Trial Outcomes & Findings for A Study of the Efficacy and Safety of Dulaglutide (LY2189265) in Participants With Type 2 Diabetes (NCT NCT03495102)
NCT ID: NCT03495102
Last Updated: 2020-06-12
Results Overview
HbA1c is measured to identify average plasma glucose concentration over prolonged periods of time. The Least Squares (LS) mean was estimated from a mixed-effects model with repeated measures (MMRM) that included the independent variables:Baseline + Pooled Country + Treatment + Time + Treatment\*Time (Type III sum of squares).
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
1842 participants
Primary outcome timeframe
Baseline, Week 36
Results posted on
2020-06-12
Participant Flow
Participant milestones
| Measure |
Dulaglutide 1.5 mg
Dulaglutide 1.5 mg administered subcutaneously (SC) once a week.
|
Dulaglutide 3 mg
Dulaglutide 3 mg administered SC once a week.
|
Dulaglutide 4.5 mg
Dulaglutide 4.5 mg administered SC once a week.
|
|---|---|---|---|
|
Overall Study
STARTED
|
612
|
616
|
614
|
|
Overall Study
Received at Least One Dose of Study Drug
|
612
|
616
|
614
|
|
Overall Study
COMPLETED
|
556
|
549
|
560
|
|
Overall Study
NOT COMPLETED
|
56
|
67
|
54
|
Reasons for withdrawal
| Measure |
Dulaglutide 1.5 mg
Dulaglutide 1.5 mg administered subcutaneously (SC) once a week.
|
Dulaglutide 3 mg
Dulaglutide 3 mg administered SC once a week.
|
Dulaglutide 4.5 mg
Dulaglutide 4.5 mg administered SC once a week.
|
|---|---|---|---|
|
Overall Study
Adverse Event
|
5
|
7
|
10
|
|
Overall Study
Death
|
3
|
4
|
4
|
|
Overall Study
Lost to Follow-up
|
15
|
16
|
17
|
|
Overall Study
Physician Decision
|
2
|
0
|
2
|
|
Overall Study
Withdrawal by Subject
|
25
|
36
|
18
|
|
Overall Study
Protocol Violation
|
1
|
1
|
0
|
|
Overall Study
Site Closure
|
3
|
1
|
2
|
|
Overall Study
Non-compliance
|
1
|
0
|
0
|
|
Overall Study
Participant Duplicated at Another Site
|
0
|
0
|
1
|
|
Overall Study
Primary Care Physician Recommendation
|
0
|
1
|
0
|
|
Overall Study
Relocated to Another Country
|
0
|
1
|
0
|
|
Overall Study
Participant was in Rehabilitation
|
1
|
0
|
0
|
Baseline Characteristics
A Study of the Efficacy and Safety of Dulaglutide (LY2189265) in Participants With Type 2 Diabetes
Baseline characteristics by cohort
| Measure |
Dulaglutide 1.5 mg
n=612 Participants
Dulaglutide 1.5 mg administered subcutaneously (SC) once a week.
|
Dulaglutide 3 mg
n=616 Participants
Dulaglutide 3 mg administered SC once a week.
|
Dulaglutide 4.5 mg
n=614 Participants
Dulaglutide 4.5 mg administered SC once a week.
|
Total
n=1842 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
57.8 years
STANDARD_DEVIATION 9.7 • n=5 Participants
|
56.9 years
STANDARD_DEVIATION 10.2 • n=7 Participants
|
56.6 years
STANDARD_DEVIATION 10.2 • n=5 Participants
|
57.1 years
STANDARD_DEVIATION 10.0 • n=4 Participants
|
|
Sex: Female, Male
Female
|
314 Participants
n=5 Participants
|
288 Participants
n=7 Participants
|
296 Participants
n=5 Participants
|
898 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
298 Participants
n=5 Participants
|
328 Participants
n=7 Participants
|
318 Participants
n=5 Participants
|
944 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
214 Participants
n=5 Participants
|
214 Participants
n=7 Participants
|
213 Participants
n=5 Participants
|
641 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
369 Participants
n=5 Participants
|
363 Participants
n=7 Participants
|
371 Participants
n=5 Participants
|
1103 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
29 Participants
n=5 Participants
|
39 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
98 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
30 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
32 Participants
n=5 Participants
|
88 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
13 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
45 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
28 Participants
n=5 Participants
|
31 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
82 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
529 Participants
n=5 Participants
|
521 Participants
n=7 Participants
|
530 Participants
n=5 Participants
|
1580 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
11 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
42 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Region of Enrollment
Argentina
|
96 Participants
n=5 Participants
|
97 Participants
n=7 Participants
|
97 Participants
n=5 Participants
|
290 Participants
n=4 Participants
|
|
Region of Enrollment
Romania
|
77 Participants
n=5 Participants
|
78 Participants
n=7 Participants
|
78 Participants
n=5 Participants
|
233 Participants
n=4 Participants
|
|
Region of Enrollment
Hungary
|
25 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
73 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
169 Participants
n=5 Participants
|
169 Participants
n=7 Participants
|
170 Participants
n=5 Participants
|
508 Participants
n=4 Participants
|
|
Region of Enrollment
Russia
|
