Trial Outcomes & Findings for A Research Study to Look Into How Well Semaglutide Medicine Works at Different Doses in People With Type 2 Diabetes and Overweight (NCT NCT05486065)
NCT ID: NCT05486065
Last Updated: 2025-12-12
Results Overview
Change in HbA1c from baseline (week 0) to end of treatment (week 40) is presented.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
245 participants
Primary outcome timeframe
Baseline (week 0) and End of treatment (week 40)
Results posted on
2025-12-12
Participant Flow
This study was conducted at 82 active sites in 4 countries, of which 75 sites enrolled participants.
Participants were randomized at a ratio of 3:1:3:1:3:1 to receive semaglutide (2 milligram \[mg\], 8 mg, 16 mg) or matching placebo.
Participant milestones
| Measure |
Semaglutide 2.0 mg
Participants received once-weekly subcutaneous (s.c.) injections of semaglutide (in a dose-escalation manner every 4 weeks \[0-4 weeks: 0.29 mg; 5-8 weeks: 0.58 mg; 9-12 weeks: 1.06 mg\], followed by the maintenance dose of 2 mg) till 40 weeks.
|
Semaglutide 8.0 mg
Participants received once-weekly s.c. injections of semaglutide (in a dose-escalation manner every 4 weeks \[0-4 weeks: 0.29 mg; 5-8 weeks: 0.58 mg; 9-12 weeks: 1.06 mg; 13-16 weeks: 2.02 mg; 17-20 weeks: 4.03 mg\], followed by the maintenance dose of 8 mg) till 40 weeks.
|
Semaglutide 16.0 mg
Participants received once-weekly s.c. injections of semaglutide (in a dose-escalation manner every 4 weeks \[0-4 weeks: 0.29 mg; 5-8 weeks: 0.58 mg; 9-12 weeks: 1.06 mg; 13-16 weeks: 2.02 mg; 17-20 weeks: 4.03 mg; 21-24 weeks: 8.06 mg\], followed by the maintenance dose of 16 mg) till 40 weeks.
|
Placebo
Participants received once-weekly s.c. injection of placebo matched to semaglutide for 40 weeks.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
61
|
62
|
62
|
60
|
|
Overall Study
Full Analysis Set
|
61
|
62
|
62
|
60
|
|
Overall Study
Safety Analysis Set
|
60
|
60
|
62
|
59
|
|
Overall Study
COMPLETED
|
56
|
54
|
55
|
54
|
|
Overall Study
NOT COMPLETED
|
5
|
8
|
7
|
6
|
Reasons for withdrawal
| Measure |
Semaglutide 2.0 mg
Participants received once-weekly subcutaneous (s.c.) injections of semaglutide (in a dose-escalation manner every 4 weeks \[0-4 weeks: 0.29 mg; 5-8 weeks: 0.58 mg; 9-12 weeks: 1.06 mg\], followed by the maintenance dose of 2 mg) till 40 weeks.
|
Semaglutide 8.0 mg
Participants received once-weekly s.c. injections of semaglutide (in a dose-escalation manner every 4 weeks \[0-4 weeks: 0.29 mg; 5-8 weeks: 0.58 mg; 9-12 weeks: 1.06 mg; 13-16 weeks: 2.02 mg; 17-20 weeks: 4.03 mg\], followed by the maintenance dose of 8 mg) till 40 weeks.
|
Semaglutide 16.0 mg
Participants received once-weekly s.c. injections of semaglutide (in a dose-escalation manner every 4 weeks \[0-4 weeks: 0.29 mg; 5-8 weeks: 0.58 mg; 9-12 weeks: 1.06 mg; 13-16 weeks: 2.02 mg; 17-20 weeks: 4.03 mg; 21-24 weeks: 8.06 mg\], followed by the maintenance dose of 16 mg) till 40 weeks.
|
Placebo
Participants received once-weekly s.c. injection of placebo matched to semaglutide for 40 weeks.
|
|---|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
5
|
4
|
3
|
|
Overall Study
Lost to Follow-up
|
4
|
2
|
2
|
2
|
|
Overall Study
Physician Decision
|
0
|
1
|
1
|
0
|
|
Overall Study
Failure to meet randomization criteria
|
0
|
0
|
0
|
1
|
Baseline Characteristics
A Research Study to Look Into How Well Semaglutide Medicine Works at Different Doses in People With Type 2 Diabetes and Overweight
Baseline characteristics by cohort
| Measure |
Placebo
n=60 Participants
Participants received once-weekly s.c. injection of placebo matched to semaglutide for 40 weeks.
|
Total
n=245 Participants
Total of all reporting groups
|
Semaglutide 2.0 mg
n=61 Participants
Participants received once-weekly subcutaneous (s.c.) injections of semaglutide (in a dose-escalation manner every 4 weeks \[0-4 weeks: 0.29 mg; 5-8 weeks: 0.58 mg; 9-12 weeks: 1.06 mg\], followed by the maintenance dose of 2 mg) till 40 weeks.
|
Semaglutide 8.0 mg
n=62 Participants
Participants received once-weekly s.c. injections of semaglutide (in a dose-escalation manner every 4 weeks \[0-4 weeks: 0.29 mg; 5-8 weeks: 0.58 mg; 9-12 weeks: 1.06 mg; 13-16 weeks: 2.02 mg; 17-20 weeks: 4.03 mg\], followed by the maintenance dose of 8 mg) till 40 weeks.
|
Semaglutide 16.0 mg
n=62 Participants
Participants received once-weekly s.c. injections of semaglutide (in a dose-escalation manner every 4 weeks \[0-4 weeks: 0.29 mg; 5-8 weeks: 0.58 mg; 9-12 weeks: 1.06 mg; 13-16 weeks: 2.02 mg; 17-20 weeks: 4.03 mg; 21-24 weeks: 8.06 mg\], followed by the maintenance dose of 16 mg) till 40 weeks.
|
|---|---|---|---|---|---|
|
Age, Continuous
|
52.1 years
STANDARD_DEVIATION 9.5 • n=78 Participants
|
52.8 years
STANDARD_DEVIATION 8.3 • n=16 Participants
|
52.3 years
STANDARD_DEVIATION 7.6 • n=9 Participants
|
53.7 years
STANDARD_DEVIATION 7.5 • n=6 Participants
|
52.9 years
STANDARD_DEVIATION 8.6 • n=9 Participants
|
|
Sex: Female, Male
Female
|
35 Participants
n=78 Participants
|
120 Participants
n=16 Participants
|
27 Participants
n=9 Participants
|
33 Participants
n=6 Participants
|
25 Participants
n=9 Participants
|
|
Sex: Female, Male
Male
|
25 Participants
n=78 Participants
|
125 Participants
n=16 Participants
|
34 Participants
n=9 Participants
|
29 Participants
n=6 Participants
|
37 Participants
n=9 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
13 Participants
n=78 Participants
|
39 Participants
n=16 Participants
|
9 Participants
n=9 Participants
|
8 Participants
n=6 Participants
|
9 Participants
n=9 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
47 Participants
n=78 Participants
|
206 Participants
n=16 Participants
|
52 Participants
n=9 Participants
|
54 Participants
n=6 Participants
|
53 Participants
n=9 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=78 Participants
|
0 Participants
n=16 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=9 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=78 Participants
|
0 Participants
n=16 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=9 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=78 Participants
|
3 Participants
n=16 Participants
|
1 Participants
n=9 Participants
|
1 Participants
n=6 Participants
|
0 Participants
n=9 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=78 Participants
|
0 Participants
n=16 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=9 Participants
|
|
Race (NIH/OMB)
Black or African American
|
4 Participants
n=78 Participants
|
25 Participants
n=16 Participants
|
6 Participants
n=9 Participants
|
11 Participants
n=6 Participants
|
4 Participants
n=9 Participants
|
|
Race (NIH/OMB)
White
|
55 Participants
n=78 Participants
|
214 Participants
n=16 Participants
|
54 Participants
n=9 Participants
|
49 Participants
n=6 Participants
|
56 Participants
n=9 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=78 Participants
|
2 Participants
n=16 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=6 Participants
|
2 Participants
n=9 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=78 Participants
|
1 Participants
n=16 Participants
|
0 Participants
n=9 Participants
|
1 Participants
n=6 Participants
|
0 Participants
n=9 Participants
|
PRIMARY outcome
Timeframe: Baseline (week 0) and End of treatment (week 40)Population: Full analysis set included all randomised participants. Here, "Overall Number of Participants Analyzed" signifies those participants who were evaluable for this outcome measure.
Change in HbA1c from baseline (week 0) to end of treatment (week 40) is presented.
Outcome measures
| Measure |
Semaglutide 16.0 mg
n=56 Participants
Participants received once-weekly s.c. injections of semaglutide (in a dose-escalation manner every 4 weeks \[0-4 weeks: 0.29 mg; 5-8 weeks: 0.58 mg; 9-12 weeks: 1.06 mg; 13-16 weeks: 2.02 mg; 17-20 weeks: 4.03 mg; 21-24 weeks: 8.06 mg\], followed by the maintenance dose of 16 mg) till 40 weeks.
|
Placebo
n=54 Participants
Participants received once-weekly s.c. injection of placebo matched to semaglutide for 40 weeks.
|
Semaglutide 2.0 mg
n=56 Participants
Participants received once-weekly subcutaneous (s.c.) injections of semaglutide (in a dose-escalation manner every 4 weeks \[0-4 weeks: 0.29 mg; 5-8 weeks: 0.58 mg; 9-12 weeks: 1.06 mg\], followed by the maintenance dose of 2 mg) till 40 weeks.
|
Semaglutide 8.0 mg
n=57 Participants
Participants received once-weekly s.c. injections of semaglutide (in a dose-escalation manner every 4 weeks \[0-4 weeks: 0.29 mg; 5-8 weeks: 0.58 mg; 9-12 weeks: 1.06 mg; 13-16 weeks: 2.02 mg; 17-20 weeks: 4.03 mg\], followed by the maintenance dose of 8 mg) till 40 weeks.
|
|---|---|---|---|---|
|
Change in Glycated Haemoglobin (HbA1c)
|
-2.1 Percentage-point of HbA1c
Standard Deviation 1.5
|
-1.1 Percentage-point of HbA1c
Standard Deviation 1.3
|
-1.9 Percentage-point of HbA1c
Standard Deviation 1.1
|
-1.8 Percentage-point of HbA1c
Standard Deviation 1.5
|
SECONDARY outcome
Timeframe: Baseline (week 0) and End of treatment (week 40)Population: Full analysis set included all randomised participants. Here, "Overall Number of Participants Analyzed" signifies those participants who were evaluable for this outcome measure.
