Trial Outcomes & Findings for Out-Patient Study in Patients With Type 2 Diabetes Mellitus Who Are Taking no Diabetes Medication or Metformin Only (NCT NCT00518115)
NCT ID: NCT00518115
Last Updated: 2016-12-16
Results Overview
HbA1c is a form of hemoglobin that is measured primarily to identify the average plasma glucose concentration over a 2- to 3-month period. The Baseline HbA1c value is defined as the last non-missing value before the start of treatment. Change from Baseline in HbA1c was calculated as the value at Week 16 minus the value at Baseline. Based on ANCOVA: Change = treatment + Baseline HbA1c + prior therapy + gender + region. The last observation carried forward (LOCF) method was used to impute missing data, in which the last valid observation recorded on treatment (scheduled or unscheduled) was used to impute the missing measurement. For participants who had missing observations before their last observation on treatment, the closest previous non-missing on-treatment observation was carried forward to missing visits. If a participant had missing observation(s) immediately after Baseline, the Baseline observation was not carried forward and was left as missing.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
361 participants
Primary outcome timeframe
Baseline and Week 16
Results posted on
2016-12-16
Participant Flow
A total of 361 participants were randomized into the study; however, only 356 of these participants received at least one dose of study drug.
Participant milestones
| Measure |
Placebo
Participants received placebo weekly, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
|
Exenatide BID
Participants self-administered exenatide as a subcutaneous injection using prefilled pens, in accordance with current prescribing information. A dose of 5 micrograms (μg) was administered twice daily (BID) for the first 4 weeks, followed by a 12-week administration of a 10 μg BID dose. Participants who could not tolerate a 10 μg dose were to continue the study on the 5 μg BID dose.
|
Albiglutide 4 mg Weekly
Participants received albiglutide 4 milligrams (mg) weekly, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
|
Albiglutide 15 mg Weekly
Participants received albiglutide 15 mg weekly, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
|
Albiglutide 30 mg Weekly
Participants received albiglutide 30 mg weekly, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
|
Albiglutide 15 mg Bi-weekly
Participants received albiglutide 15 mg every other week, alternating with placebo for each intervening week, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
|
Albiglutide 30 mg Bi-weekly
Participants received albiglutide 30 mg every other week, alternating with placebo for each intervening week, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
|
Albiglutide 50 mg Bi-weekly
Participants received albiglutide 50 mg every other week, alternating with placebo for each intervening week, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
|
Albiglutide 50 mg Every 4 Weeks
Participants received albiglutide 50 mg every 4 weeks, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
|
Albiglutide 100 mg Every 4 Weeks
Participants received albiglutide 100 mg every 4 weeks, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
52
|
35
|
36
|
35
|
31
|
34
|
33
|
35
|
35
|
35
|
|
Overall Study
Safety Population
|
51
|
35
|
35
|
35
|
31
|
33
|
32
|
35
|
35
|
34
|
|
Overall Study
COMPLETED
|
40
|
29
|
19
|
24
|
21
|
19
|
25
|
20
|
30
|
20
|
|
Overall Study
NOT COMPLETED
|
12
|
6
|
17
|
11
|
10
|
15
|
8
|
15
|
5
|
15
|
Reasons for withdrawal
| Measure |
Placebo
Participants received placebo weekly, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
|
Exenatide BID
Participants self-administered exenatide as a subcutaneous injection using prefilled pens, in accordance with current prescribing information. A dose of 5 micrograms (μg) was administered twice daily (BID) for the first 4 weeks, followed by a 12-week administration of a 10 μg BID dose. Participants who could not tolerate a 10 μg dose were to continue the study on the 5 μg BID dose.
|
Albiglutide 4 mg Weekly
Participants received albiglutide 4 milligrams (mg) weekly, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
|
Albiglutide 15 mg Weekly
Participants received albiglutide 15 mg weekly, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
|
Albiglutide 30 mg Weekly
Participants received albiglutide 30 mg weekly, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
|
Albiglutide 15 mg Bi-weekly
Participants received albiglutide 15 mg every other week, alternating with placebo for each intervening week, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
|
Albiglutide 30 mg Bi-weekly
Participants received albiglutide 30 mg every other week, alternating with placebo for each intervening week, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
|
Albiglutide 50 mg Bi-weekly
Participants received albiglutide 50 mg every other week, alternating with placebo for each intervening week, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
|
Albiglutide 50 mg Every 4 Weeks
Participants received albiglutide 50 mg every 4 weeks, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
|
Albiglutide 100 mg Every 4 Weeks
Participants received albiglutide 100 mg every 4 weeks, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
Adverse Event
|
6
|
1
|
5
|
6
|
5
|
5
|
5
|
10
|
2
|
9
|
|
Overall Study
Lost to Follow-up
|
0
|
0
|
2
|
3
|
1
|
3
|
0
|
1
|
1
|
1
|
|
Overall Study
Protocol Violation
|
1
|
3
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
Withdrawal by Subject
|
1
|
1
|
5
|
0
|
2
|
1
|
0
|
2
|
1
|
3
|
|
Overall Study
Lack of Efficacy
|
1
|
0
|
1
|
1
|
0
|
0
|
0
|
1
|
0
|
0
|
|
Overall Study
Non-Compliance
|
1
|
0
|
1
|
0
|
1
|
1
|
1
|
1
|
0
|
1
|
|
Overall Study
Treatment Eligibility Criteria Not Met
|
1
|
1
|
0
|
0
|
0
|
4
|
0
|
0
|
0
|
0
|
|
Overall Study
Physician Prescribed Antidiabetic Drug
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
Different Monotherapy Diabetic Drug
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
|
Overall Study
Wrong Monotherapy Administered
|
0
|
0
|
1
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
|
Overall Study
Violation of Exclusion Criteria
|
0
|
0
|
0
|
1
|
0
|
0
|
1
|
0
|
0
|
0
|
|
Overall Study
Family Emergency; Had to Go to England
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
Withdrew Consent
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
|
Overall Study
Moved Out of State
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
Baseline Characteristics
Out-Patient Study in Patients With Type 2 Diabetes Mellitus Who Are Taking no Diabetes Medication or Metformin Only
Baseline characteristics by cohort
| Measure |
Placebo
n=51 Participants
Participants received placebo weekly, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
|
Exenatide BID
n=35 Participants
Participants self-administered exenatide as a subcutaneous injection using prefilled pens, in accordance with current prescribing information. A dose of 5 micrograms (μg) was administered twice daily (BID) for the first 4 weeks, followed by a 12-week administration of a 10 μg BID dose. Participants who could not tolerate a 10 μg dose were to continue the study on the 5 μg BID dose.
|
Albiglutide 4 mg Weekly
n=35 Participants
Participants received albiglutide 4 milligrams (mg) weekly, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
|
Albiglutide 15 mg Weekly
n=35 Participants
Participants received albiglutide 15 mg weekly, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
|
Albiglutide 30 mg Weekly
n=31 Participants
Participants received albiglutide 30 mg weekly, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
|
Albiglutide 15 mg Bi-weekly
n=33 Participants
Participants received albiglutide 15 mg every other week, alternating with placebo for each intervening week, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
|
Albiglutide 30 mg Bi-weekly
n=32 Participants
Participants received albiglutide 30 mg every other week, alternating with placebo for each intervening week, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
|
Albiglutide 50 mg Bi-weekly
n=35 Participants
Participants received albiglutide 50 mg every other week, alternating with placebo for each intervening week, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
|
Albiglutide 50 mg Every 4 Weeks
n=35 Participants
Participants received albiglutide 50 mg every 4 weeks, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
|
Albiglutide 100 mg Every 4 Weeks
n=34 Participants
Participants received albiglutide 100 mg every 4 weeks, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
|
Total
n=356 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
54.0 Years
STANDARD_DEVIATION 10.62 • n=5 Participants
|
53.7 Years
STANDARD_DEVIATION 9.38 • n=7 Participants
|
50.4 Years
STANDARD_DEVIATION 10.25 • n=5 Participants
|
55.5 Years
STANDARD_DEVIATION 10.48 • n=4 Participants
|
54.2 Years
STANDARD_DEVIATION 9.66 • n=21 Participants
|
52.5 Years
STANDARD_DEVIATION 9.55 • n=8 Participants
|
55.5 Years
STANDARD_DEVIATION 9.87 • n=8 Participants
|
51.1 Years
STANDARD_DEVIATION 10.25 • n=24 Participants
|
54.1 Years
STANDARD_DEVIATION 11.30 • n=42 Participants
|
54.4 Years
STANDARD_DEVIATION 9.89 • n=42 Participants
|
53.5 Years
STANDARD_DEVIATION 10.17 • n=42 Participants
|
|
Gender
Female
|
23 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
17 Participants
n=4 Participants
|
23 Participants
n=21 Participants
|
19 Participants
n=8 Participants
|
16 Participants
n=8 Participants
|
16 Participants
n=24 Participants
|
18 Participants
n=42 Participants
|
15 Participants
n=42 Participants
|
186 Participants
n=42 Participants
|
|
Gender
Male
|
28 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
18 Participants
n=4 Participants
|
8 Participants
n=21 Participants
|
14 Participants
n=8 Participants
|
16 Participants
n=8 Participants
|
19 Participants
n=24 Participants
|
17 Participants
n=42 Participants
|
19 Participants
n=42 Participants
|
170 Participants
n=42 Participants
|
|
Race/Ethnicity, Customized
African American/African Heritage
|
8 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
3 Participants
n=8 Participants
|
5 Participants
n=8 Participants
|
4 Participants
n=24 Participants
|
6 Participants
n=42 Participants
|
5 Participants
n=42 Participants
|
55 Participants
n=42 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaskan Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
1 Participants
n=24 Participants
|
1 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
5 Participants
n=42 Participants
|
|
Race/Ethnicity, Customized
Asian - Central/South Asian Heritage
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
4 Participants
n=8 Participants
|
1 Participants
n=24 Participants
|
1 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
9 Participants
n=42 Participants
|
|
Race/Ethnicity, Customized
Asian - East Asian Heritage
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
1 Participants
n=24 Participants
|
1 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
8 Participants
n=42 Participants
|
|
Race/Ethnicity, Customized
Asian - Japanese Heritage
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
|
Race/Ethnicity, Customized
Asian - South East Asian Heritage
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
2 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
5 Participants
n=42 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
5 Participants
n=42 Participants
|
|
Race/Ethnicity, Customized
White- Arabic/North African Heritage
|
4 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
3 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
17 Participants
n=42 Participants
|
|
Race/Ethnicity, Customized
White - White/Caucasian/European Heritage
|
29 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
19 Participants
n=4 Participants
|
20 Participants
n=21 Participants
|
21 Participants
n=8 Participants
|
14 Participants
n=8 Participants
|
19 Participants
n=24 Participants
|
18 Participants
n=42 Participants
|
20 Participants
n=42 Participants
|
198 Participants
n=42 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
3 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
3 Participants
n=8 Participants
|
5 Participants
n=8 Participants
|
5 Participants
n=24 Participants
|
4 Participants
n=42 Participants
|
4 Participants
n=42 Participants
|
37 Participants
n=42 Participants
|
|
Race/Ethnicity, Customized
Hispanic, Puerto Rican
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
1 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
|
Race/Ethnicity, Customized
Mestizo
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
1 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
3 Participants
n=42 Participants
|
|
Race/Ethnicity, Customized
Mexican
|
3 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
2 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
1 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
8 Participants
n=42 Participants
|
|
Race/Ethnicity, Customized
Mulatto
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
3 Participants
n=42 Participants
|
|
Race/Ethnicity, Customized
Puerto Rican
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
PRIMARY outcome
Timeframe: Baseline and Week 16Population: Intent-to-Treat (ITT) Population: all randomly assigned participants with at least one post-Baseline assessment of the primary endpoint. Participants from the exenatide arm were not included in the analysis. Only those participants with a value at Baseline and at the specified visit were analyzed.
HbA1c is a form of hemoglobin that is measured primarily to identify the average plasma glucose concentration over a 2- to 3-month period. The Baseline HbA1c value is defined as the last non-missing value before the start of treatment. Change from Baseline in HbA1c was calculated as the value at Week 16 minus the value at Baseline. Based on ANCOVA: Change = treatment + Baseline HbA1c + prior therapy + gender + region. The last observation carried forward (LOCF) method was used to impute missing data, in which the last valid observation recorded on treatment (scheduled or unscheduled) was used to impute the missing measurement. For participants who had missing observations before their last observation on treatment, the closest previous non-missing on-treatment observation was carried forward to missing visits. If a participant had missing observation(s) immediately after Baseline, the Baseline observation was not carried forward and was left as missing.
Outcome measures
| Measure |
Placebo
n=50 Participants
Participants received placebo weekly, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
|
Exenatide BID
Participants self-administered exenatide as a subcutaneous injection using prefilled pens, in accordance with current prescribing information. A dose of 5 micrograms (μg) was administered twice daily (BID) for the first 4 weeks, followed by a 12-week administration of a 10 μg BID dose. Participants who could not tolerate a 10 μg dose were to continue the study on the 5 μg BID dose.
|
Albiglutide 4 mg Weekly
n=34 Participants
Participants received albiglutide 4 milligrams (mg) weekly, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
|
Albiglutide 15 mg Weekly
n=34 Participants
Participants received albiglutide 15 mg weekly, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
|
Albiglutide 30 mg Weekly
n=29 Participants
Participants received albiglutide 30 mg weekly, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
|
Albiglutide 15 mg Bi-weekly
n=30 Participants
Participants received albiglutide 15 mg every other week, alternating with placebo for each intervening week, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
|
Albiglutide 30 mg Bi-weekly
n=32 Participants
Participants received albiglutide 30 mg every other week, alternating with placebo for each intervening week, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
|
Albiglutide 50 mg Bi-weekly
n=34 Participants
Participants received albiglutide 50 mg every other week, alternating with placebo for each intervening week, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
|
Albiglutide 50 mg Every 4 Weeks
n=35 Participants
Participants received albiglutide 50 mg every 4 weeks, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
|
Albiglutide 100 mg Every 4 Weeks
n=33 Participants
Participants received albiglutide 100 mg every 4 weeks, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 16
|
-0.46 Percentage of HbA1c in the blood
Standard Error 0.136
|
—
|
-0.25 Percentage of HbA1c in the blood
Standard Error 0.159
|
-0.71 Percentage of HbA1c in the blood
Standard Error 0.160
|
-1.08 Percentage of HbA1c in the blood
Standard Error 0.175
|
-0.68 Percentage of HbA1c in the blood
Standard Error 0.167
|
-1.01 Percentage of HbA1c in the blood
Standard Error 0.162
|
-1.03 Percentage of HbA1c in the blood
Standard Error 0.159
|
-0.80 Percentage of HbA1c in the blood
Standard Error 0.157
|
-1.06 Percentage of HbA1c in the blood
Standard Error 0.161
|
SECONDARY outcome
Timeframe: Baseline and Weeks 4, 5, 7, 8, 9, 12, 15, and 16Population: ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the ITT Population.
HbA1c is a form of hemoglobin that is measured primarily to identify the average plasma glucose concentration over a 2- to 3-month period. The Baseline HbA1c value is defined as the last non-missing value before the start of treatment. Change from Baseline in HbA1c was calculated as the post-Baseline value minus the value at Baseline. The last observation carried forward (LOCF) method was used to impute missing data, in which the last valid observation recorded on treatment (scheduled or unscheduled) was used to impute the missing measurement. For participants who had missing observations before their last observation on treatment, the closest previous non-missing on-treatment observation was carried forward to missing visits. If a participant had missing observation(s) immediately after Baseline, the Baseline observation was not carried forward and was left as missing.
Outcome measures
| Measure |
Placebo
n=50 Participants
Participants received placebo weekly, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
|
Exenatide BID
n=34 Participants
Participants self-administered exenatide as a subcutaneous injection using prefilled pens, in accordance with current prescribing information. A dose of 5 micrograms (μg) was administered twice daily (BID) for the first 4 weeks, followed by a 12-week administration of a 10 μg BID dose. Participants who could not tolerate a 10 μg dose were to continue the study on the 5 μg BID dose.