9 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
29 Participants
n=4 Participants
|
|
Region of Enrollment
Spain
|
19 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
58 Participants
n=4 Participants
|
|
Region of Enrollment
Greece
|
33 Participants
n=5 Participants
|
34 Participants
n=7 Participants
|
33 Participants
n=5 Participants
|
100 Participants
n=4 Participants
|
|
Region of Enrollment
Canada
|
12 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
35 Participants
n=4 Participants
|
|
Region of Enrollment
Austria
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
13 Participants
n=4 Participants
|
|
Region of Enrollment
Taiwan
|
5 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
15 Participants
n=4 Participants
|
|
Region of Enrollment
Poland
|
56 Participants
n=5 Participants
|
56 Participants
n=7 Participants
|
55 Participants
n=5 Participants
|
167 Participants
n=4 Participants
|
|
Region of Enrollment
Mexico
|
37 Participants
n=5 Participants
|
38 Participants
n=7 Participants
|
36 Participants
n=5 Participants
|
111 Participants
n=4 Participants
|
|
Region of Enrollment
Italy
|
9 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
25 Participants
n=4 Participants
|
|
Region of Enrollment
Slovakia
|
43 Participants
n=5 Participants
|
44 Participants
n=7 Participants
|
44 Participants
n=5 Participants
|
131 Participants
n=4 Participants
|
|
Region of Enrollment
Israel
|
18 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
54 Participants
n=4 Participants
|
|
Hemoglobin A1C (HbA1c) at Baseline
|
8.64 Percentage of HbA1c
STANDARD_DEVIATION 0.94 • n=5 Participants
|
8.63 Percentage of HbA1c
STANDARD_DEVIATION 1.00 • n=7 Participants
|
8.64 Percentage of HbA1c
STANDARD_DEVIATION 0.91 • n=5 Participants
|
8.64 Percentage of HbA1c
STANDARD_DEVIATION 0.95 • n=4 Participants
|
PRIMARY outcome
Timeframe: Baseline, Week 36Population: All participants who received at least one dose of study drug and had a baseline and at least 1 post-baseline HbA1c value, excluding data post treatment discontinuation and/or initiation of new antihyperglycemic medications.
HbA1c is measured to identify average plasma glucose concentration over prolonged periods of time. The Least Squares (LS) mean was estimated from a mixed-effects model with repeated measures (MMRM) that included the independent variables:Baseline + Pooled Country + Treatment + Time + Treatment\*Time (Type III sum of squares).
Outcome measures
| Measure |
Dulaglutide 1.5 mg
n=523 Participants
Dulaglutide 1.5 mg administered subcutaneously (SC) once a week.
|
Dulaglutide 3 mg
n=521 Participants
Dulaglutide 3 mg administered SC once a week.
|
Dulaglutide 4.5 mg
n=526 Participants
Dulaglutide 4.5 mg administered SC once a week.
|
|---|---|---|---|
|
Change in Hemoglobin A1c (HbA1c) From Baseline
|
-1.53 Percentage of HbA1c
Standard Error 0.04
|
-1.71 Percentage of HbA1c
Standard Error 0.04
|
-1.87 Percentage of HbA1c
Standard Error 0.04
|
SECONDARY outcome
Timeframe: Baseline, Week 36Population: All participants who received at least one dose of study drug and had a baseline and at least 1 post-baseline body weight value, excluding data post treatment discontinuation and/or initiation of new antihyperglycemic medications.
Least Squares (LS) mean was determined by mixed-model repeated measures (MMRM) model with independent variables: Baseline + Baseline HbA1c group + Pooled Country + Treatment + Time + Treatment\*Time (Type III sum of squares).
Outcome measures
| Measure |
Dulaglutide 1.5 mg
n=522 Participants
Dulaglutide 1.5 mg administered subcutaneously (SC) once a week.
|
Dulaglutide 3 mg
n=520 Participants
Dulaglutide 3 mg administered SC once a week.
|
Dulaglutide 4.5 mg
n=526 Participants
Dulaglutide 4.5 mg administered SC once a week.
|
|---|---|---|---|
|
Change in Body Weight From Baseline
|
-3.1 Kilograms (Kg)
Standard Deviation 0.19
|
-4.0 Kilograms (Kg)
Standard Deviation 0.19
|
-4.7 Kilograms (Kg)
Standard Deviation 0.19
|
SECONDARY outcome
Timeframe: Week 36Population: All participants who received at least one dose of study drug and had a baseline and at least 1 post-baseline HbA1c value, excluding data post treatment discontinuation and/or initiation of new antihyperglycemic medications.
Percentage of participants achieving HbA1c target \<7.0%.
Outcome measures
| Measure |
Dulaglutide 1.5 mg
n=523 Participants
Dulaglutide 1.5 mg administered subcutaneously (SC) once a week.
|
Dulaglutide 3 mg
n=521 Participants
Dulaglutide 3 mg administered SC once a week.
|
Dulaglutide 4.5 mg
n=526 Participants
Dulaglutide 4.5 mg administered SC once a week.
|
|---|---|---|---|
|
Percentage of Participants Achieving HbA1c Target <7.0%
|
56.98 percentage of participants
|
64.68 percentage of participants
|
71.48 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline, Week 36Population: All participants who received at least one dose of study drug and had a baseline and at least 1 post-baseline FSG value, excluding data post treatment discontinuation and/or initiation of new antihyperglycemic medications.