Change in body weight from baseline (week 0) to end of treatment (week 40) is presented.
Outcome measures
| Measure |
Semaglutide 16.0 mg
n=55 Participants
Participants received once-weekly s.c. injections of semaglutide (in a dose-escalation manner every 4 weeks \[0-4 weeks: 0.29 mg; 5-8 weeks: 0.58 mg; 9-12 weeks: 1.06 mg; 13-16 weeks: 2.02 mg; 17-20 weeks: 4.03 mg; 21-24 weeks: 8.06 mg\], followed by the maintenance dose of 16 mg) till 40 weeks.
|
Placebo
n=53 Participants
Participants received once-weekly s.c. injection of placebo matched to semaglutide for 40 weeks.
|
Semaglutide 2.0 mg
n=56 Participants
Participants received once-weekly subcutaneous (s.c.) injections of semaglutide (in a dose-escalation manner every 4 weeks \[0-4 weeks: 0.29 mg; 5-8 weeks: 0.58 mg; 9-12 weeks: 1.06 mg\], followed by the maintenance dose of 2 mg) till 40 weeks.
|
Semaglutide 8.0 mg
n=56 Participants
Participants received once-weekly s.c. injections of semaglutide (in a dose-escalation manner every 4 weeks \[0-4 weeks: 0.29 mg; 5-8 weeks: 0.58 mg; 9-12 weeks: 1.06 mg; 13-16 weeks: 2.02 mg; 17-20 weeks: 4.03 mg\], followed by the maintenance dose of 8 mg) till 40 weeks.
|
|---|---|---|---|---|
|
Change in Body Weight
|
-13.1 Kilogram (kg)
Standard Deviation 8.4
|
-2.3 Kilogram (kg)
Standard Deviation 4.9
|
-8.9 Kilogram (kg)
Standard Deviation 8.5
|
-10.1 Kilogram (kg)
Standard Deviation 7.4
|
SECONDARY outcome
Timeframe: From baseline (week 0) up to end of study (week 49)Population: Safety analysis set included all participants who are exposed to randomised treatment.
An adverse event (AE) is any untoward medical occurrence in a clinical study participant that is temporally associated with use of investigational medicinal products (IMP), whether or not considered related to IMP. AE can therefore be any unfavourable \& unintended sign (including an abnormal laboratory finding), symptom or disease (new or exacerbated) temporally associated with use of IMP. TEAE was defined as event that had onset date (or increase in severity) during on-treatment observation period. On treatment observation period data are presented. On-treatment observation period is defined as time points from first drug date until first date of end of data point sets (DPS1) or last administration of randomised treatment +63 days. DPS1 in trial is defined as all observed data points from randomisation until first date of end of study visit or date of death or date of withdrawal of informed consent or contact as defined by investigator for participants that are lost to follow up.
Outcome measures
| Measure |
Semaglutide 16.0 mg
n=62 Participants
Participants received once-weekly s.c. injections of semaglutide (in a dose-escalation manner every 4 weeks \[0-4 weeks: 0.29 mg; 5-8 weeks: 0.58 mg; 9-12 weeks: 1.06 mg; 13-16 weeks: 2.02 mg; 17-20 weeks: 4.03 mg; 21-24 weeks: 8.06 mg\], followed by the maintenance dose of 16 mg) till 40 weeks.
|
Placebo
n=59 Participants
Participants received once-weekly s.c. injection of placebo matched to semaglutide for 40 weeks.
|
Semaglutide 2.0 mg
n=60 Participants
Participants received once-weekly subcutaneous (s.c.) injections of semaglutide (in a dose-escalation manner every 4 weeks \[0-4 weeks: 0.29 mg; 5-8 weeks: 0.58 mg; 9-12 weeks: 1.06 mg\], followed by the maintenance dose of 2 mg) till 40 weeks.
|
Semaglutide 8.0 mg
n=60 Participants
Participants received once-weekly s.c. injections of semaglutide (in a dose-escalation manner every 4 weeks \[0-4 weeks: 0.29 mg; 5-8 weeks: 0.58 mg; 9-12 weeks: 1.06 mg; 13-16 weeks: 2.02 mg; 17-20 weeks: 4.03 mg\], followed by the maintenance dose of 8 mg) till 40 weeks.
|
|---|---|---|---|---|
|
Number of Treatment-emergent Adverse Events (TEAEs)
|
55 Events
|
37 Events
|
43 Events
|
54 Events
|
SECONDARY outcome
Timeframe: From baseline (week 0) up to end of study (week 49)Population: Safety analysis set included all participants who are exposed to randomised treatment.
Number of treatment-emergent severe Hypoglycaemic episodes are presented. Severe hypoglycaemic episodes (level 3) were defined as episodes that were associated with severe cognitive impairment requiring external assistance for recovery. On treatment observation period data are presented. On-treatment oberservation period is defined as time points from first drug date until the first date of end of data point sets (DPS1) or last administration of randomised treatment +63 days. DPS1 in trial is defined as all observed data points from randomisation until the first date of end of study visit or date of death or date of withdrawal of informed consent or date of last contact as defined by investigator for participants that are lost to follow up.
Outcome measures
| Measure |
Semaglutide 16.0 mg
n=62 Participants
Participants received once-weekly s.c. injections of semaglutide (in a dose-escalation manner every 4 weeks \[0-4 weeks: 0.29 mg; 5-8 weeks: 0.58 mg; 9-12 weeks: 1.06 mg; 13-16 weeks: 2.02 mg; 17-20 weeks: 4.03 mg; 21-24 weeks: 8.06 mg\], followed by the maintenance dose of 16 mg) till 40 weeks.
|
Placebo
n=59 Participants
Participants received once-weekly s.c. injection of placebo matched to semaglutide for 40 weeks.
|
Semaglutide 2.0 mg
n=60 Participants
Participants received once-weekly subcutaneous (s.c.) injections of semaglutide (in a dose-escalation manner every 4 weeks \[0-4 weeks: 0.29 mg; 5-8 weeks: 0.58 mg; 9-12 weeks: 1.06 mg\], followed by the maintenance dose of 2 mg) till 40 weeks.
|
Semaglutide 8.0 mg
n=60 Participants
Participants received once-weekly s.c. injections of semaglutide (in a dose-escalation manner every 4 weeks \[0-4 weeks: 0.29 mg; 5-8 weeks: 0.58 mg; 9-12 weeks: 1.06 mg; 13-16 weeks: 2.02 mg; 17-20 weeks: 4.03 mg\], followed by the maintenance dose of 8 mg) till 40 weeks.
|
|---|---|---|---|---|
|
Number of Treatment-emergent Severe Hypoglycaemic Episodes
|
0 Episodes
|
0 Episodes
|
0 Episodes
|
0 Episodes
|
Adverse Events
Semaglutide 2.0 mg
Serious events: 4 serious events
Other events: 30 other events
Deaths: 0 deaths
Semaglutide 8.0 mg
Serious events: 2 serious events
Other events: 48 other events
Deaths: 0 deaths
Semaglutide 16.0 mg
Serious events: 1 serious events
Other events: 50 other events
Deaths: 0 deaths
Placebo
Serious events: 2 serious events
Other events: 29 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Semaglutide 2.0 mg
n=60 participants at risk
Participants received once-weekly subcutaneous (s.c.) injections of semaglutide (in a dose-escalation manner every 4 weeks \[0-4 weeks: 0.29 mg; 5-8 weeks: 0.58 mg; 9-12 weeks: 1.06 mg\], followed by the maintenance dose of 2 mg) till 40 weeks.
|
Semaglutide 8.0 mg
n=60 participants at risk
Participants received once-weekly s.c. injections of semaglutide (in a dose-escalation manner every 4 weeks \[0-4 weeks: 0.29 mg; 5-8 weeks: 0.58 mg; 9-12 weeks: 1.06 mg; 13-16 weeks: 2.02 mg; 17-20 weeks: 4.03 mg\], followed by the maintenance dose of 8 mg) till 40 weeks.
|
Semaglutide 16.0 mg
n=62 participants at risk
Participants received once-weekly s.c. injections of semaglutide (in a dose-escalation manner every 4 weeks \[0-4 weeks: 0.29 mg; 5-8 weeks: 0.58 mg; 9-12 weeks: 1.06 mg; 13-16 weeks: 2.02 mg; 17-20 weeks: 4.03 mg; 21-24 weeks: 8.06 mg\], followed by the maintenance dose of 16 mg) till 40 weeks.
|
Placebo
n=59 participants at risk
Participants received once-weekly s.c. injection of placebo matched to semaglutide for 40 weeks.
|
|---|---|---|---|---|
|
Cardiac disorders
Cardiac failure chronic
|
0.00%
0/60 • From baseline (week 0) up to end of study (week 49)
AEs presented here are TEAEs. TEAE was defined as event that had onset date (or increase in severity) during on-treatment observation period. On-treatment oberservation period define as time points from first drug date until the first date of end of data point sets (DPS1) or last administration of randomised treatment +63 days. Safety analysis set included all participants who are exposed to randomised treatment.
|
1.7%
1/60 • Number of events 1 • From baseline (week 0) up to end of study (week 49)
AEs presented here are TEAEs. TEAE was defined as event that had onset date (or increase in severity) during on-treatment observation period. On-treatment oberservation period define as time points from first drug date until the first date of end of data point sets (DPS1) or last administration of randomised treatment +63 days. Safety analysis set included all participants who are exposed to randomised treatment.
|
0.00%
0/62 • From baseline (week 0) up to end of study (week 49)
AEs presented here are TEAEs. TEAE was defined as event that had onset date (or increase in severity) during on-treatment observation period. On-treatment oberservation period define as time points from first drug date until the first date of end of data point sets (DPS1) or last administration of randomised treatment +63 days. Safety analysis set included all participants who are exposed to randomised treatment.
|
0.00%
0/59 • From baseline (week 0) up to end of study (week 49)
AEs presented here are TEAEs. TEAE was defined as event that had onset date (or increase in severity) during on-treatment observation period. On-treatment oberservation period define as time points from first drug date until the first date of end of data point sets (DPS1) or last administration of randomised treatment +63 days. Safety analysis set included all participants who are exposed to randomised treatment.
