Trial Outcomes & Findings for A Research Study to Investigate How Well NNC0165-1875 in Combination With Semaglutide Works in People With Obesity (NCT NCT04969939)
NCT ID: NCT04969939
Last Updated: 2026-01-08
Results Overview
A TEAE is defined as an event that has onset after administration of trial product and no later than the follow-up visit or is present before trial product administration and increases in after the first dose of trial product and no later than the follow-up visit.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
120 participants
Primary outcome timeframe
Part 1: From time of dosing (day 1) to follow-up (week 24)
Results posted on
2026-01-08
Participant Flow
The trial was conducted at 14 sites in the United States.
The trial consisted of part 1 and 2. Part 1: 24 weeks (16-week treatment + 8 week follow up). In part 1 participants received NNC0165-1875 1.0 milligrams (mg) / matching placebo or NNC0165-1875 2.0 mg / matching placebo with semaglutide 2.4 mg. Part 2 further consisted of open-label run-in part (part 2a) of 32 weeks where participants received semaglutide and part 2b of 16 weeks where participants received NNC0165-1875 or NNC0165-1875 placebo with semaglutide s.c. 2.4 mg and 8-week follow up.
Participant milestones
| Measure |
Part 1: NNC0165-1875 1.0 mg + Semaglutide 2.4 mg
Participants received once-weekly subcutaneous (s.c) injection of NNC0165-1875 in a dose escalation manner (week 0-2: 0.05 mg, week 2-4: 0.1 mg, week 4-8: 0.25 mg, week 8-12: 0.5 mg, week 12 -16: 1.0 mg) along with once-weekly s.c injection of semaglutide in a dose escalation manner (week 0-2: 0.25 mg, week 2-4: 0.5 mg, week 4-8: 1.0 mg, week 8-12: 1.7 mg, week 12 -16: 2.4 mg).
|
Part 1: NNC0165-1875 2.0 mg + Semaglutide 2.4 mg
Participants received once-weekly s.c injection of NNC0165-1875 in a dose escalation manner (week 0-2: 0.1 mg, week 2-4: 0.25 mg, week 4-8: 0.5 mg, week 8-12: 1.0 mg, week 12 -16: 2.0 mg) along with once-weekly s.c injection of semaglutide in a dose escalation manner (week 0-2: 0.25 mg, week 2-4: 0.5 mg, week 4-8: 1.0 mg, week 8-12: 1.7 mg, week 12 -16: 2.4 mg).
|
Part 1: Placebo + Semaglutide 2.4 mg
Participants received once-weekly s.c injection of NNC0165-1875 matching placebo along with once-weekly s.c injection of semaglutide in a dose escalation manner (week 0-2: 0.25 mg, week 2-4: 0.5 mg, week 4-8: 1.0 mg, week 8-12: 1.7 mg, week 12 -16: 2.4 mg).
|
Part 2a (Run-in Period): Semaglutide 2.4 mg
Participants received once-weekly s.c injection of semaglutide in a dose escalation manner (week 0-2: 0.25 mg, week 2-4: 0.5 mg, week 4-6: 1.0 mg, week 6-8: 1.7 mg, week 8 -32: 2.4 mg). At week 32, participants who reached the target dose of semaglutide s.c. 2.4 mg and fulfilled the randomisation criteria entered Part 2b and randomised to receive either once-weekly NNC0165-1875 1.0 mg/ 2.0 mg or placebo along with once-weekly semaglutide 2.4 mg.
|
Part 2b : NNC0165-1875 1.0 mg + Semaglutide 2.4 mg
Participants received once-weekly s.c injection of NNC0165-1875 in a dose escalation manner (week 32-34: 0.05 mg, week 34-36: 0.1 mg, week 36-38: 0.25 mg, week 38-40: 0.5 mg, week 40 -48: 1.0 mg) along with once-weekly s.c injection of semaglutide in a dose escalation manner (week 32-34: 0.25 mg, week 34-36: 0.5 mg, week 36-38: 1.0 mg, week 38-40: 1.7 mg, week 40-48: 2.4 mg).
|
Part 2b : NNC0165-1875 2.0 mg + Semaglutide 2.4 mg
Participants received once-weekly s.c injection of NNC0165-1875 in a dose escalation manner (week 32-34: 0.05 mg, week 34-36: 0.1 mg, week 36-38: 0.25 mg, week 38-40: 0.5 mg, week 40 -42: 1.0 mg, week 42-48: 2.0 mg,) along with once-weekly s.c injection of semaglutide in a dose escalation manner (week 32-34: 0.25 mg, week 34-36: 0.5 mg, week 36-38: 1.0 mg, week 38-40: 1.7 mg, week 40-48: 2.4 mg).
|
Part 2b: Placebo + Semaglutide 2.4 mg
Participants received once-weekly s.c injection of NNC0165-1875 matching placebo along with once-weekly s.c injection of semaglutide in a dose escalation manner (week 32-34: 0.25 mg, week 34-36: 0.5 mg, week 36-38: 1.0 mg, week 38-40: 1.7 mg, week 40-48: 2.4 mg).
|
|---|---|---|---|---|---|---|---|
|
Part 1 (24 Weeks)
STARTED
|
8
|
8
|
8
|
0
|
0
|
0
|
0
|
|
Part 1 (24 Weeks)
COMPLETED
|
8
|
8
|
8
|
0
|
0
|
0
|
0
|
|
Part 1 (24 Weeks)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Part 2a: Run in Period (32 Weeks)
STARTED
|
0
|
0
|
0
|
96
|
0
|
0
|
0
|
|
Part 2a: Run in Period (32 Weeks)
COMPLETED
|
0
|
0
|
0
|
83
|
0
|
0
|
0
|
|
Part 2a: Run in Period (32 Weeks)
NOT COMPLETED
|
0
|
0
|
0
|
13
|
0
|
0
|
0
|
|
Part 2b (16 Weeks)
STARTED
|
0
|
0
|
0
|
0
|
47
|
8
|
28
|
|
Part 2b (16 Weeks)
COMPLETED
|
0
|
0
|
0
|
0
|
44
|
7
|
28
|
|
Part 2b (16 Weeks)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
3
|
1
|
0
|
Reasons for withdrawal
| Measure |
Part 1: NNC0165-1875 1.0 mg + Semaglutide 2.4 mg
Participants received once-weekly subcutaneous (s.c) injection of NNC0165-1875 in a dose escalation manner (week 0-2: 0.05 mg, week 2-4: 0.1 mg, week 4-8: 0.25 mg, week 8-12: 0.5 mg, week 12 -16: 1.0 mg) along with once-weekly s.c injection of semaglutide in a dose escalation manner (week 0-2: 0.25 mg, week 2-4: 0.5 mg, week 4-8: 1.0 mg, week 8-12: 1.7 mg, week 12 -16: 2.4 mg).
|
Part 1: NNC0165-1875 2.0 mg + Semaglutide 2.4 mg
Participants received once-weekly s.c injection of NNC0165-1875 in a dose escalation manner (week 0-2: 0.1 mg, week 2-4: 0.25 mg, week 4-8: 0.5 mg, week 8-12: 1.0 mg, week 12 -16: 2.0 mg) along with once-weekly s.c injection of semaglutide in a dose escalation manner (week 0-2: 0.25 mg, week 2-4: 0.5 mg, week 4-8: 1.0 mg, week 8-12: 1.7 mg, week 12 -16: 2.4 mg).
|
Part 1: Placebo + Semaglutide 2.4 mg
Participants received once-weekly s.c injection of NNC0165-1875 matching placebo along with once-weekly s.c injection of semaglutide in a dose escalation manner (week 0-2: 0.25 mg, week 2-4: 0.5 mg, week 4-8: 1.0 mg, week 8-12: 1.7 mg, week 12 -16: 2.4 mg).
|
Part 2a (Run-in Period): Semaglutide 2.4 mg
Participants received once-weekly s.c injection of semaglutide in a dose escalation manner (week 0-2: 0.25 mg, week 2-4: 0.5 mg, week 4-6: 1.0 mg, week 6-8: 1.7 mg, week 8 -32: 2.4 mg). At week 32, participants who reached the target dose of semaglutide s.c. 2.4 mg and fulfilled the randomisation criteria entered Part 2b and randomised to receive either once-weekly NNC0165-1875 1.0 mg/ 2.0 mg or placebo along with once-weekly semaglutide 2.4 mg.
|
Part 2b : NNC0165-1875 1.0 mg + Semaglutide 2.4 mg
Participants received once-weekly s.c injection of NNC0165-1875 in a dose escalation manner (week 32-34: 0.05 mg, week 34-36: 0.1 mg, week 36-38: 0.25 mg, week 38-40: 0.5 mg, week 40 -48: 1.0 mg) along with once-weekly s.c injection of semaglutide in a dose escalation manner (week 32-34: 0.25 mg, week 34-36: 0.5 mg, week 36-38: 1.0 mg, week 38-40: 1.7 mg, week 40-48: 2.4 mg).
|
Part 2b : NNC0165-1875 2.0 mg + Semaglutide 2.4 mg
Participants received once-weekly s.c injection of NNC0165-1875 in a dose escalation manner (week 32-34: 0.05 mg, week 34-36: 0.1 mg, week 36-38: 0.25 mg, week 38-40: 0.5 mg, week 40 -42: 1.0 mg, week 42-48: 2.0 mg,) along with once-weekly s.c injection of semaglutide in a dose escalation manner (week 32-34: 0.25 mg, week 34-36: 0.5 mg, week 36-38: 1.0 mg, week 38-40: 1.7 mg, week 40-48: 2.4 mg).
|
Part 2b: Placebo + Semaglutide 2.4 mg
Participants received once-weekly s.c injection of NNC0165-1875 matching placebo along with once-weekly s.c injection of semaglutide in a dose escalation manner (week 32-34: 0.25 mg, week 34-36: 0.5 mg, week 36-38: 1.0 mg, week 38-40: 1.7 mg, week 40-48: 2.4 mg).