Least Squares (LS) mean was determined by mixed-model repeated measures (MMRM) model with covariates: Baseline + Baseline HbA1c group + Pooled Country + Treatment + Time + Treatment\*Time (Type III sum of squares).
Outcome measures
| Measure |
Dulaglutide 1.5 mg
n=510 Participants
Dulaglutide 1.5 mg administered subcutaneously (SC) once a week.
|
Dulaglutide 3 mg
n=509 Participants
Dulaglutide 3 mg administered SC once a week.
|
Dulaglutide 4.5 mg
n=514 Participants
Dulaglutide 4.5 mg administered SC once a week.
|
|---|---|---|---|
|
Change in Fasting Serum Glucose (FSG) From Baseline
|
-44.2 milligrams per deciliter (mg/dL)
Standard Error 1.50
|
-47.9 milligrams per deciliter (mg/dL)
Standard Error 1.50
|
-52.3 milligrams per deciliter (mg/dL)
Standard Error 1.50
|
SECONDARY outcome
Timeframe: Week 36Population: All participants who received at least one dose of study drug.
Hypoglycemia was defined as blood glucose \< 54 mg/dL, excluding post-rescue records. Estimate is based on Group Mean from negative binomial model. The negative binomial model for post-baseline comparisons between treatments and control group: Number of episodes = Pooled Country + HbA1c at Baseline (%) + Treatment, with log (exposure in days/365.25) as an offset variable.
Outcome measures
| Measure |
Dulaglutide 1.5 mg
n=612 Participants
Dulaglutide 1.5 mg administered subcutaneously (SC) once a week.
|
Dulaglutide 3 mg
n=616 Participants
Dulaglutide 3 mg administered SC once a week.
|
Dulaglutide 4.5 mg
n=614 Participants
Dulaglutide 4.5 mg administered SC once a week.
|
|---|---|---|---|
|
Rate of Documented Symptomatic Hypoglycemic Episodes
|
0.02 Episodes/participant/365.25 days
Standard Error 0.01
|
0.00 Episodes/participant/365.25 days
Standard Error 0.00
|
0.02 Episodes/participant/365.25 days
Standard Error 0.01
|
SECONDARY outcome
Timeframe: Week 4, Week 12, Week 36, Week 52Population: All participants who received at least one dose of study drug and had evaluable PK data.
Pharmacokinetic (PK): Steady-state Maximum Concentration(Cmax,ss).
Outcome measures
| Measure |
Dulaglutide 1.5 mg
n=612 Participants
Dulaglutide 1.5 mg administered subcutaneously (SC) once a week.
|
Dulaglutide 3 mg
n=616 Participants
Dulaglutide 3 mg administered SC once a week.
|
Dulaglutide 4.5 mg
n=614 Participants
Dulaglutide 4.5 mg administered SC once a week.
|
|---|---|---|---|
|
Pharmacokinetic (PK): Steady-state Maximum Concentration(Cmax,ss)
|
79.6 nanogram/milliliter (ng/mL)
Interval 77.7 to 81.7
|
159 nanogram/milliliter (ng/mL)
Interval 155.0 to 163.0
|
238 nanogram/milliliter (ng/mL)
Interval 232.0 to 243.0
|
SECONDARY outcome
Timeframe: Week 4, Week 12, Week 36, Week 52Population: All participants who received at least one dose of study drug and had evaluable PK data.
Pharmacokinetic (PK): Area Under the Curve AUC (0-168)ss at Steady State.
Outcome measures
| Measure |
Dulaglutide 1.5 mg
n=612 Participants
Dulaglutide 1.5 mg administered subcutaneously (SC) once a week.
|
Dulaglutide 3 mg
n=616 Participants
Dulaglutide 3 mg administered SC once a week.
|
Dulaglutide 4.5 mg
n=614 Participants
Dulaglutide 4.5 mg administered SC once a week.
|
|---|---|---|---|
|
Pharmacokinetic (PK): Area Under the Curve AUC (0-168)ss at Steady State
|
11200 nanogram*hour/milliliter (ng*h/mL)
Interval 10900.0 to 11500.0
|
22300 nanogram*hour/milliliter (ng*h/mL)
Interval 21800.0 to 22900.0
|
33400 nanogram*hour/milliliter (ng*h/mL)
Interval 32700.0 to 34200.0
|
Adverse Events
Dulaglutide 1.5 mg
Serious events: 53 serious events
Other events: 156 other events
Deaths: 3 deaths
Dulaglutide 3 mg
Serious events: 45 serious events
Other events: 190 other events
Deaths: 4 deaths
Dulaglutide 4.5 mg
Serious events: 38 serious events
Other events: 195 other events
Deaths: 4 deaths
Serious adverse events
| Measure |
Dulaglutide 1.5 mg
n=612 participants at risk
Dulaglutide 1.5 mg administered subcutaneously (SC) once a week.
|
Dulaglutide 3 mg
n=616 participants at risk
Dulaglutide 3 mg administered SC once a week.
|
Dulaglutide 4.5 mg
n=614 participants at risk
Dulaglutide 4.5 mg administered SC once a week.