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.00%
0/60 • From baseline (week 0) up to end of study (week 49)
AEs presented here are TEAEs. TEAE was defined as event that had onset date (or increase in severity) during on-treatment observation period. On-treatment oberservation period define as time points from first drug date until the first date of end of data point sets (DPS1) or last administration of randomised treatment +63 days. Safety analysis set included all participants who are exposed to randomised treatment.
|
0.00%
0/60 • From baseline (week 0) up to end of study (week 49)
AEs presented here are TEAEs. TEAE was defined as event that had onset date (or increase in severity) during on-treatment observation period. On-treatment oberservation period define as time points from first drug date until the first date of end of data point sets (DPS1) or last administration of randomised treatment +63 days. Safety analysis set included all participants who are exposed to randomised treatment.
|
1.6%
1/62 • Number of events 1 • From baseline (week 0) up to end of study (week 49)
AEs presented here are TEAEs. TEAE was defined as event that had onset date (or increase in severity) during on-treatment observation period. On-treatment oberservation period define as time points from first drug date until the first date of end of data point sets (DPS1) or last administration of randomised treatment +63 days. Safety analysis set included all participants who are exposed to randomised treatment.
|
0.00%
0/59 • From baseline (week 0) up to end of study (week 49)
AEs presented here are TEAEs. TEAE was defined as event that had onset date (or increase in severity) during on-treatment observation period. On-treatment oberservation period define as time points from first drug date until the first date of end of data point sets (DPS1) or last administration of randomised treatment +63 days. Safety analysis set included all participants who are exposed to randomised treatment.
|
|
Injury, poisoning and procedural complications
Incisional hernia
|
1.7%
1/60 • Number of events 1 • From baseline (week 0) up to end of study (week 49)
AEs presented here are TEAEs. TEAE was defined as event that had onset date (or increase in severity) during on-treatment observation period. On-treatment oberservation period define as time points from first drug date until the first date of end of data point sets (DPS1) or last administration of randomised treatment +63 days. Safety analysis set included all participants who are exposed to randomised treatment.
|
0.00%
0/60 • From baseline (week 0) up to end of study (week 49)
AEs presented here are TEAEs. TEAE was defined as event that had onset date (or increase in severity) during on-treatment observation period. On-treatment oberservation period define as time points from first drug date until the first date of end of data point sets (DPS1) or last administration of randomised treatment +63 days. Safety analysis set included all participants who are exposed to randomised treatment.
|
0.00%
0/62 • From baseline (week 0) up to end of study (week 49)
AEs presented here are TEAEs. TEAE was defined as event that had onset date (or increase in severity) during on-treatment observation period. On-treatment oberservation period define as time points from first drug date until the first date of end of data point sets (DPS1) or last administration of randomised treatment +63 days. Safety analysis set included all participants who are exposed to randomised treatment.
|
0.00%
0/59 • From baseline (week 0) up to end of study (week 49)
AEs presented here are TEAEs. TEAE was defined as event that had onset date (or increase in severity) during on-treatment observation period. On-treatment oberservation period define as time points from first drug date until the first date of end of data point sets (DPS1) or last administration of randomised treatment +63 days. Safety analysis set included all participants who are exposed to randomised treatment.
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.00%
0/60 • From baseline (week 0) up to end of study (week 49)
AEs presented here are TEAEs. TEAE was defined as event that had onset date (or increase in severity) during on-treatment observation period. On-treatment oberservation period define as time points from first drug date until the first date of end of data point sets (DPS1) or last administration of randomised treatment +63 days. Safety analysis set included all participants who are exposed to randomised treatment.
|
1.7%
1/60 • Number of events 1 • From baseline (week 0) up to end of study (week 49)
AEs presented here are TEAEs. TEAE was defined as event that had onset date (or increase in severity) during on-treatment observation period. On-treatment oberservation period define as time points from first drug date until the first date of end of data point sets (DPS1) or last administration of randomised treatment +63 days. Safety analysis set included all participants who are exposed to randomised treatment.
|
0.00%
0/62 • From baseline (week 0) up to end of study (week 49)
AEs presented here are TEAEs. TEAE was defined as event that had onset date (or increase in severity) during on-treatment observation period. On-treatment oberservation period define as time points from first drug date until the first date of end of data point sets (DPS1) or last administration of randomised treatment +63 days. Safety analysis set included all participants who are exposed to randomised treatment.
|
0.00%
0/59 • From baseline (week 0) up to end of study (week 49)
AEs presented here are TEAEs. TEAE was defined as event that had onset date (or increase in severity) during on-treatment observation period. On-treatment oberservation period define as time points from first drug date until the first date of end of data point sets (DPS1) or last administration of randomised treatment +63 days. Safety analysis set included all participants who are exposed to randomised treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Invasive ductal breast carcinoma
|
1.7%
1/60 • Number of events 1 • From baseline (week 0) up to end of study (week 49)
AEs presented here are TEAEs. TEAE was defined as event that had onset date (or increase in severity) during on-treatment observation period. On-treatment oberservation period define as time points from first drug date until the first date of end of data point sets (DPS1) or last administration of randomised treatment +63 days. Safety analysis set included all participants who are exposed to randomised treatment.
|
0.00%
0/60 • From baseline (week 0) up to end of study (week 49)
AEs presented here are TEAEs. TEAE was defined as event that had onset date (or increase in severity) during on-treatment observation period. On-treatment oberservation period define as time points from first drug date until the first date of end of data point sets (DPS1) or last administration of randomised treatment +63 days. Safety analysis set included all participants who are exposed to randomised treatment.
|
0.00%
0/62 • From baseline (week 0) up to end of study (week 49)
AEs presented here are TEAEs. TEAE was defined as event that had onset date (or increase in severity) during on-treatment observation period. On-treatment oberservation period define as time points from first drug date until the first date of end of data point sets (DPS1) or last administration of randomised treatment +63 days. Safety analysis set included all participants who are exposed to randomised treatment.
|
0.00%
0/59 • From baseline (week 0) up to end of study (week 49)
AEs presented here are TEAEs. TEAE was defined as event that had onset date (or increase in severity) during on-treatment observation period. On-treatment oberservation period define as time points from first drug date until the first date of end of data point sets (DPS1) or last administration of randomised treatment +63 days. Safety analysis set included all participants who are exposed to randomised treatment.
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.00%
0/60 • From baseline (week 0) up to end of study (week 49)
AEs presented here are TEAEs. TEAE was defined as event that had onset date (or increase in severity) during on-treatment observation period. On-treatment oberservation period define as time points from first drug date until the first date of end of data point sets (DPS1) or last administration of randomised treatment +63 days. Safety analysis set included all participants who are exposed to randomised treatment.
|
0.00%
0/60 • From baseline (week 0) up to end of study (week 49)
AEs presented here are TEAEs. TEAE was defined as event that had onset date (or increase in severity) during on-treatment observation period. On-treatment oberservation period define as time points from first drug date until the first date of end of data point sets (DPS1) or last administration of randomised treatment +63 days. Safety analysis set included all participants who are exposed to randomised treatment.
|
0.00%
0/62 • From baseline (week 0) up to end of study (week 49)
AEs presented here are TEAEs. TEAE was defined as event that had onset date (or increase in severity) during on-treatment observation period. On-treatment oberservation period define as time points from first drug date until the first date of end of data point sets (DPS1) or last administration of randomised treatment +63 days. Safety analysis set included all participants who are exposed to randomised treatment.
|
1.7%
1/59 • Number of events 1 • From baseline (week 0) up to end of study (week 49)
AEs presented here are TEAEs. TEAE was defined as event that had onset date (or increase in severity) during on-treatment observation period. On-treatment oberservation period define as time points from first drug date until the first date of end of data point sets (DPS1) or last administration of randomised treatment +63 days. Safety analysis set included all participants who are exposed to randomised treatment.
|
|
Injury, poisoning and procedural complications
Post procedural haemorrhage
|
1.7%
1/60 • Number of events 1 • From baseline (week 0) up to end of study (week 49)
AEs presented here are TEAEs. TEAE was defined as event that had onset date (or increase in severity) during on-treatment observation period. On-treatment oberservation period define as time points from first drug date until the first date of end of data point sets (DPS1) or last administration of randomised treatment +63 days. Safety analysis set included all participants who are exposed to randomised treatment.
|
0.00%
0/60 • From baseline (week 0) up to end of study (week 49)
AEs presented here are TEAEs. TEAE was defined as event that had onset date (or increase in severity) during on-treatment observation period. On-treatment oberservation period define as time points from first drug date until the first date of end of data point sets (DPS1) or last administration of randomised treatment +63 days. Safety analysis set included all participants who are exposed to randomised treatment.
|
0.00%
0/62 • From baseline (week 0) up to end of study (week 49)
AEs presented here are TEAEs. TEAE was defined as event that had onset date (or increase in severity) during on-treatment observation period. On-treatment oberservation period define as time points from first drug date until the first date of end of data point sets (DPS1) or last administration of randomised treatment +63 days. Safety analysis set included all participants who are exposed to randomised treatment.
|
0.00%
0/59 • From baseline (week 0) up to end of study (week 49)
AEs presented here are TEAEs. TEAE was defined as event that had onset date (or increase in severity) during on-treatment observation period. On-treatment oberservation period define as time points from first drug date until the first date of end of data point sets (DPS1) or last administration of randomised treatment +63 days. Safety analysis set included all participants who are exposed to randomised treatment.