|
|---|---|---|---|---|---|---|---|
|
Part 2a: Run in Period (32 Weeks)
Adverse Event
|
0
|
0
|
0
|
4
|
0
|
0
|
0
|
|
Part 2a: Run in Period (32 Weeks)
Other
|
0
|
0
|
0
|
5
|
0
|
0
|
0
|
|
Part 2a: Run in Period (32 Weeks)
Lost to Follow-up
|
0
|
0
|
0
|
2
|
0
|
0
|
0
|
|
Part 2a: Run in Period (32 Weeks)
Pregnancy
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
|
Part 2a: Run in Period (32 Weeks)
Protocol Violation
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
|
Part 2b (16 Weeks)
Withdrawal by Subject
|
0
|
0
|
0
|
0
|
3
|
1
|
0
|
Baseline Characteristics
A Research Study to Investigate How Well NNC0165-1875 in Combination With Semaglutide Works in People With Obesity
Baseline characteristics by cohort
| Measure |
Part 1: NNC0165-1875 1.0 mg + Semaglutide 2.4 mg
n=8 Participants
Participants received once-weekly s.c injection of NNC0165-1875 in a dose escalation manner (week 0-2: 0.05 mg, week 2-4: 0.1 mg, week 4-8: 0.25 mg, week 8-12: 0.5 mg, week 12 -16: 1.0 mg) along with once-weekly s.c injection of semaglutide in a dose escalation manner (week 0-2: 0.25 mg, week 2-4: 0.5 mg, week 4-8: 1.0 mg, week 8-12: 1.7 mg, week 12 -16: 2.4 mg).
|
Part 1: NNC0165-1875 2.0 mg + Semaglutide 2.4 mg
n=8 Participants
Participants received once-weekly s.c injection of NNC0165-1875 in a dose escalation manner (week 0-2: 0.1 mg, week 2-4: 0.25 mg, week 4-8: 0.5 mg, week 8-12: 1.0 mg, week 12 -16: 2.0 mg) along with once-weekly s.c injection of semaglutide in a dose escalation manner (week 0-2: 0.25 mg, week 2-4: 0.5 mg, week 4-8: 1.0 mg, week 8-12: 1.7 mg, week 12 -16: 2.4 mg).
|
Part 1: Placebo + Semaglutide 2.4 mg
n=8 Participants
Participants received once-weekly s.c injection of NNC0165-1875 matching placebo along with once-weekly s.c injection of semaglutide in a dose escalation manner (week 0-2: 0.25 mg, week 2-4: 0.5 mg, week 4-8: 1.0 mg, week 8-12: 1.7 mg, week 12 -16: 2.4 mg).
|
Part 2
n=96 Participants
All Participants randomised in Part 2.
|
Total
n=120 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
44 Years
STANDARD_DEVIATION 12 • n=18 Participants
|
45 Years
STANDARD_DEVIATION 14 • n=17 Participants
|
43 Years
STANDARD_DEVIATION 13 • n=35 Participants
|
50 Years
STANDARD_DEVIATION 13 • n=42 Participants
|
48.4 Years
STANDARD_DEVIATION 13.0 • n=217 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=18 Participants
|
6 Participants
n=17 Participants
|
3 Participants
n=35 Participants
|
78 Participants
n=42 Participants
|
91 Participants
n=217 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=18 Participants
|
2 Participants
n=17 Participants
|
5 Participants
n=35 Participants
|
18 Participants
n=42 Participants
|
29 Participants
n=217 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=18 Participants
|
2 Participants
n=17 Participants
|
0 Participants
n=35 Participants
|
5 Participants
n=42 Participants
|
7 Participants
n=217 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
8 Participants
n=18 Participants
|
6 Participants
n=17 Participants
|
8 Participants
n=35 Participants
|
91 Participants
n=42 Participants
|
113 Participants
n=217 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=18 Participants
|
0 Participants
n=17 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=217 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=18 Participants
|
0 Participants
n=17 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=217 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=18 Participants
|
0 Participants
n=17 Participants
|
0 Participants
n=35 Participants
|
5 Participants
n=42 Participants
|
5 Participants
n=217 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=18 Participants
|
0 Participants
n=17 Participants
|
0 Participants
n=35 Participants
|
2 Participants
n=42 Participants
|
2 Participants
n=217 Participants
|
|
Race (NIH/OMB)
Black or African American
|
6 Participants
n=18 Participants
|
3 Participants
n=17 Participants
|
4 Participants
n=35 Participants
|
16 Participants
n=42 Participants
|
29 Participants
n=217 Participants
|
|
Race (NIH/OMB)
White
|
2 Participants
n=18 Participants
|
3 Participants
n=17 Participants
|
4 Participants
n=35 Participants
|
71 Participants
n=42 Participants
|
80 Participants
n=217 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=18 Participants
|
0 Participants
n=17 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=217 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=18 Participants
|
2 Participants
n=17 Participants
|
0 Participants
n=35 Participants
|
2 Participants
n=42 Participants
|
4 Participants
n=217 Participants
|
PRIMARY outcome
Timeframe: Part 1: From time of dosing (day 1) to follow-up (week 24)Population: SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product This outcome measure is applicable for reported arms only.
A TEAE is defined as an event that has onset after administration of trial product and no later than the follow-up visit or is present before trial product administration and increases in after the first dose of trial product and no later than the follow-up visit.
Outcome measures
| Measure |
Part 1: NNC0165-1875 1.0 mg + Semaglutide 2.4 mg
n=8 Participants
Participants received once-weekly s.c injection of NNC0165-1875 in a dose escalation manner (week 0-2: 0.05 mg, week 2-4: 0.1 mg, week 4-8: 0.25 mg, week 8-12: 0.5 mg, week 12 -16: 1.0 mg) along with once-weekly s.c injection of semaglutide in a dose escalation manner (week 0-2: 0.25 mg, week 2-4: 0.5 mg, week 4-8: 1.0 mg, week 8-12: 1.7 mg, week 12 -16: 2.4 mg).
|
Part 1: NNC0165-1875 2.0 mg + Semaglutide 2.4 mg
n=8 Participants
Participants received once-weekly s.c injection of NNC0165-1875 in a dose escalation manner (week 0-2: 0.1 mg, week 2-4: 0.25 mg, week 4-8: 0.5 mg, week 8-12: 1.0 mg, week 12 -16: 2.0 mg) along with once-weekly s.c injection of semaglutide in a dose escalation manner (week 0-2: 0.25 mg, week 2-4: 0.5 mg, week 4-8: 1.0 mg, week 8-12: 1.7 mg, week 12 -16: 2.4 mg).
|
Part 1: Placebo + Semaglutide 2.4 mg
n=8 Participants
Participants received once-weekly s.c injection of NNC0165-1875 matching placebo along with once-weekly s.c injection of semaglutide in a dose escalation manner (week 0-2: 0.25 mg, week 2-4: 0.5 mg, week 4-8: 1.0 mg, week 8-12: 1.7 mg, week 12 -16: 2.4 mg).
|
|---|---|---|---|
|
Part 1: Number of Treatment-emergent Adverse Events (TEAEs)
|
56 Events
|
71 Events
|
37 Events
|
PRIMARY outcome
Timeframe: Part 2: Randomisation (week 32), end of treatment (week 48)Population: Full analysis set (FAS) included all participants who were randomised. Overall number of participants analysed = Number of participants who contributed to the analysis. This outcome measure is applicable for reported arms only.
Percentage change in body weight (%) from week 32 to week 48 is presented. For descriptive analysis and statistical analysis the endpoint was evaluated based on the data from in-trial period. In-trial period was defined as the uninterrupted time interval from date of randomisation to date of last contact with trial site.
Outcome measures
| Measure |
Part 1: NNC0165-1875 1.0 mg + Semaglutide 2.4 mg
n=44 Participants
Participants received once-weekly s.c injection of NNC0165-1875 in a dose escalation manner (week 0-2: 0.05 mg, week 2-4: 0.1 mg, week 4-8: 0.25 mg, week 8-12: 0.5 mg, week 12 -16: 1.0 mg) along with once-weekly s.c injection of semaglutide in a dose escalation manner (week 0-2: 0.25 mg, week 2-4: 0.5 mg, week 4-8: 1.0 mg, week 8-12: 1.7 mg, week 12 -16: 2.4 mg).
|
Part 1: NNC0165-1875 2.0 mg + Semaglutide 2.4 mg
n=26 Participants
Participants received once-weekly s.c injection of NNC0165-1875 in a dose escalation manner (week 0-2: 0.1 mg, week 2-4: 0.25 mg, week 4-8: 0.5 mg, week 8-12: 1.0 mg, week 12 -16: 2.0 mg) along with once-weekly s.c injection of semaglutide in a dose escalation manner (week 0-2: 0.25 mg, week 2-4: 0.5 mg, week 4-8: 1.0 mg, week 8-12: 1.7 mg, week 12 -16: 2.4 mg).
|
Part 1: Placebo + Semaglutide 2.4 mg
Participants received once-weekly s.c injection of NNC0165-1875 matching placebo along with once-weekly s.c injection of semaglutide in a dose escalation manner (week 0-2: 0.25 mg, week 2-4: 0.5 mg, week 4-8: 1.0 mg, week 8-12: 1.7 mg, week 12 -16: 2.4 mg).
|
|---|---|---|---|
|
Part 2b: Percentage Change in Body Weight
|
-5.55 Percentage change in body weight
Standard Deviation 3.97
|
-3.06 Percentage change in body weight
Standard Deviation 5.46
|
—
|
SECONDARY outcome
Timeframe: Part 2b: Randomisation (week 32), end of treatment (week 48)Population: FAS included all participants who were randomised. Overall number of participants analysed = Number of participants who contributed to the analysis. This outcome measure is applicable for reported arms only.
Change in body weight (kg) from week 32 to week 48 is presented. The endpoint was evaluated based on the data from in-trial period. In-trial period was defined as the uninterrupted time interval from date of randomisation to date of last contact with trial site.
Outcome measures
| Measure |
Part 1: NNC0165-1875 1.0 mg + Semaglutide 2.4 mg
n=44 Participants
Participants received once-weekly s.c injection of NNC0165-1875 in a dose escalation manner (week 0-2: 0.05 mg, week 2-4: 0.1 mg, week 4-8: 0.25 mg, week 8-12: 0.5 mg, week 12 -16: 1.0 mg) along with once-weekly s.c injection of semaglutide in a dose escalation manner (week 0-2: 0.25 mg, week 2-4: 0.5 mg, week 4-8: 1.0 mg, week 8-12: 1.7 mg, week 12 -16: 2.4 mg).
|
Part 1: NNC0165-1875 2.0 mg + Semaglutide 2.4 mg
n=26 Participants
Participants received once-weekly s.c injection of NNC0165-1875 in a dose escalation manner (week 0-2: 0.1 mg, week 2-4: 0.25 mg, week 4-8: 0.5 mg, week 8-12: 1.0 mg, week 12 -16: 2.0 mg) along with once-weekly s.c injection of semaglutide in a dose escalation manner (week 0-2: 0.25 mg, week 2-4: 0.5 mg, week 4-8: 1.0 mg, week 8-12: 1.7 mg, week 12 -16: 2.4 mg).
|
Part 1: Placebo + Semaglutide 2.4 mg
Participants received once-weekly s.c injection of NNC0165-1875 matching placebo along with once-weekly s.c injection of semaglutide in a dose escalation manner (week 0-2: 0.25 mg, week 2-4: 0.5 mg, week 4-8: 1.0 mg, week 8-12: 1.7 mg, week 12 -16: 2.4 mg).
|
|---|---|---|---|
|
Part 2b: Change in Body Weight (kg)
|
-4.54 kilograms (kg)
Standard Deviation 3.22
|
-2.23 kilograms (kg)
Standard Deviation 5.16
|
—
|
SECONDARY outcome
Timeframe: Part 2b: Randomisation (week 32), end of treatment (week 48)Population: FAS included all participants who were randomised. Overall number of participants analysed = Number of participants who contributed to the analysis. This outcome measure is applicable for reported arms only.
