Trial Outcomes & Findings for A Research Study Comparing RYBELSUS® to Other Blood Sugar Lowering Tablets in People Living in America With Type 2 Diabetes (REALYSE) (NCT NCT05035082)
NCT ID: NCT05035082
Last Updated: 2026-08-10
Results Overview
Change in HbA1c in percentage from week 0 to year 1 is presented
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
1018 participants
Primary outcome timeframe
Week 0, year 1
Results posted on
2026-08-10
Participant Flow
The trial was conducted at 25 sites in the United States. One participant is counted in 'Completed' and not in 'Death in Reason for Not Completed' in Participant Flow as they died after completing the study and hence, not counted as non-completer.
Participants were randomized in a 1:1 ratio to receive either oral semaglutide or one other oral glucose-lowering medication, respectively.
Participant milestones
| Measure |
Oral Semaglutide
Participants received oral semaglutide in addition to background metformin monotherapy for 52 weeks.
|
Other Oral Glucose-lowering Medication
Participants received one other oral glucose-lowering medication in addition to background metformin monotherapy for 52 weeks.
|
|---|---|---|
|
Overall Study
STARTED
|
509
|
509
|
|
Overall Study
Full Analysis Set
|
509
|
509
|
|
Overall Study
Safety Analysis Set
|
500
|
492
|
|
Overall Study
COMPLETED
|
449
|
448
|
|
Overall Study
NOT COMPLETED
|
60
|
61
|
Reasons for withdrawal
| Measure |
Oral Semaglutide
Participants received oral semaglutide in addition to background metformin monotherapy for 52 weeks.
|
Other Oral Glucose-lowering Medication
Participants received one other oral glucose-lowering medication in addition to background metformin monotherapy for 52 weeks.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
24
|
26
|
|
Overall Study
Lost to Follow-up
|
29
|
30
|
|
Overall Study
Death
|
3
|
1
|
|
Overall Study
site closure
|
0
|
1
|
|
Overall Study
Protocol specified withdrawal criterion met
|
4
|
3
|
Baseline Characteristics
A Research Study Comparing RYBELSUS® to Other Blood Sugar Lowering Tablets in People Living in America With Type 2 Diabetes (REALYSE)
Baseline characteristics by cohort
| Measure |
Total
n=1018 Participants
Total of all reporting groups
|
Oral Semaglutide
n=509 Participants
Participants received oral semaglutide in addition to background metformin monotherapy for 52 weeks.
|
Other Oral Glucose-lowering Medication
n=509 Participants
Participants received one other oral glucose-lowering medication in addition to background metformin monotherapy for 52 weeks.
|
|---|---|---|---|
|
Age, Continuous
|
59.7 Years
STANDARD_DEVIATION 12.0 • n=27 Participants
|
59.6 Years
STANDARD_DEVIATION 11.9 • n=54 Participants
|
59.8 Years
STANDARD_DEVIATION 12.0 • n=54 Participants
|
|
Sex: Female, Male
Female
|
468 Participants
n=27 Participants
|
231 Participants
n=54 Participants
|
237 Participants
n=54 Participants
|
|
Sex: Female, Male
Male
|
550 Participants
n=27 Participants
|
278 Participants
n=54 Participants
|
272 Participants
n=54 Participants
|
|
Race/Ethnicity, Customized
White
|
739 Participants
n=27 Participants
|
373 Participants
n=54 Participants
|
366 Participants
n=54 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
133 Participants
n=27 Participants
|
65 Participants
n=54 Participants
|
68 Participants
n=54 Participants
|
|
Race/Ethnicity, Customized
Asian
|
80 Participants
n=27 Participants
|
44 Participants
n=54 Participants
|
36 Participants
n=54 Participants
|
|
Race/Ethnicity, Customized
Other
|
60 Participants
n=27 Participants
|
21 Participants
n=54 Participants
|
39 Participants
n=54 Participants
|
|
Race/Ethnicity, Customized
Missing Race
|
6 Participants
n=27 Participants
|
6 Participants
n=54 Participants
|
0 Participants
n=54 Participants
|
|
Race/Ethnicity, Customized
Hispanic or Latino
|
193 Participants
n=27 Participants
|
91 Participants
n=54 Participants
|
102 Participants
n=54 Participants
|
|
Race/Ethnicity, Customized
Non-Hispanic or Non-Latino
|
812 Participants
n=27 Participants
|
408 Participants
n=54 Participants
|
404 Participants
n=54 Participants
|
|
Race/Ethnicity, Customized
Missing Ethnicity
|
13 Participants
n=27 Participants
|
10 Participants
n=54 Participants
|
3 Participants
n=54 Participants
|
PRIMARY outcome
Timeframe: Week 0, year 1Population: Full analysis set included all randomised participants. Overall number of participants analyzed = Participants with available data for the outcome measure.
Change in HbA1c in percentage from week 0 to year 1 is presented
Outcome measures
| Measure |
Oral Semaglutide
n=326 Participants
Participants received oral semaglutide in addition to background metformin monotherapy for 52 weeks.
|
Other Oral Glucose-lowering Medication
n=293 Participants
Participants received one other oral glucose-lowering medication in addition to background metformin monotherapy for 52 weeks.
|
|---|---|---|
|
Change in Glycated Haemoglobin (HbA1c)
|
-1.20 Percentage change in HbA1c
Standard Deviation 1.463
|
-0.99 Percentage change in HbA1c
Standard Deviation 1.516
|
SECONDARY outcome
Timeframe: At year 1Population: Full analysis set included all randomised participants. Overall number of participants analyzed = Participants with available data for the outcome measure.
Participants achieving HbA1c \< 7.0% (Yes /No) at year 1 is presented. 'Yes' defines participants who achieved HbA1c \< 7.0% and 'No' defines participants who did not achieve HbA1c \< 7.0 %.
Outcome measures
| Measure |
Oral Semaglutide
n=326 Participants
Participants received oral semaglutide in addition to background metformin monotherapy for 52 weeks.
|
Other Oral Glucose-lowering Medication
n=293 Participants
Participants received one other oral glucose-lowering medication in addition to background metformin monotherapy for 52 weeks.
|
|---|---|---|
|
Participants Achieving HbA1c Less Than (<) 7.0 Percentage (%) (Yes /No)
No
|
136 Participants
|
160 Participants
|
|
Participants Achieving HbA1c Less Than (<) 7.0 Percentage (%) (Yes /No)
Yes
|
190 Participants
|
133 Participants
|
SECONDARY outcome
Timeframe: At year 1Population: Full analysis set included all randomised participants. Overall number of participants analyzed = Participants with available data for the outcome measure.
Participants achieving HbA1c ≤ 6.5% (Yes/No) at year 1 is presented. 'Yes' defines participants who achieved HbA1c ≤ 6.5% and 'No' defines participants who did not achieve HbA1c ≤ 6.5%.
Outcome measures
| Measure |
Oral Semaglutide
n=326 Participants
Participants received oral semaglutide in addition to background metformin monotherapy for 52 weeks.
|
Other Oral Glucose-lowering Medication
n=293 Participants
Participants received one other oral glucose-lowering medication in addition to background metformin monotherapy for 52 weeks.
|
|---|---|---|
|
Participants Achieving HbA1c Less Than or Equal to (≤) 6.5% (Yes/No)
Yes
|
127 Participants
|
68 Participants
|
|
Participants Achieving HbA1c Less Than or Equal to (≤) 6.5% (Yes/No)
No
|
199 Participants
|
225 Participants
|
SECONDARY outcome
Timeframe: From Week 0 to year 1Population: Full analysis set included all randomised participants. Overall number of participants analyzed = Participants with available data for the outcome measure.
Participants achieving HbA1c \< 7.0% or at least 1.0%-point reduction in HbA1c (Yes/No) from week 0 to year 1 is presented. 'Yes' defines participants who achieved HbA1c \< 7.0% or reduction of at least 1.0%-point in HbA1c and 'No' defines participants who did not achieve HbA1c \< 7.0% or reduction of at least 1.0%-point in HbA1c.
Outcome measures
| Measure |
Oral Semaglutide
n=326 Participants
Participants received oral semaglutide in addition to background metformin monotherapy for 52 weeks.
|
Other Oral Glucose-lowering Medication
n=293 Participants
Participants received one other oral glucose-lowering medication in addition to background metformin monotherapy for 52 weeks.
|
|---|---|---|
|
Participants Achieving HbA1c <7.0% or at Least 1.0%-Point Reduction in HbA1c (Yes/No)
Yes
|
239 Participants
|
180 Participants
|
|
Participants Achieving HbA1c <7.0% or at Least 1.0%-Point Reduction in HbA1c (Yes/No)
No
|
87 Participants
|
113 Participants
|
SECONDARY outcome
Timeframe: From week 0 to year 1Population: Full analysis set included all randomised participants. Overall number of participants analyzed = Participants with available data for the outcome measure.
Participants achieving ≥ 5% reduction in body weight (Yes/No) from week 0 to year 1 is presented. 'Yes' defines participants who achieved ≥ 5% reduction in body weight and 'No' defines participants who did not achieve ≥ 5% reduction in body weight.
Outcome measures
| Measure |
Oral Semaglutide
n=298 Participants
Participants received oral semaglutide in addition to background metformin monotherapy for 52 weeks.
|
Other Oral Glucose-lowering Medication
n=260 Participants
Participants received one other oral glucose-lowering medication in addition to background metformin monotherapy for 52 weeks.
|
|---|---|---|
|
Participants Achieving Greater Than or Equal to (≥) 5% Reduction in Body Weight (Yes/No)
Yes
|
110 Participants
|
83 Participants
|
|
Participants Achieving Greater Than or Equal to (≥) 5% Reduction in Body Weight (Yes/No)
No
|
188 Participants
|
177 Participants
|
SECONDARY outcome
Timeframe: At year 1Population: Full analysis set included all randomised participants. Overall number of participants analyzed = Participants with available data for the outcome measure.