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/612 • Up to Week 56
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/616 • Up to Week 56
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.16%
1/614 • Number of events 1 • Up to Week 56
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Blood and lymphatic system disorders
Blood loss anaemia
|
0.16%
1/612 • Number of events 1 • Up to Week 56
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/616 • Up to Week 56
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/614 • Up to Week 56
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/612 • Up to Week 56
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.16%
1/616 • Number of events 1 • Up to Week 56
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/614 • Up to Week 56
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Cardiac disorders
Acute myocardial infarction
|
0.33%
2/612 • Number of events 2 • Up to Week 56
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.32%
2/616 • Number of events 2 • Up to Week 56
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/614 • Up to Week 56
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Cardiac disorders
Angina pectoris
|
0.00%
0/612 • Up to Week 56
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.16%
1/616 • Number of events 1 • Up to Week 56
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.16%
1/614 • Number of events 1 • Up to Week 56
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Cardiac disorders
Arteriosclerosis coronary artery
|
0.00%
0/612 • Up to Week 56
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/616 • Up to Week 56
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.16%
1/614 • Number of events 1 • Up to Week 56
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Cardiac disorders
Atrial fibrillation
|
0.49%
3/612 • Number of events 3 • Up to Week 56
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/616 • Up to Week 56
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.16%
1/614 • Number of events 1 • Up to Week 56
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Cardiac disorders
Atrioventricular block complete
|
0.16%
1/612 • Number of events 1 • Up to Week 56
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.16%
1/616 • Number of events 1 • Up to Week 56
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/614 • Up to Week 56
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Cardiac disorders
Atrioventricular block second degree
|
0.00%
0/612 • Up to Week 56
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/616 • Up to Week 56
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.16%
1/614 • Number of events 1 • Up to Week 56
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Cardiac disorders
Cardiac arrest
|
0.16%
1/612 • Number of events 1 • Up to Week 56
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/616 • Up to Week 56
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/614 • Up to Week 56
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Cardiac disorders
Cardiac failure
|
0.16%
1/612 • Number of events 1 • Up to Week 56
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/616 • Up to Week 56
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.16%
1/614 • Number of events 1 • Up to Week 56
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Cardiac disorders
Cardiac failure congestive
|
0.00%
0/612 • Up to Week 56
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/616 • Up to Week 56
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.16%
1/614 • Number of events 1 • Up to Week 56
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Cardiac disorders
Cardio-respiratory arrest
|
0.00%
0/612 • Up to Week 56
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.16%
1/616 • Number of events 1 • Up to Week 56
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.16%
1/614 • Number of events 1 • Up to Week 56
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Cardiac disorders
Congestive cardiomyopathy
|
0.00%
0/612 • Up to Week 56
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/616 • Up to Week 56
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.16%
1/614 • Number of events 1 • Up to Week 56
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Cardiac disorders
Coronary artery disease
|
0.00%
0/612 • Up to Week 56
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/616 • Up to Week 56
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.16%
1/614 • Number of events 1 • Up to Week 56
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Cardiac disorders
Left ventricular failure
|
0.00%
0/612 • Up to Week 56
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/616 • Up to Week 56
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.16%
1/614 • Number of events 1 • Up to Week 56
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Cardiac disorders
Myocardial infarction
|
0.16%
1/612 • Number of events 1 • Up to Week 56
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.32%
2/616 • Number of events 2 • Up to Week 56
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/614 • Up to Week 56
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Cardiac disorders
Myocardial ischaemia
|
0.00%
0/612 • Up to Week 56
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/616 • Up to Week 56
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.16%
1/614 • Number of events 1 • Up to Week 56
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Ear and labyrinth disorders
Acute vestibular syndrome
|
0.16%
1/612 • Number of events 1 • Up to Week 56
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/616 • Up to Week 56
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/614 • Up to Week 56
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Ear and labyrinth disorders
Vertigo
|
0.16%
1/612 • Number of events 1 • Up to Week 56
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/616 • Up to Week 56
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/614 • Up to Week 56
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Endocrine disorders
Goitre
|
0.16%
1/612 • Number of events 1 • Up to Week 56
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.16%
1/616 • Number of events 1 • Up to Week 56
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/614 • Up to Week 56
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Eye disorders
Eyelid oedema
|
0.00%
0/612 • Up to Week 56
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.16%
1/616 • Number of events 1 • Up to Week 56
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/614 • Up to Week 56
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.16%
1/612 • Number of events 1 • Up to Week 56
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/616 • Up to Week 56
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.33%
2/614 • Number of events 2 • Up to Week 56
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/612 • Up to Week 56
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/616 • Up to Week 56
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.16%
1/614 • Number of events 1 • Up to Week 56
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/612 • Up to Week 56
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/616 • Up to Week 56
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.16%
1/614 • Number of events 1 • Up to Week 56
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Gastrointestinal disorders
Gastric polyps
|
0.16%
1/612 • Number of events 1 • Up to Week 56
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/616 • Up to Week 56
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/614 • Up to Week 56
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/612 • Up to Week 56
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.16%
1/616 • Number of events 1 • Up to Week 56
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/614 • Up to Week 56
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Gastrointestinal disorders
Haematochezia
|
0.16%
1/612 • Number of events 1 • Up to Week 56
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/616 • Up to Week 56
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/614 • Up to Week 56