Change in HbA1c from week 32 to week 48 is presented. The endpoint was evaluated based on the data from in-trial period. In-trial period was defined as the uninterrupted time interval from date of randomisation to date of last contact with trial site. Percentage point is calculated by subtraction of baseline HbA1c from HbA1c at end of treatment.
Outcome measures
| Measure |
Part 1: NNC0165-1875 1.0 mg + Semaglutide 2.4 mg
n=44 Participants
Participants received once-weekly s.c injection of NNC0165-1875 in a dose escalation manner (week 0-2: 0.05 mg, week 2-4: 0.1 mg, week 4-8: 0.25 mg, week 8-12: 0.5 mg, week 12 -16: 1.0 mg) along with once-weekly s.c injection of semaglutide in a dose escalation manner (week 0-2: 0.25 mg, week 2-4: 0.5 mg, week 4-8: 1.0 mg, week 8-12: 1.7 mg, week 12 -16: 2.4 mg).
|
Part 1: NNC0165-1875 2.0 mg + Semaglutide 2.4 mg
n=26 Participants
Participants received once-weekly s.c injection of NNC0165-1875 in a dose escalation manner (week 0-2: 0.1 mg, week 2-4: 0.25 mg, week 4-8: 0.5 mg, week 8-12: 1.0 mg, week 12 -16: 2.0 mg) along with once-weekly s.c injection of semaglutide in a dose escalation manner (week 0-2: 0.25 mg, week 2-4: 0.5 mg, week 4-8: 1.0 mg, week 8-12: 1.7 mg, week 12 -16: 2.4 mg).
|
Part 1: Placebo + Semaglutide 2.4 mg
Participants received once-weekly s.c injection of NNC0165-1875 matching placebo along with once-weekly s.c injection of semaglutide in a dose escalation manner (week 0-2: 0.25 mg, week 2-4: 0.5 mg, week 4-8: 1.0 mg, week 8-12: 1.7 mg, week 12 -16: 2.4 mg).
|
|---|---|---|---|
|
Part 2b: Change in Glycosylated Haemoglobin (HbA1c)
|
-0.17 Percentage point of HbA1c
Standard Deviation 0.17
|
-0.17 Percentage point of HbA1c
Standard Deviation 0.14
|
—
|
SECONDARY outcome
Timeframe: Part 2b: Randomisation (week 32), end of treatment (week 48)Population: FAS included all partcipants who were randomised. Overall number of participants analysed = Number of participants who contributed to the analysis. This outcome measure is applicable for reported arms only.
Change in FPG (measured in millimoles per liter \[mmol/l\]) from week 32 to week 48 is presented. The endpoint was evaluated based on the data from in-trial period. In-trial period was defined as the uninterrupted time interval from date of randomisation to date of last contact with trial site.
Outcome measures
| Measure |
Part 1: NNC0165-1875 1.0 mg + Semaglutide 2.4 mg
n=43 Participants
Participants received once-weekly s.c injection of NNC0165-1875 in a dose escalation manner (week 0-2: 0.05 mg, week 2-4: 0.1 mg, week 4-8: 0.25 mg, week 8-12: 0.5 mg, week 12 -16: 1.0 mg) along with once-weekly s.c injection of semaglutide in a dose escalation manner (week 0-2: 0.25 mg, week 2-4: 0.5 mg, week 4-8: 1.0 mg, week 8-12: 1.7 mg, week 12 -16: 2.4 mg).
|
Part 1: NNC0165-1875 2.0 mg + Semaglutide 2.4 mg
n=25 Participants
Participants received once-weekly s.c injection of NNC0165-1875 in a dose escalation manner (week 0-2: 0.1 mg, week 2-4: 0.25 mg, week 4-8: 0.5 mg, week 8-12: 1.0 mg, week 12 -16: 2.0 mg) along with once-weekly s.c injection of semaglutide in a dose escalation manner (week 0-2: 0.25 mg, week 2-4: 0.5 mg, week 4-8: 1.0 mg, week 8-12: 1.7 mg, week 12 -16: 2.4 mg).
|
Part 1: Placebo + Semaglutide 2.4 mg
Participants received once-weekly s.c injection of NNC0165-1875 matching placebo along with once-weekly s.c injection of semaglutide in a dose escalation manner (week 0-2: 0.25 mg, week 2-4: 0.5 mg, week 4-8: 1.0 mg, week 8-12: 1.7 mg, week 12 -16: 2.4 mg).
|
|---|---|---|---|
|
Part 2b: Change in Fasting Plasma Glucose (FPG)
|
0.08 mmol/l
Standard Deviation 0.36
|
-0.02 mmol/l
Standard Deviation 0.42
|
—
|
SECONDARY outcome
Timeframe: Part 2b: Randomisation (week 32), end of treatment (week 48)Population: FAS included all participants who were randomised. Overall number of participants analysed = Number of participants who contributed to the analysis. This outcome measure is applicable for reported arms only.
Change in fasting insulin (measured in picomoles per liter \[pmol/l\]) from week 32 to week 48 is presented. The endpoint was evaluated based on the data from in-trial period. In-trial period was defined as the uninterrupted time interval from date of randomisation to date of last contact with trial site.
Outcome measures
| Measure |
Part 1: NNC0165-1875 1.0 mg + Semaglutide 2.4 mg
n=43 Participants
Participants received once-weekly s.c injection of NNC0165-1875 in a dose escalation manner (week 0-2: 0.05 mg, week 2-4: 0.1 mg, week 4-8: 0.25 mg, week 8-12: 0.5 mg, week 12 -16: 1.0 mg) along with once-weekly s.c injection of semaglutide in a dose escalation manner (week 0-2: 0.25 mg, week 2-4: 0.5 mg, week 4-8: 1.0 mg, week 8-12: 1.7 mg, week 12 -16: 2.4 mg).
|
Part 1: NNC0165-1875 2.0 mg + Semaglutide 2.4 mg
n=24 Participants
Participants received once-weekly s.c injection of NNC0165-1875 in a dose escalation manner (week 0-2: 0.1 mg, week 2-4: 0.25 mg, week 4-8: 0.5 mg, week 8-12: 1.0 mg, week 12 -16: 2.0 mg) along with once-weekly s.c injection of semaglutide in a dose escalation manner (week 0-2: 0.25 mg, week 2-4: 0.5 mg, week 4-8: 1.0 mg, week 8-12: 1.7 mg, week 12 -16: 2.4 mg).
|
Part 1: Placebo + Semaglutide 2.4 mg
Participants received once-weekly s.c injection of NNC0165-1875 matching placebo along with once-weekly s.c injection of semaglutide in a dose escalation manner (week 0-2: 0.25 mg, week 2-4: 0.5 mg, week 4-8: 1.0 mg, week 8-12: 1.7 mg, week 12 -16: 2.4 mg).
|
|---|---|---|---|
|
Part 2b: Change in Fasting Insulin
|
-14.10 pmol/l
Standard Deviation 39.31
|
-8.10 pmol/l
Standard Deviation 47.22
|
—
|
SECONDARY outcome
Timeframe: Part 2b: Randomisation (week 32), end of treatment (week 48)Population: FAS included all participants who were randomised. Overall number of participants analysed = Number of participants who contributed to the analysis. This outcome measure is applicable for reported arms only.
Change in waist circumference (measured in centimeter \[cm\]) from week 32 to week 48 is presented. The endpoint was evaluated based on the data from in-trial period. In-trial period was defined as the uninterrupted time interval from date of randomisation to date of last contact with trial site.
Outcome measures
| Measure |
Part 1: NNC0165-1875 1.0 mg + Semaglutide 2.4 mg
n=44 Participants
Participants received once-weekly s.c injection of NNC0165-1875 in a dose escalation manner (week 0-2: 0.05 mg, week 2-4: 0.1 mg, week 4-8: 0.25 mg, week 8-12: 0.5 mg, week 12 -16: 1.0 mg) along with once-weekly s.c injection of semaglutide in a dose escalation manner (week 0-2: 0.25 mg, week 2-4: 0.5 mg, week 4-8: 1.0 mg, week 8-12: 1.7 mg, week 12 -16: 2.4 mg).
|
Part 1: NNC0165-1875 2.0 mg + Semaglutide 2.4 mg
n=27 Participants
Participants received once-weekly s.c injection of NNC0165-1875 in a dose escalation manner (week 0-2: 0.1 mg, week 2-4: 0.25 mg, week 4-8: 0.5 mg, week 8-12: 1.0 mg, week 12 -16: 2.0 mg) along with once-weekly s.c injection of semaglutide in a dose escalation manner (week 0-2: 0.25 mg, week 2-4: 0.5 mg, week 4-8: 1.0 mg, week 8-12: 1.7 mg, week 12 -16: 2.4 mg).
|
Part 1: Placebo + Semaglutide 2.4 mg
Participants received once-weekly s.c injection of NNC0165-1875 matching placebo along with once-weekly s.c injection of semaglutide in a dose escalation manner (week 0-2: 0.25 mg, week 2-4: 0.5 mg, week 4-8: 1.0 mg, week 8-12: 1.7 mg, week 12 -16: 2.4 mg).
|
|---|---|---|---|
|
Part 2b: Change in Waist Circumference
|
-4.80 cm
Standard Deviation 6.92
|
-2.69 cm
Standard Deviation 5.73
|
—
|
SECONDARY outcome
Timeframe: Part 2b: Randomisation (week 32), end of treatment (week 48)Population: FAS included all participants who were randomised. Overall number of participants analysed = Number of participants who contributed to the analysis. This outcome measure is applicable for reported arms only.