Participants achieving individualized HbA1c target per HEDIS criteria (\< 8.0% if age ≥ 65 years or with defined comorbidities or otherwise \< 7.0%) (Yes/No) at year 1 is presented. 'Yes' defines participants who achieved individualized HbA1c target per HEDIS criteria and 'No' defines participants who did not achieve individualized HbA1c target per HEDIS criteria.
Outcome measures
| Measure |
Oral Semaglutide
n=326 Participants
Participants received oral semaglutide in addition to background metformin monotherapy for 52 weeks.
|
Other Oral Glucose-lowering Medication
n=293 Participants
Participants received one other oral glucose-lowering medication in addition to background metformin monotherapy for 52 weeks.
|
|---|---|---|
|
Participant Achieving Individualized HbA1c Target Per Healthcare Effectiveness Data and Information Set (HEDIS) Criteria (Yes/No)
Yes
|
222 Participants
|
171 Participants
|
|
Participant Achieving Individualized HbA1c Target Per Healthcare Effectiveness Data and Information Set (HEDIS) Criteria (Yes/No)
No
|
104 Participants
|
122 Participants
|
SECONDARY outcome
Timeframe: At year 1Population: Full analysis set included all randomised participants. Overall number of participants analyzed = Participants with available data for the outcome measure.
Participant achieving HbA1c ≤ treatment provider defined individualized target (Yes/No) at year 1 is presented. 'Yes' defines participant who achieved HbA1c ≤ treatment provider defined individualized target and 'No' defines participant who did not achieve HbA1c ≤ treatment provider defined individualized target.
Outcome measures
| Measure |
Oral Semaglutide
n=326 Participants
Participants received oral semaglutide in addition to background metformin monotherapy for 52 weeks.
|
Other Oral Glucose-lowering Medication
n=293 Participants
Participants received one other oral glucose-lowering medication in addition to background metformin monotherapy for 52 weeks.
|
|---|---|---|
|
Participant Achieving HbA1c ≤ Treatment Provider Defined Individualized Target (Yes/No)
Yes
|
179 Participants
|
118 Participants
|
|
Participant Achieving HbA1c ≤ Treatment Provider Defined Individualized Target (Yes/No)
No
|
147 Participants
|
175 Participants
|
SECONDARY outcome
Timeframe: Week 0, year 1Population: Full analysis set included all randomised participants. Overall number of participants analyzed = Participants with available data for the outcome measure.
Relative change in body weight from week 0 to year 1 is presented.
Outcome measures
| Measure |
Oral Semaglutide
n=290 Participants
Participants received oral semaglutide in addition to background metformin monotherapy for 52 weeks.
|
Other Oral Glucose-lowering Medication
n=258 Participants
Participants received one other oral glucose-lowering medication in addition to background metformin monotherapy for 52 weeks.
|
|---|---|---|
|
Relative Change in Body Weight (%)
|
-4.00 Percentage change in body weight
Standard Deviation 6.26
|
-3.53 Percentage change in body weight
Standard Deviation 6.49
|
SECONDARY outcome
Timeframe: Week 0, year 1Population: Full analysis set included all randomized participants. Overall number of participants analyzed = Participants with available data for the outcome measure.
Change in body weight in pounds (lbs) from week 0 to year 1 is presented.
Outcome measures
| Measure |
Oral Semaglutide
n=290 Participants
Participants received oral semaglutide in addition to background metformin monotherapy for 52 weeks.
|
Other Oral Glucose-lowering Medication
n=258 Participants
Participants received one other oral glucose-lowering medication in addition to background metformin monotherapy for 52 weeks.
|
|---|---|---|
|
Change in Body Weight (Lbs)
|
-8.68 Lbs
Standard Deviation 14.23
|
-7.75 Lbs
Standard Deviation 15.61
|
SECONDARY outcome
Timeframe: From week 0 to year 1Population: Full analysis set included all randomised participants. Overall number of participants analyzed = Participants with available data for the outcome measure.
Time to treatment intensification (add-on) or change (switch) in terms of events from week 0 to year 1 is presented.
Outcome measures
| Measure |
Oral Semaglutide
n=509 Participants
Participants received oral semaglutide in addition to background metformin monotherapy for 52 weeks.
|
Other Oral Glucose-lowering Medication
n=509 Participants
Participants received one other oral glucose-lowering medication in addition to background metformin monotherapy for 52 weeks.
|
|---|---|---|
|
Time to Treatment Intensification (add-on) or Change (Switch) in Terms of Events
|
69 Events
|
109 Events
|
SECONDARY outcome
Timeframe: At year 1Population: Full analysis set included all randomised participants. Overall number of participants analyzed = Participants with available data for the outcome measure.
DTSQc relative treatment satisfaction total score measured at year 1 is presented. DTSQc are used to evaluate patient satisfaction with treatment. The measure consists of 8 items, 6 of which assess treatment satisfaction. Scores from the 6 treatment satisfaction items are summed to a total treatment satisfaction score, which ranges from -18 (much less satisfied) to +18 (much more satisfied).
Outcome measures
| Measure |
Oral Semaglutide
n=200 Participants
Participants received oral semaglutide in addition to background metformin monotherapy for 52 weeks.
|
Other Oral Glucose-lowering Medication
n=197 Participants
Participants received one other oral glucose-lowering medication in addition to background metformin monotherapy for 52 weeks.
|
|---|---|---|
|
Diabetes Treatment Satisfaction Questionnaire, Change Version (DTSQc), Relative Treatment Satisfaction Total Score
|
12.28 Score on a scale
Standard Deviation 6.73
|
12.22 Score on a scale
Standard Deviation 6.18
|
Adverse Events
Oral Semaglutide
Serious events: 51 serious events
Other events: 81 other events
Deaths: 3 deaths
Other Oral Glucose-lowering Medication
Serious events: 55 serious events
Other events: 46 other events
Deaths: 2 deaths
Serious adverse events
| Measure |
Oral Semaglutide
n=500 participants at risk
Participants received oral semaglutide in addition to background metformin monotherapy for 52 weeks.
|
Other Oral Glucose-lowering Medication
n=492 participants at risk
Participants received one other oral glucose-lowering medication in addition to background metformin monotherapy for 52 weeks.
|
|---|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
0.20%
1/500 • Number of events 1 • From week 0 to week 52
All AEs are treatment emergent - AE with onset in datapoint set period defined as all observed data points from first date of study product until permanent discontinuation of treatment. AEs and All-Cause Mortality are assessed in Safety analysis set: all randomized participants who initiated study drug. 1 participant is counted in 'All-Cause Mortality' who was counted as 'Completed' in Participant Flow as they died after completing study hence, the event is captured in as 'All-Cause Mortality'.
|
0.00%
0/492 • From week 0 to week 52
All AEs are treatment emergent - AE with onset in datapoint set period defined as all observed data points from first date of study product until permanent discontinuation of treatment. AEs and All-Cause Mortality are assessed in Safety analysis set: all randomized participants who initiated study drug. 1 participant is counted in 'All-Cause Mortality' who was counted as 'Completed' in Participant Flow as they died after completing study hence, the event is captured in as 'All-Cause Mortality'.
|
|
Infections and infestations
Abscess intestinal
|
0.00%
0/500 • From week 0 to week 52
All AEs are treatment emergent - AE with onset in datapoint set period defined as all observed data points from first date of study product until permanent discontinuation of treatment. AEs and All-Cause Mortality are assessed in Safety analysis set: all randomized participants who initiated study drug. 1 participant is counted in 'All-Cause Mortality' who was counted as 'Completed' in Participant Flow as they died after completing study hence, the event is captured in as 'All-Cause Mortality'.
|
0.20%
1/492 • Number of events 1 • From week 0 to week 52
All AEs are treatment emergent - AE with onset in datapoint set period defined as all observed data points from first date of study product until permanent discontinuation of treatment. AEs and All-Cause Mortality are assessed in Safety analysis set: all randomized participants who initiated study drug. 1 participant is counted in 'All-Cause Mortality' who was counted as 'Completed' in Participant Flow as they died after completing study hence, the event is captured in as 'All-Cause Mortality'.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.40%
2/500 • Number of events 2 • From week 0 to week 52
All AEs are treatment emergent - AE with onset in datapoint set period defined as all observed data points from first date of study product until permanent discontinuation of treatment. AEs and All-Cause Mortality are assessed in Safety analysis set: all randomized participants who initiated study drug. 1 participant is counted in 'All-Cause Mortality' who was counted as 'Completed' in Participant Flow as they died after completing study hence, the event is captured in as 'All-Cause Mortality'.
|
0.41%
2/492 • Number of events 2 • From week 0 to week 52
All AEs are treatment emergent - AE with onset in datapoint set period defined as all observed data points from first date of study product until permanent discontinuation of treatment. AEs and All-Cause Mortality are assessed in Safety analysis set: all randomized participants who initiated study drug. 1 participant is counted in 'All-Cause Mortality' who was counted as 'Completed' in Participant Flow as they died after completing study hence, the event is captured in as 'All-Cause Mortality'.
|
|
Cardiac disorders
Acute myocardial infarction
|
0.20%
1/500 • Number of events 1 • From week 0 to week 52
All AEs are treatment emergent - AE with onset in datapoint set period defined as all observed data points from first date of study product until permanent discontinuation of treatment. AEs and All-Cause Mortality are assessed in Safety analysis set: all randomized participants who initiated study drug. 1 participant is counted in 'All-Cause Mortality' who was counted as 'Completed' in Participant Flow as they died after completing study hence, the event is captured in as 'All-Cause Mortality'.
|
0.20%
1/492 • Number of events 1 • From week 0 to week 52
All AEs are treatment emergent - AE with onset in datapoint set period defined as all observed data points from first date of study product until permanent discontinuation of treatment. AEs and All-Cause Mortality are assessed in Safety analysis set: all randomized participants who initiated study drug. 1 participant is counted in 'All-Cause Mortality' who was counted as 'Completed' in Participant Flow as they died after completing study hence, the event is captured in as 'All-Cause Mortality'.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.40%
2/500 • Number of events 2 • From week 0 to week 52
All AEs are treatment emergent - AE with onset in datapoint set period defined as all observed data points from first date of study product until permanent discontinuation of treatment. AEs and All-Cause Mortality are assessed in Safety analysis set: all randomized participants who initiated study drug. 1 participant is counted in 'All-Cause Mortality' who was counted as 'Completed' in Participant Flow as they died after completing study hence, the event is captured in as 'All-Cause Mortality'.