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/60 • From baseline (week 0) up to end of study (week 49)
AEs presented here are TEAEs. TEAE was defined as event that had onset date (or increase in severity) during on-treatment observation period. On-treatment oberservation period define as time points from first drug date until the first date of end of data point sets (DPS1) or last administration of randomised treatment +63 days. Safety analysis set included all participants who are exposed to randomised treatment.
|
0.00%
0/60 • From baseline (week 0) up to end of study (week 49)
AEs presented here are TEAEs. TEAE was defined as event that had onset date (or increase in severity) during on-treatment observation period. On-treatment oberservation period define as time points from first drug date until the first date of end of data point sets (DPS1) or last administration of randomised treatment +63 days. Safety analysis set included all participants who are exposed to randomised treatment.
|
0.00%
0/62 • From baseline (week 0) up to end of study (week 49)
AEs presented here are TEAEs. TEAE was defined as event that had onset date (or increase in severity) during on-treatment observation period. On-treatment oberservation period define as time points from first drug date until the first date of end of data point sets (DPS1) or last administration of randomised treatment +63 days. Safety analysis set included all participants who are exposed to randomised treatment.
|
1.7%
1/59 • Number of events 1 • From baseline (week 0) up to end of study (week 49)
AEs presented here are TEAEs. TEAE was defined as event that had onset date (or increase in severity) during on-treatment observation period. On-treatment oberservation period define as time points from first drug date until the first date of end of data point sets (DPS1) or last administration of randomised treatment +63 days. Safety analysis set included all participants who are exposed to randomised treatment.
|
|
Infections and infestations
Vestibular neuronitis
|
1.7%
1/60 • Number of events 1 • From baseline (week 0) up to end of study (week 49)
AEs presented here are TEAEs. TEAE was defined as event that had onset date (or increase in severity) during on-treatment observation period. On-treatment oberservation period define as time points from first drug date until the first date of end of data point sets (DPS1) or last administration of randomised treatment +63 days. Safety analysis set included all participants who are exposed to randomised treatment.
|
0.00%
0/60 • From baseline (week 0) up to end of study (week 49)
AEs presented here are TEAEs. TEAE was defined as event that had onset date (or increase in severity) during on-treatment observation period. On-treatment oberservation period define as time points from first drug date until the first date of end of data point sets (DPS1) or last administration of randomised treatment +63 days. Safety analysis set included all participants who are exposed to randomised treatment.
|
0.00%
0/62 • From baseline (week 0) up to end of study (week 49)
AEs presented here are TEAEs. TEAE was defined as event that had onset date (or increase in severity) during on-treatment observation period. On-treatment oberservation period define as time points from first drug date until the first date of end of data point sets (DPS1) or last administration of randomised treatment +63 days. Safety analysis set included all participants who are exposed to randomised treatment.
|
0.00%
0/59 • From baseline (week 0) up to end of study (week 49)
AEs presented here are TEAEs. TEAE was defined as event that had onset date (or increase in severity) during on-treatment observation period. On-treatment oberservation period define as time points from first drug date until the first date of end of data point sets (DPS1) or last administration of randomised treatment +63 days. Safety analysis set included all participants who are exposed to randomised treatment.
|
Other adverse events
| Measure |
Semaglutide 2.0 mg
n=60 participants at risk
Participants received once-weekly subcutaneous (s.c.) injections of semaglutide (in a dose-escalation manner every 4 weeks \[0-4 weeks: 0.29 mg; 5-8 weeks: 0.58 mg; 9-12 weeks: 1.06 mg\], followed by the maintenance dose of 2 mg) till 40 weeks.
|
Semaglutide 8.0 mg
n=60 participants at risk
Participants received once-weekly s.c. injections of semaglutide (in a dose-escalation manner every 4 weeks \[0-4 weeks: 0.29 mg; 5-8 weeks: 0.58 mg; 9-12 weeks: 1.06 mg; 13-16 weeks: 2.02 mg; 17-20 weeks: 4.03 mg\], followed by the maintenance dose of 8 mg) till 40 weeks.
|
Semaglutide 16.0 mg
n=62 participants at risk
Participants received once-weekly s.c. injections of semaglutide (in a dose-escalation manner every 4 weeks \[0-4 weeks: 0.29 mg; 5-8 weeks: 0.58 mg; 9-12 weeks: 1.06 mg; 13-16 weeks: 2.02 mg; 17-20 weeks: 4.03 mg; 21-24 weeks: 8.06 mg\], followed by the maintenance dose of 16 mg) till 40 weeks.
|
Placebo
n=59 participants at risk
Participants received once-weekly s.c. injection of placebo matched to semaglutide for 40 weeks.
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Abdominal distension
|
3.3%
2/60 • Number of events 3 • From baseline (week 0) up to end of study (week 49)
AEs presented here are TEAEs. TEAE was defined as event that had onset date (or increase in severity) during on-treatment observation period. On-treatment oberservation period define as time points from first drug date until the first date of end of data point sets (DPS1) or last administration of randomised treatment +63 days. Safety analysis set included all participants who are exposed to randomised treatment.
|
6.7%
4/60 • Number of events 4 • From baseline (week 0) up to end of study (week 49)
AEs presented here are TEAEs. TEAE was defined as event that had onset date (or increase in severity) during on-treatment observation period. On-treatment oberservation period define as time points from first drug date until the first date of end of data point sets (DPS1) or last administration of randomised treatment +63 days. Safety analysis set included all participants who are exposed to randomised treatment.
|
4.8%
3/62 • Number of events 3 • From baseline (week 0) up to end of study (week 49)
AEs presented here are TEAEs. TEAE was defined as event that had onset date (or increase in severity) during on-treatment observation period. On-treatment oberservation period define as time points from first drug date until the first date of end of data point sets (DPS1) or last administration of randomised treatment +63 days. Safety analysis set included all participants who are exposed to randomised treatment.
|
1.7%
1/59 • Number of events 1 • From baseline (week 0) up to end of study (week 49)
AEs presented here are TEAEs. TEAE was defined as event that had onset date (or increase in severity) during on-treatment observation period. On-treatment oberservation period define as time points from first drug date until the first date of end of data point sets (DPS1) or last administration of randomised treatment +63 days. Safety analysis set included all participants who are exposed to randomised treatment.
|
|
Gastrointestinal disorders
Abdominal pain
|
5.0%
3/60 • Number of events 3 • From baseline (week 0) up to end of study (week 49)
AEs presented here are TEAEs. TEAE was defined as event that had onset date (or increase in severity) during on-treatment observation period. On-treatment oberservation period define as time points from first drug date until the first date of end of data point sets (DPS1) or last administration of randomised treatment +63 days. Safety analysis set included all participants who are exposed to randomised treatment.
|
1.7%
1/60 • Number of events 1 • From baseline (week 0) up to end of study (week 49)
AEs presented here are TEAEs. TEAE was defined as event that had onset date (or increase in severity) during on-treatment observation period. On-treatment oberservation period define as time points from first drug date until the first date of end of data point sets (DPS1) or last administration of randomised treatment +63 days. Safety analysis set included all participants who are exposed to randomised treatment.
|
6.5%
4/62 • Number of events 4 • From baseline (week 0) up to end of study (week 49)
AEs presented here are TEAEs. TEAE was defined as event that had onset date (or increase in severity) during on-treatment observation period. On-treatment oberservation period define as time points from first drug date until the first date of end of data point sets (DPS1) or last administration of randomised treatment +63 days. Safety analysis set included all participants who are exposed to randomised treatment.
|
1.7%
1/59 • Number of events 1 • From baseline (week 0) up to end of study (week 49)
AEs presented here are TEAEs. TEAE was defined as event that had onset date (or increase in severity) during on-treatment observation period. On-treatment oberservation period define as time points from first drug date until the first date of end of data point sets (DPS1) or last administration of randomised treatment +63 days. Safety analysis set included all participants who are exposed to randomised treatment.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
8.3%
5/60 • Number of events 5 • From baseline (week 0) up to end of study (week 49)
AEs presented here are TEAEs. TEAE was defined as event that had onset date (or increase in severity) during on-treatment observation period. On-treatment oberservation period define as time points from first drug date until the first date of end of data point sets (DPS1) or last administration of randomised treatment +63 days. Safety analysis set included all participants who are exposed to randomised treatment.
|
8.3%
5/60 • Number of events 6 • From baseline (week 0) up to end of study (week 49)
AEs presented here are TEAEs. TEAE was defined as event that had onset date (or increase in severity) during on-treatment observation period. On-treatment oberservation period define as time points from first drug date until the first date of end of data point sets (DPS1) or last administration of randomised treatment +63 days. Safety analysis set included all participants who are exposed to randomised treatment.
|
3.2%
2/62 • Number of events 3 • From baseline (week 0) up to end of study (week 49)
AEs presented here are TEAEs. TEAE was defined as event that had onset date (or increase in severity) during on-treatment observation period. On-treatment oberservation period define as time points from first drug date until the first date of end of data point sets (DPS1) or last administration of randomised treatment +63 days. Safety analysis set included all participants who are exposed to randomised treatment.
|
5.1%
3/59 • Number of events 4 • From baseline (week 0) up to end of study (week 49)
AEs presented here are TEAEs. TEAE was defined as event that had onset date (or increase in severity) during on-treatment observation period. On-treatment oberservation period define as time points from first drug date until the first date of end of data point sets (DPS1) or last administration of randomised treatment +63 days. Safety analysis set included all participants who are exposed to randomised treatment.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
1.7%
1/60 • Number of events 1 • From baseline (week 0) up to end of study (week 49)
AEs presented here are TEAEs. TEAE was defined as event that had onset date (or increase in severity) during on-treatment observation period. On-treatment oberservation period define as time points from first drug date until the first date of end of data point sets (DPS1) or last administration of randomised treatment +63 days. Safety analysis set included all participants who are exposed to randomised treatment.
