
Investigations
Thyroxine decreased
|
5.6%
1/18 • Number of events 1 • From Baseline up to Week 20
TEAE is defined as an AE that starts on or after the first dose of the study drug and before 30 days after the last dose of the study drug.
|
0.00%
0/19 • From Baseline up to Week 20
TEAE is defined as an AE that starts on or after the first dose of the study drug and before 30 days after the last dose of the study drug.
|
0.00%
0/10 • From Baseline up to Week 20
TEAE is defined as an AE that starts on or after the first dose of the study drug and before 30 days after the last dose of the study drug.
|
0.00%
0/18 • From Baseline up to Week 20
TEAE is defined as an AE that starts on or after the first dose of the study drug and before 30 days after the last dose of the study drug.
|
|
Investigations
Thyroxine increased
|
5.6%
1/18 • Number of events 1 • From Baseline up to Week 20
TEAE is defined as an AE that starts on or after the first dose of the study drug and before 30 days after the last dose of the study drug.
|
0.00%
0/19 • From Baseline up to Week 20
TEAE is defined as an AE that starts on or after the first dose of the study drug and before 30 days after the last dose of the study drug.
|
0.00%
0/10 • From Baseline up to Week 20
TEAE is defined as an AE that starts on or after the first dose of the study drug and before 30 days after the last dose of the study drug.
|
0.00%
0/18 • From Baseline up to Week 20
TEAE is defined as an AE that starts on or after the first dose of the study drug and before 30 days after the last dose of the study drug.
|
|
Investigations
Tri-iodothyronine decreased
|
5.6%
1/18 • Number of events 1 • From Baseline up to Week 20
TEAE is defined as an AE that starts on or after the first dose of the study drug and before 30 days after the last dose of the study drug.
|
0.00%
0/19 • From Baseline up to Week 20
TEAE is defined as an AE that starts on or after the first dose of the study drug and before 30 days after the last dose of the study drug.
|
0.00%
0/10 • From Baseline up to Week 20
TEAE is defined as an AE that starts on or after the first dose of the study drug and before 30 days after the last dose of the study drug.
|
0.00%
0/18 • From Baseline up to Week 20
TEAE is defined as an AE that starts on or after the first dose of the study drug and before 30 days after the last dose of the study drug.
|
|
Investigations
Tri-iodothyronine increased
|
5.6%
1/18 • Number of events 1 • From Baseline up to Week 20
TEAE is defined as an AE that starts on or after the first dose of the study drug and before 30 days after the last dose of the study drug.
|
0.00%
0/19 • From Baseline up to Week 20
TEAE is defined as an AE that starts on or after the first dose of the study drug and before 30 days after the last dose of the study drug.
|
0.00%
0/10 • From Baseline up to Week 20
TEAE is defined as an AE that starts on or after the first dose of the study drug and before 30 days after the last dose of the study drug.
|
0.00%
0/18 • From Baseline up to Week 20
TEAE is defined as an AE that starts on or after the first dose of the study drug and before 30 days after the last dose of the study drug.
|
|
Investigations
Blood cholesterol increased
|
0.00%
0/18 • From Baseline up to Week 20
TEAE is defined as an AE that starts on or after the first dose of the study drug and before 30 days after the last dose of the study drug.
|
10.5%
2/19 • Number of events 2 • From Baseline up to Week 20
TEAE is defined as an AE that starts on or after the first dose of the study drug and before 30 days after the last dose of the study drug.
|
0.00%
0/10 • From Baseline up to Week 20
TEAE is defined as an AE that starts on or after the first dose of the study drug and before 30 days after the last dose of the study drug.
|
0.00%
0/18 • From Baseline up to Week 20
TEAE is defined as an AE that starts on or after the first dose of the study drug and before 30 days after the last dose of the study drug.
|
|
Investigations
Vitamin D decreased
|
0.00%
0/18 • From Baseline up to Week 20
TEAE is defined as an AE that starts on or after the first dose of the study drug and before 30 days after the last dose of the study drug.
|
0.00%
0/19 • From Baseline up to Week 20
TEAE is defined as an AE that starts on or after the first dose of the study drug and before 30 days after the last dose of the study drug.