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.16%
1/612 • Number of events 1 • Up to Week 56
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/616 • Up to Week 56
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/614 • Up to Week 56
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Gastrointestinal disorders
Hiatus hernia
|
0.16%
1/612 • Number of events 1 • Up to Week 56
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/616 • Up to Week 56
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/614 • Up to Week 56
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Gastrointestinal disorders
Mesenteric vein thrombosis
|
0.16%
1/612 • Number of events 1 • Up to Week 56
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/616 • Up to Week 56
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/614 • Up to Week 56
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Gastrointestinal disorders
Obstructive pancreatitis
|
0.00%
0/612 • Up to Week 56
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.16%
1/616 • Number of events 1 • Up to Week 56
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/614 • Up to Week 56
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.00%
0/612 • Up to Week 56
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/616 • Up to Week 56
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.16%
1/614 • Number of events 1 • Up to Week 56
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.16%
1/612 • Number of events 1 • Up to Week 56
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/616 • Up to Week 56
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/614 • Up to Week 56
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
General disorders
Death
|
0.00%
0/612 • Up to Week 56
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/616 • Up to Week 56
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.16%
1/614 • Number of events 1 • Up to Week 56
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
General disorders
Medical device site joint inflammation
|
0.00%
0/612 • Up to Week 56
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/616 • Up to Week 56
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.16%
1/614 • Number of events 1 • Up to Week 56
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
General disorders
Non-cardiac chest pain
|
0.33%
2/612 • Number of events 2 • Up to Week 56
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.16%
1/616 • Number of events 1 • Up to Week 56
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.16%
1/614 • Number of events 1 • Up to Week 56
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
General disorders
Sudden death
|
0.00%
0/612 • Up to Week 56
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.16%
1/616 • Number of events 1 • Up to Week 56
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.33%
2/614 • Number of events 2 • Up to Week 56
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.00%
0/612 • Up to Week 56
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.32%
2/616 • Number of events 2 • Up to Week 56
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.33%
2/614 • Number of events 2 • Up to Week 56
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/612 • Up to Week 56
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/616 • Up to Week 56
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.16%
1/614 • Number of events 1 • Up to Week 56
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Hepatobiliary disorders
Hepatic cirrhosis
|
0.00%
0/612 • Up to Week 56
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/616 • Up to Week 56
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.16%
1/614 • Number of events 1 • Up to Week 56
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Hepatobiliary disorders
Jaundice
|
0.00%
0/612 • Up to Week 56
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.16%
1/616 • Number of events 1 • Up to Week 56
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/614 • Up to Week 56
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Hepatobiliary disorders
Jaundice cholestatic
|
0.00%
0/612 • Up to Week 56
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.16%
1/616 • Number of events 1 • Up to Week 56
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/614 • Up to Week 56
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Hepatobiliary disorders
Portal vein thrombosis
|
0.16%
1/612 • Number of events 1 • Up to Week 56
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/616 • Up to Week 56
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/614 • Up to Week 56
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Abscess limb
|
0.16%
1/612 • Number of events 1 • Up to Week 56
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/616 • Up to Week 56
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/614 • Up to Week 56
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Abscess neck
|
0.16%
1/612 • Number of events 1 • Up to Week 56
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/616 • Up to Week 56
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/614 • Up to Week 56
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/612 • Up to Week 56
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.16%
1/616 • Number of events 1 • Up to Week 56
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/614 • Up to Week 56
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Campylobacter infection
|
0.00%
0/612 • Up to Week 56
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.16%
1/616 • Number of events 1 • Up to Week 56
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/614 • Up to Week 56
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Cholecystitis infective
|
0.00%
0/612 • Up to Week 56
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.16%
1/616 • Number of events 1 • Up to Week 56
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/614 • Up to Week 56
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Chronic sinusitis
|
0.00%
0/612 • Up to Week 56
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.16%
1/616 • Number of events 1 • Up to Week 56
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/614 • Up to Week 56
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/612 • Up to Week 56
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.16%
1/616 • Number of events 1 • Up to Week 56
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.16%
1/614 • Number of events 1 • Up to Week 56
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Herpes zoster
|
0.00%
0/612 • Up to Week 56
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/616 • Up to Week 56
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.16%
1/614 • Number of events 1 • Up to Week 56
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Infective exacerbation of chronic obstructive airways disease
|
0.00%
0/612 • Up to Week 56
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.16%
1/616 • Number of events 1 • Up to Week 56
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/614 • Up to Week 56
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Lower respiratory tract infection
|
0.16%
1/612 • Number of events 1 • Up to Week 56
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.16%
1/616 • Number of events 1 • Up to Week 56
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/614 • Up to Week 56
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Osteomyelitis
|
0.00%
0/612 • Up to Week 56
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/616 • Up to Week 56
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.16%
1/614 • Number of events 1 • Up to Week 56
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Perinephric abscess
|
0.16%
1/612 • Number of events 1 • Up to Week 56
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/616 • Up to Week 56
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/614 • Up to Week 56
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Periorbital cellulitis
|
0.00%
0/612 • Up to Week 56
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.16%
1/616 • Number of events 1 • Up to Week 56