|
Albiglutide 4 mg Weekly
n=34 Participants
Participants received albiglutide 4 milligrams (mg) weekly, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
|
Albiglutide 15 mg Weekly
n=34 Participants
Participants received albiglutide 15 mg weekly, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
|
Albiglutide 30 mg Weekly
n=29 Participants
Participants received albiglutide 30 mg weekly, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
|
Albiglutide 15 mg Bi-weekly
n=30 Participants
Participants received albiglutide 15 mg every other week, alternating with placebo for each intervening week, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
|
Albiglutide 30 mg Bi-weekly
n=32 Participants
Participants received albiglutide 30 mg every other week, alternating with placebo for each intervening week, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
|
Albiglutide 50 mg Bi-weekly
n=34 Participants
Participants received albiglutide 50 mg every other week, alternating with placebo for each intervening week, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
|
Albiglutide 50 mg Every 4 Weeks
n=35 Participants
Participants received albiglutide 50 mg every 4 weeks, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
|
Albiglutide 100 mg Every 4 Weeks
n=33 Participants
Participants received albiglutide 100 mg every 4 weeks, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Change From Baseline in HbA1c at Weeks 4, 5, 7, 8, 9, 12, 15, and 16
Week 4, n=47,34,33,34,28,29,31,34,34,30
|
-0.14 Percentage of HbA1c in the blood
Standard Deviation 0.538
|
-0.23 Percentage of HbA1c in the blood
Standard Deviation 0.485
|
-0.12 Percentage of HbA1c in the blood
Standard Deviation 0.658
|
-0.33 Percentage of HbA1c in the blood
Standard Deviation 0.442
|
-0.56 Percentage of HbA1c in the blood
Standard Deviation 0.401
|
-0.35 Percentage of HbA1c in the blood
Standard Deviation 0.470
|
-0.34 Percentage of HbA1c in the blood
Standard Deviation 0.678
|
-0.45 Percentage of HbA1c in the blood
Standard Deviation 0.547
|
-0.41 Percentage of HbA1c in the blood
Standard Deviation 0.429
|
-0.42 Percentage of HbA1c in the blood
Standard Deviation 0.523
|
|
Change From Baseline in HbA1c at Weeks 4, 5, 7, 8, 9, 12, 15, and 16
Week 5, n=49,34,34,34,29,30,32,34,35,31
|
-0.09 Percentage of HbA1c in the blood
Standard Deviation 0.570
|
-0.32 Percentage of HbA1c in the blood
Standard Deviation 0.495
|
-0.16 Percentage of HbA1c in the blood
Standard Deviation 0.758
|
-0.39 Percentage of HbA1c in the blood
Standard Deviation 0.516
|
-0.62 Percentage of HbA1c in the blood
Standard Deviation 0.439
|
-0.42 Percentage of HbA1c in the blood
Standard Deviation 0.625
|
-0.51 Percentage of HbA1c in the blood
Standard Deviation 0.756
|
-0.58 Percentage of HbA1c in the blood
Standard Deviation 0.554
|
-0.47 Percentage of HbA1c in the blood
Standard Deviation 0.608
|
-0.65 Percentage of HbA1c in the blood
Standard Deviation 0.376
|
|
Change From Baseline in HbA1c at Weeks 4, 5, 7, 8, 9, 12, 15, and 16
Week 7, n=50,34,34,34,29,30,32,34,35,32
|
-0.15 Percentage of HbA1c in the blood
Standard Deviation 0.749
|
-0.36 Percentage of HbA1c in the blood
Standard Deviation 0.554
|
-0.19 Percentage of HbA1c in the blood
Standard Deviation 0.855
|
-0.44 Percentage of HbA1c in the blood
Standard Deviation 0.619
|
-0.79 Percentage of HbA1c in the blood
Standard Deviation 0.474
|
-0.52 Percentage of HbA1c in the blood
Standard Deviation 0.648
|
0.64 Percentage of HbA1c in the blood
Standard Deviation 0.890
|
-0.68 Percentage of HbA1c in the blood
Standard Deviation 0.831
|
-0.45 Percentage of HbA1c in the blood
Standard Deviation 0.801
|
-0.63 Percentage of HbA1c in the blood
Standard Deviation 0.420
|
|
Change From Baseline in HbA1c at Weeks 4, 5, 7, 8, 9, 12, 15, and 16
Week 8, n=50,34,34,34,29,30,32,34,35,32
|
-0.17 Percentage of HbA1c in the blood
Standard Deviation 0.793
|
-0.45 Percentage of HbA1c in the blood
Standard Deviation 0.588
|
-0.24 Percentage of HbA1c in the blood
Standard Deviation 0.897
|
-0.50 Percentage of HbA1c in the blood
Standard Deviation 0.659
|
-0.77 Percentage of HbA1c in the blood
Standard Deviation 0.494
|
-0.54 Percentage of HbA1c in the blood
Standard Deviation 0.679
|
-0.67 Percentage of HbA1c in the blood
Standard Deviation 0.928
|
-0.71 Percentage of HbA1c in the blood
Standard Deviation 0.834
|
-0.41 Percentage of HbA1c in the blood
Standard Deviation 0.823
|
-0.68 Percentage of HbA1c in the blood
Standard Deviation 0.410
|
|
Change From Baseline in HbA1c at Weeks 4, 5, 7, 8, 9, 12, 15, and 16
Week 9, n=50,34,34,34,29,30,32,34,35,32
|
-0.21 Percentage of HbA1c in the blood
Standard Deviation 0.842
|
-0.51 Percentage of HbA1c in the blood
Standard Deviation 0.633
|
-0.19 Percentage of HbA1c in the blood
Standard Deviation 0.947
|
-0.55 Percentage of HbA1c in the blood
Standard Deviation 0.713
|
-0.85 Percentage of HbA1c in the blood
Standard Deviation 0.559
|
-0.56 Percentage of HbA1c in the blood
Standard Deviation 0.767
|
-0.71 Percentage of HbA1c in the blood
Standard Deviation 0.929
|
-0.77 Percentage of HbA1c in the blood
Standard Deviation 0.842
|
-0.54 Percentage of HbA1c in the blood
Standard Deviation 0.836
|
-0.82 Percentage of HbA1c in the blood
Standard Deviation 0.486
|
|
Change From Baseline in HbA1c at Weeks 4, 5, 7, 8, 9, 12, 15, and 16
Week 12, n=50,34,34,34,29,30,32,34,35,33
|
-0.19 Percentage of HbA1c in the blood
Standard Deviation 0.892
|
-0.56 Percentage of HbA1c in the blood
Standard Deviation 0.868
|
-0.18 Percentage of HbA1c in the blood
Standard Deviation 1.025
|
-0.58 Percentage of HbA1c in the blood
Standard Deviation 0.813
|
-0.96 Percentage of HbA1c in the blood
Standard Deviation 0.649
|
-0.59 Percentage of HbA1c in the blood
Standard Deviation 0.913
|
-0.71 Percentage of HbA1c in the blood
Standard Deviation 1.003
|
-0.79 Percentage of HbA1c in the blood
Standard Deviation 0.852
|
-0.51 Percentage of HbA1c in the blood
Standard Deviation 0.942
|
-0.84 Percentage of HbA1c in the blood
Standard Deviation 0.744
|
|
Change From Baseline in HbA1c at Weeks 4, 5, 7, 8, 9, 12, 15, and 16
Week 15, n=50,34,34,34,29,30,32,34,35,33
|
-0.27 Percentage of HbA1c in the blood
Standard Deviation 0.948
|
-0.53 Percentage of HbA1c in the blood
Standard Deviation 0.865
|
-0.19 Percentage of HbA1c in the blood
Standard Deviation 0.989
|
-0.49 Percentage of HbA1c in the blood
Standard Deviation 0.819
|
-0.86 Percentage of HbA1c in the blood
Standard Deviation 0.607
|
-0.61 Percentage of HbA1c in the blood
Standard Deviation 0.929
|
-0.79 Percentage of HbA1c in the blood
Standard Deviation 1.044
|
-0.80 Percentage of HbA1c in the blood
Standard Deviation 1.041
|
-0.58 Percentage of HbA1c in the blood
Standard Deviation 1.016
|
-0.88 Percentage of HbA1c in the blood
Standard Deviation 0.790
|
|
Change From Baseline in HbA1c at Weeks 4, 5, 7, 8, 9, 12, 15, and 16
Week 16, n=50,34,34,34,29,30,32,34,35,33
|
-0.17 Percentage of HbA1c in the blood
Standard Deviation 1.006
|
-0.54 Percentage of HbA1c in the blood
Standard Deviation 0.906
|
-0.11 Percentage of HbA1c in the blood
Standard Deviation 1.156
|
-0.49 Percentage of HbA1c in the blood
Standard Deviation 0.740
|
-0.87 Percentage of HbA1c in the blood
Standard Deviation 0.652
|
-0.56 Percentage of HbA1c in the blood
Standard Deviation 0.971
|
-0.79 Percentage of HbA1c in the blood
Standard Deviation 0.978
|
-0.79 Percentage of HbA1c in the blood
Standard Deviation 1.036
|
-0.55 Percentage of HbA1c in the blood
Standard Deviation 1.012
|
-0.87 Percentage of HbA1c in the blood
Standard Deviation 0.866
|
SECONDARY outcome
Timeframe: Weeks (W) 4, 5, 7, 8, 9, 12, 15, and 16Population: ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed for different parameters at different time points, so the overall number of participants analyzed reflects everyone in the ITT Population.
The number of participants who achieved target values for HbA1c (i.e., HbA1c \<6.5% and \>=6.5% to \<7%) were assessed. The last observation carried forward (LOCF) method was used to impute missing data, in which the last valid observation recorded on treatment (scheduled or unscheduled) was used to impute the missing measurement. For participants who had missing observations before their last observation on treatment, the closest previous non-missing on-treatment observation was carried forward to missing visits. If a participant had missing observation(s) immediately after Baseline, the Baseline observation was not carried forward and was left as missing.
Outcome measures
| Measure |
Placebo
n=50 Participants
Participants received placebo weekly, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
|
Exenatide BID
n=34 Participants
Participants self-administered exenatide as a subcutaneous injection using prefilled pens, in accordance with current prescribing information. A dose of 5 micrograms (μg) was administered twice daily (BID) for the first 4 weeks, followed by a 12-week administration of a 10 μg BID dose. Participants who could not tolerate a 10 μg dose were to continue the study on the 5 μg BID dose.
|
Albiglutide 4 mg Weekly
n=34 Participants
Participants received albiglutide 4 milligrams (mg) weekly, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
|
Albiglutide 15 mg Weekly
n=34 Participants
Participants received albiglutide 15 mg weekly, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
|
Albiglutide 30 mg Weekly
n=29 Participants
Participants received albiglutide 30 mg weekly, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
|
Albiglutide 15 mg Bi-weekly
n=30 Participants
Participants received albiglutide 15 mg every other week, alternating with placebo for each intervening week, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
|
Albiglutide 30 mg Bi-weekly
n=32 Participants
Participants received albiglutide 30 mg every other week, alternating with placebo for each intervening week, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
|
Albiglutide 50 mg Bi-weekly
n=34 Participants
Participants received albiglutide 50 mg every other week, alternating with placebo for each intervening week, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
|
Albiglutide 50 mg Every 4 Weeks
n=35 Participants
Participants received albiglutide 50 mg every 4 weeks, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
|
Albiglutide 100 mg Every 4 Weeks
n=33 Participants
Participants received albiglutide 100 mg every 4 weeks, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants Who Achieved Target Values for HbA1c <6.5% and >=6.5% to <7% at Weeks 4, 5, 7, 8, 9, 12, 15, and 16
W9: >=6.5% to <7%, n=50,34,34,34,29,30,32,34,35,32
|
9 Participants
|
9 Participants
|
5 Participants
|
7 Participants
|
5 Participants
|
10 Participants
|
11 Participants
|
10 Participants
|
9 Participants
|
8 Participants
|
|
Number of Participants Who Achieved Target Values for HbA1c <6.5% and >=6.5% to <7% at Weeks 4, 5, 7, 8, 9, 12, 15, and 16
W12: <6.5%, n=50,34,34,34,29,30,32,34,35,33
|
3 Participants
|
3 Participants
|
2 Participants
|
5 Participants
|
11 Participants
|
3 Participants
|
3 Participants
|
8 Participants
|
2 Participants
|
7 Participants
|
|
Number of Participants Who Achieved Target Values for HbA1c <6.5% and >=6.5% to <7% at Weeks 4, 5, 7, 8, 9, 12, 15, and 16
W12:>=6.5% to <7%, n=50,34,34,34,29,30,32,34,35,33
|
7 Participants
|
8 Participants
|
4 Participants
|
8 Participants
|
5 Participants
|
7 Participants
|
13 Participants
|
11 Participants
|
9 Participants
|
8 Participants
|
|
Number of Participants Who Achieved Target Values for HbA1c <6.5% and >=6.5% to <7% at Weeks 4, 5, 7, 8, 9, 12, 15, and 16
W15: <6.5%, n=50,34,34,34,29,30,32,34,35,33
|
3 Participants
|
4 Participants
|
2 Participants
|
4 Participants
|
8 Participants
|
4 Participants
|
6 Participants
|
10 Participants
|
3 Participants
|
9 Participants
|
|
Number of Participants Who Achieved Target Values for HbA1c <6.5% and >=6.5% to <7% at Weeks 4, 5, 7, 8, 9, 12, 15, and 16
W15:>=6.5% to <7%, n=50,34,34,34,29,30,32,34,35,33
|
8 Participants
|
6 Participants
|
5 Participants
|
8 Participants
|
7 Participants
|
7 Participants
|
8 Participants
|
9 Participants
|
8 Participants
|
7 Participants
|
|
Number of Participants Who Achieved Target Values for HbA1c <6.5% and >=6.5% to <7% at Weeks 4, 5, 7, 8, 9, 12, 15, and 16
W16: <6.5%, n=50,34,34,34,29,30,32,34,35,33
|
2 Participants
|
4 Participants
|
3 Participants
|
4 Participants
|
10 Participants
|
5 Participants
|
4 Participants
|
10 Participants
|
3 Participants
|
8 Participants
|
|
Number of Participants Who Achieved Target Values for HbA1c <6.5% and >=6.5% to <7% at Weeks 4, 5, 7, 8, 9, 12, 15, and 16
W16:>=6.5% to <7%, n=50,34,34,34,29,30,32,34,35,33
|
8 Participants
|
8 Participants
|
3 Participants
|
8 Participants
|
5 Participants
|
3 Participants
|
12 Participants
|
8 Participants
|
5 Participants
|
8 Participants
|
|
Number of Participants Who Achieved Target Values for HbA1c <6.5% and >=6.5% to <7% at Weeks 4, 5, 7, 8, 9, 12, 15, and 16
W4: <6.5%, n=47,34,33,34,28,29,31,34,34,30
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
4 Participants
|
0 Participants
|
0 Participants
|
3 Participants
|
1 Participants
|
3 Participants
|
|
Number of Participants Who Achieved Target Values for HbA1c <6.5% and >=6.5% to <7% at Weeks 4, 5, 7, 8, 9, 12, 15, and 16
W4: >=6.5% to <7%, n=47,34,33,34,28,29,31,34,34,30
|
8 Participants
|
5 Participants
|
5 Participants
|
8 Participants
|
8 Participants
|
6 Participants
|
8 Participants
|
5 Participants
|
6 Participants
|
6 Participants
|
|
Number of Participants Who Achieved Target Values for HbA1c <6.5% and >=6.5% to <7% at Weeks 4, 5, 7, 8, 9, 12, 15, and 16
W5: <6.5%, n=49,34,34,34,29,30,32,34,35,31
|
2 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
4 Participants
|
1 Participants
|
1 Participants
|
2 Participants
|
1 Participants
|
4 Participants
|
|
Number of Participants Who Achieved Target Values for HbA1c <6.5% and >=6.5% to <7% at Weeks 4, 5, 7, 8, 9, 12, 15, and 16
W5: >=6.5% to <7%, n=49,34,34,34,29,30,32,34,35,31
|
4 Participants
|
7 Participants
|
5 Participants
|
7 Participants
|
8 Participants
|
5 Participants
|
9 Participants
|
11 Participants
|
7 Participants
|
12 Participants
|
|
Number of Participants Who Achieved Target Values for HbA1c <6.5% and >=6.5% to <7% at Weeks 4, 5, 7, 8, 9, 12, 15, and 16
W7: <6.5%, n=50,34,34,34,29,30,32,34,35,32
|
1 Participants
|
1 Participants
|
1 Participants
|
4 Participants
|
8 Participants
|
1 Participants
|
3 Participants
|
6 Participants
|
2 Participants
|
5 Participants
|
|
Number of Participants Who Achieved Target Values for HbA1c <6.5% and >=6.5% to <7% at Weeks 4, 5, 7, 8, 9, 12, 15, and 16
W7: >=6.5% to <7%, n=50,34,34,34,29,30,32,34,35,32
|
9 Participants
|
9 Participants
|
4 Participants
|
4 Participants
|
5 Participants
|
9 Participants
|
11 Participants
|
9 Participants
|
8 Participants
|
8 Participants
|
|
Number of Participants Who Achieved Target Values for HbA1c <6.5% and >=6.5% to <7% at Weeks 4, 5, 7, 8, 9, 12, 15, and 16
W8: <6.5%, n=50,34,34,34,29,30,32,34,35,32
|
1 Participants
|
2 Participants
|
1 Participants
|
4 Participants
|
6 Participants
|
1 Participants
|
4 Participants
|
7 Participants
|
2 Participants
|
5 Participants
|
|
Number of Participants Who Achieved Target Values for HbA1c <6.5% and >=6.5% to <7% at Weeks 4, 5, 7, 8, 9, 12, 15, and 16
W8: >=6.5% to <7%, n=50,34,34,34,29,30,32,34,35,32
|
10 Participants
|
7 Participants
|
6 Participants
|
8 Participants
|
8 Participants
|
9 Participants
|
12 Participants
|
10 Participants
|
4 Participants
|
11 Participants
|
|
Number of Participants Who Achieved Target Values for HbA1c <6.5% and >=6.5% to <7% at Weeks 4, 5, 7, 8, 9, 12, 15, and 16
W9: <6.5%, n=50,34,34,34,29,30,32,34,35,32
|
3 Participants
|
2 Participants
|
2 Participants
|
6 Participants
|
8 Participants
|
1 Participants
|
3 Participants
|
7 Participants
|
2 Participants
|
9 Participants
|
SECONDARY outcome
Timeframe: Baseline and Week 16Population: ITT Population. Only participants with a value at Baseline and at Week 16 were analyzed.
The Baseline value is the last non-missing value before the start of treatment. Change from Baseline in waist circumference was calculated as the value at Week 16 minus the value at Baseline. The last observation carried forward (LOCF) method was used to impute missing data, in which the last valid observation recorded on treatment (scheduled or unscheduled) was used to impute the missing measurement. For participants who had missing observations before their last observation on treatment, the closest previous non-missing on-treatment observation was carried forward to missing visits. If a participant had missing observation(s) immediately after Baseline, the Baseline observation was not carried forward and was left as missing.
Outcome measures
| Measure |
Placebo
n=50 Participants
Participants received placebo weekly, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
|
Exenatide BID
n=34 Participants
Participants self-administered exenatide as a subcutaneous injection using prefilled pens, in accordance with current prescribing information. A dose of 5 micrograms (μg) was administered twice daily (BID) for the first 4 weeks, followed by a 12-week administration of a 10 μg BID dose. Participants who could not tolerate a 10 μg dose were to continue the study on the 5 μg BID dose.
|
Albiglutide 4 mg Weekly
n=34 Participants
Participants received albiglutide 4 milligrams (mg) weekly, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
|
Albiglutide 15 mg Weekly
n=34 Participants
Participants received albiglutide 15 mg weekly, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
|
Albiglutide 30 mg Weekly
n=29 Participants
Participants received albiglutide 30 mg weekly, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
|
Albiglutide 15 mg Bi-weekly
n=30 Participants
Participants received albiglutide 15 mg every other week, alternating with placebo for each intervening week, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
|
Albiglutide 30 mg Bi-weekly
n=32 Participants
Participants received albiglutide 30 mg every other week, alternating with placebo for each intervening week, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
|
Albiglutide 50 mg Bi-weekly
n=34 Participants
Participants received albiglutide 50 mg every other week, alternating with placebo for each intervening week, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
|
Albiglutide 50 mg Every 4 Weeks
n=35 Participants
Participants received albiglutide 50 mg every 4 weeks, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
|
Albiglutide 100 mg Every 4 Weeks
n=33 Participants
Participants received albiglutide 100 mg every 4 weeks, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Change From Baseline in Waist Circumference at Week 16
|
-0.51 Centimeters
Standard Deviation 3.847
|
-3.53 Centimeters
Standard Deviation 8.532
|
-1.50 Centimeters
Standard Deviation 3.902
|
-3.16 Centimeters
Standard Deviation 6.901
|
-1.14 Centimeters
Standard Deviation 3.856
|
-1.83 Centimeters
Standard Deviation 3.392
|
-0.47 Centimeters
Standard Deviation 3.589
|
-2.00 Centimeters
Standard Deviation 5.454
|
-0.88 Centimeters
Standard Deviation 5.146
|
-0.77 Centimeters
Standard Deviation 4.161
|
SECONDARY outcome
Timeframe: Baseline and Week 16Population: ITT Population. Only participants with a value at Baseline and at Week 16 were analyzed.
The Baseline value is the last non-missing value before the start of treatment. Change from Baseline in body weight was calculated as the value at Week 16 minus the value at Baseline. The last observation carried forward (LOCF) method was used to impute missing data, in which the last valid observation recorded on treatment (scheduled or unscheduled) was used to impute the missing measurement. For participants who had missing observations before their last observation on treatment, the closest previous non-missing on-treatment observation was carried forward to missing visits. If a participant had missing observation(s) immediately after Baseline, the Baseline observation was not carried forward and was left as missing.
Outcome measures
| Measure |
Placebo
n=50 Participants
Participants received placebo weekly, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
|
Exenatide BID
n=34 Participants
Participants self-administered exenatide as a subcutaneous injection using prefilled pens, in accordance with current prescribing information. A dose of 5 micrograms (μg) was administered twice daily (BID) for the first 4 weeks, followed by a 12-week administration of a 10 μg BID dose. Participants who could not tolerate a 10 μg dose were to continue the study on the 5 μg BID dose.
|
Albiglutide 4 mg Weekly
n=34 Participants
Participants received albiglutide 4 milligrams (mg) weekly, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
|
Albiglutide 15 mg Weekly
n=34 Participants
Participants received albiglutide 15 mg weekly, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
|
Albiglutide 30 mg Weekly
n=29 Participants
Participants received albiglutide 30 mg weekly, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
|
Albiglutide 15 mg Bi-weekly
n=30 Participants
Participants received albiglutide 15 mg every other week, alternating with placebo for each intervening week, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
|
Albiglutide 30 mg Bi-weekly
n=32 Participants
Participants received albiglutide 30 mg every other week, alternating with placebo for each intervening week, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
|
Albiglutide 50 mg Bi-weekly
n=34 Participants
Participants received albiglutide 50 mg every other week, alternating with placebo for each intervening week, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
|
Albiglutide 50 mg Every 4 Weeks
n=35 Participants
Participants received albiglutide 50 mg every 4 weeks, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
|
Albiglutide 100 mg Every 4 Weeks
n=33 Participants
Participants received albiglutide 100 mg every 4 weeks, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Change From Baseline in Body Weight at Week 16
|
-0.71 Kilograms (Kg)
Standard Deviation 2.883
|
-2.41 Kilograms (Kg)
Standard Deviation 3.527
|
-0.91 Kilograms (Kg)
Standard Deviation 1.733
|
-0.90 Kilograms (Kg)
Standard Deviation 2.901
|
-1.43 Kilograms (Kg)
Standard Deviation 2.371
|
-1.76 Kilograms (Kg)
Standard Deviation 2.828
|
-1.59 Kilograms (Kg)
Standard Deviation 2.455
|
-1.14 Kilograms (Kg)
Standard Deviation 2.872
|
-1.08 Kilograms (Kg)
Standard Deviation 3.177
|
-1.65 Kilograms (Kg)
Standard Deviation 3.570
|
SECONDARY outcome
Timeframe: Baseline and Week 16Population: ITT Population. Only participants with a value at Baseline and at Week 16 were analyzed.