Relative change in total cholesterol (measured in mmol/L) from week 32 to week 48 is presented as ratio to baseline. here baseline = Randomisation (week 32). The endpoint was evaluated based on the data from in-trial period. In-trial period was defined as the uninterrupted time interval from date of randomisation to date of last contact with trial site.
Outcome measures
| Measure |
Part 1: NNC0165-1875 1.0 mg + Semaglutide 2.4 mg
n=43 Participants
Participants received once-weekly s.c injection of NNC0165-1875 in a dose escalation manner (week 0-2: 0.05 mg, week 2-4: 0.1 mg, week 4-8: 0.25 mg, week 8-12: 0.5 mg, week 12 -16: 1.0 mg) along with once-weekly s.c injection of semaglutide in a dose escalation manner (week 0-2: 0.25 mg, week 2-4: 0.5 mg, week 4-8: 1.0 mg, week 8-12: 1.7 mg, week 12 -16: 2.4 mg).
|
Part 1: NNC0165-1875 2.0 mg + Semaglutide 2.4 mg
n=23 Participants
Participants received once-weekly s.c injection of NNC0165-1875 in a dose escalation manner (week 0-2: 0.1 mg, week 2-4: 0.25 mg, week 4-8: 0.5 mg, week 8-12: 1.0 mg, week 12 -16: 2.0 mg) along with once-weekly s.c injection of semaglutide in a dose escalation manner (week 0-2: 0.25 mg, week 2-4: 0.5 mg, week 4-8: 1.0 mg, week 8-12: 1.7 mg, week 12 -16: 2.4 mg).
|
Part 1: Placebo + Semaglutide 2.4 mg
Participants received once-weekly s.c injection of NNC0165-1875 matching placebo along with once-weekly s.c injection of semaglutide in a dose escalation manner (week 0-2: 0.25 mg, week 2-4: 0.5 mg, week 4-8: 1.0 mg, week 8-12: 1.7 mg, week 12 -16: 2.4 mg).
|
|---|---|---|---|
|
Part 2b: Relative Change in Total Cholesterol (Ratio to Baseline)
|
1.00 Ratio of total cholesterol
Standard Deviation 0.11
|
1.07 Ratio of total cholesterol
Standard Deviation 0.17
|
—
|
SECONDARY outcome
Timeframe: Part 2b: Randomisation (week 32), end of treatment (week 48)Population: FAS included all participants who were randomised. Overall number of participants analysed = Number of participants who contributed to the analysis. This outcome measure is applicable for reported arms only.
Relative change in HDL cholesterol (measured in mmol/L) from week 32 to week 48 is presented as ratio to baseline. here baseline = Randomisation (week 32). The endpoint was evaluated based on the data from in-trial period. In-trial period was defined as the uninterrupted time interval from date of randomisation to date of last contact with trial site.
Outcome measures
| Measure |
Part 1: NNC0165-1875 1.0 mg + Semaglutide 2.4 mg
n=43 Participants
Participants received once-weekly s.c injection of NNC0165-1875 in a dose escalation manner (week 0-2: 0.05 mg, week 2-4: 0.1 mg, week 4-8: 0.25 mg, week 8-12: 0.5 mg, week 12 -16: 1.0 mg) along with once-weekly s.c injection of semaglutide in a dose escalation manner (week 0-2: 0.25 mg, week 2-4: 0.5 mg, week 4-8: 1.0 mg, week 8-12: 1.7 mg, week 12 -16: 2.4 mg).
|
Part 1: NNC0165-1875 2.0 mg + Semaglutide 2.4 mg
n=23 Participants
Participants received once-weekly s.c injection of NNC0165-1875 in a dose escalation manner (week 0-2: 0.1 mg, week 2-4: 0.25 mg, week 4-8: 0.5 mg, week 8-12: 1.0 mg, week 12 -16: 2.0 mg) along with once-weekly s.c injection of semaglutide in a dose escalation manner (week 0-2: 0.25 mg, week 2-4: 0.5 mg, week 4-8: 1.0 mg, week 8-12: 1.7 mg, week 12 -16: 2.4 mg).
|
Part 1: Placebo + Semaglutide 2.4 mg
Participants received once-weekly s.c injection of NNC0165-1875 matching placebo along with once-weekly s.c injection of semaglutide in a dose escalation manner (week 0-2: 0.25 mg, week 2-4: 0.5 mg, week 4-8: 1.0 mg, week 8-12: 1.7 mg, week 12 -16: 2.4 mg).
|
|---|---|---|---|
|
Part 2b: Relative Change in High Density Lipoprotein (HDL) Cholesterol (Ratio to Baseline)
|
1.02 Ratio of HDL cholesterol
Standard Deviation 0.12
|
1.08 Ratio of HDL cholesterol
Standard Deviation 0.12
|
—
|
SECONDARY outcome
Timeframe: Part 2b: Randomisation (week 32), end of treatment (week 48)Population: FAS included all participants who were randomised. Overall number of participants analysed = Number of participants who contributed to the analysis. This outcome measure is applicable for reported arms only.
Relative change in LDL cholesterol (measured in mmol/L) from week 32 to week 48 is presented as ratio to baseline. here baseline = Randomisation (week 32). The endpoint was evaluated based on the data from in-trial period. In-trial period was defined as the uninterrupted time interval from date of randomisation to date of last contact with trial site.
Outcome measures
| Measure |
Part 1: NNC0165-1875 1.0 mg + Semaglutide 2.4 mg
n=43 Participants
Participants received once-weekly s.c injection of NNC0165-1875 in a dose escalation manner (week 0-2: 0.05 mg, week 2-4: 0.1 mg, week 4-8: 0.25 mg, week 8-12: 0.5 mg, week 12 -16: 1.0 mg) along with once-weekly s.c injection of semaglutide in a dose escalation manner (week 0-2: 0.25 mg, week 2-4: 0.5 mg, week 4-8: 1.0 mg, week 8-12: 1.7 mg, week 12 -16: 2.4 mg).
|
Part 1: NNC0165-1875 2.0 mg + Semaglutide 2.4 mg
n=23 Participants
Participants received once-weekly s.c injection of NNC0165-1875 in a dose escalation manner (week 0-2: 0.1 mg, week 2-4: 0.25 mg, week 4-8: 0.5 mg, week 8-12: 1.0 mg, week 12 -16: 2.0 mg) along with once-weekly s.c injection of semaglutide in a dose escalation manner (week 0-2: 0.25 mg, week 2-4: 0.5 mg, week 4-8: 1.0 mg, week 8-12: 1.7 mg, week 12 -16: 2.4 mg).
|
Part 1: Placebo + Semaglutide 2.4 mg
Participants received once-weekly s.c injection of NNC0165-1875 matching placebo along with once-weekly s.c injection of semaglutide in a dose escalation manner (week 0-2: 0.25 mg, week 2-4: 0.5 mg, week 4-8: 1.0 mg, week 8-12: 1.7 mg, week 12 -16: 2.4 mg).
|
|---|---|---|---|
|
Part 2b: Relative Change in Low Density Lipoprotein (LDL) Cholesterol (Ratio to Baseline)
|
1.01 Ratio of LDL cholesterol
Standard Deviation 0.17
|
1.08 Ratio of LDL cholesterol
Standard Deviation 0.27
|
—
|
SECONDARY outcome
Timeframe: Part 2b: Randomisation (week 32), end of treatment (week 48)Population: FAS included all participants who were randomised. Overall number of participants analysed = Number of participants who contributed to the analysis. This outcome measure is applicable for reported arms only.
Relative change in VLDL cholesterol (measured in mmol/L) from week 32 to week 48 is presented as ratio to baseline. here baseline = Randomisation (week 32). The endpoint was evaluated based on the data from in-trial period. In-trial period was defined as the uninterrupted time interval from date of randomisation to date of last contact with trial site.
Outcome measures
| Measure |
Part 1: NNC0165-1875 1.0 mg + Semaglutide 2.4 mg
n=43 Participants
Participants received once-weekly s.c injection of NNC0165-1875 in a dose escalation manner (week 0-2: 0.05 mg, week 2-4: 0.1 mg, week 4-8: 0.25 mg, week 8-12: 0.5 mg, week 12 -16: 1.0 mg) along with once-weekly s.c injection of semaglutide in a dose escalation manner (week 0-2: 0.25 mg, week 2-4: 0.5 mg, week 4-8: 1.0 mg, week 8-12: 1.7 mg, week 12 -16: 2.4 mg).
|
Part 1: NNC0165-1875 2.0 mg + Semaglutide 2.4 mg
n=23 Participants
Participants received once-weekly s.c injection of NNC0165-1875 in a dose escalation manner (week 0-2: 0.1 mg, week 2-4: 0.25 mg, week 4-8: 0.5 mg, week 8-12: 1.0 mg, week 12 -16: 2.0 mg) along with once-weekly s.c injection of semaglutide in a dose escalation manner (week 0-2: 0.25 mg, week 2-4: 0.5 mg, week 4-8: 1.0 mg, week 8-12: 1.7 mg, week 12 -16: 2.4 mg).
|
Part 1: Placebo + Semaglutide 2.4 mg
Participants received once-weekly s.c injection of NNC0165-1875 matching placebo along with once-weekly s.c injection of semaglutide in a dose escalation manner (week 0-2: 0.25 mg, week 2-4: 0.5 mg, week 4-8: 1.0 mg, week 8-12: 1.7 mg, week 12 -16: 2.4 mg).
|
|---|---|---|---|
|
Part 2b: Relative Change in Very Low Density Lipoprotein (VLDL) Cholesterol (Ratio to Baseline)
|
0.96 Ratio of VLDL cholesterol
Standard Deviation 0.25
|
1.04 Ratio of VLDL cholesterol
Standard Deviation 0.27
|
—
|
SECONDARY outcome
Timeframe: Part 2b: Randomisation (week 32), end of treatment (week 48)Population: FAS included all participants who were randomised. Overall number of participants analysed = Number of participants who contributed to the analysis. This outcome measure is applicable for reported arms only.
Relative change in triglycerides (measured in mmol/l) from week 32 to week 48 is presented as ratio to baseline. here baseline = Randomisation (week 32). The endpoint was evaluated based on the data from in-trial period. In-trial period was defined as the uninterrupted time interval from date of randomisation to date of last contact with trial site.