|
10.0%
1/10 • Number of events 1 • From Baseline up to Week 20
TEAE is defined as an AE that starts on or after the first dose of the study drug and before 30 days after the last dose of the study drug.
|
0.00%
0/18 • From Baseline up to Week 20
TEAE is defined as an AE that starts on or after the first dose of the study drug and before 30 days after the last dose of the study drug.
|
|
Investigations
Intraocular pressure increased
|
11.1%
2/18 • Number of events 2 • From Baseline up to Week 20
TEAE is defined as an AE that starts on or after the first dose of the study drug and before 30 days after the last dose of the study drug.
|
0.00%
0/19 • From Baseline up to Week 20
TEAE is defined as an AE that starts on or after the first dose of the study drug and before 30 days after the last dose of the study drug.
|
0.00%
0/10 • From Baseline up to Week 20
TEAE is defined as an AE that starts on or after the first dose of the study drug and before 30 days after the last dose of the study drug.
|
11.1%
2/18 • Number of events 2 • From Baseline up to Week 20
TEAE is defined as an AE that starts on or after the first dose of the study drug and before 30 days after the last dose of the study drug.
|
|
Metabolism and nutrition disorders
Iron deficiency
|
5.6%
1/18 • Number of events 1 • From Baseline up to Week 20
TEAE is defined as an AE that starts on or after the first dose of the study drug and before 30 days after the last dose of the study drug.
|
0.00%
0/19 • From Baseline up to Week 20
TEAE is defined as an AE that starts on or after the first dose of the study drug and before 30 days after the last dose of the study drug.
|
0.00%
0/10 • From Baseline up to Week 20
TEAE is defined as an AE that starts on or after the first dose of the study drug and before 30 days after the last dose of the study drug.
|
0.00%
0/18 • From Baseline up to Week 20
TEAE is defined as an AE that starts on or after the first dose of the study drug and before 30 days after the last dose of the study drug.
|
|
Metabolism and nutrition disorders
Hyperlipidaemia
|
0.00%
0/18 • From Baseline up to Week 20
TEAE is defined as an AE that starts on or after the first dose of the study drug and before 30 days after the last dose of the study drug.
|
5.3%
1/19 • Number of events 1 • From Baseline up to Week 20
TEAE is defined as an AE that starts on or after the first dose of the study drug and before 30 days after the last dose of the study drug.
|
0.00%
0/10 • From Baseline up to Week 20
TEAE is defined as an AE that starts on or after the first dose of the study drug and before 30 days after the last dose of the study drug.
|
0.00%
0/18 • From Baseline up to Week 20
TEAE is defined as an AE that starts on or after the first dose of the study drug and before 30 days after the last dose of the study drug.
|
|
Musculoskeletal and connective tissue disorders
Groin pain
|
0.00%
0/18 • From Baseline up to Week 20
TEAE is defined as an AE that starts on or after the first dose of the study drug and before 30 days after the last dose of the study drug.
|
5.3%
1/19 • Number of events 1 • From Baseline up to Week 20
TEAE is defined as an AE that starts on or after the first dose of the study drug and before 30 days after the last dose of the study drug.
|
0.00%
0/10 • From Baseline up to Week 20
TEAE is defined as an AE that starts on or after the first dose of the study drug and before 30 days after the last dose of the study drug.
|
0.00%
0/18 • From Baseline up to Week 20
TEAE is defined as an AE that starts on or after the first dose of the study drug and before 30 days after the last dose of the study drug.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
|
0.00%
0/18 • From Baseline up to Week 20
TEAE is defined as an AE that starts on or after the first dose of the study drug and before 30 days after the last dose of the study drug.
|
5.3%
1/19 • Number of events 1 • From Baseline up to Week 20
TEAE is defined as an AE that starts on or after the first dose of the study drug and before 30 days after the last dose of the study drug.
|
0.00%
0/10 • From Baseline up to Week 20
TEAE is defined as an AE that starts on or after the first dose of the study drug and before 30 days after the last dose of the study drug.
|
0.00%
0/18 • From Baseline up to Week 20
TEAE is defined as an AE that starts on or after the first dose of the study drug and before 30 days after the last dose of the study drug.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
5.6%
1/18 • Number of events 1 • From Baseline up to Week 20
TEAE is defined as an AE that starts on or after the first dose of the study drug and before 30 days after the last dose of the study drug.