|
0.41%
2/492 • Number of events 2 • From week 0 to week 52
All AEs are treatment emergent - AE with onset in datapoint set period defined as all observed data points from first date of study product until permanent discontinuation of treatment. AEs and All-Cause Mortality are assessed in Safety analysis set: all randomized participants who initiated study drug. 1 participant is counted in 'All-Cause Mortality' who was counted as 'Completed' in Participant Flow as they died after completing study hence, the event is captured in as 'All-Cause Mortality'.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma of colon
|
0.00%
0/500 • From week 0 to week 52
All AEs are treatment emergent - AE with onset in datapoint set period defined as all observed data points from first date of study product until permanent discontinuation of treatment. AEs and All-Cause Mortality are assessed in Safety analysis set: all randomized participants who initiated study drug. 1 participant is counted in 'All-Cause Mortality' who was counted as 'Completed' in Participant Flow as they died after completing study hence, the event is captured in as 'All-Cause Mortality'.
|
0.20%
1/492 • Number of events 1 • From week 0 to week 52
All AEs are treatment emergent - AE with onset in datapoint set period defined as all observed data points from first date of study product until permanent discontinuation of treatment. AEs and All-Cause Mortality are assessed in Safety analysis set: all randomized participants who initiated study drug. 1 participant is counted in 'All-Cause Mortality' who was counted as 'Completed' in Participant Flow as they died after completing study hence, the event is captured in as 'All-Cause Mortality'.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma pancreas
|
0.00%
0/500 • From week 0 to week 52
All AEs are treatment emergent - AE with onset in datapoint set period defined as all observed data points from first date of study product until permanent discontinuation of treatment. AEs and All-Cause Mortality are assessed in Safety analysis set: all randomized participants who initiated study drug. 1 participant is counted in 'All-Cause Mortality' who was counted as 'Completed' in Participant Flow as they died after completing study hence, the event is captured in as 'All-Cause Mortality'.
|
0.20%
1/492 • Number of events 1 • From week 0 to week 52
All AEs are treatment emergent - AE with onset in datapoint set period defined as all observed data points from first date of study product until permanent discontinuation of treatment. AEs and All-Cause Mortality are assessed in Safety analysis set: all randomized participants who initiated study drug. 1 participant is counted in 'All-Cause Mortality' who was counted as 'Completed' in Participant Flow as they died after completing study hence, the event is captured in as 'All-Cause Mortality'.
|
|
Psychiatric disorders
Alcohol withdrawal syndrome
|
0.20%
1/500 • Number of events 2 • From week 0 to week 52
All AEs are treatment emergent - AE with onset in datapoint set period defined as all observed data points from first date of study product until permanent discontinuation of treatment. AEs and All-Cause Mortality are assessed in Safety analysis set: all randomized participants who initiated study drug. 1 participant is counted in 'All-Cause Mortality' who was counted as 'Completed' in Participant Flow as they died after completing study hence, the event is captured in as 'All-Cause Mortality'.
|
0.00%
0/492 • From week 0 to week 52
All AEs are treatment emergent - AE with onset in datapoint set period defined as all observed data points from first date of study product until permanent discontinuation of treatment. AEs and All-Cause Mortality are assessed in Safety analysis set: all randomized participants who initiated study drug. 1 participant is counted in 'All-Cause Mortality' who was counted as 'Completed' in Participant Flow as they died after completing study hence, the event is captured in as 'All-Cause Mortality'.
|
|
Metabolism and nutrition disorders
Alcoholic ketoacidosis
|
0.20%
1/500 • Number of events 1 • From week 0 to week 52
All AEs are treatment emergent - AE with onset in datapoint set period defined as all observed data points from first date of study product until permanent discontinuation of treatment. AEs and All-Cause Mortality are assessed in Safety analysis set: all randomized participants who initiated study drug. 1 participant is counted in 'All-Cause Mortality' who was counted as 'Completed' in Participant Flow as they died after completing study hence, the event is captured in as 'All-Cause Mortality'.
|
0.00%
0/492 • From week 0 to week 52
All AEs are treatment emergent - AE with onset in datapoint set period defined as all observed data points from first date of study product until permanent discontinuation of treatment. AEs and All-Cause Mortality are assessed in Safety analysis set: all randomized participants who initiated study drug. 1 participant is counted in 'All-Cause Mortality' who was counted as 'Completed' in Participant Flow as they died after completing study hence, the event is captured in as 'All-Cause Mortality'.
|
|
Cardiac disorders
Angina unstable
|
0.00%
0/500 • From week 0 to week 52
All AEs are treatment emergent - AE with onset in datapoint set period defined as all observed data points from first date of study product until permanent discontinuation of treatment. AEs and All-Cause Mortality are assessed in Safety analysis set: all randomized participants who initiated study drug. 1 participant is counted in 'All-Cause Mortality' who was counted as 'Completed' in Participant Flow as they died after completing study hence, the event is captured in as 'All-Cause Mortality'.
|
0.20%
1/492 • Number of events 1 • From week 0 to week 52
All AEs are treatment emergent - AE with onset in datapoint set period defined as all observed data points from first date of study product until permanent discontinuation of treatment. AEs and All-Cause Mortality are assessed in Safety analysis set: all randomized participants who initiated study drug. 1 participant is counted in 'All-Cause Mortality' who was counted as 'Completed' in Participant Flow as they died after completing study hence, the event is captured in as 'All-Cause Mortality'.
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.00%
0/500 • From week 0 to week 52
All AEs are treatment emergent - AE with onset in datapoint set period defined as all observed data points from first date of study product until permanent discontinuation of treatment. AEs and All-Cause Mortality are assessed in Safety analysis set: all randomized participants who initiated study drug. 1 participant is counted in 'All-Cause Mortality' who was counted as 'Completed' in Participant Flow as they died after completing study hence, the event is captured in as 'All-Cause Mortality'.
|
0.20%
1/492 • Number of events 1 • From week 0 to week 52
All AEs are treatment emergent - AE with onset in datapoint set period defined as all observed data points from first date of study product until permanent discontinuation of treatment. AEs and All-Cause Mortality are assessed in Safety analysis set: all randomized participants who initiated study drug. 1 participant is counted in 'All-Cause Mortality' who was counted as 'Completed' in Participant Flow as they died after completing study hence, the event is captured in as 'All-Cause Mortality'.
|
|
Cardiac disorders
Aortic valve stenosis
|
0.00%
0/500 • From week 0 to week 52
All AEs are treatment emergent - AE with onset in datapoint set period defined as all observed data points from first date of study product until permanent discontinuation of treatment. AEs and All-Cause Mortality are assessed in Safety analysis set: all randomized participants who initiated study drug. 1 participant is counted in 'All-Cause Mortality' who was counted as 'Completed' in Participant Flow as they died after completing study hence, the event is captured in as 'All-Cause Mortality'.
|
0.20%
1/492 • Number of events 1 • From week 0 to week 52
All AEs are treatment emergent - AE with onset in datapoint set period defined as all observed data points from first date of study product until permanent discontinuation of treatment. AEs and All-Cause Mortality are assessed in Safety analysis set: all randomized participants who initiated study drug. 1 participant is counted in 'All-Cause Mortality' who was counted as 'Completed' in Participant Flow as they died after completing study hence, the event is captured in as 'All-Cause Mortality'.
|
|
Infections and infestations
Appendicitis
|
0.20%
1/500 • Number of events 1 • From week 0 to week 52
All AEs are treatment emergent - AE with onset in datapoint set period defined as all observed data points from first date of study product until permanent discontinuation of treatment. AEs and All-Cause Mortality are assessed in Safety analysis set: all randomized participants who initiated study drug. 1 participant is counted in 'All-Cause Mortality' who was counted as 'Completed' in Participant Flow as they died after completing study hence, the event is captured in as 'All-Cause Mortality'.
|
0.00%
0/492 • From week 0 to week 52
All AEs are treatment emergent - AE with onset in datapoint set period defined as all observed data points from first date of study product until permanent discontinuation of treatment. AEs and All-Cause Mortality are assessed in Safety analysis set: all randomized participants who initiated study drug. 1 participant is counted in 'All-Cause Mortality' who was counted as 'Completed' in Participant Flow as they died after completing study hence, the event is captured in as 'All-Cause Mortality'.
|
|
Cardiac disorders
Arteriosclerosis coronary artery
|
0.20%
1/500 • Number of events 1 • From week 0 to week 52
All AEs are treatment emergent - AE with onset in datapoint set period defined as all observed data points from first date of study product until permanent discontinuation of treatment. AEs and All-Cause Mortality are assessed in Safety analysis set: all randomized participants who initiated study drug. 1 participant is counted in 'All-Cause Mortality' who was counted as 'Completed' in Participant Flow as they died after completing study hence, the event is captured in as 'All-Cause Mortality'.
|
0.00%
0/492 • From week 0 to week 52
All AEs are treatment emergent - AE with onset in datapoint set period defined as all observed data points from first date of study product until permanent discontinuation of treatment. AEs and All-Cause Mortality are assessed in Safety analysis set: all randomized participants who initiated study drug. 1 participant is counted in 'All-Cause Mortality' who was counted as 'Completed' in Participant Flow as they died after completing study hence, the event is captured in as 'All-Cause Mortality'.