|
0.00%
0/60 • From baseline (week 0) up to end of study (week 49)
AEs presented here are TEAEs. TEAE was defined as event that had onset date (or increase in severity) during on-treatment observation period. On-treatment oberservation period define as time points from first drug date until the first date of end of data point sets (DPS1) or last administration of randomised treatment +63 days. Safety analysis set included all participants who are exposed to randomised treatment.
|
9.7%
6/62 • Number of events 7 • From baseline (week 0) up to end of study (week 49)
AEs presented here are TEAEs. TEAE was defined as event that had onset date (or increase in severity) during on-treatment observation period. On-treatment oberservation period define as time points from first drug date until the first date of end of data point sets (DPS1) or last administration of randomised treatment +63 days. Safety analysis set included all participants who are exposed to randomised treatment.
|
3.4%
2/59 • Number of events 4 • From baseline (week 0) up to end of study (week 49)
AEs presented here are TEAEs. TEAE was defined as event that had onset date (or increase in severity) during on-treatment observation period. On-treatment oberservation period define as time points from first drug date until the first date of end of data point sets (DPS1) or last administration of randomised treatment +63 days. Safety analysis set included all participants who are exposed to randomised treatment.
|
|
Infections and infestations
COVID-19
|
1.7%
1/60 • Number of events 1 • From baseline (week 0) up to end of study (week 49)
AEs presented here are TEAEs. TEAE was defined as event that had onset date (or increase in severity) during on-treatment observation period. On-treatment oberservation period define as time points from first drug date until the first date of end of data point sets (DPS1) or last administration of randomised treatment +63 days. Safety analysis set included all participants who are exposed to randomised treatment.
|
13.3%
8/60 • Number of events 8 • From baseline (week 0) up to end of study (week 49)
AEs presented here are TEAEs. TEAE was defined as event that had onset date (or increase in severity) during on-treatment observation period. On-treatment oberservation period define as time points from first drug date until the first date of end of data point sets (DPS1) or last administration of randomised treatment +63 days. Safety analysis set included all participants who are exposed to randomised treatment.
|
1.6%
1/62 • Number of events 1 • From baseline (week 0) up to end of study (week 49)
AEs presented here are TEAEs. TEAE was defined as event that had onset date (or increase in severity) during on-treatment observation period. On-treatment oberservation period define as time points from first drug date until the first date of end of data point sets (DPS1) or last administration of randomised treatment +63 days. Safety analysis set included all participants who are exposed to randomised treatment.
|
5.1%
3/59 • Number of events 3 • From baseline (week 0) up to end of study (week 49)
AEs presented here are TEAEs. TEAE was defined as event that had onset date (or increase in severity) during on-treatment observation period. On-treatment oberservation period define as time points from first drug date until the first date of end of data point sets (DPS1) or last administration of randomised treatment +63 days. Safety analysis set included all participants who are exposed to randomised treatment.
|
|
Gastrointestinal disorders
Constipation
|
3.3%
2/60 • Number of events 2 • From baseline (week 0) up to end of study (week 49)
AEs presented here are TEAEs. TEAE was defined as event that had onset date (or increase in severity) during on-treatment observation period. On-treatment oberservation period define as time points from first drug date until the first date of end of data point sets (DPS1) or last administration of randomised treatment +63 days. Safety analysis set included all participants who are exposed to randomised treatment.
|
13.3%
8/60 • Number of events 11 • From baseline (week 0) up to end of study (week 49)
AEs presented here are TEAEs. TEAE was defined as event that had onset date (or increase in severity) during on-treatment observation period. On-treatment oberservation period define as time points from first drug date until the first date of end of data point sets (DPS1) or last administration of randomised treatment +63 days. Safety analysis set included all participants who are exposed to randomised treatment.
|
19.4%
12/62 • Number of events 16 • From baseline (week 0) up to end of study (week 49)
AEs presented here are TEAEs. TEAE was defined as event that had onset date (or increase in severity) during on-treatment observation period. On-treatment oberservation period define as time points from first drug date until the first date of end of data point sets (DPS1) or last administration of randomised treatment +63 days. Safety analysis set included all participants who are exposed to randomised treatment.
|
5.1%
3/59 • Number of events 3 • From baseline (week 0) up to end of study (week 49)
AEs presented here are TEAEs. TEAE was defined as event that had onset date (or increase in severity) during on-treatment observation period. On-treatment oberservation period define as time points from first drug date until the first date of end of data point sets (DPS1) or last administration of randomised treatment +63 days. Safety analysis set included all participants who are exposed to randomised treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/60 • From baseline (week 0) up to end of study (week 49)
AEs presented here are TEAEs. TEAE was defined as event that had onset date (or increase in severity) during on-treatment observation period. On-treatment oberservation period define as time points from first drug date until the first date of end of data point sets (DPS1) or last administration of randomised treatment +63 days. Safety analysis set included all participants who are exposed to randomised treatment.
|
1.7%
1/60 • Number of events 1 • From baseline (week 0) up to end of study (week 49)
AEs presented here are TEAEs. TEAE was defined as event that had onset date (or increase in severity) during on-treatment observation period. On-treatment oberservation period define as time points from first drug date until the first date of end of data point sets (DPS1) or last administration of randomised treatment +63 days. Safety analysis set included all participants who are exposed to randomised treatment.
|
3.2%
2/62 • Number of events 2 • From baseline (week 0) up to end of study (week 49)
AEs presented here are TEAEs. TEAE was defined as event that had onset date (or increase in severity) during on-treatment observation period. On-treatment oberservation period define as time points from first drug date until the first date of end of data point sets (DPS1) or last administration of randomised treatment +63 days. Safety analysis set included all participants who are exposed to randomised treatment.
|
6.8%
4/59 • Number of events 6 • From baseline (week 0) up to end of study (week 49)
AEs presented here are TEAEs. TEAE was defined as event that had onset date (or increase in severity) during on-treatment observation period. On-treatment oberservation period define as time points from first drug date until the first date of end of data point sets (DPS1) or last administration of randomised treatment +63 days. Safety analysis set included all participants who are exposed to randomised treatment.
|
|
Gastrointestinal disorders
Diarrhoea
|
15.0%
9/60 • Number of events 29 • From baseline (week 0) up to end of study (week 49)
AEs presented here are TEAEs. TEAE was defined as event that had onset date (or increase in severity) during on-treatment observation period. On-treatment oberservation period define as time points from first drug date until the first date of end of data point sets (DPS1) or last administration of randomised treatment +63 days. Safety analysis set included all participants who are exposed to randomised treatment.
|
33.3%
20/60 • Number of events 30 • From baseline (week 0) up to end of study (week 49)
AEs presented here are TEAEs. TEAE was defined as event that had onset date (or increase in severity) during on-treatment observation period. On-treatment oberservation period define as time points from first drug date until the first date of end of data point sets (DPS1) or last administration of randomised treatment +63 days. Safety analysis set included all participants who are exposed to randomised treatment.
|
21.0%
13/62 • Number of events 19 • From baseline (week 0) up to end of study (week 49)
AEs presented here are TEAEs. TEAE was defined as event that had onset date (or increase in severity) during on-treatment observation period. On-treatment oberservation period define as time points from first drug date until the first date of end of data point sets (DPS1) or last administration of randomised treatment +63 days. Safety analysis set included all participants who are exposed to randomised treatment.
|
11.9%
7/59 • Number of events 56 • From baseline (week 0) up to end of study (week 49)
AEs presented here are TEAEs. TEAE was defined as event that had onset date (or increase in severity) during on-treatment observation period. On-treatment oberservation period define as time points from first drug date until the first date of end of data point sets (DPS1) or last administration of randomised treatment +63 days. Safety analysis set included all participants who are exposed to randomised treatment.
|
|
Nervous system disorders
Dizziness
|
3.3%
2/60 • Number of events 2 • From baseline (week 0) up to end of study (week 49)
AEs presented here are TEAEs. TEAE was defined as event that had onset date (or increase in severity) during on-treatment observation period. On-treatment oberservation period define as time points from first drug date until the first date of end of data point sets (DPS1) or last administration of randomised treatment +63 days. Safety analysis set included all participants who are exposed to randomised treatment.
|
10.0%
6/60 • Number of events 6 • From baseline (week 0) up to end of study (week 49)
AEs presented here are TEAEs. TEAE was defined as event that had onset date (or increase in severity) during on-treatment observation period. On-treatment oberservation period define as time points from first drug date until the first date of end of data point sets (DPS1) or last administration of randomised treatment +63 days. Safety analysis set included all participants who are exposed to randomised treatment.
|
4.8%
3/62 • Number of events 3 • From baseline (week 0) up to end of study (week 49)
AEs presented here are TEAEs. TEAE was defined as event that had onset date (or increase in severity) during on-treatment observation period. On-treatment oberservation period define as time points from first drug date until the first date of end of data point sets (DPS1) or last administration of randomised treatment +63 days. Safety analysis set included all participants who are exposed to randomised treatment.
|
6.8%
4/59 • Number of events 5 • From baseline (week 0) up to end of study (week 49)
AEs presented here are TEAEs. TEAE was defined as event that had onset date (or increase in severity) during on-treatment observation period. On-treatment oberservation period define as time points from first drug date until the first date of end of data point sets (DPS1) or last administration of randomised treatment +63 days. Safety analysis set included all participants who are exposed to randomised treatment.
|
|
Gastrointestinal disorders
Dry mouth
|
5.0%
3/60 • Number of events 3 • From baseline (week 0) up to end of study (week 49)
AEs presented here are TEAEs. TEAE was defined as event that had onset date (or increase in severity) during on-treatment observation period. On-treatment oberservation period define as time points from first drug date until the first date of end of data point sets (DPS1) or last administration of randomised treatment +63 days. Safety analysis set included all participants who are exposed to randomised treatment.
|
3.3%
2/60 • Number of events 2 • From baseline (week 0) up to end of study (week 49)
AEs presented here are TEAEs. TEAE was defined as event that had onset date (or increase in severity) during on-treatment observation period. On-treatment oberservation period define as time points from first drug date until the first date of end of data point sets (DPS1) or last administration of randomised treatment +63 days. Safety analysis set included all participants who are exposed to randomised treatment.