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/614 • Up to Week 56
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Pneumonia
|
0.33%
2/612 • Number of events 2 • Up to Week 56
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.32%
2/616 • Number of events 2 • Up to Week 56
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.16%
1/614 • Number of events 1 • Up to Week 56
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Pyelonephritis acute
|
0.00%
0/612 • Up to Week 56
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.16%
1/616 • Number of events 1 • Up to Week 56
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/614 • Up to Week 56
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Pyoderma
|
0.00%
0/612 • Up to Week 56
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.16%
1/616 • Number of events 1 • Up to Week 56
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/614 • Up to Week 56
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Renal abscess
|
0.16%
1/612 • Number of events 1 • Up to Week 56
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/616 • Up to Week 56
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/614 • Up to Week 56
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Sepsis
|
0.00%
0/612 • Up to Week 56
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.16%
1/616 • Number of events 1 • Up to Week 56
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/614 • Up to Week 56
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Viral infection
|
0.16%
1/612 • Number of events 1 • Up to Week 56
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/616 • Up to Week 56
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/614 • Up to Week 56
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Infections and infestations
West nile viral infection
|
0.16%
1/612 • Number of events 1 • Up to Week 56
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/616 • Up to Week 56
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/614 • Up to Week 56
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Injury, poisoning and procedural complications
Alcohol poisoning
|
0.00%
0/612 • Up to Week 56
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.16%
1/616 • Number of events 2 • Up to Week 56
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/614 • Up to Week 56
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Injury, poisoning and procedural complications
Comminuted fracture
|
0.16%
1/612 • Number of events 1 • Up to Week 56
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/616 • Up to Week 56
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/614 • Up to Week 56
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/612 • Up to Week 56
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/616 • Up to Week 56
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.16%
1/614 • Number of events 1 • Up to Week 56
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Injury, poisoning and procedural complications
Exposure to toxic agent
|
0.16%
1/612 • Number of events 1 • Up to Week 56
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/616 • Up to Week 56
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/614 • Up to Week 56
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Injury, poisoning and procedural complications
Fall
|
0.16%
1/612 • Number of events 1 • Up to Week 56
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/616 • Up to Week 56
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/614 • Up to Week 56
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Injury, poisoning and procedural complications
Femoral neck fracture
|
0.16%
1/612 • Number of events 1 • Up to Week 56
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/616 • Up to Week 56
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/614 • Up to Week 56
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Injury, poisoning and procedural complications
Fibula fracture
|
0.00%
0/612 • Up to Week 56
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.16%
1/616 • Number of events 1 • Up to Week 56
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/614 • Up to Week 56
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Injury, poisoning and procedural complications
Hand fracture
|
0.00%
0/612 • Up to Week 56
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.16%
1/616 • Number of events 1 • Up to Week 56
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/614 • Up to Week 56
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Injury, poisoning and procedural complications
Head injury
|
0.16%
1/612 • Number of events 1 • Up to Week 56
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/616 • Up to Week 56
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/614 • Up to Week 56
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Injury, poisoning and procedural complications
Humerus fracture
|
0.00%
0/612 • Up to Week 56
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.16%
1/616 • Number of events 1 • Up to Week 56
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/614 • Up to Week 56
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Injury, poisoning and procedural complications
Limb traumatic amputation
|
0.00%
0/612 • Up to Week 56
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/616 • Up to Week 56
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.16%
1/614 • Number of events 1 • Up to Week 56
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Injury, poisoning and procedural complications
Lower limb fracture
|
0.00%
0/612 • Up to Week 56
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/616 • Up to Week 56
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.16%
1/614 • Number of events 1 • Up to Week 56
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Injury, poisoning and procedural complications
Lumbar vertebral fracture
|
0.16%
1/612 • Number of events 1 • Up to Week 56
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.16%
1/616 • Number of events 1 • Up to Week 56
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/614 • Up to Week 56
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Injury, poisoning and procedural complications
Post procedural haemorrhage
|
0.00%
0/612 • Up to Week 56
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.16%
1/616 • Number of events 1 • Up to Week 56
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/614 • Up to Week 56
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Investigations
Amylase increased
|
0.16%
1/612 • Number of events 1 • Up to Week 56
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/616 • Up to Week 56
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/614 • Up to Week 56
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Investigations
Ecg signs of myocardial ischaemia
|
0.00%
0/612 • Up to Week 56
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/616 • Up to Week 56
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.16%
1/614 • Number of events 1 • Up to Week 56
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Investigations
Electrocardiogram t wave inversion
|
0.00%
0/612 • Up to Week 56
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/616 • Up to Week 56
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.16%
1/614 • Number of events 1 • Up to Week 56
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Investigations
Lipase increased
|
0.33%
2/612 • Number of events 2 • Up to Week 56
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/616 • Up to Week 56
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.16%
1/614 • Number of events 1 • Up to Week 56
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Metabolism and nutrition disorders
Diabetic ketoacidosis
|
0.16%
1/612 • Number of events 1 • Up to Week 56
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/616 • Up to Week 56
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/614 • Up to Week 56
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.16%
1/612 • Number of events 1 • Up to Week 56
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/616 • Up to Week 56
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.16%