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
0.40%
2/500 • Number of events 2 • From week 0 to week 52
All AEs are treatment emergent - AE with onset in datapoint set period defined as all observed data points from first date of study product until permanent discontinuation of treatment. AEs and All-Cause Mortality are assessed in Safety analysis set: all randomized participants who initiated study drug. 1 participant is counted in 'All-Cause Mortality' who was counted as 'Completed' in Participant Flow as they died after completing study hence, the event is captured in as 'All-Cause Mortality'.
|
0.00%
0/492 • From week 0 to week 52
All AEs are treatment emergent - AE with onset in datapoint set period defined as all observed data points from first date of study product until permanent discontinuation of treatment. AEs and All-Cause Mortality are assessed in Safety analysis set: all randomized participants who initiated study drug. 1 participant is counted in 'All-Cause Mortality' who was counted as 'Completed' in Participant Flow as they died after completing study hence, the event is captured in as 'All-Cause Mortality'.
|
|
Cardiac disorders
Atrial fibrillation
|
0.20%
1/500 • Number of events 1 • From week 0 to week 52
All AEs are treatment emergent - AE with onset in datapoint set period defined as all observed data points from first date of study product until permanent discontinuation of treatment. AEs and All-Cause Mortality are assessed in Safety analysis set: all randomized participants who initiated study drug. 1 participant is counted in 'All-Cause Mortality' who was counted as 'Completed' in Participant Flow as they died after completing study hence, the event is captured in as 'All-Cause Mortality'.
|
0.41%
2/492 • Number of events 3 • From week 0 to week 52
All AEs are treatment emergent - AE with onset in datapoint set period defined as all observed data points from first date of study product until permanent discontinuation of treatment. AEs and All-Cause Mortality are assessed in Safety analysis set: all randomized participants who initiated study drug. 1 participant is counted in 'All-Cause Mortality' who was counted as 'Completed' in Participant Flow as they died after completing study hence, the event is captured in as 'All-Cause Mortality'.
|
|
Cardiac disorders
Atrial flutter
|
0.00%
0/500 • From week 0 to week 52
All AEs are treatment emergent - AE with onset in datapoint set period defined as all observed data points from first date of study product until permanent discontinuation of treatment. AEs and All-Cause Mortality are assessed in Safety analysis set: all randomized participants who initiated study drug. 1 participant is counted in 'All-Cause Mortality' who was counted as 'Completed' in Participant Flow as they died after completing study hence, the event is captured in as 'All-Cause Mortality'.
|
0.20%
1/492 • Number of events 1 • From week 0 to week 52
All AEs are treatment emergent - AE with onset in datapoint set period defined as all observed data points from first date of study product until permanent discontinuation of treatment. AEs and All-Cause Mortality are assessed in Safety analysis set: all randomized participants who initiated study drug. 1 participant is counted in 'All-Cause Mortality' who was counted as 'Completed' in Participant Flow as they died after completing study hence, the event is captured in as 'All-Cause Mortality'.
|
|
Injury, poisoning and procedural complications
Avulsion fracture
|
0.00%
0/500 • From week 0 to week 52
All AEs are treatment emergent - AE with onset in datapoint set period defined as all observed data points from first date of study product until permanent discontinuation of treatment. AEs and All-Cause Mortality are assessed in Safety analysis set: all randomized participants who initiated study drug. 1 participant is counted in 'All-Cause Mortality' who was counted as 'Completed' in Participant Flow as they died after completing study hence, the event is captured in as 'All-Cause Mortality'.
|
0.20%
1/492 • Number of events 1 • From week 0 to week 52
All AEs are treatment emergent - AE with onset in datapoint set period defined as all observed data points from first date of study product until permanent discontinuation of treatment. AEs and All-Cause Mortality are assessed in Safety analysis set: all randomized participants who initiated study drug. 1 participant is counted in 'All-Cause Mortality' who was counted as 'Completed' in Participant Flow as they died after completing study hence, the event is captured in as 'All-Cause Mortality'.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
B-cell lymphoma
|
0.20%
1/500 • Number of events 1 • From week 0 to week 52
All AEs are treatment emergent - AE with onset in datapoint set period defined as all observed data points from first date of study product until permanent discontinuation of treatment. AEs and All-Cause Mortality are assessed in Safety analysis set: all randomized participants who initiated study drug. 1 participant is counted in 'All-Cause Mortality' who was counted as 'Completed' in Participant Flow as they died after completing study hence, the event is captured in as 'All-Cause Mortality'.
|
0.00%
0/492 • From week 0 to week 52
All AEs are treatment emergent - AE with onset in datapoint set period defined as all observed data points from first date of study product until permanent discontinuation of treatment. AEs and All-Cause Mortality are assessed in Safety analysis set: all randomized participants who initiated study drug. 1 participant is counted in 'All-Cause Mortality' who was counted as 'Completed' in Participant Flow as they died after completing study hence, the event is captured in as 'All-Cause Mortality'.
|
|
Hepatobiliary disorders
Biliary colic
|
0.00%
0/500 • From week 0 to week 52
All AEs are treatment emergent - AE with onset in datapoint set period defined as all observed data points from first date of study product until permanent discontinuation of treatment. AEs and All-Cause Mortality are assessed in Safety analysis set: all randomized participants who initiated study drug. 1 participant is counted in 'All-Cause Mortality' who was counted as 'Completed' in Participant Flow as they died after completing study hence, the event is captured in as 'All-Cause Mortality'.
|
0.20%
1/492 • Number of events 1 • From week 0 to week 52
All AEs are treatment emergent - AE with onset in datapoint set period defined as all observed data points from first date of study product until permanent discontinuation of treatment. AEs and All-Cause Mortality are assessed in Safety analysis set: all randomized participants who initiated study drug. 1 participant is counted in 'All-Cause Mortality' who was counted as 'Completed' in Participant Flow as they died after completing study hence, the event is captured in as 'All-Cause Mortality'.
|
|
Investigations
Blood glucose increased
|
0.20%
1/500 • Number of events 2 • From week 0 to week 52
All AEs are treatment emergent - AE with onset in datapoint set period defined as all observed data points from first date of study product until permanent discontinuation of treatment. AEs and All-Cause Mortality are assessed in Safety analysis set: all randomized participants who initiated study drug. 1 participant is counted in 'All-Cause Mortality' who was counted as 'Completed' in Participant Flow as they died after completing study hence, the event is captured in as 'All-Cause Mortality'.
|
0.00%
0/492 • From week 0 to week 52
All AEs are treatment emergent - AE with onset in datapoint set period defined as all observed data points from first date of study product until permanent discontinuation of treatment. AEs and All-Cause Mortality are assessed in Safety analysis set: all randomized participants who initiated study drug. 1 participant is counted in 'All-Cause Mortality' who was counted as 'Completed' in Participant Flow as they died after completing study hence, the event is captured in as 'All-Cause Mortality'.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer metastatic
|
0.00%
0/500 • From week 0 to week 52
All AEs are treatment emergent - AE with onset in datapoint set period defined as all observed data points from first date of study product until permanent discontinuation of treatment. AEs and All-Cause Mortality are assessed in Safety analysis set: all randomized participants who initiated study drug. 1 participant is counted in 'All-Cause Mortality' who was counted as 'Completed' in Participant Flow as they died after completing study hence, the event is captured in as 'All-Cause Mortality'.
|
0.20%
1/492 • Number of events 1 • From week 0 to week 52
All AEs are treatment emergent - AE with onset in datapoint set period defined as all observed data points from first date of study product until permanent discontinuation of treatment. AEs and All-Cause Mortality are assessed in Safety analysis set: all randomized participants who initiated study drug. 1 participant is counted in 'All-Cause Mortality' who was counted as 'Completed' in Participant Flow as they died after completing study hence, the event is captured in as 'All-Cause Mortality'.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchiectasis
|
0.00%
0/500 • From week 0 to week 52
All AEs are treatment emergent - AE with onset in datapoint set period defined as all observed data points from first date of study product until permanent discontinuation of treatment. AEs and All-Cause Mortality are assessed in Safety analysis set: all randomized participants who initiated study drug. 1 participant is counted in 'All-Cause Mortality' who was counted as 'Completed' in Participant Flow as they died after completing study hence, the event is captured in as 'All-Cause Mortality'.
|
0.20%
1/492 • Number of events 1 • From week 0 to week 52
All AEs are treatment emergent - AE with onset in datapoint set period defined as all observed data points from first date of study product until permanent discontinuation of treatment. AEs and All-Cause Mortality are assessed in Safety analysis set: all randomized participants who initiated study drug. 1 participant is counted in 'All-Cause Mortality' who was counted as 'Completed' in Participant Flow as they died after completing study hence, the event is captured in as 'All-Cause Mortality'.
|
|
Infections and infestations
Bronchitis
|
0.20%
1/500 • Number of events 1 • From week 0 to week 52
All AEs are treatment emergent - AE with onset in datapoint set period defined as all observed data points from first date of study product until permanent discontinuation of treatment. AEs and All-Cause Mortality are assessed in Safety analysis set: all randomized participants who initiated study drug. 1 participant is counted in 'All-Cause Mortality' who was counted as 'Completed' in Participant Flow as they died after completing study hence, the event is captured in as 'All-Cause Mortality'.
|
0.00%
0/492 • From week 0 to week 52
All AEs are treatment emergent - AE with onset in datapoint set period defined as all observed data points from first date of study product until permanent discontinuation of treatment. AEs and All-Cause Mortality are assessed in Safety analysis set: all randomized participants who initiated study drug. 1 participant is counted in 'All-Cause Mortality' who was counted as 'Completed' in Participant Flow as they died after completing study hence, the event is captured in as 'All-Cause Mortality'.
|
|
Infections and infestations
COVID-19
|
0.00%
0/500 • From week 0 to week 52
All AEs are treatment emergent - AE with onset in datapoint set period defined as all observed data points from first date of study product until permanent discontinuation of treatment. AEs and All-Cause Mortality are assessed in Safety analysis set: all randomized participants who initiated study drug. 1 participant is counted in 'All-Cause Mortality' who was counted as 'Completed' in Participant Flow as they died after completing study hence, the event is captured in as 'All-Cause Mortality'.