Outcome measures
| Measure |
Part 1: NNC0165-1875 1.0 mg + Semaglutide 2.4 mg
n=43 Participants
Participants received once-weekly s.c injection of NNC0165-1875 in a dose escalation manner (week 0-2: 0.05 mg, week 2-4: 0.1 mg, week 4-8: 0.25 mg, week 8-12: 0.5 mg, week 12 -16: 1.0 mg) along with once-weekly s.c injection of semaglutide in a dose escalation manner (week 0-2: 0.25 mg, week 2-4: 0.5 mg, week 4-8: 1.0 mg, week 8-12: 1.7 mg, week 12 -16: 2.4 mg).
|
Part 1: NNC0165-1875 2.0 mg + Semaglutide 2.4 mg
n=23 Participants
Participants received once-weekly s.c injection of NNC0165-1875 in a dose escalation manner (week 0-2: 0.1 mg, week 2-4: 0.25 mg, week 4-8: 0.5 mg, week 8-12: 1.0 mg, week 12 -16: 2.0 mg) along with once-weekly s.c injection of semaglutide in a dose escalation manner (week 0-2: 0.25 mg, week 2-4: 0.5 mg, week 4-8: 1.0 mg, week 8-12: 1.7 mg, week 12 -16: 2.4 mg).
|
Part 1: Placebo + Semaglutide 2.4 mg
Participants received once-weekly s.c injection of NNC0165-1875 matching placebo along with once-weekly s.c injection of semaglutide in a dose escalation manner (week 0-2: 0.25 mg, week 2-4: 0.5 mg, week 4-8: 1.0 mg, week 8-12: 1.7 mg, week 12 -16: 2.4 mg).
|
|---|---|---|---|
|
Part 2b: Relative Change in Triglycerides (TG) (Ratio to Baseline)
|
0.96 Ratio of triglycerides
Standard Deviation 0.26
|
1.03 Ratio of triglycerides
Standard Deviation 0.26
|
—
|
SECONDARY outcome
Timeframe: Part 2b: Randomisation (week 32), end of treatment (week 48)Population: FAS included all participants who were randomised. Overall number of participants analysed = Number of participants who contributed to the analysis. This outcome measure is applicable for reported arms only.
Relative change in free fatty acids (measured in mmol/L) from week 32 to week 48 is presented as ratio to baseline. here baseline = Randomisation (week 32). The endpoint was evaluated based on the data from in-trial period. In-trial period was defined as the uninterrupted time interval from date of randomisation to date of last contact with trial site.
Outcome measures
| Measure |
Part 1: NNC0165-1875 1.0 mg + Semaglutide 2.4 mg
n=43 Participants
Participants received once-weekly s.c injection of NNC0165-1875 in a dose escalation manner (week 0-2: 0.05 mg, week 2-4: 0.1 mg, week 4-8: 0.25 mg, week 8-12: 0.5 mg, week 12 -16: 1.0 mg) along with once-weekly s.c injection of semaglutide in a dose escalation manner (week 0-2: 0.25 mg, week 2-4: 0.5 mg, week 4-8: 1.0 mg, week 8-12: 1.7 mg, week 12 -16: 2.4 mg).
|
Part 1: NNC0165-1875 2.0 mg + Semaglutide 2.4 mg
n=25 Participants
Participants received once-weekly s.c injection of NNC0165-1875 in a dose escalation manner (week 0-2: 0.1 mg, week 2-4: 0.25 mg, week 4-8: 0.5 mg, week 8-12: 1.0 mg, week 12 -16: 2.0 mg) along with once-weekly s.c injection of semaglutide in a dose escalation manner (week 0-2: 0.25 mg, week 2-4: 0.5 mg, week 4-8: 1.0 mg, week 8-12: 1.7 mg, week 12 -16: 2.4 mg).
|
Part 1: Placebo + Semaglutide 2.4 mg
Participants received once-weekly s.c injection of NNC0165-1875 matching placebo along with once-weekly s.c injection of semaglutide in a dose escalation manner (week 0-2: 0.25 mg, week 2-4: 0.5 mg, week 4-8: 1.0 mg, week 8-12: 1.7 mg, week 12 -16: 2.4 mg).
|
|---|---|---|---|
|
Part 2b: Relative Change in Free Fatty Acids (Ratio to Baseline)
|
0.87 Ratio of free fatty acids
Standard Deviation 0.39
|
1.07 Ratio of free fatty acids
Standard Deviation 0.48
|
—
|
SECONDARY outcome
Timeframe: From randomisation (week 32) to end of the trial (week 56)Population: SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product. This outcome measure is applicable for reported arms only.
An AE is any untoward medical occurrence in a clinical trial participant that is temporally associated with the use of an IMP, whether or not considered related to the IMP. All AEs reported here are TEAEs. A TEAE is defined as an event that has onset after administration of trial product and no later than the follow-up visits or is present before trial product administration and increases in after the first dose of trial product and no later than the follow-up visit. The TEAEs occurred from week 32 to week 56 is presented. The endpoint was evaluated based on the data from in-trial period. In-trial period was defined as the uninterrupted time interval from date of randomisation to date of last contact with trial site.
Outcome measures
| Measure |
Part 1: NNC0165-1875 1.0 mg + Semaglutide 2.4 mg
n=47 Participants
Participants received once-weekly s.c injection of NNC0165-1875 in a dose escalation manner (week 0-2: 0.05 mg, week 2-4: 0.1 mg, week 4-8: 0.25 mg, week 8-12: 0.5 mg, week 12 -16: 1.0 mg) along with once-weekly s.c injection of semaglutide in a dose escalation manner (week 0-2: 0.25 mg, week 2-4: 0.5 mg, week 4-8: 1.0 mg, week 8-12: 1.7 mg, week 12 -16: 2.4 mg).
|
Part 1: NNC0165-1875 2.0 mg + Semaglutide 2.4 mg
n=8 Participants
Participants received once-weekly s.c injection of NNC0165-1875 in a dose escalation manner (week 0-2: 0.1 mg, week 2-4: 0.25 mg, week 4-8: 0.5 mg, week 8-12: 1.0 mg, week 12 -16: 2.0 mg) along with once-weekly s.c injection of semaglutide in a dose escalation manner (week 0-2: 0.25 mg, week 2-4: 0.5 mg, week 4-8: 1.0 mg, week 8-12: 1.7 mg, week 12 -16: 2.4 mg).
|
Part 1: Placebo + Semaglutide 2.4 mg
n=28 Participants
Participants received once-weekly s.c injection of NNC0165-1875 matching placebo along with once-weekly s.c injection of semaglutide in a dose escalation manner (week 0-2: 0.25 mg, week 2-4: 0.5 mg, week 4-8: 1.0 mg, week 8-12: 1.7 mg, week 12 -16: 2.4 mg).
|
|---|---|---|---|
|
Part 2b: Number of Treatment -Emergent Adverse Events (TEAEs)
|
220 Events
|
45 Events
|
56 Events
|
SECONDARY outcome
Timeframe: From randomisation (week 32) to end of the trial (week 56)Population: SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product. This outcome measure is applicable for reported arms only.
A serious adverse event (SAE) is defined as any untoward medical occurrence that at any dose results in death, or is life-threatening, or requires inpatient hospitalization or causes prolongation of existing hospitalization results in persistent or significant disability/incapacity, or may have caused a congenital anomaly/birth defect, or requires intervention to prevent permanent impairment or damage. The SAEs occurred from week 32 to week 56 is presented. The endpoint was evaluated based on the data from in-trial period. In-trial period was defined as the uninterrupted time interval from date of randomisation to date of last contact with trial site.
Outcome measures
| Measure |
Part 1: NNC0165-1875 1.0 mg + Semaglutide 2.4 mg
n=47 Participants
Participants received once-weekly s.c injection of NNC0165-1875 in a dose escalation manner (week 0-2: 0.05 mg, week 2-4: 0.1 mg, week 4-8: 0.25 mg, week 8-12: 0.5 mg, week 12 -16: 1.0 mg) along with once-weekly s.c injection of semaglutide in a dose escalation manner (week 0-2: 0.25 mg, week 2-4: 0.5 mg, week 4-8: 1.0 mg, week 8-12: 1.7 mg, week 12 -16: 2.4 mg).
|
Part 1: NNC0165-1875 2.0 mg + Semaglutide 2.4 mg
n=8 Participants
Participants received once-weekly s.c injection of NNC0165-1875 in a dose escalation manner (week 0-2: 0.1 mg, week 2-4: 0.25 mg, week 4-8: 0.5 mg, week 8-12: 1.0 mg, week 12 -16: 2.0 mg) along with once-weekly s.c injection of semaglutide in a dose escalation manner (week 0-2: 0.25 mg, week 2-4: 0.5 mg, week 4-8: 1.0 mg, week 8-12: 1.7 mg, week 12 -16: 2.4 mg).
|
Part 1: Placebo + Semaglutide 2.4 mg
n=28 Participants
Participants received once-weekly s.c injection of NNC0165-1875 matching placebo along with once-weekly s.c injection of semaglutide in a dose escalation manner (week 0-2: 0.25 mg, week 2-4: 0.5 mg, week 4-8: 1.0 mg, week 8-12: 1.7 mg, week 12 -16: 2.4 mg).
|
|---|---|---|---|
|
Part 2b: Number of Treatment-emergent Serious Adverse Events (SAEs)
|
2 Events
|
0 Events
|
0 Events
|
Adverse Events
Part 1: NNC0165-1875 1.0 mg + Semaglutide 2.4 mg
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Part 1: NNC0165-1875 2.0 mg + Semaglutide 2.4 mg
Serious events: 1 serious events
Other events: 8 other events
Deaths: 0 deaths
Part 1: Placebo + Semaglutide 2.4 mg
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Part 2a (Run-in Period): Semaglutide 2.4 mg
Serious events: 2 serious events
Other events: 69 other events
Deaths: 0 deaths
Part 2b : NNC0165-1875 1.0 mg + Semaglutide 2.4 mg
Serious events: 2 serious events
Other events: 36 other events
Deaths: 0 deaths
Part 2b : NNC0165-1875 2.0 mg + Semaglutide 2.4 mg
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Part 2b: Placebo + Semaglutide 2.4 mg
Serious events: 0 serious events
Other events: 16 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Part 1: NNC0165-1875 1.0 mg + Semaglutide 2.4 mg
n=8 participants at risk
Participants received once-weekly s.c injection of NNC0165-1875 in a dose escalation manner (week 0-2: 0.05 mg, week 2-4: 0.1 mg, week 4-8: 0.25 mg, week 8-12: 0.5 mg, week 12 -16: 1.0 mg) along with once-weekly s.c injection of semaglutide in a dose escalation manner (week 0-2: 0.25 mg, week 2-4: 0.5 mg, week 4-8: 1.0 mg, week 8-12: 1.7 mg, week 12 -16: 2.4 mg).