The Baseline value is the last non-missing value before the start of treatment. Change from Baseline in body weight was calculated as the value at Week 16 minus the value at Baseline. Percent change from Baseline was calculated as the (\[value at Week 16 minus the Baseline value\] divided by the Baseline value) multiplied by 100. The LOCF method was used to impute missing data, in which the last valid observation recorded on treatment (scheduled or unscheduled) was used to impute the missing measurement. For participants who had missing observations before their last observation on treatment, the closest previous non-missing on-treatment observation was carried forward to missing visits. If a participant had missing observation(s) immediately after Baseline, the Baseline observation was not carried forward and was left as missing.
Outcome measures
| Measure |
Placebo
n=50 Participants
Participants received placebo weekly, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
|
Exenatide BID
n=34 Participants
Participants self-administered exenatide as a subcutaneous injection using prefilled pens, in accordance with current prescribing information. A dose of 5 micrograms (μg) was administered twice daily (BID) for the first 4 weeks, followed by a 12-week administration of a 10 μg BID dose. Participants who could not tolerate a 10 μg dose were to continue the study on the 5 μg BID dose.
|
Albiglutide 4 mg Weekly
n=34 Participants
Participants received albiglutide 4 milligrams (mg) weekly, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
|
Albiglutide 15 mg Weekly
n=34 Participants
Participants received albiglutide 15 mg weekly, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
|
Albiglutide 30 mg Weekly
n=29 Participants
Participants received albiglutide 30 mg weekly, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
|
Albiglutide 15 mg Bi-weekly
n=30 Participants
Participants received albiglutide 15 mg every other week, alternating with placebo for each intervening week, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
|
Albiglutide 30 mg Bi-weekly
n=32 Participants
Participants received albiglutide 30 mg every other week, alternating with placebo for each intervening week, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
|
Albiglutide 50 mg Bi-weekly
n=34 Participants
Participants received albiglutide 50 mg every other week, alternating with placebo for each intervening week, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
|
Albiglutide 50 mg Every 4 Weeks
n=35 Participants
Participants received albiglutide 50 mg every 4 weeks, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
|
Albiglutide 100 mg Every 4 Weeks
n=33 Participants
Participants received albiglutide 100 mg every 4 weeks, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Percent Change From Baseline in Body Weight at Week 16
|
-0.72 Percent change
Standard Deviation 3.403
|
-2.53 Percent change
Standard Deviation 4.307
|
-0.94 Percent change
Standard Deviation 1.838
|
-1.04 Percent change
Standard Deviation 3.261
|
-1.59 Percent change
Standard Deviation 2.663
|
-1.97 Percent change
Standard Deviation 2.908
|
-1.69 Percent change
Standard Deviation 2.773
|
-1.32 Percent change
Standard Deviation 3.160
|
-1.37 Percent change
Standard Deviation 3.571
|
-1.89 Percent change
Standard Deviation 3.190
|
SECONDARY outcome
Timeframe: Baseline and Weeks 4, 5, 7, 8, 9, 12, 15, and 16Population: ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the ITT Population.
The FPG test measures blood sugar levels after the participant has not eaten (fasted) for at least eight hours prior to the sampling. The Baseline FPG value is the last non-missing value before the start of treatment. Change from Baseline in FPG was calculated as the post-Baseline value minus the Baseline value. The LOCF method was used to impute missing data, in which the last valid observation recorded on treatment (scheduled or unscheduled) was used to impute the missing measurement. For participants who had missing observations before their last observation on treatment, the closest previous non-missing on-treatment observation was carried forward to missing visits. If a participant had missing observation(s) immediately after Baseline, the Baseline observation was not carried forward and was left as missing.
Outcome measures
| Measure |
Placebo
n=50 Participants
Participants received placebo weekly, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
|
Exenatide BID
n=34 Participants
Participants self-administered exenatide as a subcutaneous injection using prefilled pens, in accordance with current prescribing information. A dose of 5 micrograms (μg) was administered twice daily (BID) for the first 4 weeks, followed by a 12-week administration of a 10 μg BID dose. Participants who could not tolerate a 10 μg dose were to continue the study on the 5 μg BID dose.
|
Albiglutide 4 mg Weekly
n=34 Participants
Participants received albiglutide 4 milligrams (mg) weekly, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
|
Albiglutide 15 mg Weekly
n=34 Participants
Participants received albiglutide 15 mg weekly, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
|
Albiglutide 30 mg Weekly
n=29 Participants
Participants received albiglutide 30 mg weekly, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
|
Albiglutide 15 mg Bi-weekly
n=30 Participants
Participants received albiglutide 15 mg every other week, alternating with placebo for each intervening week, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
|
Albiglutide 30 mg Bi-weekly
n=32 Participants
Participants received albiglutide 30 mg every other week, alternating with placebo for each intervening week, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
|
Albiglutide 50 mg Bi-weekly
n=34 Participants
Participants received albiglutide 50 mg every other week, alternating with placebo for each intervening week, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
|
Albiglutide 50 mg Every 4 Weeks
n=35 Participants
Participants received albiglutide 50 mg every 4 weeks, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
|
Albiglutide 100 mg Every 4 Weeks
n=33 Participants
Participants received albiglutide 100 mg every 4 weeks, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Change From Baseline in Fasting Plasma Glucose (FPG) at Weeks 4, 5, 7, 8, 9, 12, 15, and 16
Week 4, n=47,33,32,32,29,28,32,32,34,32
|
-0.40 Millimoles per liter (mmol/L)
Standard Deviation 2.565
|
-1.11 Millimoles per liter (mmol/L)
Standard Deviation 1.953
|
-0.99 Millimoles per liter (mmol/L)
Standard Deviation 3.037
|
-0.58 Millimoles per liter (mmol/L)
Standard Deviation 1.693
|
-1.39 Millimoles per liter (mmol/L)
Standard Deviation 1.968
|
-1.06 Millimoles per liter (mmol/L)
Standard Deviation 2.110
|
-0.97 Millimoles per liter (mmol/L)
Standard Deviation 1.629
|
-1.35 Millimoles per liter (mmol/L)
Standard Deviation 2.533
|
-0.14 Millimoles per liter (mmol/L)
Standard Deviation 3.192
|
-0.61 Millimoles per liter (mmol/L)
Standard Deviation 2.267
|
|
Change From Baseline in Fasting Plasma Glucose (FPG) at Weeks 4, 5, 7, 8, 9, 12, 15, and 16
Week 5, n=47,33,32,32,29,28,32,32,34,32
|
-0.40 Millimoles per liter (mmol/L)
Standard Deviation 2.774
|
-1.06 Millimoles per liter (mmol/L)
Standard Deviation 2.377
|
-1.02 Millimoles per liter (mmol/L)
Standard Deviation 2.964
|
-1.05 Millimoles per liter (mmol/L)
Standard Deviation 1.705
|
-1.53 Millimoles per liter (mmol/L)
Standard Deviation 1.898
|
-1.41 Millimoles per liter (mmol/L)
Standard Deviation 2.363
|
-1.72 Millimoles per liter (mmol/L)
Standard Deviation 1.933
|
-2.17 Millimoles per liter (mmol/L)
Standard Deviation 2.453
|
-1.55 Millimoles per liter (mmol/L)
Standard Deviation 3.032
|
-2.12 Millimoles per liter (mmol/L)
Standard Deviation 1.959
|
|
Change From Baseline in Fasting Plasma Glucose (FPG) at Weeks 4, 5, 7, 8, 9, 12, 15, and 16
Week 7, n=47,33,32,32,29,28,32,32,34,33
|
-0.19 Millimoles per liter (mmol/L)
Standard Deviation 2.924
|
-1.25 Millimoles per liter (mmol/L)
Standard Deviation 2.204
|
-0.80 Millimoles per liter (mmol/L)
Standard Deviation 2.942
|
-0.13 Millimoles per liter (mmol/L)
Standard Deviation 2.261
|
-1.54 Millimoles per liter (mmol/L)
Standard Deviation 1.723
|
-1.16 Millimoles per liter (mmol/L)
Standard Deviation 2.651
|
-1.51 Millimoles per liter (mmol/L)
Standard Deviation 2.065
|
-1.87 Millimoles per liter (mmol/L)
Standard Deviation 2.801
|
-0.41 Millimoles per liter (mmol/L)
Standard Deviation 2.844
|
-1.07 Millimoles per liter (mmol/L)
Standard Deviation 2.519
|
|
Change From Baseline in Fasting Plasma Glucose (FPG) at Weeks 4, 5, 7, 8, 9, 12, 15, and 16
Week 8, n=47,33,32,32,29,28,32,32,34,33
|
-0.44 Millimoles per liter (mmol/L)
Standard Deviation 2.689
|
-1.43 Millimoles per liter (mmol/L)
Standard Deviation 2.258
|
-1.22 Millimoles per liter (mmol/L)
Standard Deviation 2.958
|
-0.80 Millimoles per liter (mmol/L)
Standard Deviation 1.856
|
-1.60 Millimoles per liter (mmol/L)
Standard Deviation 1.925
|
-1.29 Millimoles per liter (mmol/L)
Standard Deviation 2.520
|
-1.27 Millimoles per liter (mmol/L)
Standard Deviation 2.092
|
-1.29 Millimoles per liter (mmol/L)
Standard Deviation 2.655
|
-0.66 Millimoles per liter (mmol/L)
Standard Deviation 2.202
|
-1.29 Millimoles per liter (mmol/L)
Standard Deviation 2.898
|
|
Change From Baseline in Fasting Plasma Glucose (FPG) at Weeks 4, 5, 7, 8, 9, 12, 15, and 16
Week 9, n=47,33,32,32,29,28,32,32,34,33
|
-0.25 Millimoles per liter (mmol/L)
Standard Deviation 3.185
|
-1.54 Millimoles per liter (mmol/L)
Standard Deviation 2.044
|
-1.13 Millimoles per liter (mmol/L)
Standard Deviation 2.915
|
-0.71 Millimoles per liter (mmol/L)
Standard Deviation 1.674
|
-1.49 Millimoles per liter (mmol/L)
Standard Deviation 2.122
|
-1.29 Millimoles per liter (mmol/L)
Standard Deviation 2.617
|
-1.64 Millimoles per liter (mmol/L)
Standard Deviation 2.505
|
-1.68 Millimoles per liter (mmol/L)
Standard Deviation 3.012
|
-1.48 Millimoles per liter (mmol/L)
Standard Deviation 2.887
|
-2.25 Millimoles per liter (mmol/L)
Standard Deviation 2.388
|
|
Change From Baseline in Fasting Plasma Glucose (FPG) at Weeks 4, 5, 7, 8, 9, 12, 15, and 16
Week 12, n=47,33,32,32,29,28,32,32,34,33
|
-0.27 Millimoles per liter (mmol/L)
Standard Deviation 2.833
|
-1.32 Millimoles per liter (mmol/L)
Standard Deviation 2.518
|
-1.04 Millimoles per liter (mmol/L)
Standard Deviation 2.863
|
-0.70 Millimoles per liter (mmol/L)
Standard Deviation 2.413
|
-1.85 Millimoles per liter (mmol/L)
Standard Deviation 1.722
|
-1.11 Millimoles per liter (mmol/L)
Standard Deviation 2.492
|
-1.57 Millimoles per liter (mmol/L)
Standard Deviation 2.196
|
-1.49 Millimoles per liter (mmol/L)
Standard Deviation 2.908
|
-0.49 Millimoles per liter (mmol/L)
Standard Deviation 3.103
|
-1.50 Millimoles per liter (mmol/L)
Standard Deviation 3.310
|
|
Change From Baseline in Fasting Plasma Glucose (FPG) at Weeks 4, 5, 7, 8, 9, 12, 15, and 16
Week 15, n=47,33,32,32,29,28,32,32,34,33
|
-0.44 Millimoles per liter (mmol/L)
Standard Deviation 2.733
|
-1.27 Millimoles per liter (mmol/L)
Standard Deviation 2.343
|
-0.67 Millimoles per liter (mmol/L)
Standard Deviation 2.984
|
-0.70 Millimoles per liter (mmol/L)
Standard Deviation 1.755
|
-1.54 Millimoles per liter (mmol/L)
Standard Deviation 1.680
|
-1.45 Millimoles per liter (mmol/L)
Standard Deviation 2.320
|
-1.71 Millimoles per liter (mmol/L)
Standard Deviation 2.133
|
-1.66 Millimoles per liter (mmol/L)
Standard Deviation 3.662
|
-0.79 Millimoles per liter (mmol/L)
Standard Deviation 2.757
|
-1.27 Millimoles per liter (mmol/L)
Standard Deviation 3.502
|
|
Change From Baseline in Fasting Plasma Glucose (FPG) at Weeks 4, 5, 7, 8, 9, 12, 15, and 16
Week 16, n=47,33,32,32,29,28,32,32,34,33
|
-0.10 Millimoles per liter (mmol/L)
Standard Deviation 2.895
|
-0.80 Millimoles per liter (mmol/L)
Standard Deviation 2.482
|
-0.47 Millimoles per liter (mmol/L)
Standard Deviation 3.118
|
-0.72 Millimoles per liter (mmol/L)
Standard Deviation 1.683
|
-1.44 Millimoles per liter (mmol/L)
Standard Deviation 2.027
|
-1.28 Millimoles per liter (mmol/L)
Standard Deviation 2.427
|
-1.58 Millimoles per liter (mmol/L)
Standard Deviation 2.059
|
-1.32 Millimoles per liter (mmol/L)
Standard Deviation 3.523
|
-0.72 Millimoles per liter (mmol/L)
Standard Deviation 2.765
|
-1.22 Millimoles per liter (mmol/L)
Standard Deviation 3.497
|
SECONDARY outcome
Timeframe: Baseline and Weeks 5, 8, 12, and 16Population: ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the ITT Population.
Fasting fructosamine levels were measured after the participant had not eaten (fasted) for at least eight hours prior to the sampling. The Baseline fructosamine value is the last non-missing value before the start of treatment. Change from Baseline in fructosamine was calculated as the post-Baseline value minus the Baseline value. The LOCF method was used to impute missing data, in which the last valid observation recorded on treatment (scheduled or unscheduled) was used to impute the missing measurement. For participants who had missing observations before their last observation on treatment, the closest previous non-missing on-treatment observation was carried forward to missing visits. If a participant had missing observation(s) immediately after Baseline, the Baseline observation was not carried forward and was left as missing.
Outcome measures
| Measure |
Placebo
n=50 Participants
Participants received placebo weekly, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
|
Exenatide BID
n=34 Participants
Participants self-administered exenatide as a subcutaneous injection using prefilled pens, in accordance with current prescribing information. A dose of 5 micrograms (μg) was administered twice daily (BID) for the first 4 weeks, followed by a 12-week administration of a 10 μg BID dose. Participants who could not tolerate a 10 μg dose were to continue the study on the 5 μg BID dose.
|
Albiglutide 4 mg Weekly
n=34 Participants
Participants received albiglutide 4 milligrams (mg) weekly, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
|
Albiglutide 15 mg Weekly
n=34 Participants
Participants received albiglutide 15 mg weekly, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
|
Albiglutide 30 mg Weekly
n=29 Participants
Participants received albiglutide 30 mg weekly, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
|
Albiglutide 15 mg Bi-weekly
n=30 Participants
Participants received albiglutide 15 mg every other week, alternating with placebo for each intervening week, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
|
Albiglutide 30 mg Bi-weekly
n=32 Participants
Participants received albiglutide 30 mg every other week, alternating with placebo for each intervening week, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
|
Albiglutide 50 mg Bi-weekly
n=34 Participants
Participants received albiglutide 50 mg every other week, alternating with placebo for each intervening week, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
|
Albiglutide 50 mg Every 4 Weeks
n=35 Participants
Participants received albiglutide 50 mg every 4 weeks, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
|
Albiglutide 100 mg Every 4 Weeks
n=33 Participants
Participants received albiglutide 100 mg every 4 weeks, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Change From Baseline in Fasting Fructosamine at Weeks 5, 8, 12, and 16
Week 5, n=48,34,32,33,28,29,32,34,35,29
|
-8.3 Micromoles per liter (µmol/L)
Standard Deviation 38.68
|
-24.7 Micromoles per liter (µmol/L)
Standard Deviation 38.65
|
-11.9 Micromoles per liter (µmol/L)
Standard Deviation 50.55
|
-23.8 Micromoles per liter (µmol/L)
Standard Deviation 20.74
|
-30.7 Micromoles per liter (µmol/L)
Standard Deviation 31.28
|
-21.3 Micromoles per liter (µmol/L)
Standard Deviation 36.67
|
-34.4 Micromoles per liter (µmol/L)
Standard Deviation 41.71
|
-30.1 Micromoles per liter (µmol/L)
Standard Deviation 41.75
|
-29.2 Micromoles per liter (µmol/L)
Standard Deviation 46.57
|
-32.5 Micromoles per liter (µmol/L)
Standard Deviation 32.40
|
|
Change From Baseline in Fasting Fructosamine at Weeks 5, 8, 12, and 16
Week 8, n=50,34,33,34,28,29,32,34,35,31
|
-10.1 Micromoles per liter (µmol/L)
Standard Deviation 41.37
|
-30.6 Micromoles per liter (µmol/L)
Standard Deviation 32.47
|
-13.1 Micromoles per liter (µmol/L)
Standard Deviation 50.64
|
-25.7 Micromoles per liter (µmol/L)
Standard Deviation 31.34
|
-35.5 Micromoles per liter (µmol/L)
Standard Deviation 26.97
|
-28.9 Micromoles per liter (µmol/L)
Standard Deviation 42.46
|
-40.9 Micromoles per liter (µmol/L)
Standard Deviation 43.73
|
-32.7 Micromoles per liter (µmol/L)
Standard Deviation 42.44
|
-24.9 Micromoles per liter (µmol/L)
Standard Deviation 40.03
|
-29.5 Micromoles per liter (µmol/L)
Standard Deviation 49.98
|
|
Change From Baseline in Fasting Fructosamine at Weeks 5, 8, 12, and 16
Week 12, n=50,34,33,34,28,29,32,34,35,33
|
-11.2 Micromoles per liter (µmol/L)
Standard Deviation 41.61
|
-30.1 Micromoles per liter (µmol/L)
Standard Deviation 35.78
|
-12.5 Micromoles per liter (µmol/L)
Standard Deviation 55.41
|
-26.7 Micromoles per liter (µmol/L)
Standard Deviation 30.61
|
-31.8 Micromoles per liter (µmol/L)
Standard Deviation 35.07
|
-25.2 Micromoles per liter (µmol/L)
Standard Deviation 46.21
|
-40.2 Micromoles per liter (µmol/L)
Standard Deviation 43.37
|
-32.7 Micromoles per liter (µmol/L)
Standard Deviation 48.01
|
-26.4 Micromoles per liter (µmol/L)
Standard Deviation 46.85
|
-31.1 Micromoles per liter (µmol/L)
Standard Deviation 52.14
|
|
Change From Baseline in Fasting Fructosamine at Weeks 5, 8, 12, and 16
Week 16, n=50,34,33,34,28,29,32,34,35,33
|
-3.2 Micromoles per liter (µmol/L)
Standard Deviation 46.33
|
-24.6 Micromoles per liter (µmol/L)
Standard Deviation 41.88
|
-7.8 Micromoles per liter (µmol/L)
Standard Deviation 56.38
|
-18.2 Micromoles per liter (µmol/L)
Standard Deviation 28.01
|
-30.8 Micromoles per liter (µmol/L)
Standard Deviation 31.05
|
-23.0 Micromoles per liter (µmol/L)
Standard Deviation 49.58
|
-38.1 Micromoles per liter (µmol/L)
Standard Deviation 43.17
|
-29.4 Micromoles per liter (µmol/L)
Standard Deviation 56.23
|
-26.5 Micromoles per liter (µmol/L)
Standard Deviation 40.27
|
-24.9 Micromoles per liter (µmol/L)
Standard Deviation 49.08
|
SECONDARY outcome
Timeframe: Baseline and Weeks 5, 8, 12, and 16Population: ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the ITT Population.