|
0.41%
2/492 • Number of events 2 • From week 0 to week 52
All AEs are treatment emergent - AE with onset in datapoint set period defined as all observed data points from first date of study product until permanent discontinuation of treatment. AEs and All-Cause Mortality are assessed in Safety analysis set: all randomized participants who initiated study drug. 1 participant is counted in 'All-Cause Mortality' who was counted as 'Completed' in Participant Flow as they died after completing study hence, the event is captured in as 'All-Cause Mortality'.
|
|
Cardiac disorders
Cardiac arrest
|
0.20%
1/500 • Number of events 1 • From week 0 to week 52
All AEs are treatment emergent - AE with onset in datapoint set period defined as all observed data points from first date of study product until permanent discontinuation of treatment. AEs and All-Cause Mortality are assessed in Safety analysis set: all randomized participants who initiated study drug. 1 participant is counted in 'All-Cause Mortality' who was counted as 'Completed' in Participant Flow as they died after completing study hence, the event is captured in as 'All-Cause Mortality'.
|
0.00%
0/492 • From week 0 to week 52
All AEs are treatment emergent - AE with onset in datapoint set period defined as all observed data points from first date of study product until permanent discontinuation of treatment. AEs and All-Cause Mortality are assessed in Safety analysis set: all randomized participants who initiated study drug. 1 participant is counted in 'All-Cause Mortality' who was counted as 'Completed' in Participant Flow as they died after completing study hence, the event is captured in as 'All-Cause Mortality'.
|
|
Cardiac disorders
Cardiac failure congestive
|
0.20%
1/500 • Number of events 1 • From week 0 to week 52
All AEs are treatment emergent - AE with onset in datapoint set period defined as all observed data points from first date of study product until permanent discontinuation of treatment. AEs and All-Cause Mortality are assessed in Safety analysis set: all randomized participants who initiated study drug. 1 participant is counted in 'All-Cause Mortality' who was counted as 'Completed' in Participant Flow as they died after completing study hence, the event is captured in as 'All-Cause Mortality'.
|
0.41%
2/492 • Number of events 2 • From week 0 to week 52
All AEs are treatment emergent - AE with onset in datapoint set period defined as all observed data points from first date of study product until permanent discontinuation of treatment. AEs and All-Cause Mortality are assessed in Safety analysis set: all randomized participants who initiated study drug. 1 participant is counted in 'All-Cause Mortality' who was counted as 'Completed' in Participant Flow as they died after completing study hence, the event is captured in as 'All-Cause Mortality'.
|
|
Infections and infestations
Cellulitis
|
0.20%
1/500 • Number of events 1 • From week 0 to week 52
All AEs are treatment emergent - AE with onset in datapoint set period defined as all observed data points from first date of study product until permanent discontinuation of treatment. AEs and All-Cause Mortality are assessed in Safety analysis set: all randomized participants who initiated study drug. 1 participant is counted in 'All-Cause Mortality' who was counted as 'Completed' in Participant Flow as they died after completing study hence, the event is captured in as 'All-Cause Mortality'.
|
0.00%
0/492 • From week 0 to week 52
All AEs are treatment emergent - AE with onset in datapoint set period defined as all observed data points from first date of study product until permanent discontinuation of treatment. AEs and All-Cause Mortality are assessed in Safety analysis set: all randomized participants who initiated study drug. 1 participant is counted in 'All-Cause Mortality' who was counted as 'Completed' in Participant Flow as they died after completing study hence, the event is captured in as 'All-Cause Mortality'.
|
|
Nervous system disorders
Cerebral artery occlusion
|
0.00%
0/500 • From week 0 to week 52
All AEs are treatment emergent - AE with onset in datapoint set period defined as all observed data points from first date of study product until permanent discontinuation of treatment. AEs and All-Cause Mortality are assessed in Safety analysis set: all randomized participants who initiated study drug. 1 participant is counted in 'All-Cause Mortality' who was counted as 'Completed' in Participant Flow as they died after completing study hence, the event is captured in as 'All-Cause Mortality'.
|
0.20%
1/492 • Number of events 1 • From week 0 to week 52
All AEs are treatment emergent - AE with onset in datapoint set period defined as all observed data points from first date of study product until permanent discontinuation of treatment. AEs and All-Cause Mortality are assessed in Safety analysis set: all randomized participants who initiated study drug. 1 participant is counted in 'All-Cause Mortality' who was counted as 'Completed' in Participant Flow as they died after completing study hence, the event is captured in as 'All-Cause Mortality'.
|
|
Nervous system disorders
Cerebral haemorrhage
|
0.40%
2/500 • Number of events 2 • From week 0 to week 52
All AEs are treatment emergent - AE with onset in datapoint set period defined as all observed data points from first date of study product until permanent discontinuation of treatment. AEs and All-Cause Mortality are assessed in Safety analysis set: all randomized participants who initiated study drug. 1 participant is counted in 'All-Cause Mortality' who was counted as 'Completed' in Participant Flow as they died after completing study hence, the event is captured in as 'All-Cause Mortality'.
|
0.00%
0/492 • From week 0 to week 52
All AEs are treatment emergent - AE with onset in datapoint set period defined as all observed data points from first date of study product until permanent discontinuation of treatment. AEs and All-Cause Mortality are assessed in Safety analysis set: all randomized participants who initiated study drug. 1 participant is counted in 'All-Cause Mortality' who was counted as 'Completed' in Participant Flow as they died after completing study hence, the event is captured in as 'All-Cause Mortality'.
|
|
Nervous system disorders
Cerebral infarction
|
0.00%
0/500 • From week 0 to week 52
All AEs are treatment emergent - AE with onset in datapoint set period defined as all observed data points from first date of study product until permanent discontinuation of treatment. AEs and All-Cause Mortality are assessed in Safety analysis set: all randomized participants who initiated study drug. 1 participant is counted in 'All-Cause Mortality' who was counted as 'Completed' in Participant Flow as they died after completing study hence, the event is captured in as 'All-Cause Mortality'.
|
0.20%
1/492 • Number of events 1 • From week 0 to week 52
All AEs are treatment emergent - AE with onset in datapoint set period defined as all observed data points from first date of study product until permanent discontinuation of treatment. AEs and All-Cause Mortality are assessed in Safety analysis set: all randomized participants who initiated study drug. 1 participant is counted in 'All-Cause Mortality' who was counted as 'Completed' in Participant Flow as they died after completing study hence, the event is captured in as 'All-Cause Mortality'.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/500 • From week 0 to week 52
All AEs are treatment emergent - AE with onset in datapoint set period defined as all observed data points from first date of study product until permanent discontinuation of treatment. AEs and All-Cause Mortality are assessed in Safety analysis set: all randomized participants who initiated study drug. 1 participant is counted in 'All-Cause Mortality' who was counted as 'Completed' in Participant Flow as they died after completing study hence, the event is captured in as 'All-Cause Mortality'.
|
0.20%
1/492 • Number of events 1 • From week 0 to week 52
All AEs are treatment emergent - AE with onset in datapoint set period defined as all observed data points from first date of study product until permanent discontinuation of treatment. AEs and All-Cause Mortality are assessed in Safety analysis set: all randomized participants who initiated study drug. 1 participant is counted in 'All-Cause Mortality' who was counted as 'Completed' in Participant Flow as they died after completing study hence, the event is captured in as 'All-Cause Mortality'.
|
|
General disorders
Chest pain
|
0.40%
2/500 • Number of events 3 • From week 0 to week 52
All AEs are treatment emergent - AE with onset in datapoint set period defined as all observed data points from first date of study product until permanent discontinuation of treatment. AEs and All-Cause Mortality are assessed in Safety analysis set: all randomized participants who initiated study drug. 1 participant is counted in 'All-Cause Mortality' who was counted as 'Completed' in Participant Flow as they died after completing study hence, the event is captured in as 'All-Cause Mortality'.
|
0.61%
3/492 • Number of events 3 • From week 0 to week 52
All AEs are treatment emergent - AE with onset in datapoint set period defined as all observed data points from first date of study product until permanent discontinuation of treatment. AEs and All-Cause Mortality are assessed in Safety analysis set: all randomized participants who initiated study drug. 1 participant is counted in 'All-Cause Mortality' who was counted as 'Completed' in Participant Flow as they died after completing study hence, the event is captured in as 'All-Cause Mortality'.
|
|
Hepatobiliary disorders
Cholangitis
|
0.00%
0/500 • From week 0 to week 52
All AEs are treatment emergent - AE with onset in datapoint set period defined as all observed data points from first date of study product until permanent discontinuation of treatment. AEs and All-Cause Mortality are assessed in Safety analysis set: all randomized participants who initiated study drug. 1 participant is counted in 'All-Cause Mortality' who was counted as 'Completed' in Participant Flow as they died after completing study hence, the event is captured in as 'All-Cause Mortality'.
|
0.20%
1/492 • Number of events 1 • From week 0 to week 52
All AEs are treatment emergent - AE with onset in datapoint set period defined as all observed data points from first date of study product until permanent discontinuation of treatment. AEs and All-Cause Mortality are assessed in Safety analysis set: all randomized participants who initiated study drug. 1 participant is counted in 'All-Cause Mortality' who was counted as 'Completed' in Participant Flow as they died after completing study hence, the event is captured in as 'All-Cause Mortality'.
|
|
Renal and urinary disorders
Chromaturia
|
0.00%
0/500 • From week 0 to week 52
All AEs are treatment emergent - AE with onset in datapoint set period defined as all observed data points from first date of study product until permanent discontinuation of treatment. AEs and All-Cause Mortality are assessed in Safety analysis set: all randomized participants who initiated study drug. 1 participant is counted in 'All-Cause Mortality' who was counted as 'Completed' in Participant Flow as they died after completing study hence, the event is captured in as 'All-Cause Mortality'.