|
Part 1: NNC0165-1875 2.0 mg + Semaglutide 2.4 mg
n=8 participants at risk
Participants received once-weekly s.c injection of NNC0165-1875 in a dose escalation manner (week 0-2: 0.1 mg, week 2-4: 0.25 mg, week 4-8: 0.5 mg, week 8-12: 1.0 mg, week 12 -16: 2.0 mg) along with once-weekly s.c injection of semaglutide in a dose escalation manner (week 0-2: 0.25 mg, week 2-4: 0.5 mg, week 4-8: 1.0 mg, week 8-12: 1.7 mg, week 12 -16: 2.4 mg).
|
Part 1: Placebo + Semaglutide 2.4 mg
n=8 participants at risk
Participants received once-weekly s.c injection of NNC0165-1875 matching placebo along with once-weekly s.c injection of semaglutide in a dose escalation manner (week 0-2: 0.25 mg, week 2-4: 0.5 mg, week 4-8: 1.0 mg, week 8-12: 1.7 mg, week 12 -16: 2.4 mg).
|
Part 2a (Run-in Period): Semaglutide 2.4 mg
n=96 participants at risk
Participants received once-weekly s.c injection of semaglutide in a dose escalation manner (week 0-2: 0.25 mg, week 2-4: 0.5 mg, week 4-6: 1.0 mg, week 6-8: 1.7 mg, week 8 -32: 2.4 mg). At week 32, participants who reached the target dose of semaglutide s.c. 2.4 mg and fulfilled the randomisation criteria entered Part 2b and randomised to receive either once-weekly NNC0165-1875 1.0 mg/ 2.0 mg or placebo along with once-weekly semaglutide 2.4 mg.
|
Part 2b : NNC0165-1875 1.0 mg + Semaglutide 2.4 mg
n=47 participants at risk
Participants received once-weekly s.c injection of NNC0165-1875 in a dose escalation manner (week 32-34: 0.05 mg, week 34-36: 0.1 mg, week 36-38: 0.25 mg, week 38-40: 0.5 mg, week 40 -48: 1.0 mg) along with once-weekly s.c injection of semaglutide in a dose escalation manner (week 32-34: 0.25 mg, week 34-36: 0.5 mg, week 36-38: 1.0 mg, week 38-40: 1.7 mg, week 40-48: 2.4 mg).
|
Part 2b : NNC0165-1875 2.0 mg + Semaglutide 2.4 mg
n=8 participants at risk
Participants received once-weekly s.c injection of NNC0165-1875 in a dose escalation manner (week 32-34: 0.05 mg, week 34-36: 0.1 mg, week 36-38: 0.25 mg, week 38-40: 0.5 mg, week 40 -42: 1.0 mg, week 42-48: 2.0 mg,) along with once-weekly s.c injection of semaglutide in a dose escalation manner (week 32-34: 0.25 mg, week 34-36: 0.5 mg, week 36-38: 1.0 mg, week 38-40: 1.7 mg, week 40-48: 2.4 mg).
|
Part 2b: Placebo + Semaglutide 2.4 mg
n=28 participants at risk
Participants received once-weekly s.c injection of NNC0165-1875 matching placebo along with once-weekly s.c injection of semaglutide in a dose escalation manner (week 32-34: 0.25 mg, week 34-36: 0.5 mg, week 36-38: 1.0 mg, week 38-40: 1.7 mg, week 40-48: 2.4 mg).
|
|---|---|---|---|---|---|---|---|
|
Infections and infestations
Appendicitis
|
0.00%
0/8 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
0.00%
0/8 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
0.00%
0/8 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
0.00%
0/96 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
2.1%
1/47 • Number of events 1 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
0.00%
0/8 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
0.00%
0/28 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
|
Infections and infestations
Tooth Abscess
|
0.00%
0/8 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
0.00%
0/8 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
0.00%
0/8 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
1.0%
1/96 • Number of events 1 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
0.00%
0/47 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
0.00%
0/8 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
0.00%
0/28 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine Leiomyoma
|
0.00%
0/8 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
0.00%
0/8 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
0.00%
0/8 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
1.0%
1/96 • Number of events 1 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
0.00%
0/47 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
0.00%
0/8 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
0.00%
0/28 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
|
Pregnancy, puerperium and perinatal conditions
Abortion Spontaneous
|
0.00%
0/8 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
12.5%
1/8 • Number of events 1 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
0.00%
0/8 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
0.00%
0/96 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
0.00%
0/47 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
0.00%
0/8 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
0.00%
0/28 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
|
Infections and infestations
Clostridium difficile colitis
|
0.00%
0/8 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
0.00%
0/8 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
0.00%
0/8 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
0.00%
0/96 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
2.1%
1/47 • Number of events 1 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
0.00%
0/8 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
0.00%
0/28 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
Other adverse events
| Measure |
Part 1: NNC0165-1875 1.0 mg + Semaglutide 2.4 mg
n=8 participants at risk
Participants received once-weekly s.c injection of NNC0165-1875 in a dose escalation manner (week 0-2: 0.05 mg, week 2-4: 0.1 mg, week 4-8: 0.25 mg, week 8-12: 0.5 mg, week 12 -16: 1.0 mg) along with once-weekly s.c injection of semaglutide in a dose escalation manner (week 0-2: 0.25 mg, week 2-4: 0.5 mg, week 4-8: 1.0 mg, week 8-12: 1.7 mg, week 12 -16: 2.4 mg).
|
Part 1: NNC0165-1875 2.0 mg + Semaglutide 2.4 mg
n=8 participants at risk
Participants received once-weekly s.c injection of NNC0165-1875 in a dose escalation manner (week 0-2: 0.1 mg, week 2-4: 0.25 mg, week 4-8: 0.5 mg, week 8-12: 1.0 mg, week 12 -16: 2.0 mg) along with once-weekly s.c injection of semaglutide in a dose escalation manner (week 0-2: 0.25 mg, week 2-4: 0.5 mg, week 4-8: 1.0 mg, week 8-12: 1.7 mg, week 12 -16: 2.4 mg).
|
Part 1: Placebo + Semaglutide 2.4 mg
n=8 participants at risk
Participants received once-weekly s.c injection of NNC0165-1875 matching placebo along with once-weekly s.c injection of semaglutide in a dose escalation manner (week 0-2: 0.25 mg, week 2-4: 0.5 mg, week 4-8: 1.0 mg, week 8-12: 1.7 mg, week 12 -16: 2.4 mg).
|
Part 2a (Run-in Period): Semaglutide 2.4 mg
n=96 participants at risk
Participants received once-weekly s.c injection of semaglutide in a dose escalation manner (week 0-2: 0.25 mg, week 2-4: 0.5 mg, week 4-6: 1.0 mg, week 6-8: 1.7 mg, week 8 -32: 2.4 mg). At week 32, participants who reached the target dose of semaglutide s.c. 2.4 mg and fulfilled the randomisation criteria entered Part 2b and randomised to receive either once-weekly NNC0165-1875 1.0 mg/ 2.0 mg or placebo along with once-weekly semaglutide 2.4 mg.
|
Part 2b : NNC0165-1875 1.0 mg + Semaglutide 2.4 mg
n=47 participants at risk
Participants received once-weekly s.c injection of NNC0165-1875 in a dose escalation manner (week 32-34: 0.05 mg, week 34-36: 0.1 mg, week 36-38: 0.25 mg, week 38-40: 0.5 mg, week 40 -48: 1.0 mg) along with once-weekly s.c injection of semaglutide in a dose escalation manner (week 32-34: 0.25 mg, week 34-36: 0.5 mg, week 36-38: 1.0 mg, week 38-40: 1.7 mg, week 40-48: 2.4 mg).
|
Part 2b : NNC0165-1875 2.0 mg + Semaglutide 2.4 mg
n=8 participants at risk
Participants received once-weekly s.c injection of NNC0165-1875 in a dose escalation manner (week 32-34: 0.05 mg, week 34-36: 0.1 mg, week 36-38: 0.25 mg, week 38-40: 0.5 mg, week 40 -42: 1.0 mg, week 42-48: 2.0 mg,) along with once-weekly s.c injection of semaglutide in a dose escalation manner (week 32-34: 0.25 mg, week 34-36: 0.5 mg, week 36-38: 1.0 mg, week 38-40: 1.7 mg, week 40-48: 2.4 mg).
|
Part 2b: Placebo + Semaglutide 2.4 mg
n=28 participants at risk
Participants received once-weekly s.c injection of NNC0165-1875 matching placebo along with once-weekly s.c injection of semaglutide in a dose escalation manner (week 32-34: 0.25 mg, week 34-36: 0.5 mg, week 36-38: 1.0 mg, week 38-40: 1.7 mg, week 40-48: 2.4 mg).