|
5.3%
1/19 • Number of events 1 • From Baseline up to Week 20
TEAE is defined as an AE that starts on or after the first dose of the study drug and before 30 days after the last dose of the study drug.
|
0.00%
0/10 • From Baseline up to Week 20
TEAE is defined as an AE that starts on or after the first dose of the study drug and before 30 days after the last dose of the study drug.
|
0.00%
0/18 • From Baseline up to Week 20
TEAE is defined as an AE that starts on or after the first dose of the study drug and before 30 days after the last dose of the study drug.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
5.6%
1/18 • Number of events 1 • From Baseline up to Week 20
TEAE is defined as an AE that starts on or after the first dose of the study drug and before 30 days after the last dose of the study drug.
|
15.8%
3/19 • Number of events 3 • From Baseline up to Week 20
TEAE is defined as an AE that starts on or after the first dose of the study drug and before 30 days after the last dose of the study drug.
|
0.00%
0/10 • From Baseline up to Week 20
TEAE is defined as an AE that starts on or after the first dose of the study drug and before 30 days after the last dose of the study drug.
|
0.00%
0/18 • From Baseline up to Week 20
TEAE is defined as an AE that starts on or after the first dose of the study drug and before 30 days after the last dose of the study drug.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/18 • From Baseline up to Week 20
TEAE is defined as an AE that starts on or after the first dose of the study drug and before 30 days after the last dose of the study drug.
|
0.00%
0/19 • From Baseline up to Week 20
TEAE is defined as an AE that starts on or after the first dose of the study drug and before 30 days after the last dose of the study drug.
|
0.00%
0/10 • From Baseline up to Week 20
TEAE is defined as an AE that starts on or after the first dose of the study drug and before 30 days after the last dose of the study drug.
|
5.6%
1/18 • Number of events 1 • From Baseline up to Week 20
TEAE is defined as an AE that starts on or after the first dose of the study drug and before 30 days after the last dose of the study drug.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
5.6%
1/18 • Number of events 1 • From Baseline up to Week 20
TEAE is defined as an AE that starts on or after the first dose of the study drug and before 30 days after the last dose of the study drug.
|
0.00%
0/19 • From Baseline up to Week 20
TEAE is defined as an AE that starts on or after the first dose of the study drug and before 30 days after the last dose of the study drug.
|
0.00%
0/10 • From Baseline up to Week 20
TEAE is defined as an AE that starts on or after the first dose of the study drug and before 30 days after the last dose of the study drug.
|
5.6%
1/18 • Number of events 1 • From Baseline up to Week 20
TEAE is defined as an AE that starts on or after the first dose of the study drug and before 30 days after the last dose of the study drug.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/18 • From Baseline up to Week 20
TEAE is defined as an AE that starts on or after the first dose of the study drug and before 30 days after the last dose of the study drug.
|
0.00%
0/19 • From Baseline up to Week 20
TEAE is defined as an AE that starts on or after the first dose of the study drug and before 30 days after the last dose of the study drug.
|
10.0%
1/10 • Number of events 1 • From Baseline up to Week 20
TEAE is defined as an AE that starts on or after the first dose of the study drug and before 30 days after the last dose of the study drug.
|
11.1%
2/18 • Number of events 2 • From Baseline up to Week 20
TEAE is defined as an AE that starts on or after the first dose of the study drug and before 30 days after the last dose of the study drug.
|
|
Nervous system disorders
Paraesthesia
|
5.6%
1/18 • Number of events 1 • From Baseline up to Week 20
TEAE is defined as an AE that starts on or after the first dose of the study drug and before 30 days after the last dose of the study drug.
|
0.00%
0/19 • From Baseline up to Week 20
TEAE is defined as an AE that starts on or after the first dose of the study drug and before 30 days after the last dose of the study drug.
|
0.00%
0/10 • From Baseline up to Week 20
TEAE is defined as an AE that starts on or after the first dose of the study drug and before 30 days after the last dose of the study drug.
|
0.00%
0/18 • From Baseline up to Week 20
TEAE is defined as an AE that starts on or after the first dose of the study drug and before 30 days after the last dose of the study drug.