|
0.20%
1/492 • Number of events 1 • From week 0 to week 52
All AEs are treatment emergent - AE with onset in datapoint set period defined as all observed data points from first date of study product until permanent discontinuation of treatment. AEs and All-Cause Mortality are assessed in Safety analysis set: all randomized participants who initiated study drug. 1 participant is counted in 'All-Cause Mortality' who was counted as 'Completed' in Participant Flow as they died after completing study hence, the event is captured in as 'All-Cause Mortality'.
|
|
Renal and urinary disorders
Chronic kidney disease
|
0.20%
1/500 • Number of events 1 • From week 0 to week 52
All AEs are treatment emergent - AE with onset in datapoint set period defined as all observed data points from first date of study product until permanent discontinuation of treatment. AEs and All-Cause Mortality are assessed in Safety analysis set: all randomized participants who initiated study drug. 1 participant is counted in 'All-Cause Mortality' who was counted as 'Completed' in Participant Flow as they died after completing study hence, the event is captured in as 'All-Cause Mortality'.
|
0.00%
0/492 • From week 0 to week 52
All AEs are treatment emergent - AE with onset in datapoint set period defined as all observed data points from first date of study product until permanent discontinuation of treatment. AEs and All-Cause Mortality are assessed in Safety analysis set: all randomized participants who initiated study drug. 1 participant is counted in 'All-Cause Mortality' who was counted as 'Completed' in Participant Flow as they died after completing study hence, the event is captured in as 'All-Cause Mortality'.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.00%
0/500 • From week 0 to week 52
All AEs are treatment emergent - AE with onset in datapoint set period defined as all observed data points from first date of study product until permanent discontinuation of treatment. AEs and All-Cause Mortality are assessed in Safety analysis set: all randomized participants who initiated study drug. 1 participant is counted in 'All-Cause Mortality' who was counted as 'Completed' in Participant Flow as they died after completing study hence, the event is captured in as 'All-Cause Mortality'.
|
0.41%
2/492 • Number of events 2 • From week 0 to week 52
All AEs are treatment emergent - AE with onset in datapoint set period defined as all observed data points from first date of study product until permanent discontinuation of treatment. AEs and All-Cause Mortality are assessed in Safety analysis set: all randomized participants who initiated study drug. 1 participant is counted in 'All-Cause Mortality' who was counted as 'Completed' in Participant Flow as they died after completing study hence, the event is captured in as 'All-Cause Mortality'.
|
|
Gastrointestinal disorders
Colitis
|
0.20%
1/500 • Number of events 1 • From week 0 to week 52
All AEs are treatment emergent - AE with onset in datapoint set period defined as all observed data points from first date of study product until permanent discontinuation of treatment. AEs and All-Cause Mortality are assessed in Safety analysis set: all randomized participants who initiated study drug. 1 participant is counted in 'All-Cause Mortality' who was counted as 'Completed' in Participant Flow as they died after completing study hence, the event is captured in as 'All-Cause Mortality'.
|
0.00%
0/492 • From week 0 to week 52
All AEs are treatment emergent - AE with onset in datapoint set period defined as all observed data points from first date of study product until permanent discontinuation of treatment. AEs and All-Cause Mortality are assessed in Safety analysis set: all randomized participants who initiated study drug. 1 participant is counted in 'All-Cause Mortality' who was counted as 'Completed' in Participant Flow as they died after completing study hence, the event is captured in as 'All-Cause Mortality'.
|
|
Gastrointestinal disorders
Colitis ulcerative
|
0.00%
0/500 • From week 0 to week 52
All AEs are treatment emergent - AE with onset in datapoint set period defined as all observed data points from first date of study product until permanent discontinuation of treatment. AEs and All-Cause Mortality are assessed in Safety analysis set: all randomized participants who initiated study drug. 1 participant is counted in 'All-Cause Mortality' who was counted as 'Completed' in Participant Flow as they died after completing study hence, the event is captured in as 'All-Cause Mortality'.
|
0.20%
1/492 • Number of events 1 • From week 0 to week 52
All AEs are treatment emergent - AE with onset in datapoint set period defined as all observed data points from first date of study product until permanent discontinuation of treatment. AEs and All-Cause Mortality are assessed in Safety analysis set: all randomized participants who initiated study drug. 1 participant is counted in 'All-Cause Mortality' who was counted as 'Completed' in Participant Flow as they died after completing study hence, the event is captured in as 'All-Cause Mortality'.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colorectal adenoma
|
0.20%
1/500 • Number of events 1 • From week 0 to week 52
All AEs are treatment emergent - AE with onset in datapoint set period defined as all observed data points from first date of study product until permanent discontinuation of treatment. AEs and All-Cause Mortality are assessed in Safety analysis set: all randomized participants who initiated study drug. 1 participant is counted in 'All-Cause Mortality' who was counted as 'Completed' in Participant Flow as they died after completing study hence, the event is captured in as 'All-Cause Mortality'.
|
0.00%
0/492 • From week 0 to week 52
All AEs are treatment emergent - AE with onset in datapoint set period defined as all observed data points from first date of study product until permanent discontinuation of treatment. AEs and All-Cause Mortality are assessed in Safety analysis set: all randomized participants who initiated study drug. 1 participant is counted in 'All-Cause Mortality' who was counted as 'Completed' in Participant Flow as they died after completing study hence, the event is captured in as 'All-Cause Mortality'.
|
|
Injury, poisoning and procedural complications
Comminuted fracture
|
0.00%
0/500 • From week 0 to week 52
All AEs are treatment emergent - AE with onset in datapoint set period defined as all observed data points from first date of study product until permanent discontinuation of treatment. AEs and All-Cause Mortality are assessed in Safety analysis set: all randomized participants who initiated study drug. 1 participant is counted in 'All-Cause Mortality' who was counted as 'Completed' in Participant Flow as they died after completing study hence, the event is captured in as 'All-Cause Mortality'.
|
0.20%
1/492 • Number of events 1 • From week 0 to week 52
All AEs are treatment emergent - AE with onset in datapoint set period defined as all observed data points from first date of study product until permanent discontinuation of treatment. AEs and All-Cause Mortality are assessed in Safety analysis set: all randomized participants who initiated study drug. 1 participant is counted in 'All-Cause Mortality' who was counted as 'Completed' in Participant Flow as they died after completing study hence, the event is captured in as 'All-Cause Mortality'.
|
|
Infections and infestations
Complicated appendicitis
|
0.20%
1/500 • Number of events 1 • From week 0 to week 52
All AEs are treatment emergent - AE with onset in datapoint set period defined as all observed data points from first date of study product until permanent discontinuation of treatment. AEs and All-Cause Mortality are assessed in Safety analysis set: all randomized participants who initiated study drug. 1 participant is counted in 'All-Cause Mortality' who was counted as 'Completed' in Participant Flow as they died after completing study hence, the event is captured in as 'All-Cause Mortality'.
|
0.00%
0/492 • From week 0 to week 52
All AEs are treatment emergent - AE with onset in datapoint set period defined as all observed data points from first date of study product until permanent discontinuation of treatment. AEs and All-Cause Mortality are assessed in Safety analysis set: all randomized participants who initiated study drug. 1 participant is counted in 'All-Cause Mortality' who was counted as 'Completed' in Participant Flow as they died after completing study hence, the event is captured in as 'All-Cause Mortality'.
|
|
Cardiac disorders
Coronary artery disease
|
0.40%
2/500 • Number of events 2 • From week 0 to week 52
All AEs are treatment emergent - AE with onset in datapoint set period defined as all observed data points from first date of study product until permanent discontinuation of treatment. AEs and All-Cause Mortality are assessed in Safety analysis set: all randomized participants who initiated study drug. 1 participant is counted in 'All-Cause Mortality' who was counted as 'Completed' in Participant Flow as they died after completing study hence, the event is captured in as 'All-Cause Mortality'.
|
0.20%
1/492 • Number of events 1 • From week 0 to week 52
All AEs are treatment emergent - AE with onset in datapoint set period defined as all observed data points from first date of study product until permanent discontinuation of treatment. AEs and All-Cause Mortality are assessed in Safety analysis set: all randomized participants who initiated study drug. 1 participant is counted in 'All-Cause Mortality' who was counted as 'Completed' in Participant Flow as they died after completing study hence, the event is captured in as 'All-Cause Mortality'.
|
|
Cardiac disorders
Coronary artery stenosis
|
0.00%
0/500 • From week 0 to week 52
All AEs are treatment emergent - AE with onset in datapoint set period defined as all observed data points from first date of study product until permanent discontinuation of treatment. AEs and All-Cause Mortality are assessed in Safety analysis set: all randomized participants who initiated study drug. 1 participant is counted in 'All-Cause Mortality' who was counted as 'Completed' in Participant Flow as they died after completing study hence, the event is captured in as 'All-Cause Mortality'.
|
0.20%
1/492 • Number of events 1 • From week 0 to week 52
All AEs are treatment emergent - AE with onset in datapoint set period defined as all observed data points from first date of study product until permanent discontinuation of treatment. AEs and All-Cause Mortality are assessed in Safety analysis set: all randomized participants who initiated study drug. 1 participant is counted in 'All-Cause Mortality' who was counted as 'Completed' in Participant Flow as they died after completing study hence, the event is captured in as 'All-Cause Mortality'.
|
|
General disorders
Death
|
0.20%
1/500 • Number of events 1 • From week 0 to week 52
All AEs are treatment emergent - AE with onset in datapoint set period defined as all observed data points from first date of study product until permanent discontinuation of treatment. AEs and All-Cause Mortality are assessed in Safety analysis set: all randomized participants who initiated study drug. 1 participant is counted in 'All-Cause Mortality' who was counted as 'Completed' in Participant Flow as they died after completing study hence, the event is captured in as 'All-Cause Mortality'.
|
0.00%
0/492 • From week 0 to week 52
All AEs are treatment emergent - AE with onset in datapoint set period defined as all observed data points from first date of study product until permanent discontinuation of treatment. AEs and All-Cause Mortality are assessed in Safety analysis set: all randomized participants who initiated study drug. 1 participant is counted in 'All-Cause Mortality' who was counted as 'Completed' in Participant Flow as they died after completing study hence, the event is captured in as 'All-Cause Mortality'.