|
|---|---|---|---|---|---|---|---|
|
Metabolism and nutrition disorders
Decreased appetite
|
87.5%
7/8 • Number of events 7 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
87.5%
7/8 • Number of events 7 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
75.0%
6/8 • Number of events 6 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
5.2%
5/96 • Number of events 5 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
4.3%
2/47 • Number of events 2 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
25.0%
2/8 • Number of events 2 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
0.00%
0/28 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
|
Psychiatric disorders
Depressive symptom
|
0.00%
0/8 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
0.00%
0/8 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
0.00%
0/8 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
0.00%
0/96 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
0.00%
0/47 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
12.5%
1/8 • Number of events 1 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
0.00%
0/28 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.00%
0/8 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
0.00%
0/8 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
0.00%
0/8 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
0.00%
0/96 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
0.00%
0/47 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
12.5%
1/8 • Number of events 1 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
0.00%
0/28 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
|
Renal and urinary disorders
Hypercalciuria
|
0.00%
0/8 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
0.00%
0/8 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
0.00%
0/8 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
0.00%
0/96 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
0.00%
0/47 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
12.5%
1/8 • Number of events 1 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
0.00%
0/28 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
|
Metabolism and nutrition disorders
Increased appetite
|
0.00%
0/8 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
0.00%
0/8 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
0.00%
0/8 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
0.00%
0/96 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
6.4%
3/47 • Number of events 3 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
0.00%
0/8 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
3.6%
1/28 • Number of events 2 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
|
Renal and urinary disorders
Microalbuminuria
|
0.00%
0/8 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
0.00%
0/8 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
0.00%
0/8 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
0.00%
0/96 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
0.00%
0/47 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
12.5%
1/8 • Number of events 1 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
0.00%
0/28 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
|
Ear and labyrinth disorders
Cerumen Impaction
|
12.5%
1/8 • Number of events 1 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
0.00%
0/8 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
0.00%
0/8 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
0.00%
0/96 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
0.00%
0/47 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
0.00%
0/8 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
0.00%
0/28 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
|
Gastrointestinal disorders
Abdominal Tenderness
|
12.5%
1/8 • Number of events 1 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
0.00%
0/8 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
12.5%
1/8 • Number of events 1 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
0.00%
0/96 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
0.00%
0/47 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
0.00%
0/8 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
0.00%
0/28 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
|
Gastrointestinal disorders
Dry Mouth
|
0.00%
0/8 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
25.0%
2/8 • Number of events 2 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
0.00%
0/8 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
1.0%
1/96 • Number of events 1 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
0.00%
0/47 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
0.00%
0/8 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
0.00%
0/28 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
|
Gastrointestinal disorders
Dyspepsia
|
12.5%
1/8 • Number of events 1 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
50.0%
4/8 • Number of events 4 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
12.5%
1/8 • Number of events 1 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
9.4%
9/96 • Number of events 9 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
0.00%
0/47 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
0.00%
0/8 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
0.00%
0/28 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
|
General disorders
Asthenia
|
12.5%
1/8 • Number of events 1 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
12.5%
1/8 • Number of events 1 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
0.00%
0/8 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
0.00%
0/96 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
0.00%
0/47 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
0.00%
0/8 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
0.00%
0/28 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
|
General disorders
Chest Pain
|
12.5%
1/8 • Number of events 1 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
0.00%
0/8 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
0.00%
0/8 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
0.00%
0/96 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
0.00%
0/47 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
0.00%
0/8 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
0.00%
0/28 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
|
General disorders
Early Satiety
|
37.5%
3/8 • Number of events 3 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
25.0%
2/8 • Number of events 2 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
50.0%
4/8 • Number of events 4 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
0.00%
0/96 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
0.00%
0/47 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
0.00%
0/8 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
0.00%
0/28 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
|
General disorders
Injection Site Haemorrhage
|
0.00%
0/8 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
0.00%
0/8 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
12.5%
1/8 • Number of events 1 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
1.0%
1/96 • Number of events 1 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
0.00%
0/47 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
0.00%
0/8 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
0.00%
0/28 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
|
General disorders
Injection Site Reaction
|
25.0%
2/8 • Number of events 4 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
12.5%
1/8 • Number of events 1 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
25.0%
2/8 • Number of events 2 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
0.00%
0/96 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
0.00%
0/47 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
0.00%
0/8 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
0.00%
0/28 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
0.00%
0/8 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
25.0%
2/8 • Number of events 2 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
0.00%
0/8 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
6.2%
6/96 • Number of events 6 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
0.00%
0/47 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
0.00%
0/8 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
0.00%
0/28 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
|
Injury, poisoning and procedural complications
Arthropod Bite
|
0.00%
0/8 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
12.5%
1/8 • Number of events 1 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
12.5%
1/8 • Number of events 1 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
2.1%
2/96 • Number of events 2 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
0.00%
0/47 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
0.00%
0/8 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
0.00%
0/28 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
|
Injury, poisoning and procedural complications
Skin Abrasion
|
12.5%
1/8 • Number of events 1 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
0.00%
0/8 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
0.00%
0/8 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
1.0%
1/96 • Number of events 1 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
0.00%
0/47 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
0.00%
0/8 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
0.00%
0/28 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
|
Injury, poisoning and procedural complications
Skin Laceration
|
12.5%
1/8 • Number of events 1 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
0.00%
0/8 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
0.00%
0/8 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
0.00%
0/96 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
0.00%
0/47 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
0.00%
0/8 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
0.00%
0/28 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
|
Investigations
Alanine Aminotransferase Increased
|
12.5%
1/8 • Number of events 1 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
0.00%
0/8 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
12.5%
1/8 • Number of events 1 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
0.00%
0/96 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
0.00%
0/47 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
0.00%
0/8 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
0.00%
0/28 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
|
Investigations
Amylase Abnormal
|
0.00%
0/8 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
0.00%
0/8 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
12.5%
1/8 • Number of events 1 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
0.00%
0/96 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
0.00%
0/47 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
0.00%
0/8 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
0.00%
0/28 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
|
Investigations
Aspartate Aminotransferase Increased
|
12.5%
1/8 • Number of events 1 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
0.00%
0/8 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
12.5%
1/8 • Number of events 1 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
0.00%
0/96 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
0.00%
0/47 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
0.00%
0/8 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
0.00%
0/28 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
|
Investigations
Blood Creatine Phosphokinase Increased
|
0.00%
0/8 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
0.00%
0/8 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
12.5%
1/8 • Number of events 1 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
0.00%
0/96 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
0.00%
0/47 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
0.00%
0/8 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
0.00%
0/28 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
|
Investigations
Blood Creatinine Increased
|
0.00%
0/8 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
0.00%
0/8 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
12.5%
1/8 • Number of events 1 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
0.00%
0/96 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
0.00%
0/47 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
0.00%
0/8 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
0.00%
0/28 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
|
Investigations
Gamma-Glutamyltransferase Increased
|
12.5%
1/8 • Number of events 1 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
0.00%
0/8 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
0.00%
0/8 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
0.00%
0/96 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
0.00%
0/47 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
0.00%
0/8 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
0.00%
0/28 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
|
Investigations
Glomerular Filtration Rate Abnormal
|
0.00%
0/8 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
0.00%
0/8 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
12.5%
1/8 • Number of events 1 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
0.00%
0/96 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
0.00%
0/47 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
0.00%
0/8 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
0.00%
0/28 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
|
Investigations
Lipase Abnormal
|
0.00%
0/8 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
0.00%
0/8 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
12.5%
1/8 • Number of events 1 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
0.00%
0/96 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
0.00%
0/47 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
0.00%
0/8 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
0.00%
0/28 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
|
Investigations
Neutrophil Count Decreased
|
0.00%
0/8 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
12.5%
1/8 • Number of events 1 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
0.00%
0/8 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
0.00%
0/96 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
0.00%
0/47 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
0.00%
0/8 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
0.00%
0/28 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
|
Investigations
White Blood Cell Count Decreased
|
0.00%
0/8 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
12.5%
1/8 • Number of events 1 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
0.00%
0/8 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
0.00%
0/96 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
0.00%
0/47 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
0.00%
0/8 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
0.00%
0/28 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/8 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
0.00%
0/8 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
0.00%
0/8 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
5.2%
5/96 • Number of events 6 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
0.00%
0/47 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
0.00%
0/8 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
0.00%
0/28 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal Pain
|
0.00%
0/8 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
12.5%
1/8 • Number of events 1 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
0.00%
0/8 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
0.00%
0/96 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
0.00%
0/47 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
0.00%
0/8 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
0.00%
0/28 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/8 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
0.00%
0/8 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
12.5%
1/8 • Number of events 1 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
1.0%
1/96 • Number of events 1 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
0.00%
0/47 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
0.00%
0/8 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
0.00%
0/28 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
|
Nervous system disorders
Depressed Level Of Consciousness
|
0.00%
0/8 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
12.5%
1/8 • Number of events 1 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
0.00%
0/8 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
0.00%
0/96 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
0.00%
0/47 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
0.00%
0/8 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
0.00%
0/28 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/8 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
12.5%
1/8 • Number of events 1 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
0.00%
0/8 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
3.1%
3/96 • Number of events 3 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
0.00%
0/47 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
0.00%
0/8 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
0.00%
0/28 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
|
Nervous system disorders
Hypoaesthesia
|
12.5%
1/8 • Number of events 1 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
0.00%
0/8 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
0.00%
0/8 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
0.00%
0/96 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
0.00%
0/47 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
0.00%
0/8 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
0.00%
0/28 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
|
Nervous system disorders
Presyncope
|
0.00%
0/8 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
0.00%
0/8 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
12.5%
1/8 • Number of events 1 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
1.0%
1/96 • Number of events 2 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
0.00%
0/47 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
0.00%
0/8 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
0.00%
0/28 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
|
Nervous system disorders
Taste Disorder
|
12.5%
1/8 • Number of events 1 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
25.0%
2/8 • Number of events 2 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
0.00%
0/8 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
0.00%
0/96 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
0.00%
0/47 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
0.00%
0/8 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
0.00%
0/28 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
|
Psychiatric disorders
Anxiety
|
12.5%
1/8 • Number of events 1 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
0.00%
0/8 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
0.00%
0/8 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
1.0%
1/96 • Number of events 1 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
0.00%
0/47 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
0.00%
0/8 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
0.00%
0/28 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
|
Psychiatric disorders
Depressed Mood
|
12.5%
1/8 • Number of events 1 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
0.00%
0/8 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
0.00%
0/8 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
0.00%
0/96 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
0.00%
0/47 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
0.00%
0/8 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
0.00%
0/28 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/8 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
0.00%
0/8 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
12.5%
1/8 • Number of events 1 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
1.0%
1/96 • Number of events 1 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
0.00%
0/47 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
0.00%
0/8 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
0.00%
0/28 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
|
Psychiatric disorders
Mood Swings
|
0.00%
0/8 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
12.5%
1/8 • Number of events 1 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
0.00%
0/8 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
0.00%
0/96 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
0.00%
0/47 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
0.00%
0/8 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
0.00%