|
0.00%
0/62 • From baseline (week 0) up to end of study (week 49)
AEs presented here are TEAEs. TEAE was defined as event that had onset date (or increase in severity) during on-treatment observation period. On-treatment oberservation period define as time points from first drug date until the first date of end of data point sets (DPS1) or last administration of randomised treatment +63 days. Safety analysis set included all participants who are exposed to randomised treatment.
|
0.00%
0/59 • From baseline (week 0) up to end of study (week 49)
AEs presented here are TEAEs. TEAE was defined as event that had onset date (or increase in severity) during on-treatment observation period. On-treatment oberservation period define as time points from first drug date until the first date of end of data point sets (DPS1) or last administration of randomised treatment +63 days. Safety analysis set included all participants who are exposed to randomised treatment.
|
|
Metabolism and nutrition disorders
Dyslipidaemia
|
0.00%
0/60 • From baseline (week 0) up to end of study (week 49)
AEs presented here are TEAEs. TEAE was defined as event that had onset date (or increase in severity) during on-treatment observation period. On-treatment oberservation period define as time points from first drug date until the first date of end of data point sets (DPS1) or last administration of randomised treatment +63 days. Safety analysis set included all participants who are exposed to randomised treatment.
|
5.0%
3/60 • Number of events 3 • From baseline (week 0) up to end of study (week 49)
AEs presented here are TEAEs. TEAE was defined as event that had onset date (or increase in severity) during on-treatment observation period. On-treatment oberservation period define as time points from first drug date until the first date of end of data point sets (DPS1) or last administration of randomised treatment +63 days. Safety analysis set included all participants who are exposed to randomised treatment.
|
3.2%
2/62 • Number of events 2 • From baseline (week 0) up to end of study (week 49)
AEs presented here are TEAEs. TEAE was defined as event that had onset date (or increase in severity) during on-treatment observation period. On-treatment oberservation period define as time points from first drug date until the first date of end of data point sets (DPS1) or last administration of randomised treatment +63 days. Safety analysis set included all participants who are exposed to randomised treatment.
|
0.00%
0/59 • From baseline (week 0) up to end of study (week 49)
AEs presented here are TEAEs. TEAE was defined as event that had onset date (or increase in severity) during on-treatment observation period. On-treatment oberservation period define as time points from first drug date until the first date of end of data point sets (DPS1) or last administration of randomised treatment +63 days. Safety analysis set included all participants who are exposed to randomised treatment.
|
|
Gastrointestinal disorders
Dyspepsia
|
8.3%
5/60 • Number of events 5 • From baseline (week 0) up to end of study (week 49)
AEs presented here are TEAEs. TEAE was defined as event that had onset date (or increase in severity) during on-treatment observation period. On-treatment oberservation period define as time points from first drug date until the first date of end of data point sets (DPS1) or last administration of randomised treatment +63 days. Safety analysis set included all participants who are exposed to randomised treatment.
|
8.3%
5/60 • Number of events 5 • From baseline (week 0) up to end of study (week 49)
AEs presented here are TEAEs. TEAE was defined as event that had onset date (or increase in severity) during on-treatment observation period. On-treatment oberservation period define as time points from first drug date until the first date of end of data point sets (DPS1) or last administration of randomised treatment +63 days. Safety analysis set included all participants who are exposed to randomised treatment.
|
8.1%
5/62 • Number of events 13 • From baseline (week 0) up to end of study (week 49)
AEs presented here are TEAEs. TEAE was defined as event that had onset date (or increase in severity) during on-treatment observation period. On-treatment oberservation period define as time points from first drug date until the first date of end of data point sets (DPS1) or last administration of randomised treatment +63 days. Safety analysis set included all participants who are exposed to randomised treatment.
|
1.7%
1/59 • Number of events 1 • From baseline (week 0) up to end of study (week 49)
AEs presented here are TEAEs. TEAE was defined as event that had onset date (or increase in severity) during on-treatment observation period. On-treatment oberservation period define as time points from first drug date until the first date of end of data point sets (DPS1) or last administration of randomised treatment +63 days. Safety analysis set included all participants who are exposed to randomised treatment.
|
|
Gastrointestinal disorders
Eructation
|
5.0%
3/60 • Number of events 3 • From baseline (week 0) up to end of study (week 49)
AEs presented here are TEAEs. TEAE was defined as event that had onset date (or increase in severity) during on-treatment observation period. On-treatment oberservation period define as time points from first drug date until the first date of end of data point sets (DPS1) or last administration of randomised treatment +63 days. Safety analysis set included all participants who are exposed to randomised treatment.
|
5.0%
3/60 • Number of events 3 • From baseline (week 0) up to end of study (week 49)
AEs presented here are TEAEs. TEAE was defined as event that had onset date (or increase in severity) during on-treatment observation period. On-treatment oberservation period define as time points from first drug date until the first date of end of data point sets (DPS1) or last administration of randomised treatment +63 days. Safety analysis set included all participants who are exposed to randomised treatment.
|
8.1%
5/62 • Number of events 8 • From baseline (week 0) up to end of study (week 49)
AEs presented here are TEAEs. TEAE was defined as event that had onset date (or increase in severity) during on-treatment observation period. On-treatment oberservation period define as time points from first drug date until the first date of end of data point sets (DPS1) or last administration of randomised treatment +63 days. Safety analysis set included all participants who are exposed to randomised treatment.
|
1.7%
1/59 • Number of events 2 • From baseline (week 0) up to end of study (week 49)
AEs presented here are TEAEs. TEAE was defined as event that had onset date (or increase in severity) during on-treatment observation period. On-treatment oberservation period define as time points from first drug date until the first date of end of data point sets (DPS1) or last administration of randomised treatment +63 days. Safety analysis set included all participants who are exposed to randomised treatment.
|
|
General disorders
Fatigue
|
3.3%
2/60 • Number of events 3 • From baseline (week 0) up to end of study (week 49)
AEs presented here are TEAEs. TEAE was defined as event that had onset date (or increase in severity) during on-treatment observation period. On-treatment oberservation period define as time points from first drug date until the first date of end of data point sets (DPS1) or last administration of randomised treatment +63 days. Safety analysis set included all participants who are exposed to randomised treatment.
|
6.7%
4/60 • Number of events 4 • From baseline (week 0) up to end of study (week 49)
AEs presented here are TEAEs. TEAE was defined as event that had onset date (or increase in severity) during on-treatment observation period. On-treatment oberservation period define as time points from first drug date until the first date of end of data point sets (DPS1) or last administration of randomised treatment +63 days. Safety analysis set included all participants who are exposed to randomised treatment.
|
9.7%
6/62 • Number of events 7 • From baseline (week 0) up to end of study (week 49)
AEs presented here are TEAEs. TEAE was defined as event that had onset date (or increase in severity) during on-treatment observation period. On-treatment oberservation period define as time points from first drug date until the first date of end of data point sets (DPS1) or last administration of randomised treatment +63 days. Safety analysis set included all participants who are exposed to randomised treatment.
|
3.4%
2/59 • Number of events 2 • From baseline (week 0) up to end of study (week 49)
AEs presented here are TEAEs. TEAE was defined as event that had onset date (or increase in severity) during on-treatment observation period. On-treatment oberservation period define as time points from first drug date until the first date of end of data point sets (DPS1) or last administration of randomised treatment +63 days. Safety analysis set included all participants who are exposed to randomised treatment.
|
|
Gastrointestinal disorders
Flatulence
|
3.3%
2/60 • Number of events 2 • From baseline (week 0) up to end of study (week 49)
AEs presented here are TEAEs. TEAE was defined as event that had onset date (or increase in severity) during on-treatment observation period. On-treatment oberservation period define as time points from first drug date until the first date of end of data point sets (DPS1) or last administration of randomised treatment +63 days. Safety analysis set included all participants who are exposed to randomised treatment.
|
5.0%
3/60 • Number of events 3 • From baseline (week 0) up to end of study (week 49)
AEs presented here are TEAEs. TEAE was defined as event that had onset date (or increase in severity) during on-treatment observation period. On-treatment oberservation period define as time points from first drug date until the first date of end of data point sets (DPS1) or last administration of randomised treatment +63 days. Safety analysis set included all participants who are exposed to randomised treatment.
|
1.6%
1/62 • Number of events 1 • From baseline (week 0) up to end of study (week 49)
AEs presented here are TEAEs. TEAE was defined as event that had onset date (or increase in severity) during on-treatment observation period. On-treatment oberservation period define as time points from first drug date until the first date of end of data point sets (DPS1) or last administration of randomised treatment +63 days. Safety analysis set included all participants who are exposed to randomised treatment.
|
0.00%
0/59 • From baseline (week 0) up to end of study (week 49)
AEs presented here are TEAEs. TEAE was defined as event that had onset date (or increase in severity) during on-treatment observation period. On-treatment oberservation period define as time points from first drug date until the first date of end of data point sets (DPS1) or last administration of randomised treatment +63 days. Safety analysis set included all participants who are exposed to randomised treatment.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
1.7%
1/60 • Number of events 1 • From baseline (week 0) up to end of study (week 49)
AEs presented here are TEAEs. TEAE was defined as event that had onset date (or increase in severity) during on-treatment observation period. On-treatment oberservation period define as time points from first drug date until the first date of end of data point sets (DPS1) or last administration of randomised treatment +63 days. Safety analysis set included all participants who are exposed to randomised treatment.
|
6.7%
4/60 • Number of events 4 • From baseline (week 0) up to end of study (week 49)
AEs presented here are TEAEs. TEAE was defined as event that had onset date (or increase in severity) during on-treatment observation period. On-treatment oberservation period define as time points from first drug date until the first date of end of data point sets (DPS1) or last administration of randomised treatment +63 days. Safety analysis set included all participants who are exposed to randomised treatment.