|
|
Infections and infestations
Device related infection
|
0.20%
1/500 • Number of events 1 • From week 0 to week 52
All AEs are treatment emergent - AE with onset in datapoint set period defined as all observed data points from first date of study product until permanent discontinuation of treatment. AEs and All-Cause Mortality are assessed in Safety analysis set: all randomized participants who initiated study drug. 1 participant is counted in 'All-Cause Mortality' who was counted as 'Completed' in Participant Flow as they died after completing study hence, the event is captured in as 'All-Cause Mortality'.
|
0.00%
0/492 • From week 0 to week 52
All AEs are treatment emergent - AE with onset in datapoint set period defined as all observed data points from first date of study product until permanent discontinuation of treatment. AEs and All-Cause Mortality are assessed in Safety analysis set: all randomized participants who initiated study drug. 1 participant is counted in 'All-Cause Mortality' who was counted as 'Completed' in Participant Flow as they died after completing study hence, the event is captured in as 'All-Cause Mortality'.
|
|
Infections and infestations
Diabetic foot infection
|
0.00%
0/500 • From week 0 to week 52
All AEs are treatment emergent - AE with onset in datapoint set period defined as all observed data points from first date of study product until permanent discontinuation of treatment. AEs and All-Cause Mortality are assessed in Safety analysis set: all randomized participants who initiated study drug. 1 participant is counted in 'All-Cause Mortality' who was counted as 'Completed' in Participant Flow as they died after completing study hence, the event is captured in as 'All-Cause Mortality'.
|
0.20%
1/492 • Number of events 1 • From week 0 to week 52
All AEs are treatment emergent - AE with onset in datapoint set period defined as all observed data points from first date of study product until permanent discontinuation of treatment. AEs and All-Cause Mortality are assessed in Safety analysis set: all randomized participants who initiated study drug. 1 participant is counted in 'All-Cause Mortality' who was counted as 'Completed' in Participant Flow as they died after completing study hence, the event is captured in as 'All-Cause Mortality'.
|
|
Metabolism and nutrition disorders
Diabetic ketoacidosis
|
0.20%
1/500 • Number of events 1 • From week 0 to week 52
All AEs are treatment emergent - AE with onset in datapoint set period defined as all observed data points from first date of study product until permanent discontinuation of treatment. AEs and All-Cause Mortality are assessed in Safety analysis set: all randomized participants who initiated study drug. 1 participant is counted in 'All-Cause Mortality' who was counted as 'Completed' in Participant Flow as they died after completing study hence, the event is captured in as 'All-Cause Mortality'.
|
0.41%
2/492 • Number of events 2 • From week 0 to week 52
All AEs are treatment emergent - AE with onset in datapoint set period defined as all observed data points from first date of study product until permanent discontinuation of treatment. AEs and All-Cause Mortality are assessed in Safety analysis set: all randomized participants who initiated study drug. 1 participant is counted in 'All-Cause Mortality' who was counted as 'Completed' in Participant Flow as they died after completing study hence, the event is captured in as 'All-Cause Mortality'.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/500 • From week 0 to week 52
All AEs are treatment emergent - AE with onset in datapoint set period defined as all observed data points from first date of study product until permanent discontinuation of treatment. AEs and All-Cause Mortality are assessed in Safety analysis set: all randomized participants who initiated study drug. 1 participant is counted in 'All-Cause Mortality' who was counted as 'Completed' in Participant Flow as they died after completing study hence, the event is captured in as 'All-Cause Mortality'.
|
0.20%
1/492 • Number of events 1 • From week 0 to week 52
All AEs are treatment emergent - AE with onset in datapoint set period defined as all observed data points from first date of study product until permanent discontinuation of treatment. AEs and All-Cause Mortality are assessed in Safety analysis set: all randomized participants who initiated study drug. 1 participant is counted in 'All-Cause Mortality' who was counted as 'Completed' in Participant Flow as they died after completing study hence, the event is captured in as 'All-Cause Mortality'.
|
|
Infections and infestations
Diverticulitis
|
0.00%
0/500 • From week 0 to week 52
All AEs are treatment emergent - AE with onset in datapoint set period defined as all observed data points from first date of study product until permanent discontinuation of treatment. AEs and All-Cause Mortality are assessed in Safety analysis set: all randomized participants who initiated study drug. 1 participant is counted in 'All-Cause Mortality' who was counted as 'Completed' in Participant Flow as they died after completing study hence, the event is captured in as 'All-Cause Mortality'.
|
0.41%
2/492 • Number of events 2 • From week 0 to week 52
All AEs are treatment emergent - AE with onset in datapoint set period defined as all observed data points from first date of study product until permanent discontinuation of treatment. AEs and All-Cause Mortality are assessed in Safety analysis set: all randomized participants who initiated study drug. 1 participant is counted in 'All-Cause Mortality' who was counted as 'Completed' in Participant Flow as they died after completing study hence, the event is captured in as 'All-Cause Mortality'.
|
|
Nervous system disorders
Dizziness
|
0.20%
1/500 • Number of events 1 • From week 0 to week 52
All AEs are treatment emergent - AE with onset in datapoint set period defined as all observed data points from first date of study product until permanent discontinuation of treatment. AEs and All-Cause Mortality are assessed in Safety analysis set: all randomized participants who initiated study drug. 1 participant is counted in 'All-Cause Mortality' who was counted as 'Completed' in Participant Flow as they died after completing study hence, the event is captured in as 'All-Cause Mortality'.
|
0.41%
2/492 • Number of events 2 • From week 0 to week 52
All AEs are treatment emergent - AE with onset in datapoint set period defined as all observed data points from first date of study product until permanent discontinuation of treatment. AEs and All-Cause Mortality are assessed in Safety analysis set: all randomized participants who initiated study drug. 1 participant is counted in 'All-Cause Mortality' who was counted as 'Completed' in Participant Flow as they died after completing study hence, the event is captured in as 'All-Cause Mortality'.
|
|
General disorders
Drug withdrawal syndrome
|
0.20%
1/500 • Number of events 1 • From week 0 to week 52
All AEs are treatment emergent - AE with onset in datapoint set period defined as all observed data points from first date of study product until permanent discontinuation of treatment. AEs and All-Cause Mortality are assessed in Safety analysis set: all randomized participants who initiated study drug. 1 participant is counted in 'All-Cause Mortality' who was counted as 'Completed' in Participant Flow as they died after completing study hence, the event is captured in as 'All-Cause Mortality'.
|
0.00%
0/492 • From week 0 to week 52
All AEs are treatment emergent - AE with onset in datapoint set period defined as all observed data points from first date of study product until permanent discontinuation of treatment. AEs and All-Cause Mortality are assessed in Safety analysis set: all randomized participants who initiated study drug. 1 participant is counted in 'All-Cause Mortality' who was counted as 'Completed' in Participant Flow as they died after completing study hence, the event is captured in as 'All-Cause Mortality'.
|
|
Gastrointestinal disorders
Duodenal ulcer haemorrhage
|
0.00%
0/500 • From week 0 to week 52
All AEs are treatment emergent - AE with onset in datapoint set period defined as all observed data points from first date of study product until permanent discontinuation of treatment. AEs and All-Cause Mortality are assessed in Safety analysis set: all randomized participants who initiated study drug. 1 participant is counted in 'All-Cause Mortality' who was counted as 'Completed' in Participant Flow as they died after completing study hence, the event is captured in as 'All-Cause Mortality'.
|
0.20%
1/492 • Number of events 1 • From week 0 to week 52
All AEs are treatment emergent - AE with onset in datapoint set period defined as all observed data points from first date of study product until permanent discontinuation of treatment. AEs and All-Cause Mortality are assessed in Safety analysis set: all randomized participants who initiated study drug. 1 participant is counted in 'All-Cause Mortality' who was counted as 'Completed' in Participant Flow as they died after completing study hence, the event is captured in as 'All-Cause Mortality'.
|
|
Nervous system disorders
Dysarthria
|
0.00%
0/500 • From week 0 to week 52
All AEs are treatment emergent - AE with onset in datapoint set period defined as all observed data points from first date of study product until permanent discontinuation of treatment. AEs and All-Cause Mortality are assessed in Safety analysis set: all randomized participants who initiated study drug. 1 participant is counted in 'All-Cause Mortality' who was counted as 'Completed' in Participant Flow as they died after completing study hence, the event is captured in as 'All-Cause Mortality'.
|
0.20%
1/492 • Number of events 1 • From week 0 to week 52
All AEs are treatment emergent - AE with onset in datapoint set period defined as all observed data points from first date of study product until permanent discontinuation of treatment. AEs and All-Cause Mortality are assessed in Safety analysis set: all randomized participants who initiated study drug. 1 participant is counted in 'All-Cause Mortality' who was counted as 'Completed' in Participant Flow as they died after completing study hence, the event is captured in as 'All-Cause Mortality'.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.20%
1/500 • Number of events 1 • From week 0 to week 52
All AEs are treatment emergent - AE with onset in datapoint set period defined as all observed data points from first date of study product until permanent discontinuation of treatment. AEs and All-Cause Mortality are assessed in Safety analysis set: all randomized participants who initiated study drug. 1 participant is counted in 'All-Cause Mortality' who was counted as 'Completed' in Participant Flow as they died after completing study hence, the event is captured in as 'All-Cause Mortality'.
|
0.00%
0/492 • From week 0 to week 52
All AEs are treatment emergent - AE with onset in datapoint set period defined as all observed data points from first date of study product until permanent discontinuation of treatment. AEs and All-Cause Mortality are assessed in Safety analysis set: all randomized participants who initiated study drug. 1 participant is counted in 'All-Cause Mortality' who was counted as 'Completed' in Participant Flow as they died after completing study hence, the event is captured in as 'All-Cause Mortality'.