0/28 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
|
Reproductive system and breast disorders
Breast Cyst
|
12.5%
1/8 • Number of events 1 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
0.00%
0/8 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
0.00%
0/8 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
0.00%
0/96 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
0.00%
0/47 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
0.00%
0/8 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
0.00%
0/28 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
12.5%
1/8 • Number of events 1 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
0.00%
0/8 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
0.00%
0/8 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
3.1%
3/96 • Number of events 3 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
0.00%
0/47 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
0.00%
0/8 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
0.00%
0/28 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
12.5%
1/8 • Number of events 1 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
0.00%
0/8 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
0.00%
0/8 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
1.0%
1/96 • Number of events 1 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
0.00%
0/47 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
0.00%
0/8 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
0.00%
0/28 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal Congestion
|
0.00%
0/8 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
0.00%
0/8 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
12.5%
1/8 • Number of events 1 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
0.00%
0/96 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
0.00%
0/47 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
0.00%
0/8 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
0.00%
0/28 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
|
Skin and subcutaneous tissue disorders
Dermatitis Contact
|
0.00%
0/8 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
12.5%
1/8 • Number of events 1 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
12.5%
1/8 • Number of events 1 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
0.00%
0/96 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
0.00%
0/47 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
0.00%
0/8 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
0.00%
0/28 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/8 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
0.00%
0/8 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
12.5%
1/8 • Number of events 1 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
1.0%
1/96 • Number of events 1 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
0.00%
0/47 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
0.00%
0/8 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
0.00%
0/28 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
12.5%
1/8 • Number of events 1 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
0.00%
0/8 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
0.00%
0/8 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
0.00%
0/96 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
0.00%
0/47 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
0.00%
0/8 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
0.00%
0/28 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
|
Vascular disorders
Hot Flush
|
0.00%
0/8 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
12.5%
1/8 • Number of events 1 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
0.00%
0/8 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
0.00%
0/96 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
0.00%
0/47 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
0.00%
0/8 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
0.00%
0/28 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/8 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
0.00%
0/8 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
0.00%
0/8 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
5.2%
5/96 • Number of events 6 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
2.1%
1/47 • Number of events 1 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
12.5%
1/8 • Number of events 1 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
0.00%
0/28 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
|
Gastrointestinal disorders
Abdominal pain
|
37.5%
3/8 • Number of events 4 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
25.0%
2/8 • Number of events 3 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
0.00%
0/8 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
1.0%
1/96 • Number of events 1 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
8.5%
4/47 • Number of events 9 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
12.5%
1/8 • Number of events 1 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
0.00%
0/28 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
|
Gastrointestinal disorders
Constipation
|
12.5%
1/8 • Number of events 1 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
25.0%
2/8 • Number of events 3 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
0.00%
0/8 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
18.8%
18/96 • Number of events 19 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
25.5%
12/47 • Number of events 12 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
50.0%
4/8 • Number of events 4 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
14.3%
4/28 • Number of events 4 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
|
Gastrointestinal disorders
Diarrhoea
|
12.5%
1/8 • Number of events 1 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
12.5%
1/8 • Number of events 1 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
0.00%
0/8 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
16.7%
16/96 • Number of events 20 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
10.6%
5/47 • Number of events 8 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
12.5%
1/8 • Number of events 1 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
0.00%
0/28 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
|
Gastrointestinal disorders
Eructation
|
12.5%
1/8 • Number of events 1 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
37.5%
3/8 • Number of events 3 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
0.00%
0/8 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
6.2%
6/96 • Number of events 6 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
6.4%
3/47 • Number of events 3 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
0.00%
0/8 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
0.00%
0/28 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
|
Gastrointestinal disorders
Flatulence
|
12.5%
1/8 • Number of events 1 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
0.00%
0/8 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
12.5%
1/8 • Number of events 1 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
6.2%
6/96 • Number of events 7 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
6.4%
3/47 • Number of events 3 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
0.00%
0/8 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
3.6%
1/28 • Number of events 1 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/8 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
0.00%
0/8 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
0.00%
0/8 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
8.3%
8/96 • Number of events 9 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
4.3%
2/47 • Number of events 3 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
12.5%
1/8 • Number of events 1 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
0.00%
0/28 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
|
Gastrointestinal disorders
Haematochezia
|
0.00%
0/8 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
12.5%
1/8 • Number of events 1 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
0.00%
0/8 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
0.00%
0/96 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
0.00%
0/47 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
12.5%
1/8 • Number of events 1 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
0.00%
0/28 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
|
Gastrointestinal disorders
Nausea
|
50.0%
4/8 • Number of events 5 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
87.5%
7/8 • Number of events 9 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
12.5%
1/8 • Number of events 1 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
40.6%
39/96 • Number of events 50 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
44.7%
21/47 • Number of events 39 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
62.5%
5/8 • Number of events 8 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
10.7%
3/28 • Number of events 3 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
|
Gastrointestinal disorders
Vomiting
|
37.5%
3/8 • Number of events 6 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
75.0%
6/8 • Number of events 8 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
0.00%
0/8 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
16.7%
16/96 • Number of events 21 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
31.9%
15/47 • Number of events 34 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
37.5%
3/8 • Number of events 5 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
3.6%
1/28 • Number of events 1 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/8 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
0.00%
0/8 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
0.00%
0/8 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
0.00%
0/96 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
2.1%
1/47 • Number of events 3 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
12.5%
1/8 • Number of events 1 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
0.00%
0/28 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
|
Gastrointestinal disorders
Epigastric discomfort
|
0.00%
0/8 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
0.00%
0/8 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
0.00%
0/8 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
0.00%
0/96 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
2.1%
1/47 • Number of events 1 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
12.5%
1/8 • Number of events 2 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
0.00%
0/28 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
|
Gastrointestinal disorders
Transient lingual papillitis
|
0.00%
0/8 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
0.00%
0/8 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
0.00%
0/8 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
0.00%
0/96 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
0.00%
0/47 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
12.5%
1/8 • Number of events 1 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
0.00%
0/28 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
|
Injury, poisoning and procedural complications
Accidental overdose
|
12.5%
1/8 • Number of events 1 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
25.0%
2/8 • Number of events 2 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
0.00%
0/8 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
0.00%
0/96 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
10.6%
5/47 • Number of events 5 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
0.00%
0/8 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
10.7%
3/28 • Number of events 3 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/8 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
0.00%
0/8 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
12.5%
1/8 • Number of events 1 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
1.0%
1/96 • Number of events 1 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
6.4%
3/47 • Number of events 3 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
0.00%
0/8 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
0.00%
0/28 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
|
Injury, poisoning and procedural complications
Medication error
|
0.00%
0/8 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
0.00%
0/8 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
0.00%
0/8 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
0.00%
0/96 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
0.00%
0/47 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
12.5%
1/8 • Number of events 1 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
3.6%
1/28 • Number of events 1 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
|
Nervous system disorders
Headache
|
12.5%
1/8 • Number of events 1 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
25.0%
2/8 • Number of events 2 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
12.5%
1/8 • Number of events 1 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
8.3%
8/96 • Number of events 9 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
8.5%
4/47 • Number of events 10 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
0.00%
0/8 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
3.6%
1/28 • Number of events 3 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
|
Nervous system disorders
Cervical radiculopathy
|
0.00%
0/8 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
0.00%
0/8 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
0.00%
0/8 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
0.00%
0/96 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
0.00%
0/47 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
12.5%
1/8 • Number of events 1 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
0.00%
0/28 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
|
Nervous system disorders
Syncope
|
0.00%
0/8 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
0.00%
0/8 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
0.00%
0/8 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
0.00%
0/96 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
4.3%
2/47 • Number of events 2 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
12.5%
1/8 • Number of events 1 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
3.6%
1/28 • Number of events 1 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
|
Investigations
Amylase increased
|
0.00%
0/8 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
12.5%
1/8 • Number of events 1 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
12.5%
1/8 • Number of events 1 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
0.00%
0/96 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
0.00%
0/47 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
0.00%
0/8 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
7.1%
2/28 • Number of events 2 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
|
Investigations
Lipase increased
|
0.00%
0/8 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
12.5%
1/8 • Number of events 1 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
12.5%
1/8 • Number of events 2 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
0.00%
0/96 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
0.00%
0/47 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
0.00%
0/8 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
7.1%
2/28 • Number of events 2 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
|
General disorders
Fatigue
|
12.5%
1/8 • Number of events 2 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
62.5%
5/8 • Number of events 5 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
12.5%
1/8 • Number of events 1 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
8.3%
8/96 • Number of events 8 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
2.1%
1/47 • Number of events 1 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
12.5%
1/8 • Number of events 2 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
3.6%
1/28 • Number of events 1 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
|
General disorders
Injection site erythema
|
0.00%
0/8 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
0.00%
0/8 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
0.00%
0/8 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
0.00%
0/96 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
0.00%
0/47 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
12.5%
1/8 • Number of events 1 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
3.6%
1/28 • Number of events 2 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
|
General disorders
Peripheral swelling
|
0.00%
0/8 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
0.00%
0/8 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
0.00%
0/8 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
0.00%
0/96 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
2.1%
1/47 • Number of events 1 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
12.5%
1/8 • Number of events 1 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
0.00%
0/28 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
|
General disorders
Sensation of foreign body
|
0.00%
0/8 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
0.00%
0/8 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
0.00%
0/8 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
0.00%
0/96 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
0.00%
0/47 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
12.5%
1/8 • Number of events 2 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
0.00%
0/28 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
|
Infections and infestations
COVID-19
|
12.5%
1/8 • Number of events 1 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
12.5%
1/8 • Number of events 1 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
0.00%
0/8 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
17.7%
17/96 • Number of events 17 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
8.5%
4/47 • Number of events 4 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
0.00%
0/8 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
10.7%
3/28 • Number of events 3 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
|
Infections and infestations
Pyuria
|
0.00%
0/8 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
0.00%
0/8 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
0.00%
0/8 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
0.00%
0/96 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
0.00%
0/47 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
12.5%
1/8 • Number of events 1 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
0.00%
0/28 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
|
Reproductive system and breast disorders
Breast calcifications
|
0.00%
0/8 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
0.00%
0/8 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
0.00%
0/8 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
0.00%
0/96 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
0.00%
0/47 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
12.5%
1/8 • Number of events 1 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
0.00%
0/28 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
|
Vascular disorders
Orthostatic hypotension
|
0.00%
0/8 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
0.00%
0/8 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
0.00%
0/8 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
0.00%
0/96 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
0.00%
0/47 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
12.5%
1/8 • Number of events 1 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
0.00%
0/28 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/8 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
0.00%
0/8 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
0.00%
0/8 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
0.00%
0/96 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
0.00%
0/47 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
12.5%
1/8 • Number of events 1 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
0.00%
0/28 • From week 0 to week 80 (Part 1: week 0 to follow-up (week 24); Part 2: From baseline at (week 0) to end of trial (week 56) Results are based on the SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
All AEs reported here are TEAEs. A TEAE is defined as an event that either has onset after administration of trial product and no later than the follow-up visit. SAS included all participants randomly assigned to trial treatment and who took at least one dose of trial product.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee At the end of the trial, one or more scientific publications may be prepared collaboratively by the investigator(s) and Novo Nordisk. Novo Nordisk reserves the right to postpone publication and/or communication for up to 60 days to protect intellectual property.
- Publication restrictions are in place
Restriction type: OTHER