Fasting C-peptide levels were measured after the participant had not eaten (fasted) for at least eight hours prior to the sampling. The Baseline C-peptide value is the last non-missing value before the start of treatment. Change from Baseline in C-peptide was calculated as the post-Baseline value minus the Baseline value. The LOCF method was used to impute missing data, in which the last valid observation recorded on treatment (scheduled or unscheduled) was used to impute the missing measurement. For participants who had missing observations before their last observation on treatment, the closest previous non-missing on-treatment observation was carried forward to missing visits. If a participant had missing observation(s) immediately after Baseline, the Baseline observation was not carried forward and was left as missing.
Outcome measures
| Measure |
Placebo
n=50 Participants
Participants received placebo weekly, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
|
Exenatide BID
n=34 Participants
Participants self-administered exenatide as a subcutaneous injection using prefilled pens, in accordance with current prescribing information. A dose of 5 micrograms (μg) was administered twice daily (BID) for the first 4 weeks, followed by a 12-week administration of a 10 μg BID dose. Participants who could not tolerate a 10 μg dose were to continue the study on the 5 μg BID dose.
|
Albiglutide 4 mg Weekly
n=34 Participants
Participants received albiglutide 4 milligrams (mg) weekly, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
|
Albiglutide 15 mg Weekly
n=34 Participants
Participants received albiglutide 15 mg weekly, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
|
Albiglutide 30 mg Weekly
n=29 Participants
Participants received albiglutide 30 mg weekly, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
|
Albiglutide 15 mg Bi-weekly
n=30 Participants
Participants received albiglutide 15 mg every other week, alternating with placebo for each intervening week, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
|
Albiglutide 30 mg Bi-weekly
n=32 Participants
Participants received albiglutide 30 mg every other week, alternating with placebo for each intervening week, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
|
Albiglutide 50 mg Bi-weekly
n=34 Participants
Participants received albiglutide 50 mg every other week, alternating with placebo for each intervening week, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
|
Albiglutide 50 mg Every 4 Weeks
n=35 Participants
Participants received albiglutide 50 mg every 4 weeks, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
|
Albiglutide 100 mg Every 4 Weeks
n=33 Participants
Participants received albiglutide 100 mg every 4 weeks, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Change From Baseline in Fasting C-peptide at Weeks 5, 8, 12, and 16
Week 5, n=48,33,32,33,27,28,32,33,35,30
|
0.004 Nanomoles per liter (nmol/L)
Standard Deviation 0.4464
|
0.274 Nanomoles per liter (nmol/L)
Standard Deviation 0.7431
|
-0.020 Nanomoles per liter (nmol/L)
Standard Deviation 0.3374
|
-0.034 Nanomoles per liter (nmol/L)
Standard Deviation 0.6149
|
0.089 Nanomoles per liter (nmol/L)
Standard Deviation 0.3459
|
0.015 Nanomoles per liter (nmol/L)
Standard Deviation 0.3782
|
-0.128 Nanomoles per liter (nmol/L)
Standard Deviation 0.6990
|
0.004 Nanomoles per liter (nmol/L)
Standard Deviation 0.4130
|
0.072 Nanomoles per liter (nmol/L)
Standard Deviation 0.4130
|
0.230 Nanomoles per liter (nmol/L)
Standard Deviation 0.3595
|
|
Change From Baseline in Fasting C-peptide at Weeks 5, 8, 12, and 16
Week 8, n=50,34,33,34,28,29,32,33,35,31
|
-0.019 Nanomoles per liter (nmol/L)
Standard Deviation 0.4044
|
0.104 Nanomoles per liter (nmol/L)
Standard Deviation 0.4643
|
-0.073 Nanomoles per liter (nmol/L)
Standard Deviation 0.2813
|
-0.026 Nanomoles per liter (nmol/L)
Standard Deviation 0.6237
|
0.095 Nanomoles per liter (nmol/L)
Standard Deviation 0.5520
|
-0.038 Nanomoles per liter (nmol/L)
Standard Deviation 0.3931
|
-0.015 Nanomoles per liter (nmol/L)
Standard Deviation 0.7842
|
-0.062 Nanomoles per liter (nmol/L)
Standard Deviation 0.3735
|
0.031 Nanomoles per liter (nmol/L)
Standard Deviation 0.4738
|
0.007 Nanomoles per liter (nmol/L)
Standard Deviation 0.3363
|
|
Change From Baseline in Fasting C-peptide at Weeks 5, 8, 12, and 16
Week 12, n=50,34,33,34,28,29,32,33,35,33
|
-0.092 Nanomoles per liter (nmol/L)
Standard Deviation 0.4264
|
0.174 Nanomoles per liter (nmol/L)
Standard Deviation 0.5445
|
-0.044 Nanomoles per liter (nmol/L)
Standard Deviation 0.3426
|
-0.046 Nanomoles per liter (nmol/L)
Standard Deviation 0.5904
|
0.023 Nanomoles per liter (nmol/L)
Standard Deviation 0.3698
|
-0.098 Nanomoles per liter (nmol/L)
Standard Deviation 0.3773
|
-0.153 Nanomoles per liter (nmol/L)
Standard Deviation 0.6463
|
-0.076 Nanomoles per liter (nmol/L)
Standard Deviation 0.4458
|
0.155 Nanomoles per liter (nmol/L)
Standard Deviation 0.5257
|
0.062 Nanomoles per liter (nmol/L)
Standard Deviation 0.6038
|
|
Change From Baseline in Fasting C-peptide at Weeks 5, 8, 12, and 16
Week 16, n=50,34,33,34,28,29,32,33,35,33
|
-0.091 Nanomoles per liter (nmol/L)
Standard Deviation 0.3149
|
0.216 Nanomoles per liter (nmol/L)
Standard Deviation 0.6786
|
-0.051 Nanomoles per liter (nmol/L)
Standard Deviation 0.3877
|
-0.075 Nanomoles per liter (nmol/L)
Standard Deviation 0.6046
|
0.171 Nanomoles per liter (nmol/L)
Standard Deviation 0.4400
|
-0.059 Nanomoles per liter (nmol/L)
Standard Deviation 0.4010
|
-0.137 Nanomoles per liter (nmol/L)
Standard Deviation 0.6540
|
-0.066 Nanomoles per liter (nmol/L)
Standard Deviation 0.4025
|
0.076 Nanomoles per liter (nmol/L)
Standard Deviation 0.5365
|
-0.005 Nanomoles per liter (nmol/L)
Standard Deviation 0.4312
|
SECONDARY outcome
Timeframe: Baseline and Weeks 5, 8, 12, and 16Population: ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the ITT Population.
Fasting glucagon levels were measured after the participant had not eaten (fasted) for at least eight hours prior to the sampling. The Baseline glucagon value is the last non-missing value before the start of treatment. Change from Baseline in glucagon was calculated as the post-Baseline value minus the Baseline value. The LOCF method was used to impute missing data, in which the last valid observation recorded on treatment (scheduled or unscheduled) was used to impute the missing measurement. For participants who had missing observations before their last observation on treatment, the closest previous non-missing on-treatment observation was carried forward to missing visits. If a participant had missing observation(s) immediately after Baseline, the Baseline observation was not carried forward and was left as missing.
Outcome measures
| Measure |
Placebo
n=50 Participants
Participants received placebo weekly, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
|
Exenatide BID
n=34 Participants
Participants self-administered exenatide as a subcutaneous injection using prefilled pens, in accordance with current prescribing information. A dose of 5 micrograms (μg) was administered twice daily (BID) for the first 4 weeks, followed by a 12-week administration of a 10 μg BID dose. Participants who could not tolerate a 10 μg dose were to continue the study on the 5 μg BID dose.
|
Albiglutide 4 mg Weekly
n=34 Participants
Participants received albiglutide 4 milligrams (mg) weekly, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
|
Albiglutide 15 mg Weekly
n=34 Participants
Participants received albiglutide 15 mg weekly, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
|
Albiglutide 30 mg Weekly
n=29 Participants
Participants received albiglutide 30 mg weekly, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
|
Albiglutide 15 mg Bi-weekly
n=30 Participants
Participants received albiglutide 15 mg every other week, alternating with placebo for each intervening week, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
|
Albiglutide 30 mg Bi-weekly
n=32 Participants
Participants received albiglutide 30 mg every other week, alternating with placebo for each intervening week, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
|
Albiglutide 50 mg Bi-weekly
n=34 Participants
Participants received albiglutide 50 mg every other week, alternating with placebo for each intervening week, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
|
Albiglutide 50 mg Every 4 Weeks
n=35 Participants
Participants received albiglutide 50 mg every 4 weeks, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
|
Albiglutide 100 mg Every 4 Weeks
n=33 Participants
Participants received albiglutide 100 mg every 4 weeks, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Change From Baseline in Fasting Glucagon at Weeks 5, 8, 12, and 16
Week 16, n=50,34,34,34,28,29,32,34,35,33
|
-2.1 Nanograms per liter (ng/L)
Standard Deviation 45.73
|
-4.5 Nanograms per liter (ng/L)
Standard Deviation 41.10
|
-3.9 Nanograms per liter (ng/L)
Standard Deviation 26.72
|
-20.5 Nanograms per liter (ng/L)
Standard Deviation 36.06
|
-2.6 Nanograms per liter (ng/L)
Standard Deviation 22.70
|
-7.1 Nanograms per liter (ng/L)
Standard Deviation 32.75
|
-5.0 Nanograms per liter (ng/L)
Standard Deviation 17.95
|
-10.9 Nanograms per liter (ng/L)
Standard Deviation 34.41
|
-11.5 Nanograms per liter (ng/L)
Standard Deviation 25.21
|
-4.7 Nanograms per liter (ng/L)
Standard Deviation 18.59
|
|
Change From Baseline in Fasting Glucagon at Weeks 5, 8, 12, and 16
Week 5, n=48,33,33,33,27,28,32,34,35,30
|
3.8 Nanograms per liter (ng/L)
Standard Deviation 43.63
|
-3.9 Nanograms per liter (ng/L)
Standard Deviation 39.26
|
-3.2 Nanograms per liter (ng/L)
Standard Deviation 27.16
|
-13.9 Nanograms per liter (ng/L)
Standard Deviation 29.05
|
-3.6 Nanograms per liter (ng/L)
Standard Deviation 21.95
|
-6.0 Nanograms per liter (ng/L)
Standard Deviation 26.83
|
-7.6 Nanograms per liter (ng/L)
Standard Deviation 20.72
|
-11.6 Nanograms per liter (ng/L)
Standard Deviation 29.48
|
-9.3 Nanograms per liter (ng/L)
Standard Deviation 23.21
|
1.9 Nanograms per liter (ng/L)
Standard Deviation 30.27
|
|
Change From Baseline in Fasting Glucagon at Weeks 5, 8, 12, and 16
Week 8, n=50,34,34,34,28,29,32,34,35,31
|
6.9 Nanograms per liter (ng/L)
Standard Deviation 49.05
|
-14.8 Nanograms per liter (ng/L)
Standard Deviation 38.34
|
-5.6 Nanograms per liter (ng/L)
Standard Deviation 22.91
|
-15.6 Nanograms per liter (ng/L)
Standard Deviation 32.75
|
-2.4 Nanograms per liter (ng/L)
Standard Deviation 17.78
|
-12.4 Nanograms per liter (ng/L)
Standard Deviation 32.17
|
-3.1 Nanograms per liter (ng/L)
Standard Deviation 22.64
|
-10.7 Nanograms per liter (ng/L)
Standard Deviation 34.48
|
-0.3 Nanograms per liter (ng/L)
Standard Deviation 41.71
|
0.5 Nanograms per liter (ng/L)
Standard Deviation 27.94
|
|
Change From Baseline in Fasting Glucagon at Weeks 5, 8, 12, and 16
Week 12, n=50,34,34,34,28,29,32,34,35,33
|
0.1 Nanograms per liter (ng/L)
Standard Deviation 49.48
|
-5.5 Nanograms per liter (ng/L)
Standard Deviation 32.41
|
-8.6 Nanograms per liter (ng/L)
Standard Deviation 31.51
|
-20.1 Nanograms per liter (ng/L)
Standard Deviation 36.53
|
-4.5 Nanograms per liter (ng/L)
Standard Deviation 21.60
|
-11.1 Nanograms per liter (ng/L)
Standard Deviation 39.08
|
0.2 Nanograms per liter (ng/L)
Standard Deviation 24.55
|
-3.3 Nanograms per liter (ng/L)
Standard Deviation 35.85
|
-3.7 Nanograms per liter (ng/L)
Standard Deviation 38.02
|
-2.1 Nanograms per liter (ng/L)
Standard Deviation 23.58
|
SECONDARY outcome
Timeframe: Baseline and Weeks 5, 8, 12, and 16Population: ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the ITT Population.
Fasting insulin levels were measured after the participant had not eaten (fasted) for at least eight hours prior to the sampling. The Baseline insulin value is the last non-missing value before the start of treatment. Change from Baseline in insulin was calculated as the post-Baseline value minus the Baseline value. The LOCF method was used to impute missing data, in which the last valid observation recorded on treatment (scheduled or unscheduled) was used to impute the missing measurement. For participants who had missing observations before their last observation on treatment, the closest previous non-missing on-treatment observation was carried forward to missing visits. If a participant had missing observation(s) immediately after Baseline, the Baseline observation was not carried forward and was left as missing.
Outcome measures
| Measure |
Placebo
n=50 Participants
Participants received placebo weekly, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
|
Exenatide BID
n=34 Participants
Participants self-administered exenatide as a subcutaneous injection using prefilled pens, in accordance with current prescribing information. A dose of 5 micrograms (μg) was administered twice daily (BID) for the first 4 weeks, followed by a 12-week administration of a 10 μg BID dose. Participants who could not tolerate a 10 μg dose were to continue the study on the 5 μg BID dose.
|
Albiglutide 4 mg Weekly
n=34 Participants
Participants received albiglutide 4 milligrams (mg) weekly, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
|
Albiglutide 15 mg Weekly
n=34 Participants
Participants received albiglutide 15 mg weekly, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
|
Albiglutide 30 mg Weekly
n=29 Participants
Participants received albiglutide 30 mg weekly, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
|
Albiglutide 15 mg Bi-weekly
n=30 Participants
Participants received albiglutide 15 mg every other week, alternating with placebo for each intervening week, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
|
Albiglutide 30 mg Bi-weekly
n=32 Participants
Participants received albiglutide 30 mg every other week, alternating with placebo for each intervening week, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
|
Albiglutide 50 mg Bi-weekly
n=34 Participants
Participants received albiglutide 50 mg every other week, alternating with placebo for each intervening week, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
|
Albiglutide 50 mg Every 4 Weeks
n=35 Participants
Participants received albiglutide 50 mg every 4 weeks, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
|
Albiglutide 100 mg Every 4 Weeks
n=33 Participants
Participants received albiglutide 100 mg every 4 weeks, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Change From Baseline in Fasting Insulin at Weeks 5, 8, 12, and 16
Week 5, n=47,31,32,33,27,28,31,30,33,30
|
5.1 Picomoles per liter (pmol/L)
Standard Deviation 106.67
|
29.6 Picomoles per liter (pmol/L)
Standard Deviation 104.29
|
-12.4 Picomoles per liter (pmol/L)
Standard Deviation 72.90
|
-16.4 Picomoles per liter (pmol/L)
Standard Deviation 114.61
|
0.4 Picomoles per liter (pmol/L)
Standard Deviation 75.97
|
28.5 Picomoles per liter (pmol/L)
Standard Deviation 99.26
|
-38.3 Picomoles per liter (pmol/L)
Standard Deviation 104.22
|
-8.4 Picomoles per liter (pmol/L)
Standard Deviation 75.38
|
11.1 Picomoles per liter (pmol/L)
Standard Deviation 97.92
|
36.2 Picomoles per liter (pmol/L)
Standard Deviation 115.31
|
|
Change From Baseline in Fasting Insulin at Weeks 5, 8, 12, and 16
Week 8, n=49,32,33,34,28,29,32,31,33,31
|
9.2 Picomoles per liter (pmol/L)
Standard Deviation 106.05
|
5.4 Picomoles per liter (pmol/L)
Standard Deviation 52.47
|
-16.5 Picomoles per liter (pmol/L)
Standard Deviation 64.88
|
-8.5 Picomoles per liter (pmol/L)
Standard Deviation 116.41
|
2.4 Picomoles per liter (pmol/L)
Standard Deviation 98.07
|
18.6 Picomoles per liter (pmol/L)
Standard Deviation 102.92
|
-14.4 Picomoles per liter (pmol/L)
Standard Deviation 104.76
|
-16.8 Picomoles per liter (pmol/L)
Standard Deviation 84.12
|
12.9 Picomoles per liter (pmol/L)
Standard Deviation 92.97
|
6.6 Picomoles per liter (pmol/L)
Standard Deviation 62.90
|
|
Change From Baseline in Fasting Insulin at Weeks 5, 8, 12, and 16
Week 12, n=49,32,33,34,28,29,32,31,33,33
|
8.8 Picomoles per liter (pmol/L)
Standard Deviation 79.93
|
18.0 Picomoles per liter (pmol/L)
Standard Deviation 60.31
|
-12.4 Picomoles per liter (pmol/L)
Standard Deviation 67.03
|
-7.9 Picomoles per liter (pmol/L)
Standard Deviation 106.19
|
-1.1 Picomoles per liter (pmol/L)
Standard Deviation 86.02
|
17.8 Picomoles per liter (pmol/L)
Standard Deviation 99.18
|
-26.1 Picomoles per liter (pmol/L)
Standard Deviation 94.10
|
0.2 Picomoles per liter (pmol/L)
Standard Deviation 90.27
|
38.0 Picomoles per liter (pmol/L)
Standard Deviation 158.33
|
11.6 Picomoles per liter (pmol/L)
Standard Deviation 73.33
|
|
Change From Baseline in Fasting Insulin at Weeks 5, 8, 12, and 16
Week 16, n=49,32,33,34,28,29,32,31,33,33
|
-5.8 Picomoles per liter (pmol/L)
Standard Deviation 42.74
|
17.4 Picomoles per liter (pmol/L)
Standard Deviation 52.62
|
2.9 Picomoles per liter (pmol/L)
Standard Deviation 81.64
|
-19.9 Picomoles per liter (pmol/L)
Standard Deviation 112.32
|
25.1 Picomoles per liter (pmol/L)
Standard Deviation 114.95
|
21.9 Picomoles per liter (pmol/L)
Standard Deviation 99.41
|
-24.0 Picomoles per liter (pmol/L)
Standard Deviation 90.05
|
-17.4 Picomoles per liter (pmol/L)
Standard Deviation 80.04
|
12.9 Picomoles per liter (pmol/L)
Standard Deviation 72.22
|
18.4 Picomoles per liter (pmol/L)
Standard Deviation 80.83
|
SECONDARY outcome
Timeframe: Baseline and Weeks 5, 8, 12, and 16Population: ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed for different parameters at different time points, so the overall number of participants analyzed reflects everyone in the ITT Population.