1/614 • Number of events 1 • Up to Week 56
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/612 • Up to Week 56
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.16%
1/616 • Number of events 1 • Up to Week 56
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/614 • Up to Week 56
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Metabolism and nutrition disorders
Type 2 diabetes mellitus
|
0.00%
0/612 • Up to Week 56
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.16%
1/616 • Number of events 1 • Up to Week 56
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/614 • Up to Week 56
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.00%
0/612 • Up to Week 56
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/616 • Up to Week 56
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.16%
1/614 • Number of events 1 • Up to Week 56
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Musculoskeletal and connective tissue disorders
Lumbar spinal stenosis
|
0.16%
1/612 • Number of events 1 • Up to Week 56
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/616 • Up to Week 56
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/614 • Up to Week 56
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/612 • Up to Week 56
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/616 • Up to Week 56
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.16%
1/614 • Number of events 1 • Up to Week 56
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthropathy
|
0.16%
1/612 • Number of events 1 • Up to Week 56
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/616 • Up to Week 56
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/614 • Up to Week 56
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Musculoskeletal and connective tissue disorders
Plica syndrome
|
0.16%
1/612 • Number of events 1 • Up to Week 56
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/616 • Up to Week 56
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/614 • Up to Week 56
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma pancreas
|
0.16%
1/612 • Number of events 1 • Up to Week 56
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/616 • Up to Week 56
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/614 • Up to Week 56
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder cancer recurrent
|
0.16%
1/612 • Number of events 1 • Up to Week 56
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/616 • Up to Week 56
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/614 • Up to Week 56
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Clear cell renal cell carcinoma
|
0.16%
1/612 • Number of events 1 • Up to Week 56
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/616 • Up to Week 56
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/614 • Up to Week 56
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung adenocarcinoma
|
0.00%
0/612 • Up to Week 56
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/616 • Up to Week 56
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.16%
1/614 • Number of events 1 • Up to Week 56
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to abdominal cavity
|
0.16%
1/612 • Number of events 1 • Up to Week 56
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/616 • Up to Week 56
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/614 • Up to Week 56
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastatic uterine cancer
|
0.32%
1/314 • Number of events 1 • Up to Week 56
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/288 • Up to Week 56
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/296 • Up to Week 56
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neuroendocrine tumour
|
0.00%
0/612 • Up to Week 56
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.16%
1/616 • Number of events 1 • Up to Week 56
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/614 • Up to Week 56
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Papillary thyroid cancer
|
0.16%
1/612 • Number of events 1 • Up to Week 56
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/616 • Up to Week 56
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/614 • Up to Week 56
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Phaeochromocytoma
|
0.00%
0/612 • Up to Week 56
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.16%
1/616 • Number of events 1 • Up to Week 56
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/614 • Up to Week 56
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Plasma cell myeloma
|
0.00%
0/612 • Up to Week 56
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.16%
1/616 • Number of events 1 • Up to Week 56
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/614 • Up to Week 56
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.34%
1/298 • Number of events 1 • Up to Week 56
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/328 • Up to Week 56
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/318 • Up to Week 56
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine leiomyoma
|
0.32%
1/314 • Number of events 1 • Up to Week 56
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/288 • Up to Week 56
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/296 • Up to Week 56
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Nervous system disorders
Balance disorder
|
0.16%
1/612 • Number of events 1 • Up to Week 56
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/616 • Up to Week 56
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/614 • Up to Week 56
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Nervous system disorders
Cerebral artery occlusion
|
0.00%
0/612 • Up to Week 56
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/616 • Up to Week 56
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.16%
1/614 • Number of events 1 • Up to Week 56
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/612 • Up to Week 56
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.16%
1/616 • Number of events 1 • Up to Week 56
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/614 • Up to Week 56
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Nervous system disorders
Diabetic mononeuropathy
|
0.00%
0/612 • Up to Week 56
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/616 • Up to Week 56
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.16%
1/614 • Number of events 1 • Up to Week 56
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Nervous system disorders
Ischaemic stroke
|
0.00%
0/612 • Up to Week 56
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.32%
2/616 • Number of events 2 • Up to Week 56
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.16%
1/614 • Number of events 1 • Up to Week 56
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Nervous system disorders
Loss of consciousness
|
0.16%
1/612 • Number of events 1 • Up to Week 56
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/616 • Up to Week 56
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/614 • Up to Week 56
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Nervous system disorders
Neuralgia
|
0.16%
1/612 • Number of events 1 • Up to Week 56
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/616 • Up to Week 56
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/614 • Up to Week 56
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Nervous system disorders
Subarachnoid haemorrhage
|
0.00%
0/612 • Up to Week 56
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/616 • Up to Week 56
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.16%
1/614 • Number of events 1 • Up to Week 56
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Nervous system disorders
Syncope
|
0.00%
0/612 • Up to Week 56
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.16%
1/616 • Number of events 1 • Up to Week 56
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/614 • Up to Week 56
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Nervous system disorders
Wernicke's encephalopathy
|
0.00%
0/612 • Up to Week 56
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/616 • Up to Week 56
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.16%
1/614 • Number of events 1 • Up to Week 56