|
|
Nervous system disorders
Paresis
|
5.6%
1/18 • Number of events 1 • From Baseline up to Week 20
TEAE is defined as an AE that starts on or after the first dose of the study drug and before 30 days after the last dose of the study drug.
|
0.00%
0/19 • From Baseline up to Week 20
TEAE is defined as an AE that starts on or after the first dose of the study drug and before 30 days after the last dose of the study drug.
|
0.00%
0/10 • From Baseline up to Week 20
TEAE is defined as an AE that starts on or after the first dose of the study drug and before 30 days after the last dose of the study drug.
|
0.00%
0/18 • From Baseline up to Week 20
TEAE is defined as an AE that starts on or after the first dose of the study drug and before 30 days after the last dose of the study drug.
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/18 • From Baseline up to Week 20
TEAE is defined as an AE that starts on or after the first dose of the study drug and before 30 days after the last dose of the study drug.
|
5.3%
1/19 • Number of events 1 • From Baseline up to Week 20
TEAE is defined as an AE that starts on or after the first dose of the study drug and before 30 days after the last dose of the study drug.
|
0.00%
0/10 • From Baseline up to Week 20
TEAE is defined as an AE that starts on or after the first dose of the study drug and before 30 days after the last dose of the study drug.
|
0.00%
0/18 • From Baseline up to Week 20
TEAE is defined as an AE that starts on or after the first dose of the study drug and before 30 days after the last dose of the study drug.
|
|
Nervous system disorders
Tension headache
|
0.00%
0/18 • From Baseline up to Week 20
TEAE is defined as an AE that starts on or after the first dose of the study drug and before 30 days after the last dose of the study drug.
|
5.3%
1/19 • Number of events 1 • From Baseline up to Week 20
TEAE is defined as an AE that starts on or after the first dose of the study drug and before 30 days after the last dose of the study drug.
|
0.00%
0/10 • From Baseline up to Week 20
TEAE is defined as an AE that starts on or after the first dose of the study drug and before 30 days after the last dose of the study drug.
|
0.00%
0/18 • From Baseline up to Week 20
TEAE is defined as an AE that starts on or after the first dose of the study drug and before 30 days after the last dose of the study drug.
|
|
Nervous system disorders
Dyspraxia
|
0.00%
0/18 • From Baseline up to Week 20
TEAE is defined as an AE that starts on or after the first dose of the study drug and before 30 days after the last dose of the study drug.
|
0.00%
0/19 • From Baseline up to Week 20
TEAE is defined as an AE that starts on or after the first dose of the study drug and before 30 days after the last dose of the study drug.
|
10.0%
1/10 • Number of events 1 • From Baseline up to Week 20
TEAE is defined as an AE that starts on or after the first dose of the study drug and before 30 days after the last dose of the study drug.
|
0.00%
0/18 • From Baseline up to Week 20
TEAE is defined as an AE that starts on or after the first dose of the study drug and before 30 days after the last dose of the study drug.
|
|
Nervous system disorders
Migraine
|
0.00%
0/18 • From Baseline up to Week 20
TEAE is defined as an AE that starts on or after the first dose of the study drug and before 30 days after the last dose of the study drug.
|
0.00%
0/19 • From Baseline up to Week 20
TEAE is defined as an AE that starts on or after the first dose of the study drug and before 30 days after the last dose of the study drug.
|
10.0%
1/10 • Number of events 1 • From Baseline up to Week 20
TEAE is defined as an AE that starts on or after the first dose of the study drug and before 30 days after the last dose of the study drug.
|
0.00%
0/18 • From Baseline up to Week 20
TEAE is defined as an AE that starts on or after the first dose of the study drug and before 30 days after the last dose of the study drug.
|
|
Nervous system disorders
Parosmia
|
0.00%
0/18 • From Baseline up to Week 20
TEAE is defined as an AE that starts on or after the first dose of the study drug and before 30 days after the last dose of the study drug.
|
0.00%
0/19 • From Baseline up to Week 20
TEAE is defined as an AE that starts on or after the first dose of the study drug and before 30 days after the last dose of the study drug.
|
10.0%
1/10 • Number of events 1 • From Baseline up to Week 20
TEAE is defined as an AE that starts on or after the first dose of the study drug and before 30 days after the last dose of the study drug.