Serum lipid components, including triglycerides (TG), free fatty acids (FFA), total cholesterol (CL), low-density lipoprotein cholesterol (LDL-C), and high-density lipoprotein cholesterol (HDL-C), were measured at Baseline and Weeks 5, 8, 12, and 16. The Baseline value is the last non-missing value before the start of treatment. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. The LOCF method was used to impute missing data, in which the last valid observation recorded on treatment (scheduled or unscheduled) was used to impute the missing measurement. For participants who had missing observations before their last observation on treatment, the closest previous non-missing on-treatment observation was carried forward to missing visits. If a participant had missing observation(s) immediately after Baseline, the Baseline observation was not carried forward and was left as missing.
Outcome measures
| Measure |
Placebo
n=50 Participants
Participants received placebo weekly, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
|
Exenatide BID
n=34 Participants
Participants self-administered exenatide as a subcutaneous injection using prefilled pens, in accordance with current prescribing information. A dose of 5 micrograms (μg) was administered twice daily (BID) for the first 4 weeks, followed by a 12-week administration of a 10 μg BID dose. Participants who could not tolerate a 10 μg dose were to continue the study on the 5 μg BID dose.
|
Albiglutide 4 mg Weekly
n=34 Participants
Participants received albiglutide 4 milligrams (mg) weekly, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
|
Albiglutide 15 mg Weekly
n=34 Participants
Participants received albiglutide 15 mg weekly, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
|
Albiglutide 30 mg Weekly
n=29 Participants
Participants received albiglutide 30 mg weekly, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
|
Albiglutide 15 mg Bi-weekly
n=30 Participants
Participants received albiglutide 15 mg every other week, alternating with placebo for each intervening week, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
|
Albiglutide 30 mg Bi-weekly
n=32 Participants
Participants received albiglutide 30 mg every other week, alternating with placebo for each intervening week, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
|
Albiglutide 50 mg Bi-weekly
n=34 Participants
Participants received albiglutide 50 mg every other week, alternating with placebo for each intervening week, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
|
Albiglutide 50 mg Every 4 Weeks
n=35 Participants
Participants received albiglutide 50 mg every 4 weeks, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
|
Albiglutide 100 mg Every 4 Weeks
n=33 Participants
Participants received albiglutide 100 mg every 4 weeks, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Change From Baseline in Triglycerides, Free Fatty Acids, Total Cholesterol, Low-density Lipoprotein Cholesterol, and High-density Lipoprotein Cholesterol at Weeks 5, 8, 12, and 16
TG, Week 5, n=45,31,34,31,27,29,31,34,35,30
|
-0.225 mmol/L
Standard Deviation 1.0354
|
-0.068 mmol/L
Standard Deviation 0.7288
|
0.303 mmol/L
Standard Deviation 2.1539
|
-0.376 mmol/L
Standard Deviation 1.1387
|
0.112 mmol/L
Standard Deviation 0.6974
|
-0.266 mmol/L
Standard Deviation 1.2296
|
-0.147 mmol/L
Standard Deviation 1.0251
|
-1.423 mmol/L
Standard Deviation 3.7638
|
-0.725 mmol/L
Standard Deviation 1.3749
|
-0.184 mmol/L
Standard Deviation 0.5912
|
|
Change From Baseline in Triglycerides, Free Fatty Acids, Total Cholesterol, Low-density Lipoprotein Cholesterol, and High-density Lipoprotein Cholesterol at Weeks 5, 8, 12, and 16
TG, Week 8, n=50,33,34,34,27,30,32,34,35,31
|
-0.222 mmol/L
Standard Deviation 1.5590
|
-0.238 mmol/L
Standard Deviation 0.6205
|
0.178 mmol/L
Standard Deviation 2.1883
|
-0.408 mmol/L
Standard Deviation 1.3143
|
-0.009 mmol/L
Standard Deviation 0.6977
|
-0.219 mmol/L
Standard Deviation 1.0210
|
-0.150 mmol/L
Standard Deviation 0.9610
|
-1.494 mmol/L
Standard Deviation 3.8212
|
-0.175 mmol/L
Standard Deviation 1.6289
|
-0.028 mmol/L
Standard Deviation 1.1012
|
|
Change From Baseline in Triglycerides, Free Fatty Acids, Total Cholesterol, Low-density Lipoprotein Cholesterol, and High-density Lipoprotein Cholesterol at Weeks 5, 8, 12, and 16
TG, Week 12, n=50,34,34,34,28,30,32,34,35,33
|
-0.329 mmol/L
Standard Deviation 1.2941
|
0.094 mmol/L
Standard Deviation 1.4597
|
0.221 mmol/L
Standard Deviation 2.3056
|
-0.341 mmol/L
Standard Deviation 1.2139
|
0.106 mmol/L
Standard Deviation 0.8936
|
-0.380 mmol/L
Standard Deviation 0.8947
|
-0.269 mmol/L
Standard Deviation 1.0358
|
-1.539 mmol/L
Standard Deviation 3.9093
|
-0.362 mmol/L
Standard Deviation 1.5880
|
0.070 mmol/L
Standard Deviation 0.8288
|
|
Change From Baseline in Triglycerides, Free Fatty Acids, Total Cholesterol, Low-density Lipoprotein Cholesterol, and High-density Lipoprotein Cholesterol at Weeks 5, 8, 12, and 16
TG, Week 16, n=50,34,34,34,28,30,32,34,35,33
|
-0.377 mmol/L
Standard Deviation 1.6534
|
-0.149 mmol/L
Standard Deviation 0.8423
|
0.122 mmol/L
Standard Deviation 2.1274
|
-0.296 mmol/L
Standard Deviation 1.2876
|
0.099 mmol/L
Standard Deviation 0.9002
|
-0.258 mmol/L
Standard Deviation 0.9248
|
-0.331 mmol/L
Standard Deviation 0.9529
|
-1.469 mmol/L
Standard Deviation 3.8476
|
-0.426 mmol/L
Standard Deviation 1.7338
|
-0.114 mmol/L
Standard Deviation 1.1446
|
|
Change From Baseline in Triglycerides, Free Fatty Acids, Total Cholesterol, Low-density Lipoprotein Cholesterol, and High-density Lipoprotein Cholesterol at Weeks 5, 8, 12, and 16
FFA, Week 5, n=48,33,32,33,27,28,32,34,35,29
|
0.029 mmol/L
Standard Deviation 0.1867
|
-0.038 mmol/L
Standard Deviation 0.2518
|
-0.032 mmol/L
Standard Deviation 0.1691
|
-0.008 mmol/L
Standard Deviation 0.1392
|
0.014 mmol/L
Standard Deviation 0.1381
|
0.025 mmol/L
Standard Deviation 0.1927
|
-0.028 mmol/L
Standard Deviation 0.2017
|
-0.012 mmol/L
Standard Deviation 0.2266
|
-0.001 mmol/L
Standard Deviation 0.1568
|
0.006 mmol/L
Standard Deviation 0.2237
|
|
Change From Baseline in Triglycerides, Free Fatty Acids, Total Cholesterol, Low-density Lipoprotein Cholesterol, and High-density Lipoprotein Cholesterol at Weeks 5, 8, 12, and 16
FFA, Week 8, n=50,34,33,34,28,29,32,34,35,31
|
0.034 mmol/L
Standard Deviation 0.2021
|
-0.045 mmol/L
Standard Deviation 0.2186
|
0.033 mmol/L
Standard Deviation 0.1699
|
-0.048 mmol/L
Standard Deviation 0.1345
|
0.046 mmol/L
Standard Deviation 0.1934
|
0.017 mmol/L
Standard Deviation 0.1897
|
-0.027 mmol/L
Standard Deviation 0.1974
|
-0.004 mmol/L
Standard Deviation 0.2359
|
0.055 mmol/L
Standard Deviation 0.1843
|
0.175 mmol/L
Standard Deviation 0.8591
|
|
Change From Baseline in Triglycerides, Free Fatty Acids, Total Cholesterol, Low-density Lipoprotein Cholesterol, and High-density Lipoprotein Cholesterol at Weeks 5, 8, 12, and 16
FFA, Week 12, n=50,34,33,34,28,29,32,34,35,33
|
0.075 mmol/L
Standard Deviation 0.2018
|
-0.007 mmol/L
Standard Deviation 0.1882
|
0.022 mmol/L
Standard Deviation 0.2003
|
-0.013 mmol/L
Standard Deviation 0.1870
|
0.043 mmol/L
Standard Deviation 0.1826
|
0.010 mmol/L
Standard Deviation 0.1920
|
-0.051 mmol/L
Standard Deviation 0.2250
|
0.011 mmol/L
Standard Deviation 0.2481
|
-0.030 mmol/L
Standard Deviation 0.1796
|
0.123 mmol/L
Standard Deviation 0.8347
|
|
Change From Baseline in Triglycerides, Free Fatty Acids, Total Cholesterol, Low-density Lipoprotein Cholesterol, and High-density Lipoprotein Cholesterol at Weeks 5, 8, 12, and 16
FFA, Week 16, n=50,34,33,34,28,29,32,34,35,33
|
0.078 mmol/L
Standard Deviation 0.2047
|
-0.031 mmol/L
Standard Deviation 0.1631
|
0.020 mmol/L
Standard Deviation 0.2084
|
0.016 mmol/L
Standard Deviation 0.2159
|
0.050 mmol/L
Standard Deviation 0.1695
|
0.034 mmol/L
Standard Deviation 0.2006
|
-0.005 mmol/L
Standard Deviation 0.2494
|
0.025 mmol/L
Standard Deviation 0.2319
|
0.012 mmol/L
Standard Deviation 0.2065
|
0.094 mmol/L
Standard Deviation 0.8399
|
|
Change From Baseline in Triglycerides, Free Fatty Acids, Total Cholesterol, Low-density Lipoprotein Cholesterol, and High-density Lipoprotein Cholesterol at Weeks 5, 8, 12, and 16
Total CL, Week 5, n=45,31,34,31,27,29,31,34,35,30
|
-0.023 mmol/L
Standard Deviation 0.6128
|
-0.239 mmol/L
Standard Deviation 0.6613
|
-0.153 mmol/L
Standard Deviation 0.8765
|
-0.139 mmol/L
Standard Deviation 0.5795
|
-0.113 mmol/L
Standard Deviation 0.6588
|
-0.372 mmol/L
Standard Deviation 0.6998
|
-0.140 mmol/L
Standard Deviation 0.4168
|
-0.451 mmol/L
Standard Deviation 0.9158
|
-0.407 mmol/L
Standard Deviation 0.6393
|
-0.245 mmol/L
Standard Deviation 0.5284
|
|
Change From Baseline in Triglycerides, Free Fatty Acids, Total Cholesterol, Low-density Lipoprotein Cholesterol, and High-density Lipoprotein Cholesterol at Weeks 5, 8, 12, and 16
Total CL, Week 8, n=50,33,34,34,27,30,32,34,35,31
|
-0.050 mmol/L
Standard Deviation 0.5932
|
-0.182 mmol/L
Standard Deviation 0.6517
|
-0.060 mmol/L
Standard Deviation 0.9192
|
-0.162 mmol/L
Standard Deviation 0.4772
|
0.002 mmol/L
Standard Deviation 0.5870
|
-0.172 mmol/L
Standard Deviation 0.6633
|
-0.094 mmol/L
Standard Deviation 0.4566
|
-0.418 mmol/L
Standard Deviation 0.8572
|
-0.183 mmol/L
Standard Deviation 0.8011
|
0.060 mmol/L
Standard Deviation 0.6296
|
|
Change From Baseline in Triglycerides, Free Fatty Acids, Total Cholesterol, Low-density Lipoprotein Cholesterol, and High-density Lipoprotein Cholesterol at Weeks 5, 8, 12, and 16
Total CL, Week 12, n=50,34,34,34,28,30,32,34,35,33
|
0.045 mmol/L
Standard Deviation 0.6465
|
0.054 mmol/L
Standard Deviation 0.7723
|
-0.025 mmol/L
Standard Deviation 0.9136
|
-0.140 mmol/L
Standard Deviation 0.5686
|
-0.020 mmol/L
Standard Deviation 0.6926
|
-0.190 mmol/L
Standard Deviation 0.5975
|
-0.092 mmol/L
Standard Deviation 0.8249
|
-0.338 mmol/L
Standard Deviation 0.9449
|
-0.134 mmol/L
Standard Deviation 0.6620
|
0.015 mmol/L
Standard Deviation 0.5786
|
|
Change From Baseline in Triglycerides, Free Fatty Acids, Total Cholesterol, Low-density Lipoprotein Cholesterol, and High-density Lipoprotein Cholesterol at Weeks 5, 8, 12, and 16
Total CL, Week 16, n=50,34,34,34,28,30,32,34,35,33
|
0.095 mmol/L
Standard Deviation 0.7695
|
-0.031 mmol/L
Standard Deviation 0.8271
|
-0.032 mmol/L
Standard Deviation 0.9312
|
-0.037 mmol/L
Standard Deviation 0.5402
|
0.009 mmol/L
Standard Deviation 0.5964
|
-0.225 mmol/L
Standard Deviation 0.5420
|
-0.178 mmol/L
Standard Deviation 0.4476
|
-0.447 mmol/L
Standard Deviation 0.8464
|
-0.217 mmol/L
Standard Deviation 0.7376
|
0.018 mmol/L
Standard Deviation 0.5532
|
|
Change From Baseline in Triglycerides, Free Fatty Acids, Total Cholesterol, Low-density Lipoprotein Cholesterol, and High-density Lipoprotein Cholesterol at Weeks 5, 8, 12, and 16
LDL-C, Week 5, n=41,29,31,29,26,28,29,27,32,29
|
0.066 mmol/L
Standard Deviation 0.5417
|
-0.153 mmol/L
Standard Deviation 0.5479
|
-0.294 mmol/L
Standard Deviation 0.7053
|
-0.155 mmol/L
Standard Deviation 0.5653
|
-0.068 mmol/L
Standard Deviation 0.6225
|
-0.285 mmol/L
Standard Deviation 0.5345
|
-0.082 mmol/L
Standard Deviation 0.3708
|
0.026 mmol/L
Standard Deviation 0.5064
|
-0.106 mmol/L
Standard Deviation 0.4576
|
-0.091 mmol/L
Standard Deviation 0.4910
|
|
Change From Baseline in Triglycerides, Free Fatty Acids, Total Cholesterol, Low-density Lipoprotein Cholesterol, and High-density Lipoprotein Cholesterol at Weeks 5, 8, 12, and 16
LDL-C, Week 8, n=45,32,32,32,26,30,31,28,32,30
|
0.066 mmol/L
Standard Deviation 0.5123
|
-0.014 mmol/L
Standard Deviation 0.5556
|
-0.132 mmol/L
Standard Deviation 0.7398
|
-0.157 mmol/L
Standard Deviation 0.5620
|
0.089 mmol/L
Standard Deviation 0.6053
|
-0.160 mmol/L
Standard Deviation 0.5305
|
-0.052 mmol/L
Standard Deviation 0.4403
|
0.053 mmol/L
Standard Deviation 0.4543
|
-0.087 mmol/L
Standard Deviation 0.4336
|
0.054 mmol/L
Standard Deviation 0.5581
|
|
Change From Baseline in Triglycerides, Free Fatty Acids, Total Cholesterol, Low-density Lipoprotein Cholesterol, and High-density Lipoprotein Cholesterol at Weeks 5, 8, 12, and 16
LDL-C, Week 12, n=45,33,32,32,28,30,31,28,32,32
|
0.138 mmol/L
Standard Deviation 0.4923
|
0.105 mmol/L
Standard Deviation 0.6259
|
-0.096 mmol/L
Standard Deviation 0.6483
|
-0.152 mmol/L
Standard Deviation 0.6477
|
0.004 mmol/L
Standard Deviation 0.6456
|
-0.034 mmol/L
Standard Deviation 0.5547
|
-0.004 mmol/L
Standard Deviation 0.7153
|
0.156 mmol/L
Standard Deviation 0.4614
|
-0.061 mmol/L
Standard Deviation 0.3790
|
0.010 mmol/L
Standard Deviation 0.4771
|
|
Change From Baseline in Triglycerides, Free Fatty Acids, Total Cholesterol, Low-density Lipoprotein Cholesterol, and High-density Lipoprotein Cholesterol at Weeks 5, 8, 12, and 16
LDL-C, Week 16, n=46,33,32,32,28,30,31,28,32,32
|
0.190 mmol/L
Standard Deviation 0.6025
|
0.096 mmol/L
Standard Deviation 0.6960
|
-0.109 mmol/L
Standard Deviation 0.6558
|
-0.045 mmol/L
Standard Deviation 0.6183
|
0.003 mmol/L
Standard Deviation 0.6010
|
-0.123 mmol/L
Standard Deviation 0.5198
|
-0.062 mmol/L
Standard Deviation 0.3943
|
0.059 mmol/L
Standard Deviation 0.5750
|
-0.088 mmol/L
Standard Deviation 0.5125
|
0.054 mmol/L
Standard Deviation 0.4475
|
|
Change From Baseline in Triglycerides, Free Fatty Acids, Total Cholesterol, Low-density Lipoprotein Cholesterol, and High-density Lipoprotein Cholesterol at Weeks 5, 8, 12, and 16
HDL-C, Week 5, n=45,31,34,31,27,29,31,34,35,30
|
-0.020 mmol/L
Standard Deviation 0.1189
|
-0.047 mmol/L
Standard Deviation 0.1420
|
0.001 mmol/L
Standard Deviation 0.1203
|
-0.010 mmol/L
Standard Deviation 0.1491
|
-0.063 mmol/L
Standard Deviation 0.1425
|
-0.038 mmol/L
Standard Deviation 0.1215
|
-0.045 mmol/L
Standard Deviation 0.1434
|
-0.076 mmol/L
Standard Deviation 0.1553
|
-0.047 mmol/L
Standard Deviation 0.1765
|
-0.053 mmol/L
Standard Deviation 0.1129
|
|
Change From Baseline in Triglycerides, Free Fatty Acids, Total Cholesterol, Low-density Lipoprotein Cholesterol, and High-density Lipoprotein Cholesterol at Weeks 5, 8, 12, and 16
HDL-C, Week 8, n=50,33,34,34,27,30,32,34,35,31
|
-0.005 mmol/L
Standard Deviation 0.1192
|
-0.058 mmol/L
Standard Deviation 0.1606
|
0.006 mmol/L
Standard Deviation 0.1160
|
0.019 mmol/L
Standard Deviation 0.1187
|
-0.061 mmol/L
Standard Deviation 0.1368
|
-0.018 mmol/L
Standard Deviation 0.1417
|
-0.030 mmol/L
Standard Deviation 0.1217
|
-0.050 mmol/L
Standard Deviation 0.1403
|
-0.054 mmol/L
Standard Deviation 0.1746
|
-0.016 mmol/L
Standard Deviation 0.1567
|
|
Change From Baseline in Triglycerides, Free Fatty Acids, Total Cholesterol, Low-density Lipoprotein Cholesterol, and High-density Lipoprotein Cholesterol at Weeks 5, 8, 12, and 16
HDL-C, Week 12, n=50,34,34,34,28,30,32,34,35,33
|
-0.011 mmol/L
Standard Deviation 0.1341
|
-0.003 mmol/L
Standard Deviation 0.2269
|
0.004 mmol/L
Standard Deviation 0.1258
|
-0.019 mmol/L
Standard Deviation 0.1115
|
-0.061 mmol/L
Standard Deviation 0.1674
|
-0.018 mmol/L
Standard Deviation 0.1323
|
-0.041 mmol/L
Standard Deviation 0.1998
|
-0.029 mmol/L
Standard Deviation 0.1303
|
-0.033 mmol/L
Standard Deviation 0.1445
|
-0.045 mmol/L
Standard Deviation 0.1411
|
|
Change From Baseline in Triglycerides, Free Fatty Acids, Total Cholesterol, Low-density Lipoprotein Cholesterol, and High-density Lipoprotein Cholesterol at Weeks 5, 8, 12, and 16
HDL-C, Week 16, n=50,34,34,34,28,30,32,34,35,33
|
-0.002 mmol/L
Standard Deviation 0.1274
|
-0.025 mmol/L
Standard Deviation 0.2192
|
-0.007 mmol/L
Standard Deviation 0.1366
|
-0.010 mmol/L
Standard Deviation 0.1342
|
-0.046 mmol/L
Standard Deviation 0.1699
|
-0.015 mmol/L
Standard Deviation 0.1146
|
-0.031 mmol/L
Standard Deviation 0.1413
|
-0.065 mmol/L
Standard Deviation 0.1730
|
-0.033 mmol/L
Standard Deviation 0.1595
|
-0.048 mmol/L
Standard Deviation 0.1930
|
SECONDARY outcome
Timeframe: Baseline and Week 16Population: Safety Population: all randomly assigned participants who received at least one dose of study drug. Only those participants available at the specified time point were analyzed. Change from Baseline was calculated as the score at Week 16 minus the score at Baseline.