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Pregnancy, puerperium and perinatal conditions
Pregnancy
|
0.00%
0/314 • Up to Week 56
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.69%
2/288 • Number of events 2 • Up to Week 56
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/296 • Up to Week 56
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Psychiatric disorders
Major depression
|
0.16%
1/612 • Number of events 1 • Up to Week 56
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/616 • Up to Week 56
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/614 • Up to Week 56
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Psychiatric disorders
Panic attack
|
0.00%
0/612 • Up to Week 56
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.16%
1/616 • Number of events 1 • Up to Week 56
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/614 • Up to Week 56
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Psychiatric disorders
Stress
|
0.16%
1/612 • Number of events 1 • Up to Week 56
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/616 • Up to Week 56
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/614 • Up to Week 56
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Psychiatric disorders
Suicidal ideation
|
0.16%
1/612 • Number of events 1 • Up to Week 56
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/616 • Up to Week 56
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/614 • Up to Week 56
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.16%
1/612 • Number of events 1 • Up to Week 56
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.16%
1/616 • Number of events 1 • Up to Week 56
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/614 • Up to Week 56
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/612 • Up to Week 56
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.16%
1/616 • Number of events 1 • Up to Week 56
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/614 • Up to Week 56
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Reproductive system and breast disorders
Cervical polyp
|
0.00%
0/314 • Up to Week 56
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.35%
1/288 • Number of events 1 • Up to Week 56
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/296 • Up to Week 56
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Reproductive system and breast disorders
Oedema genital
|
0.00%
0/612 • Up to Week 56
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.16%
1/616 • Number of events 1 • Up to Week 56
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/614 • Up to Week 56
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Reproductive system and breast disorders
Ovarian cyst
|
0.00%
0/314 • Up to Week 56
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/288 • Up to Week 56
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.34%
1/296 • Number of events 1 • Up to Week 56
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.16%
1/612 • Number of events 1 • Up to Week 56
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.32%
2/616 • Number of events 2 • Up to Week 56
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/614 • Up to Week 56
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.16%
1/612 • Number of events 1 • Up to Week 56
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/616 • Up to Week 56
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/614 • Up to Week 56
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Respiratory, thoracic and mediastinal disorders
Hypersensitivity pneumonitis
|
0.00%
0/612 • Up to Week 56
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/616 • Up to Week 56
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.16%
1/614 • Number of events 1 • Up to Week 56
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal polyps
|
0.00%
0/612 • Up to Week 56
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/616 • Up to Week 56
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.16%
1/614 • Number of events 1 • Up to Week 56
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal septum deviation
|
0.00%
0/612 • Up to Week 56
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/616 • Up to Week 56
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.16%
1/614 • Number of events 1 • Up to Week 56
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Skin and subcutaneous tissue disorders
Angioedema
|
0.16%
1/612 • Number of events 1 • Up to Week 56
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/616 • Up to Week 56
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/614 • Up to Week 56
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/612 • Up to Week 56
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.16%
1/616 • Number of events 1 • Up to Week 56
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/614 • Up to Week 56
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Surgical and medical procedures
Cholecystectomy
|
0.16%
1/612 • Number of events 1 • Up to Week 56
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/616 • Up to Week 56
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/614 • Up to Week 56
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Vascular disorders
Arteriosclerosis
|
0.16%
1/612 • Number of events 1 • Up to Week 56
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/616 • Up to Week 56
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/614 • Up to Week 56
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Vascular disorders
Hypertension
|
0.00%
0/612 • Up to Week 56
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.16%
1/616 • Number of events 1 • Up to Week 56
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/614 • Up to Week 56
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Vascular disorders
Hypertensive emergency
|
0.00%
0/612 • Up to Week 56
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.16%
1/616 • Number of events 1 • Up to Week 56
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/614 • Up to Week 56
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
Other adverse events
| Measure |
Dulaglutide 1.5 mg
n=612 participants at risk
Dulaglutide 1.5 mg administered subcutaneously (SC) once a week.
|
Dulaglutide 3 mg
n=616 participants at risk
Dulaglutide 3 mg administered SC once a week.
|
Dulaglutide 4.5 mg
n=614 participants at risk
Dulaglutide 4.5 mg administered SC once a week.
|
|---|---|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
7.8%
48/612 • Number of events 83 • Up to Week 56
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
12.2%
75/616 • Number of events 118 • Up to Week 56
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
11.4%
70/614 • Number of events 176 • Up to Week 56
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Gastrointestinal disorders
Dyspepsia
|
2.8%
17/612 • Number of events 26 • Up to Week 56
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
5.4%
33/616 • Number of events 56 • Up to Week 56
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
2.9%
18/614 • Number of events 35 • Up to Week 56
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Gastrointestinal disorders
Nausea
|
14.2%
87/612 • Number of events 121 • Up to Week 56
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
16.1%
99/616 • Number of events 180 • Up to Week 56
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
17.3%
106/614 • Number of events 192 • Up to Week 56
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Gastrointestinal disorders
Vomiting
|
6.5%
40/612 • Number of events 63 • Up to Week 56
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
9.3%
57/616 • Number of events 89 • Up to Week 56
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
10.4%
64/614 • Number of events 108 • Up to Week 56
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Nasopharyngitis
|
4.7%
29/612 • Number of events 38 • Up to Week 56
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
5.4%
33/616 • Number of events 41 • Up to Week 56
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
6.4%
39/614 • Number of events 48 • Up to Week 56
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60