|
0.00%
0/18 • From Baseline up to Week 20
TEAE is defined as an AE that starts on or after the first dose of the study drug and before 30 days after the last dose of the study drug.
|
|
Nervous system disorders
Headache
|
0.00%
0/18 • From Baseline up to Week 20
TEAE is defined as an AE that starts on or after the first dose of the study drug and before 30 days after the last dose of the study drug.
|
5.3%
1/19 • Number of events 1 • From Baseline up to Week 20
TEAE is defined as an AE that starts on or after the first dose of the study drug and before 30 days after the last dose of the study drug.
|
0.00%
0/10 • From Baseline up to Week 20
TEAE is defined as an AE that starts on or after the first dose of the study drug and before 30 days after the last dose of the study drug.
|
5.6%
1/18 • Number of events 1 • From Baseline up to Week 20
TEAE is defined as an AE that starts on or after the first dose of the study drug and before 30 days after the last dose of the study drug.
|
|
Nervous system disorders
Lethargy
|
11.1%
2/18 • Number of events 2 • From Baseline up to Week 20
TEAE is defined as an AE that starts on or after the first dose of the study drug and before 30 days after the last dose of the study drug.
|
26.3%
5/19 • Number of events 5 • From Baseline up to Week 20
TEAE is defined as an AE that starts on or after the first dose of the study drug and before 30 days after the last dose of the study drug.
|
10.0%
1/10 • Number of events 1 • From Baseline up to Week 20
TEAE is defined as an AE that starts on or after the first dose of the study drug and before 30 days after the last dose of the study drug.
|
22.2%
4/18 • Number of events 4 • From Baseline up to Week 20
TEAE is defined as an AE that starts on or after the first dose of the study drug and before 30 days after the last dose of the study drug.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/18 • From Baseline up to Week 20
TEAE is defined as an AE that starts on or after the first dose of the study drug and before 30 days after the last dose of the study drug.
|
0.00%
0/19 • From Baseline up to Week 20
TEAE is defined as an AE that starts on or after the first dose of the study drug and before 30 days after the last dose of the study drug.
|
10.0%
1/10 • Number of events 1 • From Baseline up to Week 20
TEAE is defined as an AE that starts on or after the first dose of the study drug and before 30 days after the last dose of the study drug.
|
5.6%
1/18 • Number of events 1 • From Baseline up to Week 20
TEAE is defined as an AE that starts on or after the first dose of the study drug and before 30 days after the last dose of the study drug.
|
|
Reproductive system and breast disorders
Menstruation irregular
|
0.00%
0/18 • From Baseline up to Week 20
TEAE is defined as an AE that starts on or after the first dose of the study drug and before 30 days after the last dose of the study drug.
|
5.3%
1/19 • Number of events 1 • From Baseline up to Week 20
TEAE is defined as an AE that starts on or after the first dose of the study drug and before 30 days after the last dose of the study drug.
|
0.00%
0/10 • From Baseline up to Week 20
TEAE is defined as an AE that starts on or after the first dose of the study drug and before 30 days after the last dose of the study drug.
|
0.00%
0/18 • From Baseline up to Week 20
TEAE is defined as an AE that starts on or after the first dose of the study drug and before 30 days after the last dose of the study drug.
|
|
Reproductive system and breast disorders
Menorrhagia
|
0.00%
0/18 • From Baseline up to Week 20
TEAE is defined as an AE that starts on or after the first dose of the study drug and before 30 days after the last dose of the study drug.
|
0.00%
0/19 • From Baseline up to Week 20
TEAE is defined as an AE that starts on or after the first dose of the study drug and before 30 days after the last dose of the study drug.
|
10.0%
1/10 • Number of events 1 • From Baseline up to Week 20
TEAE is defined as an AE that starts on or after the first dose of the study drug and before 30 days after the last dose of the study drug.
|
0.00%
0/18 • From Baseline up to Week 20
TEAE is defined as an AE that starts on or after the first dose of the study drug and before 30 days after the last dose of the study drug.
|
|
Reproductive system and breast disorders
Dysmenorrhoea
|
5.6%
1/18 • Number of events 1 • From Baseline up to Week 20
TEAE is defined as an AE that starts on or after the first dose of the study drug and before 30 days after the last dose of the study drug.