The FLIE questionnaire is used to record the participant's feelings/opinions concerning the effects of nausea/vomiting on their quality of life during the past five days. Participants completed the questionnaire by responding to 18 questions. The first set of 9 questions refer to nausea, and the second set of 9 questions refer to vomiting. Each question is scored on a seven-point visual analog scale (1 to 7). On this scale, a score of 1 corresponds to 0 millimeters (mm), and a score of 7 correspond to 100 mm. Anything in between is marked at the appropriate point on the scale and is measured in mm. Data are reported in mm in this table. In FLIE questions (FLIEQ) 1, 2, 4, 5, 7, 8, 9, 10, 12, 13, 14, 16, and 17, a score of 1 indicates no effect on the quality of life, and a score of 7 indicates a great effect on the quality of life. In FLIEQ 3, 6, 11, 15, and 18, a score of 1 indicates a great effect on the quality of life, and a score of 7 indicates no effect on the quality of life.
Outcome measures
| Measure |
Placebo
n=37 Participants
Participants received placebo weekly, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
|
Exenatide BID
n=28 Participants
Participants self-administered exenatide as a subcutaneous injection using prefilled pens, in accordance with current prescribing information. A dose of 5 micrograms (μg) was administered twice daily (BID) for the first 4 weeks, followed by a 12-week administration of a 10 μg BID dose. Participants who could not tolerate a 10 μg dose were to continue the study on the 5 μg BID dose.
|
Albiglutide 4 mg Weekly
n=19 Participants
Participants received albiglutide 4 milligrams (mg) weekly, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
|
Albiglutide 15 mg Weekly
n=25 Participants
Participants received albiglutide 15 mg weekly, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
|
Albiglutide 30 mg Weekly
n=22 Participants
Participants received albiglutide 30 mg weekly, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
|
Albiglutide 15 mg Bi-weekly
n=19 Participants
Participants received albiglutide 15 mg every other week, alternating with placebo for each intervening week, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
|
Albiglutide 30 mg Bi-weekly
n=24 Participants
Participants received albiglutide 30 mg every other week, alternating with placebo for each intervening week, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
|
Albiglutide 50 mg Bi-weekly
n=21 Participants
Participants received albiglutide 50 mg every other week, alternating with placebo for each intervening week, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
|
Albiglutide 50 mg Every 4 Weeks
n=29 Participants
Participants received albiglutide 50 mg every 4 weeks, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
|
Albiglutide 100 mg Every 4 Weeks
n=22 Participants
Participants received albiglutide 100 mg every 4 weeks, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Change From Baseline in Functional Living Index - Emesis (FLIE) Scores at Week 16
FLIEQ1
|
-0.1 Score on a scale
Standard Deviation 6.79
|
-4.4 Score on a scale
Standard Deviation 19.25
|
5.7 Score on a scale
Standard Deviation 23.42
|
1.0 Score on a scale
Standard Deviation 19.54
|
4.6 Score on a scale
Standard Deviation 11.35
|
8.6 Score on a scale
Standard Deviation 24.35
|
-1.0 Score on a scale
Standard Deviation 2.22
|
8.2 Score on a scale
Standard Deviation 22.66
|
-0.3 Score on a scale
Standard Deviation 7.18
|
-2.8 Score on a scale
Standard Deviation 8.30
|
|
Change From Baseline in Functional Living Index - Emesis (FLIE) Scores at Week 16
FLIEQ2
|
0.2 Score on a scale
Standard Deviation 2.15
|
-3.5 Score on a scale
Standard Deviation 18.64
|
5.5 Score on a scale
Standard Deviation 23.42
|
2.6 Score on a scale
Standard Deviation 18.20
|
3.0 Score on a scale
Standard Deviation 11.67
|
5.9 Score on a scale
Standard Deviation 22.87
|
-0.8 Score on a scale
Standard Deviation 4.03
|
4.7 Score on a scale
Standard Deviation 21.95
|
-0.6 Score on a scale
Standard Deviation 3.21
|
-0.2 Score on a scale
Standard Deviation 1.84
|
|
Change From Baseline in Functional Living Index - Emesis (FLIE) Scores at Week 16
FLIEQ3
|
15.6 Score on a scale
Standard Deviation 36.34
|
7.8 Score on a scale
Standard Deviation 25.52
|
10.3 Score on a scale
Standard Deviation 42.11
|
-4.0 Score on a scale
Standard Deviation 19.64
|
18.6 Score on a scale
Standard Deviation 47.37
|
10.3 Score on a scale
Standard Deviation 45.34
|
3.9 Score on a scale
Standard Deviation 32.47
|
18.2 Score on a scale
Standard Deviation 39.83
|
4.5 Score on a scale
Standard Deviation 28.67
|
7.3 Score on a scale
Standard Deviation 29.72
|
|
Change From Baseline in Functional Living Index - Emesis (FLIE) Scores at Week 16
FLIEQ4
|
0.4 Score on a scale
Standard Deviation 2.06
|
-3.5 Score on a scale
Standard Deviation 18.32
|
6.4 Score on a scale
Standard Deviation 24.11
|
-2.8 Score on a scale
Standard Deviation 11.95
|
1.5 Score on a scale
Standard Deviation 5.16
|
5.6 Score on a scale
Standard Deviation 22.91
|
-1.6 Score on a scale
Standard Deviation 8.84
|
5.9 Score on a scale
Standard Deviation 22.48
|
-1.9 Score on a scale
Standard Deviation 16.90
|
-1.8 Score on a scale
Standard Deviation 6.68
|
|
Change From Baseline in Functional Living Index - Emesis (FLIE) Scores at Week 16
FLIEQ5
|
-0.3 Score on a scale
Standard Deviation 3.46
|
-4.0 Score on a scale
Standard Deviation 18.21
|
6.4 Score on a scale
Standard Deviation 23.09
|
-1.8 Score on a scale
Standard Deviation 7.18
|
2.9 Score on a scale
Standard Deviation 11.23
|
0.2 Score on a scale
Standard Deviation 33.34
|
-1.3 Score on a scale
Standard Deviation 5.41
|
4.5 Score on a scale
Standard Deviation 21.97
|
1.5 Score on a scale
Standard Deviation 6.42
|
-1.4 Score on a scale
Standard Deviation 6.03
|
|
Change From Baseline in Functional Living Index - Emesis (FLIE) Scores at Week 16
FLIEQ6
|
11.2 Score on a scale
Standard Deviation 38.64
|
3.6 Score on a scale
Standard Deviation 29.76
|
9.4 Score on a scale
Standard Deviation 40.77
|
-0.5 Score on a scale
Standard Deviation 26.11
|
20.0 Score on a scale
Standard Deviation 44.44
|
10.2 Score on a scale
Standard Deviation 45.38
|
4.2 Score on a scale
Standard Deviation 31.38
|
18.0 Score on a scale
Standard Deviation 40.06
|
5.6 Score on a scale
Standard Deviation 26.54
|
3.9 Score on a scale
Standard Deviation 36.69
|
|
Change From Baseline in Functional Living Index - Emesis (FLIE) Scores at Week 16
FLIEQ7
|
0.4 Score on a scale
Standard Deviation 2.20
|
-3.1 Score on a scale
Standard Deviation 19.16
|
5.7 Score on a scale
Standard Deviation 23.46
|
1.5 Score on a scale
Standard Deviation 16.77
|
0.2 Score on a scale
Standard Deviation 0.69
|
5.7 Score on a scale
Standard Deviation 22.88
|
-1.0 Score on a scale
Standard Deviation 6.71
|
4.9 Score on a scale
Standard Deviation 21.93
|
-0.1 Score on a scale
Standard Deviation 4.85
|
-1.9 Score on a scale
Standard Deviation 6.44
|
|
Change From Baseline in Functional Living Index - Emesis (FLIE) Scores at Week 16
FLIEQ8
|
-0.6 Score on a scale
Standard Deviation 4.46
|
-3.5 Score on a scale
Standard Deviation 18.60
|
5.7 Score on a scale
Standard Deviation 23.36
|
-1.0 Score on a scale
Standard Deviation 10.95
|
2.6 Score on a scale
Standard Deviation 9.80
|
10.1 Score on a scale
Standard Deviation 29.33
|
-0.7 Score on a scale
Standard Deviation 3.14
|
6.2 Score on a scale
Standard Deviation 22.05
|
-0.4 Score on a scale
Standard Deviation 4.91
|
-2.3 Score on a scale
Standard Deviation 7.08
|
|
Change From Baseline in Functional Living Index - Emesis (FLIE) Scores at Week 16
FLIEQ9
|
-0.1 Score on a scale
Standard Deviation 3.55
|
-3.4 Score on a scale
Standard Deviation 17.86
|
5.3 Score on a scale
Standard Deviation 23.45
|
-0.5 Score on a scale
Standard Deviation 3.64
|
2.3 Score on a scale
Standard Deviation 8.70
|
5.6 Score on a scale
Standard Deviation 22.91
|
-0.7 Score on a scale
Standard Deviation 3.20
|
4.0 Score on a scale
Standard Deviation 22.33
|
-0.1 Score on a scale
Standard Deviation 4.63
|
-3.2 Score on a scale
Standard Deviation 9.80
|
|
Change From Baseline in Functional Living Index - Emesis (FLIE) Scores at Week 16
FLIEQ10
|
-0.3 Score on a scale
Standard Deviation 3.27
|
-4.9 Score on a scale
Standard Deviation 18.81
|
5.8 Score on a scale
Standard Deviation 22.70
|
-1.6 Score on a scale
Standard Deviation 6.51
|
-0.1 Score on a scale
Standard Deviation 3.55
|
4.5 Score on a scale
Standard Deviation 23.37
|
-0.3 Score on a scale
Standard Deviation 1.81
|
4.3 Score on a scale
Standard Deviation 22.00
|
0.2 Score on a scale
Standard Deviation 1.90
|
-2.0 Score on a scale
Standard Deviation 5.12
|
|
Change From Baseline in Functional Living Index - Emesis (FLIE) Scores at Week 16
FLIEQ11
|
15.3 Score on a scale
Standard Deviation 36.17
|
3.3 Score on a scale
Standard Deviation 30.36
|
13.8 Score on a scale
Standard Deviation 34.10
|
-0.5 Score on a scale
Standard Deviation 38.39
|
21.9 Score on a scale
Standard Deviation 42.11
|
7.9 Score on a scale
Standard Deviation 46.96
|
3.6 Score on a scale
Standard Deviation 19.32
|
18.3 Score on a scale
Standard Deviation 40.27
|
7.2 Score on a scale
Standard Deviation 25.77
|
4.0 Score on a scale
Standard Deviation 36.47
|
|
Change From Baseline in Functional Living Index - Emesis (FLIE) Scores at Week 16
FLIEQ12
|
0.1 Score on a scale
Standard Deviation 1.52
|
-3.1 Score on a scale
Standard Deviation 17.45
|
6.4 Score on a scale
Standard Deviation 23.00
|
-0.8 Score on a scale
Standard Deviation 8.09
|
1.8 Score on a scale
Standard Deviation 6.40
|
5.3 Score on a scale
Standard Deviation 22.95
|
-0.2 Score on a scale
Standard Deviation 2.26
|
4.4 Score on a scale
Standard Deviation 21.97
|
-0.4 Score on a scale
Standard Deviation 3.17
|
-0.8 Score on a scale
Standard Deviation 3.49
|
|
Change From Baseline in Functional Living Index - Emesis (FLIE) Scores at Week 16
FLIEQ13
|
0.1 Score on a scale
Standard Deviation 1.57
|
-4.0 Score on a scale
Standard Deviation 18.31
|
6.3 Score on a scale
Standard Deviation 23.03
|
-2.2 Score on a scale
Standard Deviation 8.43
|
1.0 Score on a scale
Standard Deviation 6.12
|
9.8 Score on a scale
Standard Deviation 29.41
|
-0.3 Score on a scale
Standard Deviation 1.71
|
4.3 Score on a scale
Standard Deviation 22.02
|
0.0 Score on a scale
Standard Deviation 1.72
|
-2.1 Score on a scale
Standard Deviation 6.55
|
|
Change From Baseline in Functional Living Index - Emesis (FLIE) Scores at Week 16
FLIEQ14
|
-0.3 Score on a scale
Standard Deviation 2.95
|
-4.1 Score on a scale
Standard Deviation 18.18
|
6.4 Score on a scale
Standard Deviation 23.12
|
-1.4 Score on a scale
Standard Deviation 6.22
|
1.8 Score on a scale
Standard Deviation 6.15
|
5.3 Score on a scale
Standard Deviation 22.94
|
-0.1 Score on a scale
Standard Deviation 1.61
|
4.3 Score on a scale
Standard Deviation 22.0
|
-0.1 Score on a scale
Standard Deviation 1.81
|
-2.1 Score on a scale
Standard Deviation 6.36
|
|
Change From Baseline in Functional Living Index - Emesis (FLIE) Scores at Week 16
FLIEQ15
|
15.5 Score on a scale
Standard Deviation 36.06
|
7.0 Score on a scale
Standard Deviation 23.57
|
14.2 Score on a scale
Standard Deviation 34.03
|
-4.9 Score on a scale
Standard Deviation 18.87
|
19.7 Score on a scale
Standard Deviation 46.48
|
5.6 Score on a scale
Standard Deviation 50.36
|
3.5 Score on a scale
Standard Deviation 19.32
|
18.4 Score on a scale
Standard Deviation 40.22
|
1.5 Score on a scale
Standard Deviation 20.48
|
4.0 Score on a scale
Standard Deviation 36.71
|
|
Change From Baseline in Functional Living Index - Emesis (FLIE) Scores at Week 16
FLIEQ16
|
-0.4 Score on a scale
Standard Deviation 2.58
|
-3.8 Score on a scale
Standard Deviation 18.20
|
6.3 Score on a scale
Standard Deviation 23.02
|
-1.4 Score on a scale
Standard Deviation 7.37
|
-0.5 Score on a scale
Standard Deviation 3.66
|
8.2 Score on a scale
Standard Deviation 25.92
|
-0.1 Score on a scale
Standard Deviation 1.80
|
4.5 Score on a scale
Standard Deviation 21.95
|
0.9 Score on a scale
Standard Deviation 5.55
|
-1.5 Score on a scale
Standard Deviation 4.32
|
|
Change From Baseline in Functional Living Index - Emesis (FLIE) Scores at Week 16
FLIEQ17
|
0.1 Score on a scale
Standard Deviation 1.60
|
-4.1 Score on a scale
Standard Deviation 18.14
|
6.3 Score on a scale
Standard Deviation 22.97
|
-1.2 Score on a scale
Standard Deviation 6.08
|
-1.2 Score on a scale
Standard Deviation 5.10
|
4.5 Score on a scale
Standard Deviation 23.36
|
-0.2 Score on a scale
Standard Deviation 1.98
|
4.3 Score on a scale
Standard Deviation 22.02
|
-1.1 Score on a scale
Standard Deviation 5.62
|
-0.6 Score on a scale
Standard Deviation 3.89
|
|
Change From Baseline in Functional Living Index - Emesis (FLIE) Scores at Week 16
FLIEQ18
|
18.1 Score on a scale
Standard Deviation 37.82
|
6.9 Score on a scale
Standard Deviation 23.47
|
14.2 Score on a scale
Standard Deviation 33.91
|
-3.2 Score on a scale
Standard Deviation 17.62
|
14.9 Score on a scale
Standard Deviation 34.45
|
10.1 Score on a scale
Standard Deviation 45.39
|
7.1 Score on a scale
Standard Deviation 26.96
|
18.5 Score on a scale
Standard Deviation 40.09
|
5.7 Score on a scale
Standard Deviation 26.48
|
6.9 Score on a scale
Standard Deviation 30.76
|
SECONDARY outcome
Timeframe: Week 16Population: Safety Population. Only those participants available at the specified time point were analyzed.
The HCFQ questionnaire is used to record how often participants have felt hungry or craved food, and how full participants felt after finishing meals, on average, in the past week. Participants answered the following seven questions with the response that best described their feelings of hunger, craving, and fullness: Q1, "In the past week I was hungry"; Q2, "In the past week I thought about food"; Q3, "In the past week I wanted to eat"; Q4, "In the past week I ate more than I should have"; Q5, "In the past week, I craved specific food"; Q6, "In the past week when finished meals I felt full"; Q7, "In the past week when finished meals I felt satisfied."