|
4.8%
3/62 • Number of events 3 • From baseline (week 0) up to end of study (week 49)
AEs presented here are TEAEs. TEAE was defined as event that had onset date (or increase in severity) during on-treatment observation period. On-treatment oberservation period define as time points from first drug date until the first date of end of data point sets (DPS1) or last administration of randomised treatment +63 days. Safety analysis set included all participants who are exposed to randomised treatment.
|
1.7%
1/59 • Number of events 1 • From baseline (week 0) up to end of study (week 49)
AEs presented here are TEAEs. TEAE was defined as event that had onset date (or increase in severity) during on-treatment observation period. On-treatment oberservation period define as time points from first drug date until the first date of end of data point sets (DPS1) or last administration of randomised treatment +63 days. Safety analysis set included all participants who are exposed to randomised treatment.
|
|
Investigations
Glycosylated haemoglobin increased
|
0.00%
0/60 • From baseline (week 0) up to end of study (week 49)
AEs presented here are TEAEs. TEAE was defined as event that had onset date (or increase in severity) during on-treatment observation period. On-treatment oberservation period define as time points from first drug date until the first date of end of data point sets (DPS1) or last administration of randomised treatment +63 days. Safety analysis set included all participants who are exposed to randomised treatment.
|
1.7%
1/60 • Number of events 1 • From baseline (week 0) up to end of study (week 49)
AEs presented here are TEAEs. TEAE was defined as event that had onset date (or increase in severity) during on-treatment observation period. On-treatment oberservation period define as time points from first drug date until the first date of end of data point sets (DPS1) or last administration of randomised treatment +63 days. Safety analysis set included all participants who are exposed to randomised treatment.
|
0.00%
0/62 • From baseline (week 0) up to end of study (week 49)
AEs presented here are TEAEs. TEAE was defined as event that had onset date (or increase in severity) during on-treatment observation period. On-treatment oberservation period define as time points from first drug date until the first date of end of data point sets (DPS1) or last administration of randomised treatment +63 days. Safety analysis set included all participants who are exposed to randomised treatment.
|
5.1%
3/59 • Number of events 3 • From baseline (week 0) up to end of study (week 49)
AEs presented here are TEAEs. TEAE was defined as event that had onset date (or increase in severity) during on-treatment observation period. On-treatment oberservation period define as time points from first drug date until the first date of end of data point sets (DPS1) or last administration of randomised treatment +63 days. Safety analysis set included all participants who are exposed to randomised treatment.
|
|
Nervous system disorders
Headache
|
3.3%
2/60 • Number of events 6 • From baseline (week 0) up to end of study (week 49)
AEs presented here are TEAEs. TEAE was defined as event that had onset date (or increase in severity) during on-treatment observation period. On-treatment oberservation period define as time points from first drug date until the first date of end of data point sets (DPS1) or last administration of randomised treatment +63 days. Safety analysis set included all participants who are exposed to randomised treatment.
|
10.0%
6/60 • Number of events 13 • From baseline (week 0) up to end of study (week 49)
AEs presented here are TEAEs. TEAE was defined as event that had onset date (or increase in severity) during on-treatment observation period. On-treatment oberservation period define as time points from first drug date until the first date of end of data point sets (DPS1) or last administration of randomised treatment +63 days. Safety analysis set included all participants who are exposed to randomised treatment.
|
11.3%
7/62 • Number of events 9 • From baseline (week 0) up to end of study (week 49)
AEs presented here are TEAEs. TEAE was defined as event that had onset date (or increase in severity) during on-treatment observation period. On-treatment oberservation period define as time points from first drug date until the first date of end of data point sets (DPS1) or last administration of randomised treatment +63 days. Safety analysis set included all participants who are exposed to randomised treatment.
|
13.6%
8/59 • Number of events 23 • From baseline (week 0) up to end of study (week 49)
AEs presented here are TEAEs. TEAE was defined as event that had onset date (or increase in severity) during on-treatment observation period. On-treatment oberservation period define as time points from first drug date until the first date of end of data point sets (DPS1) or last administration of randomised treatment +63 days. Safety analysis set included all participants who are exposed to randomised treatment.
|
|
Nervous system disorders
Hyperaesthesia
|
0.00%
0/60 • From baseline (week 0) up to end of study (week 49)
AEs presented here are TEAEs. TEAE was defined as event that had onset date (or increase in severity) during on-treatment observation period. On-treatment oberservation period define as time points from first drug date until the first date of end of data point sets (DPS1) or last administration of randomised treatment +63 days. Safety analysis set included all participants who are exposed to randomised treatment.
|
0.00%
0/60 • From baseline (week 0) up to end of study (week 49)
AEs presented here are TEAEs. TEAE was defined as event that had onset date (or increase in severity) during on-treatment observation period. On-treatment oberservation period define as time points from first drug date until the first date of end of data point sets (DPS1) or last administration of randomised treatment +63 days. Safety analysis set included all participants who are exposed to randomised treatment.
|
8.1%
5/62 • Number of events 6 • From baseline (week 0) up to end of study (week 49)
AEs presented here are TEAEs. TEAE was defined as event that had onset date (or increase in severity) during on-treatment observation period. On-treatment oberservation period define as time points from first drug date until the first date of end of data point sets (DPS1) or last administration of randomised treatment +63 days. Safety analysis set included all participants who are exposed to randomised treatment.
|
0.00%
0/59 • From baseline (week 0) up to end of study (week 49)
AEs presented here are TEAEs. TEAE was defined as event that had onset date (or increase in severity) during on-treatment observation period. On-treatment oberservation period define as time points from first drug date until the first date of end of data point sets (DPS1) or last administration of randomised treatment +63 days. Safety analysis set included all participants who are exposed to randomised treatment.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/60 • From baseline (week 0) up to end of study (week 49)
AEs presented here are TEAEs. TEAE was defined as event that had onset date (or increase in severity) during on-treatment observation period. On-treatment oberservation period define as time points from first drug date until the first date of end of data point sets (DPS1) or last administration of randomised treatment +63 days. Safety analysis set included all participants who are exposed to randomised treatment.
|
1.7%
1/60 • Number of events 1 • From baseline (week 0) up to end of study (week 49)
AEs presented here are TEAEs. TEAE was defined as event that had onset date (or increase in severity) during on-treatment observation period. On-treatment oberservation period define as time points from first drug date until the first date of end of data point sets (DPS1) or last administration of randomised treatment +63 days. Safety analysis set included all participants who are exposed to randomised treatment.
|
0.00%
0/62 • From baseline (week 0) up to end of study (week 49)
AEs presented here are TEAEs. TEAE was defined as event that had onset date (or increase in severity) during on-treatment observation period. On-treatment oberservation period define as time points from first drug date until the first date of end of data point sets (DPS1) or last administration of randomised treatment +63 days. Safety analysis set included all participants who are exposed to randomised treatment.
|
6.8%
4/59 • Number of events 4 • From baseline (week 0) up to end of study (week 49)
AEs presented here are TEAEs. TEAE was defined as event that had onset date (or increase in severity) during on-treatment observation period. On-treatment oberservation period define as time points from first drug date until the first date of end of data point sets (DPS1) or last administration of randomised treatment +63 days. Safety analysis set included all participants who are exposed to randomised treatment.
|
|
Metabolism and nutrition disorders
Hyperlipidaemia
|
0.00%
0/60 • From baseline (week 0) up to end of study (week 49)
AEs presented here are TEAEs. TEAE was defined as event that had onset date (or increase in severity) during on-treatment observation period. On-treatment oberservation period define as time points from first drug date until the first date of end of data point sets (DPS1) or last administration of randomised treatment +63 days. Safety analysis set included all participants who are exposed to randomised treatment.
|
1.7%
1/60 • Number of events 1 • From baseline (week 0) up to end of study (week 49)
AEs presented here are TEAEs. TEAE was defined as event that had onset date (or increase in severity) during on-treatment observation period. On-treatment oberservation period define as time points from first drug date until the first date of end of data point sets (DPS1) or last administration of randomised treatment +63 days. Safety analysis set included all participants who are exposed to randomised treatment.
|
0.00%
0/62 • From baseline (week 0) up to end of study (week 49)
AEs presented here are TEAEs. TEAE was defined as event that had onset date (or increase in severity) during on-treatment observation period. On-treatment oberservation period define as time points from first drug date until the first date of end of data point sets (DPS1) or last administration of randomised treatment +63 days. Safety analysis set included all participants who are exposed to randomised treatment.
|
6.8%
4/59 • Number of events 4 • From baseline (week 0) up to end of study (week 49)
AEs presented here are TEAEs. TEAE was defined as event that had onset date (or increase in severity) during on-treatment observation period. On-treatment oberservation period define as time points from first drug date until the first date of end of data point sets (DPS1) or last administration of randomised treatment +63 days. Safety analysis set included all participants who are exposed to randomised treatment.
|
|
Vascular disorders
Hypertension
|
1.7%
1/60 • Number of events 1 • From baseline (week 0) up to end of study (week 49)
AEs presented here are TEAEs. TEAE was defined as event that had onset date (or increase in severity) during on-treatment observation period. On-treatment oberservation period define as time points from first drug date until the first date of end of data point sets (DPS1) or last administration of randomised treatment +63 days. Safety analysis set included all participants who are exposed to randomised treatment.
|
5.0%
3/60 • Number of events 3 • From baseline (week 0) up to end of study (week 49)
AEs presented here are TEAEs. TEAE was defined as event that had onset date (or increase in severity) during on-treatment observation period. On-treatment oberservation period define as time points from first drug date until the first date of end of data point sets (DPS1) or last administration of randomised treatment +63 days. Safety analysis set included all participants who are exposed to randomised treatment.
|
0.00%
0/62 • From baseline (week 0) up to end of study (week 49)
AEs presented here are TEAEs. TEAE was defined as event that had onset date (or increase in severity) during on-treatment observation period. On-treatment oberservation period define as time points from first drug date until the first date of end of data point sets (DPS1) or last administration of randomised treatment +63 days. Safety analysis set included all participants who are exposed to randomised treatment.