|
0.00%
0/19 • From Baseline up to Week 20
TEAE is defined as an AE that starts on or after the first dose of the study drug and before 30 days after the last dose of the study drug.
|
10.0%
1/10 • Number of events 1 • From Baseline up to Week 20
TEAE is defined as an AE that starts on or after the first dose of the study drug and before 30 days after the last dose of the study drug.
|
0.00%
0/18 • From Baseline up to Week 20
TEAE is defined as an AE that starts on or after the first dose of the study drug and before 30 days after the last dose of the study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/18 • From Baseline up to Week 20
TEAE is defined as an AE that starts on or after the first dose of the study drug and before 30 days after the last dose of the study drug.
|
0.00%
0/19 • From Baseline up to Week 20
TEAE is defined as an AE that starts on or after the first dose of the study drug and before 30 days after the last dose of the study drug.
|
10.0%
1/10 • Number of events 1 • From Baseline up to Week 20
TEAE is defined as an AE that starts on or after the first dose of the study drug and before 30 days after the last dose of the study drug.
|
0.00%
0/18 • From Baseline up to Week 20
TEAE is defined as an AE that starts on or after the first dose of the study drug and before 30 days after the last dose of the study drug.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/18 • From Baseline up to Week 20
TEAE is defined as an AE that starts on or after the first dose of the study drug and before 30 days after the last dose of the study drug.
|
5.3%
1/19 • Number of events 1 • From Baseline up to Week 20
TEAE is defined as an AE that starts on or after the first dose of the study drug and before 30 days after the last dose of the study drug.
|
0.00%
0/10 • From Baseline up to Week 20
TEAE is defined as an AE that starts on or after the first dose of the study drug and before 30 days after the last dose of the study drug.
|
0.00%
0/18 • From Baseline up to Week 20
TEAE is defined as an AE that starts on or after the first dose of the study drug and before 30 days after the last dose of the study drug.
|
|
Skin and subcutaneous tissue disorders
Neurodermatitis
|
0.00%
0/18 • From Baseline up to Week 20
TEAE is defined as an AE that starts on or after the first dose of the study drug and before 30 days after the last dose of the study drug.
|
0.00%
0/19 • From Baseline up to Week 20
TEAE is defined as an AE that starts on or after the first dose of the study drug and before 30 days after the last dose of the study drug.
|
0.00%
0/10 • From Baseline up to Week 20
TEAE is defined as an AE that starts on or after the first dose of the study drug and before 30 days after the last dose of the study drug.
|
5.6%
1/18 • Number of events 1 • From Baseline up to Week 20
TEAE is defined as an AE that starts on or after the first dose of the study drug and before 30 days after the last dose of the study drug.
|
|
Vascular disorders
Hot flush
|
0.00%
0/18 • From Baseline up to Week 20
TEAE is defined as an AE that starts on or after the first dose of the study drug and before 30 days after the last dose of the study drug.
|
0.00%
0/19 • From Baseline up to Week 20
TEAE is defined as an AE that starts on or after the first dose of the study drug and before 30 days after the last dose of the study drug.
|
10.0%
1/10 • Number of events 1 • From Baseline up to Week 20
TEAE is defined as an AE that starts on or after the first dose of the study drug and before 30 days after the last dose of the study drug.
|
0.00%
0/18 • From Baseline up to Week 20
TEAE is defined as an AE that starts on or after the first dose of the study drug and before 30 days after the last dose of the study drug.
|
|
Vascular disorders
Hypertension
|
0.00%
0/18 • From Baseline up to Week 20
TEAE is defined as an AE that starts on or after the first dose of the study drug and before 30 days after the last dose of the study drug.
|
0.00%
0/19 • From Baseline up to Week 20
TEAE is defined as an AE that starts on or after the first dose of the study drug and before 30 days after the last dose of the study drug.
|
10.0%
1/10 • Number of events 1 • From Baseline up to Week 20
TEAE is defined as an AE that starts on or after the first dose of the study drug and before 30 days after the last dose of the study drug.
|
5.6%
1/18 • Number of events 1 • From Baseline up to Week 20
TEAE is defined as an AE that starts on or after the first dose of the study drug and before 30 days after the last dose of the study drug.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place