Outcome measures
| Measure |
Placebo
n=39 Participants
Participants received placebo weekly, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
|
Exenatide BID
n=30 Participants
Participants self-administered exenatide as a subcutaneous injection using prefilled pens, in accordance with current prescribing information. A dose of 5 micrograms (μg) was administered twice daily (BID) for the first 4 weeks, followed by a 12-week administration of a 10 μg BID dose. Participants who could not tolerate a 10 μg dose were to continue the study on the 5 μg BID dose.
|
Albiglutide 4 mg Weekly
n=21 Participants
Participants received albiglutide 4 milligrams (mg) weekly, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
|
Albiglutide 15 mg Weekly
n=25 Participants
Participants received albiglutide 15 mg weekly, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
|
Albiglutide 30 mg Weekly
n=22 Participants
Participants received albiglutide 30 mg weekly, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
|
Albiglutide 15 mg Bi-weekly
n=19 Participants
Participants received albiglutide 15 mg every other week, alternating with placebo for each intervening week, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
|
Albiglutide 30 mg Bi-weekly
n=25 Participants
Participants received albiglutide 30 mg every other week, alternating with placebo for each intervening week, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
|
Albiglutide 50 mg Bi-weekly
n=21 Participants
Participants received albiglutide 50 mg every other week, alternating with placebo for each intervening week, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
|
Albiglutide 50 mg Every 4 Weeks
n=30 Participants
Participants received albiglutide 50 mg every 4 weeks, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
|
Albiglutide 100 mg Every 4 Weeks
n=22 Participants
Participants received albiglutide 100 mg every 4 weeks, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With the Indicated Response to Questions on the Hunger, Craving, and Fullness Questionnaire (HCFQ) at Week 16
Q6: Very hungry
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With the Indicated Response to Questions on the Hunger, Craving, and Fullness Questionnaire (HCFQ) at Week 16
Q7: Extremely satisfied
|
3 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
2 Participants
|
1 Participants
|
|
Number of Participants With the Indicated Response to Questions on the Hunger, Craving, and Fullness Questionnaire (HCFQ) at Week 16
Q7: Satisfied
|
27 Participants
|
27 Participants
|
17 Participants
|
17 Participants
|
19 Participants
|
15 Participants
|
22 Participants
|
15 Participants
|
23 Participants
|
14 Participants
|
|
Number of Participants With the Indicated Response to Questions on the Hunger, Craving, and Fullness Questionnaire (HCFQ) at Week 16
Q7: Neither satisfied nor dissatisfied
|
9 Participants
|
3 Participants
|
3 Participants
|
5 Participants
|
1 Participants
|
3 Participants
|
1 Participants
|
5 Participants
|
4 Participants
|
5 Participants
|
|
Number of Participants With the Indicated Response to Questions on the Hunger, Craving, and Fullness Questionnaire (HCFQ) at Week 16
Q7: Dissatisfied
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
|
Number of Participants With the Indicated Response to Questions on the Hunger, Craving, and Fullness Questionnaire (HCFQ) at Week 16
Q7: Extremely dissatisfied
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With the Indicated Response to Questions on the Hunger, Craving, and Fullness Questionnaire (HCFQ) at Week 16
Q1: Often
|
5 Participants
|
5 Participants
|
2 Participants
|
7 Participants
|
6 Participants
|
3 Participants
|
5 Participants
|
2 Participants
|
6 Participants
|
6 Participants
|
|
Number of Participants With the Indicated Response to Questions on the Hunger, Craving, and Fullness Questionnaire (HCFQ) at Week 16
Q1: Sometimes
|
28 Participants
|
17 Participants
|
15 Participants
|
14 Participants
|
14 Participants
|
8 Participants
|
17 Participants
|
11 Participants
|
20 Participants
|
12 Participants
|
|
Number of Participants With the Indicated Response to Questions on the Hunger, Craving, and Fullness Questionnaire (HCFQ) at Week 16
Q5: Never
|
1 Participants
|
4 Participants
|
3 Participants
|
4 Participants
|
0 Participants
|
3 Participants
|
0 Participants
|
3 Participants
|
5 Participants
|
3 Participants
|
|
Number of Participants With the Indicated Response to Questions on the Hunger, Craving, and Fullness Questionnaire (HCFQ) at Week 16
Q1: Always
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
2 Participants
|
2 Participants
|
2 Participants
|
1 Participants
|
|
Number of Participants With the Indicated Response to Questions on the Hunger, Craving, and Fullness Questionnaire (HCFQ) at Week 16
Q1: Rarely
|
4 Participants
|
7 Participants
|
3 Participants
|
4 Participants
|
2 Participants
|
6 Participants
|
0 Participants
|
4 Participants
|
2 Participants
|
2 Participants
|
|
Number of Participants With the Indicated Response to Questions on the Hunger, Craving, and Fullness Questionnaire (HCFQ) at Week 16
Q1: Never
|
1 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With the Indicated Response to Questions on the Hunger, Craving, and Fullness Questionnaire (HCFQ) at Week 16
Q2: Always
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
3 Participants
|
2 Participants
|
3 Participants
|
2 Participants
|
|
Number of Participants With the Indicated Response to Questions on the Hunger, Craving, and Fullness Questionnaire (HCFQ) at Week 16
Q2: Often
|
4 Participants
|
5 Participants
|
2 Participants
|
7 Participants
|
7 Participants
|
3 Participants
|
6 Participants
|
3 Participants
|
6 Participants
|
6 Participants
|
|
Number of Participants With the Indicated Response to Questions on the Hunger, Craving, and Fullness Questionnaire (HCFQ) at Week 16
Q2: Sometimes
|
28 Participants
|
19 Participants
|
14 Participants
|
13 Participants
|
11 Participants
|
10 Participants
|
15 Participants
|
9 Participants
|
16 Participants
|
11 Participants
|
|
Number of Participants With the Indicated Response to Questions on the Hunger, Craving, and Fullness Questionnaire (HCFQ) at Week 16
Q2: Rarely
|
5 Participants
|
4 Participants
|
5 Participants
|
5 Participants
|
4 Participants
|
4 Participants
|
0 Participants
|
4 Participants
|
4 Participants
|
2 Participants
|
|
Number of Participants With the Indicated Response to Questions on the Hunger, Craving, and Fullness Questionnaire (HCFQ) at Week 16
Q2: Never
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
3 Participants
|
1 Participants
|
1 Participants
|
|
Number of Participants With the Indicated Response to Questions on the Hunger, Craving, and Fullness Questionnaire (HCFQ) at Week 16
Q3: Always
|
3 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
4 Participants
|
3 Participants
|
3 Participants
|
0 Participants
|
|
Number of Participants With the Indicated Response to Questions on the Hunger, Craving, and Fullness Questionnaire (HCFQ) at Week 16
Q3: Often
|
7 Participants
|
5 Participants
|
4 Participants
|
4 Participants
|
7 Participants
|
4 Participants
|
4 Participants
|
2 Participants
|
6 Participants
|
9 Participants
|
|
Number of Participants With the Indicated Response to Questions on the Hunger, Craving, and Fullness Questionnaire (HCFQ) at Week 16
Q3: Sometimes
|
26 Participants
|
20 Participants
|
16 Participants
|
18 Participants
|
13 Participants
|
10 Participants
|
16 Participants
|
12 Participants
|
17 Participants
|
11 Participants
|
|
Number of Participants With the Indicated Response to Questions on the Hunger, Craving, and Fullness Questionnaire (HCFQ) at Week 16
Q3: Rarely
|
3 Participants
|
5 Participants
|
1 Participants
|
2 Participants
|
1 Participants
|
4 Participants
|
1 Participants
|
2 Participants
|
4 Participants
|
1 Participants
|
|
Number of Participants With the Indicated Response to Questions on the Hunger, Craving, and Fullness Questionnaire (HCFQ) at Week 16
Q3: Never
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With the Indicated Response to Questions on the Hunger, Craving, and Fullness Questionnaire (HCFQ) at Week 16
Q4: Yes, definitely
|
4 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
2 Participants
|
2 Participants
|
2 Participants
|
2 Participants
|
7 Participants
|
3 Participants
|
|
Number of Participants With the Indicated Response to Questions on the Hunger, Craving, and Fullness Questionnaire (HCFQ) at Week 16
Q4: Yes, probably
|
15 Participants
|
8 Participants
|
8 Participants
|
9 Participants
|
9 Participants
|
9 Participants
|
12 Participants
|
5 Participants
|
9 Participants
|
12 Participants
|
|
Number of Participants With the Indicated Response to Questions on the Hunger, Craving, and Fullness Questionnaire (HCFQ) at Week 16
Q4: I don't know
|
10 Participants
|
5 Participants
|
2 Participants
|
1 Participants
|
1 Participants
|
2 Participants
|
4 Participants
|
2 Participants
|
2 Participants
|
2 Participants
|
|
Number of Participants With the Indicated Response to Questions on the Hunger, Craving, and Fullness Questionnaire (HCFQ) at Week 16
Q4: Probably not
|
7 Participants
|
12 Participants
|
10 Participants
|
9 Participants
|
7 Participants
|
4 Participants
|
4 Participants
|
5 Participants
|
10 Participants
|
4 Participants
|
|
Number of Participants With the Indicated Response to Questions on the Hunger, Craving, and Fullness Questionnaire (HCFQ) at Week 16
Q4: Definitely not
|
3 Participants
|
4 Participants
|
1 Participants
|
4 Participants
|
3 Participants
|
2 Participants
|
3 Participants
|
7 Participants
|
2 Participants
|
1 Participants
|
|
Number of Participants With the Indicated Response to Questions on the Hunger, Craving, and Fullness Questionnaire (HCFQ) at Week 16
Q5: Always
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With the Indicated Response to Questions on the Hunger, Craving, and Fullness Questionnaire (HCFQ) at Week 16
Q5: Often
|
2 Participants
|
2 Participants
|
2 Participants
|
4 Participants
|
1 Participants
|
1 Participants
|
6 Participants
|
3 Participants
|
5 Participants
|
3 Participants
|
|
Number of Participants With the Indicated Response to Questions on the Hunger, Craving, and Fullness Questionnaire (HCFQ) at Week 16
Q5: Sometimes
|
19 Participants
|
15 Participants
|
5 Participants
|
13 Participants
|
14 Participants
|
7 Participants
|
15 Participants
|
9 Participants
|
11 Participants
|
8 Participants
|
|
Number of Participants With the Indicated Response to Questions on the Hunger, Craving, and Fullness Questionnaire (HCFQ) at Week 16
Q5: Rarely
|
16 Participants
|
8 Participants
|
11 Participants
|
4 Participants
|
5 Participants
|
8 Participants
|
2 Participants
|
6 Participants
|
9 Participants
|
8 Participants
|
|
Number of Participants With the Indicated Response to Questions on the Hunger, Craving, and Fullness Questionnaire (HCFQ) at Week 16
Q6: Much too full
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
2 Participants
|
1 Participants
|
|
Number of Participants With the Indicated Response to Questions on the Hunger, Craving, and Fullness Questionnaire (HCFQ) at Week 16
Q6: Very full
|
10 Participants
|
2 Participants
|
3 Participants
|
5 Participants
|
3 Participants
|
4 Participants
|
4 Participants
|
2 Participants
|
7 Participants
|
2 Participants
|
|
Number of Participants With the Indicated Response to Questions on the Hunger, Craving, and Fullness Questionnaire (HCFQ) at Week 16
Q6: Comfortably full
|
26 Participants
|
28 Participants
|
18 Participants
|
17 Participants
|
18 Participants
|
13 Participants
|
20 Participants
|
18 Participants
|
18 Participants
|
17 Participants
|
|
Number of Participants With the Indicated Response to Questions on the Hunger, Craving, and Fullness Questionnaire (HCFQ) at Week 16
Q6: Slightly hungry
|
3 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: Weeks 0, 4, 5, 7, 8, 9, 12, 15, 16, 17 18, 20, 23, and 27Population: PK Analysis Population: all participants for whom a PK sample was obtained and analyzed
Clearance is defined as the volume of plasma cleared of albiglutide per unit time. Samples were collected prior to the administration of study medication on dosing days (Weeks 0, 4, 5, 7, 8, 9, 12, 15) and on the day of the clinic visit at Weeks 16, 17, 18, 20, 23, and 27. The Week 5, 8, and 12 post-dose pharmacokinetic (PK) sampling was performed within 6 days of drug administration.
Outcome measures
| Measure |
Placebo
n=267 Participants
Participants received placebo weekly, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
|
Exenatide BID
Participants self-administered exenatide as a subcutaneous injection using prefilled pens, in accordance with current prescribing information. A dose of 5 micrograms (μg) was administered twice daily (BID) for the first 4 weeks, followed by a 12-week administration of a 10 μg BID dose. Participants who could not tolerate a 10 μg dose were to continue the study on the 5 μg BID dose.
|
Albiglutide 4 mg Weekly
Participants received albiglutide 4 milligrams (mg) weekly, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
|
Albiglutide 15 mg Weekly
Participants received albiglutide 15 mg weekly, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
|
Albiglutide 30 mg Weekly
Participants received albiglutide 30 mg weekly, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
|
Albiglutide 15 mg Bi-weekly
Participants received albiglutide 15 mg every other week, alternating with placebo for each intervening week, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
|
Albiglutide 30 mg Bi-weekly
Participants received albiglutide 30 mg every other week, alternating with placebo for each intervening week, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
|
Albiglutide 50 mg Bi-weekly
Participants received albiglutide 50 mg every other week, alternating with placebo for each intervening week, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
|
Albiglutide 50 mg Every 4 Weeks
Participants received albiglutide 50 mg every 4 weeks, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
|
Albiglutide 100 mg Every 4 Weeks
Participants received albiglutide 100 mg every 4 weeks, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Mean Clearance of Albiglutide
|
94.2 milliliters per hour
Interval 90.1 to 98.9
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Weeks 0, 4, 5, 7, 8, 9, 12, 15, 16, 17 18, 20, 23, and 27Population: PK Analysis Population
Volume of distribution is defined as the apparent volume in which albiglutide is distributed. Samples were collected prior to the administration of study medication on dosing days (Weeks 0, 4, 5, 7, 8, 9, 12, 15) and on the day of the clinic visit at Weeks 16, 17, 18, 20, 23, and 27. The Week 5, 8, and 12 post-dose (PK sampling was performed within 6 days of drug administration.
Outcome measures
| Measure |
Placebo
n=267 Participants
Participants received placebo weekly, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
|
Exenatide BID
Participants self-administered exenatide as a subcutaneous injection using prefilled pens, in accordance with current prescribing information. A dose of 5 micrograms (μg) was administered twice daily (BID) for the first 4 weeks, followed by a 12-week administration of a 10 μg BID dose. Participants who could not tolerate a 10 μg dose were to continue the study on the 5 μg BID dose.
|
Albiglutide 4 mg Weekly
Participants received albiglutide 4 milligrams (mg) weekly, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
|
Albiglutide 15 mg Weekly
Participants received albiglutide 15 mg weekly, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
|
Albiglutide 30 mg Weekly
Participants received albiglutide 30 mg weekly, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
|
Albiglutide 15 mg Bi-weekly
Participants received albiglutide 15 mg every other week, alternating with placebo for each intervening week, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
|
Albiglutide 30 mg Bi-weekly
Participants received albiglutide 30 mg every other week, alternating with placebo for each intervening week, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
|
Albiglutide 50 mg Bi-weekly
Participants received albiglutide 50 mg every other week, alternating with placebo for each intervening week, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
|
Albiglutide 50 mg Every 4 Weeks
Participants received albiglutide 50 mg every 4 weeks, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
|
Albiglutide 100 mg Every 4 Weeks
Participants received albiglutide 100 mg every 4 weeks, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Mean Volume of Distribution of Albiglutide
|
16400 Liters
Interval 15600.0 to 17300.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Weeks 0, 4, 5, 7, 8, 9, 12, 15, 16, 17 18, 20, 23, and 27Population: PK Analysis Population
Absorption rate is defined as the rate at which albiglutide enters the blood circulation. Samples were collected prior to the administration of study medication on dosing days (Weeks 0, 4, 5, 7, 8, 9, 12, 15) and on the day of the clinic visit at Weeks 16, 17, 18, 20, 23, and 27. The Week 5, 8, and 12 post-dose (PK sampling was performed within 6 days of drug administration.
Outcome measures
| Measure |
Placebo
n=267 Participants
Participants received placebo weekly, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
|
Exenatide BID
Participants self-administered exenatide as a subcutaneous injection using prefilled pens, in accordance with current prescribing information. A dose of 5 micrograms (μg) was administered twice daily (BID) for the first 4 weeks, followed by a 12-week administration of a 10 μg BID dose. Participants who could not tolerate a 10 μg dose were to continue the study on the 5 μg BID dose.
|
Albiglutide 4 mg Weekly
Participants received albiglutide 4 milligrams (mg) weekly, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
|
Albiglutide 15 mg Weekly
Participants received albiglutide 15 mg weekly, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
|
Albiglutide 30 mg Weekly
Participants received albiglutide 30 mg weekly, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
|
Albiglutide 15 mg Bi-weekly
Participants received albiglutide 15 mg every other week, alternating with placebo for each intervening week, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
|
Albiglutide 30 mg Bi-weekly
Participants received albiglutide 30 mg every other week, alternating with placebo for each intervening week, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
|
Albiglutide 50 mg Bi-weekly
Participants received albiglutide 50 mg every other week, alternating with placebo for each intervening week, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
|
Albiglutide 50 mg Every 4 Weeks
Participants received albiglutide 50 mg every 4 weeks, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
|
Albiglutide 100 mg Every 4 Weeks
Participants received albiglutide 100 mg every 4 weeks, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Mean Absorption Rate of Albiglutide
|
0.0193 hour^-1
Interval 0.017 to 0.022
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Weeks 0, 4, 5, 7, 8, 9, 12, 15, 16, 17 18, 20, 23, and 27Population: PK/PD Analysis Population: all participants in the PK Analysis Population with sufficient dosing history for inclusion in the PK/PD analysis
EC50 is defined as the concentration of albiglutide that give a half-maximal HbA1c and FPG response. Samples were collected prior to the administration of study medication on dosing days (Weeks 0, 4, 5, 7, 8, 9, 12, 15) and on the day of the clinic visit at Weeks 16, 17, 18, 20, 23, and 27. The Week 5, 8, and 12 post-dose (PK sampling was performed within 6 days of drug administration. EC50 estimates used PK data as well as HbA1c and FPG efficacy data. EC50 was estimated from an inhibitory Emax (maximal possible effect of albiglutide) model.