|
3.4%
2/59 • Number of events 2 • From baseline (week 0) up to end of study (week 49)
AEs presented here are TEAEs. TEAE was defined as event that had onset date (or increase in severity) during on-treatment observation period. On-treatment oberservation period define as time points from first drug date until the first date of end of data point sets (DPS1) or last administration of randomised treatment +63 days. Safety analysis set included all participants who are exposed to randomised treatment.
|
|
Investigations
Lipase increased
|
5.0%
3/60 • Number of events 3 • From baseline (week 0) up to end of study (week 49)
AEs presented here are TEAEs. TEAE was defined as event that had onset date (or increase in severity) during on-treatment observation period. On-treatment oberservation period define as time points from first drug date until the first date of end of data point sets (DPS1) or last administration of randomised treatment +63 days. Safety analysis set included all participants who are exposed to randomised treatment.
|
3.3%
2/60 • Number of events 2 • From baseline (week 0) up to end of study (week 49)
AEs presented here are TEAEs. TEAE was defined as event that had onset date (or increase in severity) during on-treatment observation period. On-treatment oberservation period define as time points from first drug date until the first date of end of data point sets (DPS1) or last administration of randomised treatment +63 days. Safety analysis set included all participants who are exposed to randomised treatment.
|
4.8%
3/62 • Number of events 3 • From baseline (week 0) up to end of study (week 49)
AEs presented here are TEAEs. TEAE was defined as event that had onset date (or increase in severity) during on-treatment observation period. On-treatment oberservation period define as time points from first drug date until the first date of end of data point sets (DPS1) or last administration of randomised treatment +63 days. Safety analysis set included all participants who are exposed to randomised treatment.
|
1.7%
1/59 • Number of events 2 • From baseline (week 0) up to end of study (week 49)
AEs presented here are TEAEs. TEAE was defined as event that had onset date (or increase in severity) during on-treatment observation period. On-treatment oberservation period define as time points from first drug date until the first date of end of data point sets (DPS1) or last administration of randomised treatment +63 days. Safety analysis set included all participants who are exposed to randomised treatment.
|
|
Infections and infestations
Nasopharyngitis
|
5.0%
3/60 • Number of events 4 • From baseline (week 0) up to end of study (week 49)
AEs presented here are TEAEs. TEAE was defined as event that had onset date (or increase in severity) during on-treatment observation period. On-treatment oberservation period define as time points from first drug date until the first date of end of data point sets (DPS1) or last administration of randomised treatment +63 days. Safety analysis set included all participants who are exposed to randomised treatment.
|
1.7%
1/60 • Number of events 1 • From baseline (week 0) up to end of study (week 49)
AEs presented here are TEAEs. TEAE was defined as event that had onset date (or increase in severity) during on-treatment observation period. On-treatment oberservation period define as time points from first drug date until the first date of end of data point sets (DPS1) or last administration of randomised treatment +63 days. Safety analysis set included all participants who are exposed to randomised treatment.
|
4.8%
3/62 • Number of events 3 • From baseline (week 0) up to end of study (week 49)
AEs presented here are TEAEs. TEAE was defined as event that had onset date (or increase in severity) during on-treatment observation period. On-treatment oberservation period define as time points from first drug date until the first date of end of data point sets (DPS1) or last administration of randomised treatment +63 days. Safety analysis set included all participants who are exposed to randomised treatment.
|
3.4%
2/59 • Number of events 3 • From baseline (week 0) up to end of study (week 49)
AEs presented here are TEAEs. TEAE was defined as event that had onset date (or increase in severity) during on-treatment observation period. On-treatment oberservation period define as time points from first drug date until the first date of end of data point sets (DPS1) or last administration of randomised treatment +63 days. Safety analysis set included all participants who are exposed to randomised treatment.
|
|
Gastrointestinal disorders
Nausea
|
21.7%
13/60 • Number of events 17 • From baseline (week 0) up to end of study (week 49)
AEs presented here are TEAEs. TEAE was defined as event that had onset date (or increase in severity) during on-treatment observation period. On-treatment oberservation period define as time points from first drug date until the first date of end of data point sets (DPS1) or last administration of randomised treatment +63 days. Safety analysis set included all participants who are exposed to randomised treatment.
|
41.7%
25/60 • Number of events 54 • From baseline (week 0) up to end of study (week 49)
AEs presented here are TEAEs. TEAE was defined as event that had onset date (or increase in severity) during on-treatment observation period. On-treatment oberservation period define as time points from first drug date until the first date of end of data point sets (DPS1) or last administration of randomised treatment +63 days. Safety analysis set included all participants who are exposed to randomised treatment.
|
37.1%
23/62 • Number of events 29 • From baseline (week 0) up to end of study (week 49)
AEs presented here are TEAEs. TEAE was defined as event that had onset date (or increase in severity) during on-treatment observation period. On-treatment oberservation period define as time points from first drug date until the first date of end of data point sets (DPS1) or last administration of randomised treatment +63 days. Safety analysis set included all participants who are exposed to randomised treatment.
|
15.3%
9/59 • Number of events 18 • From baseline (week 0) up to end of study (week 49)
AEs presented here are TEAEs. TEAE was defined as event that had onset date (or increase in severity) during on-treatment observation period. On-treatment oberservation period define as time points from first drug date until the first date of end of data point sets (DPS1) or last administration of randomised treatment +63 days. Safety analysis set included all participants who are exposed to randomised treatment.
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/60 • From baseline (week 0) up to end of study (week 49)
AEs presented here are TEAEs. TEAE was defined as event that had onset date (or increase in severity) during on-treatment observation period. On-treatment oberservation period define as time points from first drug date until the first date of end of data point sets (DPS1) or last administration of randomised treatment +63 days. Safety analysis set included all participants who are exposed to randomised treatment.
|
0.00%
0/60 • From baseline (week 0) up to end of study (week 49)
AEs presented here are TEAEs. TEAE was defined as event that had onset date (or increase in severity) during on-treatment observation period. On-treatment oberservation period define as time points from first drug date until the first date of end of data point sets (DPS1) or last administration of randomised treatment +63 days. Safety analysis set included all participants who are exposed to randomised treatment.
|
8.1%
5/62 • Number of events 5 • From baseline (week 0) up to end of study (week 49)
AEs presented here are TEAEs. TEAE was defined as event that had onset date (or increase in severity) during on-treatment observation period. On-treatment oberservation period define as time points from first drug date until the first date of end of data point sets (DPS1) or last administration of randomised treatment +63 days. Safety analysis set included all participants who are exposed to randomised treatment.
|
0.00%
0/59 • From baseline (week 0) up to end of study (week 49)
AEs presented here are TEAEs. TEAE was defined as event that had onset date (or increase in severity) during on-treatment observation period. On-treatment oberservation period define as time points from first drug date until the first date of end of data point sets (DPS1) or last administration of randomised treatment +63 days. Safety analysis set included all participants who are exposed to randomised treatment.
|
|
Infections and infestations
Upper respiratory tract infection
|
1.7%
1/60 • Number of events 1 • From baseline (week 0) up to end of study (week 49)
AEs presented here are TEAEs. TEAE was defined as event that had onset date (or increase in severity) during on-treatment observation period. On-treatment oberservation period define as time points from first drug date until the first date of end of data point sets (DPS1) or last administration of randomised treatment +63 days. Safety analysis set included all participants who are exposed to randomised treatment.
|
1.7%
1/60 • Number of events 1 • From baseline (week 0) up to end of study (week 49)
AEs presented here are TEAEs. TEAE was defined as event that had onset date (or increase in severity) during on-treatment observation period. On-treatment oberservation period define as time points from first drug date until the first date of end of data point sets (DPS1) or last administration of randomised treatment +63 days. Safety analysis set included all participants who are exposed to randomised treatment.
|
8.1%
5/62 • Number of events 5 • From baseline (week 0) up to end of study (week 49)
AEs presented here are TEAEs. TEAE was defined as event that had onset date (or increase in severity) during on-treatment observation period. On-treatment oberservation period define as time points from first drug date until the first date of end of data point sets (DPS1) or last administration of randomised treatment +63 days. Safety analysis set included all participants who are exposed to randomised treatment.
|
0.00%
0/59 • From baseline (week 0) up to end of study (week 49)
AEs presented here are TEAEs. TEAE was defined as event that had onset date (or increase in severity) during on-treatment observation period. On-treatment oberservation period define as time points from first drug date until the first date of end of data point sets (DPS1) or last administration of randomised treatment +63 days. Safety analysis set included all participants who are exposed to randomised treatment.
|
|
Gastrointestinal disorders
Vomiting
|
18.3%
11/60 • Number of events 16 • From baseline (week 0) up to end of study (week 49)
AEs presented here are TEAEs. TEAE was defined as event that had onset date (or increase in severity) during on-treatment observation period. On-treatment oberservation period define as time points from first drug date until the first date of end of data point sets (DPS1) or last administration of randomised treatment +63 days. Safety analysis set included all participants who are exposed to randomised treatment.
|
23.3%
14/60 • Number of events 26 • From baseline (week 0) up to end of study (week 49)
AEs presented here are TEAEs. TEAE was defined as event that had onset date (or increase in severity) during on-treatment observation period. On-treatment oberservation period define as time points from first drug date until the first date of end of data point sets (DPS1) or last administration of randomised treatment +63 days. Safety analysis set included all participants who are exposed to randomised treatment.
|
25.8%
16/62 • Number of events 32 • From baseline (week 0) up to end of study (week 49)
AEs presented here are TEAEs. TEAE was defined as event that had onset date (or increase in severity) during on-treatment observation period. On-treatment oberservation period define as time points from first drug date until the first date of end of data point sets (DPS1) or last administration of randomised treatment +63 days. Safety analysis set included all participants who are exposed to randomised treatment.
|
6.8%
4/59 • Number of events 4 • From baseline (week 0) up to end of study (week 49)
AEs presented here are TEAEs. TEAE was defined as event that had onset date (or increase in severity) during on-treatment observation period. On-treatment oberservation period define as time points from first drug date until the first date of end of data point sets (DPS1) or last administration of randomised treatment +63 days. Safety analysis set included all participants who are exposed to randomised treatment.
|
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