Outcome measures
| Measure |
Placebo
n=318 Participants
Participants received placebo weekly, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
|
Exenatide BID
Participants self-administered exenatide as a subcutaneous injection using prefilled pens, in accordance with current prescribing information. A dose of 5 micrograms (μg) was administered twice daily (BID) for the first 4 weeks, followed by a 12-week administration of a 10 μg BID dose. Participants who could not tolerate a 10 μg dose were to continue the study on the 5 μg BID dose.
|
Albiglutide 4 mg Weekly
Participants received albiglutide 4 milligrams (mg) weekly, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
|
Albiglutide 15 mg Weekly
Participants received albiglutide 15 mg weekly, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
|
Albiglutide 30 mg Weekly
Participants received albiglutide 30 mg weekly, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
|
Albiglutide 15 mg Bi-weekly
Participants received albiglutide 15 mg every other week, alternating with placebo for each intervening week, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
|
Albiglutide 30 mg Bi-weekly
Participants received albiglutide 30 mg every other week, alternating with placebo for each intervening week, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
|
Albiglutide 50 mg Bi-weekly
Participants received albiglutide 50 mg every other week, alternating with placebo for each intervening week, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
|
Albiglutide 50 mg Every 4 Weeks
Participants received albiglutide 50 mg every 4 weeks, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
|
Albiglutide 100 mg Every 4 Weeks
Participants received albiglutide 100 mg every 4 weeks, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Mean Half-maximal Effective Concentration (EC50) of Albiglutide for HbA1c and FPG
HbA1c, Treatment-naïve group
|
1140 nanograms per milliliter
Interval 483.0 to 2990.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Mean Half-maximal Effective Concentration (EC50) of Albiglutide for HbA1c and FPG
HbA1c, Prior monotherapy group
|
1230 nanograms per milliliter
Interval 403.0 to 3560.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Mean Half-maximal Effective Concentration (EC50) of Albiglutide for HbA1c and FPG
FPG
|
1970 nanograms per milliliter
Interval 950.0 to 5410.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
Adverse Events
Placebo
Serious events: 2 serious events
Other events: 29 other events
Deaths: 0 deaths
Exenatide BID
Serious events: 1 serious events
Other events: 22 other events
Deaths: 0 deaths
Albiglutide 4 mg Weekly
Serious events: 0 serious events
Other events: 24 other events
Deaths: 0 deaths
Albiglutide 15 mg Weekly
Serious events: 3 serious events
Other events: 20 other events
Deaths: 0 deaths
Albiglutide 30 mg Weekly
Serious events: 7 serious events
Other events: 22 other events
Deaths: 0 deaths
Albiglutide 15 mg Bi-weekly
Serious events: 2 serious events
Other events: 22 other events
Deaths: 0 deaths
Albiglutide 30 mg Bi-weekly
Serious events: 5 serious events
Other events: 25 other events
Deaths: 0 deaths
Albiglutide 50 mg Bi-weekly
Serious events: 5 serious events
Other events: 27 other events
Deaths: 0 deaths
Albiglutide 50 mg Every 4 Weeks
Serious events: 7 serious events
Other events: 27 other events
Deaths: 0 deaths
Albiglutide 100 mg Every 4 Weeks
Serious events: 5 serious events
Other events: 26 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo
n=51 participants at risk
Participants received placebo weekly, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
|
Exenatide BID
n=35 participants at risk
Participants self-administered exenatide as a subcutaneous injection using prefilled pens, in accordance with current prescribing information. A dose of 5 micrograms (μg) was administered twice daily (BID) for the first 4 weeks, followed by a 12-week administration of a 10 μg BID dose. Participants who could not tolerate a 10 μg dose were to continue the study on the 5 μg BID dose.
|
Albiglutide 4 mg Weekly
n=35 participants at risk
Participants received albiglutide 4 milligrams (mg) weekly, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
|
Albiglutide 15 mg Weekly
n=35 participants at risk
Participants received albiglutide 15 mg weekly, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
|
Albiglutide 30 mg Weekly
n=31 participants at risk
Participants received albiglutide 30 mg weekly, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
|
Albiglutide 15 mg Bi-weekly
n=33 participants at risk
Participants received albiglutide 15 mg every other week, alternating with placebo for each intervening week, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
|
Albiglutide 30 mg Bi-weekly
n=32 participants at risk
Participants received albiglutide 30 mg every other week, alternating with placebo for each intervening week, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
|
Albiglutide 50 mg Bi-weekly
n=35 participants at risk
Participants received albiglutide 50 mg every other week, alternating with placebo for each intervening week, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
|
Albiglutide 50 mg Every 4 Weeks
n=35 participants at risk
Participants received albiglutide 50 mg every 4 weeks, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
|
Albiglutide 100 mg Every 4 Weeks
n=34 participants at risk
Participants received albiglutide 100 mg every 4 weeks, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Nervous system disorders
Nerve compression
|
0.00%
0/51 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/35 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/35 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/35 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/31 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/33 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
3.1%
1/32 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/35 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/35 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/34 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
|
Nervous system disorders
Syncope
|
0.00%
0/51 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
2.9%
1/35 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/35 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/35 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/31 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/33 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
3.1%
1/32 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/35 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/35 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/34 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
|
Nervous system disorders
Transient ischaemic attack
|
0.00%
0/51 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/35 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/35 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/35 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/31 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/33 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/32 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
2.9%
1/35 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/35 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/34 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
|
Cardiac disorders
Angina pectoris
|
0.00%
0/51 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/35 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/35 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/35 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/31 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/33 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/32 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/35 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/35 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
2.9%
1/34 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
|
Cardiac disorders
Coronary artery disease
|
0.00%
0/51 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/35 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/35 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/35 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/31 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/33 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/32 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/35 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
2.9%
1/35 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/34 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
|
Cardiac disorders
Prinzmetal angina
|
0.00%
0/51 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/35 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/35 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/35 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/31 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
3.0%
1/33 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/32 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/35 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/35 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/34 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
|
Gastrointestinal disorders
Gastric ulcer
|
0.00%
0/51 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/35 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/35 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/35 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/31 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/33 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/32 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/35 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/35 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
2.9%
1/34 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
|
General disorders
Injection site erythema
|
0.00%
0/51 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/35 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/35 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/35 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/31 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
3.0%
1/33 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/32 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
5.7%
2/35 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
5.7%
2/35 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
2.9%
1/34 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
|
General disorders
Injection site hypersensitivity
|
0.00%
0/51 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/35 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/35 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
2.9%
1/35 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/31 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/33 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
3.1%
1/32 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
2.9%
1/35 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
2.9%
1/35 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/34 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
|
General disorders
Injection site pruritus
|
2.0%
1/51 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/35 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/35 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/35 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/31 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/33 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/32 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/35 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/35 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/34 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
|
General disorders
Injection site rash
|
0.00%
0/51 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/35 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/35 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
5.7%
2/35 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
6.5%
2/31 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/33 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
3.1%
1/32 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
5.7%
2/35 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/35 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/34 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
|
General disorders
Injection site reaction
|
2.0%
1/51 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/35 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/35 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/35 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
9.7%
3/31 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
3.0%
1/33 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
3.1%
1/32 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/35 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
2.9%
1/35 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/34 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
|
General disorders
Injection site urticaria
|
0.00%
0/51 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/35 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/35 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/35 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/31 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/33 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/32 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/35 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/35 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
2.9%
1/34 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
|
Immune system disorders
Hypersensitivity
|
0.00%
0/51 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/35 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/35 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/35 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/31 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/33 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/32 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/35 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
5.7%
2/35 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/34 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
|
Reproductive system and breast disorders
Postmenopausal haemorrhage
|
0.00%
0/51 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/35 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/35 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/35 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
3.2%
1/31 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/33 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/32 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/35 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/35 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/34 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/51 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/35 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/35 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/35 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/31 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/33 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/32 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/35 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/35 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
2.9%
1/34 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/51 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/35 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/35 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/35 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
3.2%
1/31 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/33 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/32 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/35 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/35 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/34 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/51 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/35 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/35 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/35 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/31 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/33 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/32 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/35 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/35 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
2.9%
1/34 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
Other adverse events
| Measure |
Placebo
n=51 participants at risk
Participants received placebo weekly, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
|
Exenatide BID
n=35 participants at risk
Participants self-administered exenatide as a subcutaneous injection using prefilled pens, in accordance with current prescribing information. A dose of 5 micrograms (μg) was administered twice daily (BID) for the first 4 weeks, followed by a 12-week administration of a 10 μg BID dose. Participants who could not tolerate a 10 μg dose were to continue the study on the 5 μg BID dose.
|
Albiglutide 4 mg Weekly
n=35 participants at risk
Participants received albiglutide 4 milligrams (mg) weekly, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
|
Albiglutide 15 mg Weekly
n=35 participants at risk
Participants received albiglutide 15 mg weekly, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
|
Albiglutide 30 mg Weekly
n=31 participants at risk
Participants received albiglutide 30 mg weekly, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
|
Albiglutide 15 mg Bi-weekly
n=33 participants at risk
Participants received albiglutide 15 mg every other week, alternating with placebo for each intervening week, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
|
Albiglutide 30 mg Bi-weekly
n=32 participants at risk
Participants received albiglutide 30 mg every other week, alternating with placebo for each intervening week, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
|
Albiglutide 50 mg Bi-weekly
n=35 participants at risk
Participants received albiglutide 50 mg every other week, alternating with placebo for each intervening week, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
|
Albiglutide 50 mg Every 4 Weeks
n=35 participants at risk
Participants received albiglutide 50 mg every 4 weeks, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
|
Albiglutide 100 mg Every 4 Weeks
n=34 participants at risk
Participants received albiglutide 100 mg every 4 weeks, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
General disorders
Asthenia
|
0.00%
0/51 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/35 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/35 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
2.9%
1/35 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
3.2%
1/31 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
3.0%
1/33 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/32 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
5.7%
2/35 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/35 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
2.9%
1/34 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
|
General disorders
Injection site pruritus
|
0.00%
0/51 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/35 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/35 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/35 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/31 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/33 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/32 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/35 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
5.7%
2/35 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/34 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
|
General disorders
Injection site pain
|
0.00%
0/51 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/35 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/35 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/35 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/31 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
6.1%
2/33 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/32 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/35 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/35 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/34 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
2.0%
1/51 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/35 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
2.9%
1/35 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
5.7%
2/35 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/31 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
3.0%
1/33 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
9.4%
3/32 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/35 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
2.9%
1/35 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/34 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
0.00%
0/51 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
2.9%
1/35 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/35 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/35 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
12.9%
4/31 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
3.0%
1/33 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/32 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/35 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
2.9%
1/35 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/34 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
|
Gastrointestinal disorders
Nausea
|
11.8%
6/51 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
40.0%
14/35 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
14.3%
5/35 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
20.0%
7/35 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
25.8%
8/31 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
27.3%
9/33 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
25.0%
8/32 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
54.3%
19/35 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
37.1%
13/35 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
52.9%
18/34 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
|
Gastrointestinal disorders
Vomiting
|
2.0%
1/51 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
17.1%
6/35 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/35 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
8.6%
3/35 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
12.9%
4/31 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
9.1%
3/33 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
9.4%
3/32 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
28.6%
10/35 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
17.1%
6/35 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
41.2%
14/34 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
|
Gastrointestinal disorders
Diarrhoea
|
3.9%
2/51 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
22.9%
8/35 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
14.3%
5/35 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
5.7%
2/35 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
16.1%
5/31 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
12.1%
4/33 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
21.9%
7/32 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
17.1%
6/35 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
17.1%
6/35 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
20.6%
7/34 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
|
Gastrointestinal disorders
Flatulence
|
2.0%
1/51 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/35 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/35 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
2.9%
1/35 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
3.2%
1/31 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/33 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
3.1%
1/32 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/35 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
5.7%
2/35 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
11.8%
4/34 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
|
Gastrointestinal disorders
Dyspepsia
|
3.9%
2/51 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/35 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/35 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
2.9%
1/35 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
6.5%
2/31 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
6.1%
2/33 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
6.2%
2/32 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
8.6%
3/35 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/35 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
8.8%
3/34 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
|
Gastrointestinal disorders
Abdominal pain
|
2.0%
1/51 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
5.7%
2/35 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/35 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/35 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/31 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
3.0%
1/33 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
3.1%
1/32 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
11.4%
4/35 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
2.9%
1/35 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
5.9%
2/34 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
|
Gastrointestinal disorders
Abdominal distension
|
3.9%
2/51 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/35 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
2.9%
1/35 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
2.9%
1/35 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
3.2%
1/31 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/33 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
9.4%
3/32 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
5.7%
2/35 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
2.9%
1/35 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
2.9%
1/34 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/51 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
5.7%
2/35 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
2.9%
1/35 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
5.7%
2/35 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
3.2%
1/31 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/33 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
6.2%
2/32 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
5.7%
2/35 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
2.9%
1/35 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
2.9%
1/34 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
2.0%
1/51 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/35 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/35 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/35 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
6.5%
2/31 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/33 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/32 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
2.9%
1/35 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
2.9%
1/35 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
2.9%
1/34 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
2.0%
1/51 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
2.9%
1/35 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
2.9%
1/35 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
11.4%
4/35 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/31 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
3.0%
1/33 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/32 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
2.9%
1/35 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/35 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/34 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
|
Gastrointestinal disorders
Stomach discomfort
|
0.00%
0/51 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/35 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/35 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/35 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
3.2%
1/31 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/33 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/32 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
5.7%
2/35 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
5.7%
2/35 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/34 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/51 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/35 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
5.7%
2/35 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/35 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/31 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/33 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/32 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/35 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/35 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/34 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
|
Infections and infestations
Sinusitis
|
2.0%
1/51 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/35 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
8.6%
3/35 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/35 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
3.2%
1/31 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
3.0%
1/33 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
3.1%
1/32 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/35 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/35 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
8.8%
3/34 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
|
Infections and infestations
Nasopharyngitis
|
5.9%
3/51 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
5.7%
2/35 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
5.7%
2/35 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
11.4%
4/35 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
9.7%
3/31 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
6.1%
2/33 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
9.4%
3/32 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
11.4%
4/35 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
11.4%
4/35 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
5.9%
2/34 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
|
Infections and infestations
Urinary tract infection
|
5.9%
3/51 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/35 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
5.7%
2/35 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
5.7%
2/35 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
3.2%
1/31 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/33 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/32 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
2.9%
1/35 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
2.9%
1/35 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
2.9%
1/34 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
|
Infections and infestations
Upper respiratory tract infection
|
9.8%
5/51 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
11.4%
4/35 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
8.6%
3/35 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/35 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
9.7%
3/31 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
15.2%
5/33 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
6.2%
2/32 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
2.9%
1/35 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
8.6%
3/35 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/34 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
|
Infections and infestations
Influenza
|
0.00%
0/51 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/35 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
2.9%
1/35 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/35 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
9.7%
3/31 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
9.1%
3/33 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
6.2%
2/32 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
8.6%
3/35 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
8.6%
3/35 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/34 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/51 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
5.7%
2/35 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/35 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/35 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
3.2%
1/31 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
3.0%
1/33 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
6.2%
2/32 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
2.9%
1/35 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
2.9%
1/35 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/34 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/51 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/35 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
2.9%
1/35 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/35 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/31 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
9.1%
3/33 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
3.1%
1/32 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/35 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
5.7%
2/35 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/34 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
|
Nervous system disorders
Headache
|
5.9%
3/51 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
11.4%
4/35 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
17.1%
6/35 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
14.3%
5/35 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
16.1%
5/31 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
18.2%
6/33 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
15.6%
5/32 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
11.4%
4/35 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
14.3%
5/35 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
23.5%
8/34 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
|
Nervous system disorders
Dizziness
|
7.8%
4/51 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
8.6%
3/35 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
14.3%
5/35 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
5.7%
2/35 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
6.5%
2/31 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
6.1%
2/33 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
6.2%
2/32 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
5.7%
2/35 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
14.3%
5/35 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
5.9%
2/34 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
|
Nervous system disorders
Sinus headache
|
0.00%
0/51 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/35 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/35 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/35 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
6.5%
2/31 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/33 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/32 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/35 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
2.9%
1/35 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
2.9%
1/34 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
13.7%
7/51 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/35 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
17.1%
6/35 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
5.7%
2/35 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
6.5%
2/31 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
12.1%
4/33 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
12.5%
4/32 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
11.4%
4/35 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
2.9%
1/35 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
11.8%
4/34 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
|
Metabolism and nutrition disorders
Anorexia
|
0.00%
0/51 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
2.9%
1/35 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/35 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/35 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/31 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
6.1%
2/33 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
3.1%
1/32 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/35 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
2.9%
1/35 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
2.9%
1/34 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
|
Metabolism and nutrition disorders
Hypertriglyceridaemia
|
0.00%
0/51 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/35 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/35 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
2.9%
1/35 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/31 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
6.1%
2/33 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/32 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
8.6%
3/35 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/35 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/34 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/51 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/35 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/35 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/35 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
3.2%
1/31 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/33 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
3.1%
1/32 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
5.7%
2/35 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
2.9%
1/35 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/34 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
|
Metabolism and nutrition disorders
Increased appetite
|
0.00%
0/51 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/35 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/35 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/35 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/31 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/33 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
3.1%
1/32 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/35 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
5.7%
2/35 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/34 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/51 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/35 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
5.7%
2/35 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/35 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/31 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/33 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/32 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/35 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/35 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/34 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
2.0%
1/51 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/35 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/35 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
8.6%
3/35 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
3.2%
1/31 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/33 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/32 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
2.9%
1/35 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/35 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
8.8%
3/34 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
5.9%
3/51 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/35 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
14.3%
5/35 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
5.7%
2/35 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
6.5%
2/31 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
6.1%
2/33 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
6.2%
2/32 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
5.7%
2/35 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
5.7%
2/35 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
5.9%
2/34 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/51 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/35 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/35 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/35 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
3.2%
1/31 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/33 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
3.1%
1/32 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/35 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
2.9%
1/35 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
5.9%
2/34 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
2.0%
1/51 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/35 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
2.9%
1/35 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
2.9%
1/35 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/31 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
3.0%
1/33 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/32 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
11.4%
4/35 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
5.7%
2/35 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
2.9%
1/34 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/51 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/35 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/35 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
2.9%
1/35 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/31 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
6.1%
2/33 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/32 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
2.9%
1/35 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/35 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
2.9%
1/34 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
2.0%
1/51 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
2.9%
1/35 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/35 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
8.6%
3/35 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/31 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
3.0%
1/33 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/32 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
5.7%
2/35 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
2.9%
1/35 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/34 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
|
General disorders
Fatigue
|
2.0%
1/51 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
2.9%
1/35 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
2.9%
1/35 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
2.9%
1/35 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
6.5%
2/31 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
3.0%
1/33 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
6.2%
2/32 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
5.7%
2/35 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
5.7%
2/35 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
2.9%
1/34 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
|
General disorders
Injection site erythema
|
2.0%
1/51 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/35 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/35 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/35 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/31 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
3.0%
1/33 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
3.1%
1/32 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
2.9%
1/35 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
5.7%
2/35 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
2.9%
1/34 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
0.00%
0/51 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/35 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/35 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/35 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
6.5%
2/31 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/33 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/32 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
2.9%
1/35 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/35 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/34 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Allergic sinusitis
|
0.00%
0/51 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/35 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/35 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/35 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
6.5%
2/31 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/33 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/32 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/35 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/35 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/34 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
|
Psychiatric disorders
Insomnia
|
2.0%
1/51 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/35 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/35 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
5.7%
2/35 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
3.2%
1/31 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/33 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
3.1%
1/32 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
2.9%
1/35 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
2.9%
1/35 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
2.9%
1/34 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
|
Psychiatric disorders
Anxiety
|
2.0%
1/51 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
2.9%
1/35 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
2.9%
1/35 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
2.9%
1/35 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/31 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
3.0%
1/33 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
9.4%
3/32 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/35 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
2.9%
1/35 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/34 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
|
Vascular disorders
Hypotension
|
0.00%
0/51 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
2.9%
1/35 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/35 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
2.9%
1/35 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/31 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/33 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/32 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/35 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/35 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
5.9%
2/34 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
|
Vascular disorders
Hypertension
|
3.9%
2/51 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
5.7%
2/35 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
8.6%
3/35 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/35 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
6.5%
2/31 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
3.0%
1/33 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
3.1%
1/32 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/35 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/35 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
2.9%
1/34 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
|
Investigations
Weight decreased
|
0.00%
0/51 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/35 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/35 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/35 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/31 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/33 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/32 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/35 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/35 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
5.9%
2/34 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
|
Investigations
Blood creatine phosphokinase increased
|
2.0%
1/51 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
2.9%
1/35 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/35 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/35 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/31 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/33 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
6.2%
2/32 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
2.9%
1/35 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/35 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/34 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
2.0%
1/51 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/35 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/35 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
2.9%
1/35 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/31 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/33 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/32 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/35 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
5.7%
2/35 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/34 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
|
Skin and subcutaneous tissue disorders
Ingrowing nail
|
0.00%
0/51 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/35 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/35 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/35 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/31 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/33 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/32 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/35 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
5.7%
2/35 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/34 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
|
Eye disorders
Conjunctivitis
|
2.0%
1/51 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/35 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
2.9%
1/35 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/35 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/31 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/33 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
3.1%
1/32 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/35 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
5.7%
2/35 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/34 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
|
Injury, poisoning and procedural complications
Joint sprain
|
0.00%
0/51 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
2.9%
1/35 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/35 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
2.9%
1/35 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
6.5%
2/31 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/33 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/32 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/35 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/35 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/34 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
|
Reproductive system and breast disorders
Erectile dysfunction
|
0.00%
0/51 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/35 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/35 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
5.7%
2/35 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/31 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/33 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/32 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/35 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/35 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
2.9%
1/34 • On-therapy serious adverse events (SAEs) and non-serious AEs, defined as those that have a start date on or after the first day of study medication and within 56 days after the end of study medication, are reported.
SAEs and non-serious AEs are reported for members of the Safety Population, comprised of all participants who received at least one dose of study treatment.
|
Additional Information
GSK Response Center
GlaxoSmithKline
Phone: 866-435-7343
Results disclosure agreements
- Principal investigator is a sponsor employee GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
- Publication restrictions are in place
Restriction type: OTHER