|
|
Gastrointestinal disorders
Enteritis
|
0.20%
1/500 • Number of events 1 • From week 0 to week 52
All AEs are treatment emergent - AE with onset in datapoint set period defined as all observed data points from first date of study product until permanent discontinuation of treatment. AEs and All-Cause Mortality are assessed in Safety analysis set: all randomized participants who initiated study drug. 1 participant is counted in 'All-Cause Mortality' who was counted as 'Completed' in Participant Flow as they died after completing study hence, the event is captured in as 'All-Cause Mortality'.
|
0.00%
0/492 • From week 0 to week 52
All AEs are treatment emergent - AE with onset in datapoint set period defined as all observed data points from first date of study product until permanent discontinuation of treatment. AEs and All-Cause Mortality are assessed in Safety analysis set: all randomized participants who initiated study drug. 1 participant is counted in 'All-Cause Mortality' who was counted as 'Completed' in Participant Flow as they died after completing study hence, the event is captured in as 'All-Cause Mortality'.
|
|
Injury, poisoning and procedural complications
Fall
|
0.80%
4/500 • Number of events 4 • From week 0 to week 52
All AEs are treatment emergent - AE with onset in datapoint set period defined as all observed data points from first date of study product until permanent discontinuation of treatment. AEs and All-Cause Mortality are assessed in Safety analysis set: all randomized participants who initiated study drug. 1 participant is counted in 'All-Cause Mortality' who was counted as 'Completed' in Participant Flow as they died after completing study hence, the event is captured in as 'All-Cause Mortality'.
|
0.61%
3/492 • Number of events 3 • From week 0 to week 52
All AEs are treatment emergent - AE with onset in datapoint set period defined as all observed data points from first date of study product until permanent discontinuation of treatment. AEs and All-Cause Mortality are assessed in Safety analysis set: all randomized participants who initiated study drug. 1 participant is counted in 'All-Cause Mortality' who was counted as 'Completed' in Participant Flow as they died after completing study hence, the event is captured in as 'All-Cause Mortality'.
|
|
Injury, poisoning and procedural complications
Femoral neck fracture
|
0.20%
1/500 • Number of events 1 • From week 0 to week 52
All AEs are treatment emergent - AE with onset in datapoint set period defined as all observed data points from first date of study product until permanent discontinuation of treatment. AEs and All-Cause Mortality are assessed in Safety analysis set: all randomized participants who initiated study drug. 1 participant is counted in 'All-Cause Mortality' who was counted as 'Completed' in Participant Flow as they died after completing study hence, the event is captured in as 'All-Cause Mortality'.
|
0.20%
1/492 • Number of events 1 • From week 0 to week 52
All AEs are treatment emergent - AE with onset in datapoint set period defined as all observed data points from first date of study product until permanent discontinuation of treatment. AEs and All-Cause Mortality are assessed in Safety analysis set: all randomized participants who initiated study drug. 1 participant is counted in 'All-Cause Mortality' who was counted as 'Completed' in Participant Flow as they died after completing study hence, the event is captured in as 'All-Cause Mortality'.
|
|
General disorders
Gait disturbance
|
0.00%
0/500 • From week 0 to week 52
All AEs are treatment emergent - AE with onset in datapoint set period defined as all observed data points from first date of study product until permanent discontinuation of treatment. AEs and All-Cause Mortality are assessed in Safety analysis set: all randomized participants who initiated study drug. 1 participant is counted in 'All-Cause Mortality' who was counted as 'Completed' in Participant Flow as they died after completing study hence, the event is captured in as 'All-Cause Mortality'.
|
0.20%
1/492 • Number of events 1 • From week 0 to week 52
All AEs are treatment emergent - AE with onset in datapoint set period defined as all observed data points from first date of study product until permanent discontinuation of treatment. AEs and All-Cause Mortality are assessed in Safety analysis set: all randomized participants who initiated study drug. 1 participant is counted in 'All-Cause Mortality' who was counted as 'Completed' in Participant Flow as they died after completing study hence, the event is captured in as 'All-Cause Mortality'.
|
|
Infections and infestations
Gangrene
|
0.00%
0/500 • From week 0 to week 52
All AEs are treatment emergent - AE with onset in datapoint set period defined as all observed data points from first date of study product until permanent discontinuation of treatment. AEs and All-Cause Mortality are assessed in Safety analysis set: all randomized participants who initiated study drug. 1 participant is counted in 'All-Cause Mortality' who was counted as 'Completed' in Participant Flow as they died after completing study hence, the event is captured in as 'All-Cause Mortality'.
|
0.20%
1/492 • Number of events 1 • From week 0 to week 52
All AEs are treatment emergent - AE with onset in datapoint set period defined as all observed data points from first date of study product until permanent discontinuation of treatment. AEs and All-Cause Mortality are assessed in Safety analysis set: all randomized participants who initiated study drug. 1 participant is counted in 'All-Cause Mortality' who was counted as 'Completed' in Participant Flow as they died after completing study hence, the event is captured in as 'All-Cause Mortality'.
|
|
Gastrointestinal disorders
Gastritis
|
0.20%
1/500 • Number of events 1 • From week 0 to week 52
All AEs are treatment emergent - AE with onset in datapoint set period defined as all observed data points from first date of study product until permanent discontinuation of treatment. AEs and All-Cause Mortality are assessed in Safety analysis set: all randomized participants who initiated study drug. 1 participant is counted in 'All-Cause Mortality' who was counted as 'Completed' in Participant Flow as they died after completing study hence, the event is captured in as 'All-Cause Mortality'.
|
0.00%
0/492 • From week 0 to week 52
All AEs are treatment emergent - AE with onset in datapoint set period defined as all observed data points from first date of study product until permanent discontinuation of treatment. AEs and All-Cause Mortality are assessed in Safety analysis set: all randomized participants who initiated study drug. 1 participant is counted in 'All-Cause Mortality' who was counted as 'Completed' in Participant Flow as they died after completing study hence, the event is captured in as 'All-Cause Mortality'.
|
|
Infections and infestations
Gastroenteritis
|
0.20%
1/500 • Number of events 1 • From week 0 to week 52
All AEs are treatment emergent - AE with onset in datapoint set period defined as all observed data points from first date of study product until permanent discontinuation of treatment. AEs and All-Cause Mortality are assessed in Safety analysis set: all randomized participants who initiated study drug. 1 participant is counted in 'All-Cause Mortality' who was counted as 'Completed' in Participant Flow as they died after completing study hence, the event is captured in as 'All-Cause Mortality'.
|
0.00%
0/492 • From week 0 to week 52
All AEs are treatment emergent - AE with onset in datapoint set period defined as all observed data points from first date of study product until permanent discontinuation of treatment. AEs and All-Cause Mortality are assessed in Safety analysis set: all randomized participants who initiated study drug. 1 participant is counted in 'All-Cause Mortality' who was counted as 'Completed' in Participant Flow as they died after completing study hence, the event is captured in as 'All-Cause Mortality'.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.00%
0/500 • From week 0 to week 52
All AEs are treatment emergent - AE with onset in datapoint set period defined as all observed data points from first date of study product until permanent discontinuation of treatment. AEs and All-Cause Mortality are assessed in Safety analysis set: all randomized participants who initiated study drug. 1 participant is counted in 'All-Cause Mortality' who was counted as 'Completed' in Participant Flow as they died after completing study hence, the event is captured in as 'All-Cause Mortality'.
|
0.20%
1/492 • Number of events 1 • From week 0 to week 52
All AEs are treatment emergent - AE with onset in datapoint set period defined as all observed data points from first date of study product until permanent discontinuation of treatment. AEs and All-Cause Mortality are assessed in Safety analysis set: all randomized participants who initiated study drug. 1 participant is counted in 'All-Cause Mortality' who was counted as 'Completed' in Participant Flow as they died after completing study hence, the event is captured in as 'All-Cause Mortality'.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Glioblastoma
|
0.00%
0/500 • From week 0 to week 52
All AEs are treatment emergent - AE with onset in datapoint set period defined as all observed data points from first date of study product until permanent discontinuation of treatment. AEs and All-Cause Mortality are assessed in Safety analysis set: all randomized participants who initiated study drug. 1 participant is counted in 'All-Cause Mortality' who was counted as 'Completed' in Participant Flow as they died after completing study hence, the event is captured in as 'All-Cause Mortality'.
|
0.20%
1/492 • Number of events 1 • From week 0 to week 52
All AEs are treatment emergent - AE with onset in datapoint set period defined as all observed data points from first date of study product until permanent discontinuation of treatment. AEs and All-Cause Mortality are assessed in Safety analysis set: all randomized participants who initiated study drug. 1 participant is counted in 'All-Cause Mortality' who was counted as 'Completed' in Participant Flow as they died after completing study hence, the event is captured in as 'All-Cause Mortality'.
|
|
Gastrointestinal disorders
Haematemesis
|
0.20%
1/500 • Number of events 1 • From week 0 to week 52
All AEs are treatment emergent - AE with onset in datapoint set period defined as all observed data points from first date of study product until permanent discontinuation of treatment. AEs and All-Cause Mortality are assessed in Safety analysis set: all randomized participants who initiated study drug. 1 participant is counted in 'All-Cause Mortality' who was counted as 'Completed' in Participant Flow as they died after completing study hence, the event is captured in as 'All-Cause Mortality'.
|
0.00%
0/492 • From week 0 to week 52
All AEs are treatment emergent - AE with onset in datapoint set period defined as all observed data points from first date of study product until permanent discontinuation of treatment. AEs and All-Cause Mortality are assessed in Safety analysis set: all randomized participants who initiated study drug. 1 participant is counted in 'All-Cause Mortality' who was counted as 'Completed' in Participant Flow as they died after completing study hence, the event is captured in as 'All-Cause Mortality'.
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.20%
1/500 • Number of events 1 • From week 0 to week 52
All AEs are treatment emergent - AE with onset in datapoint set period defined as all observed data points from first date of study product until permanent discontinuation of treatment. AEs and All-Cause Mortality are assessed in Safety analysis set: all randomized participants who initiated study drug. 1 participant is counted in 'All-Cause Mortality' who was counted as 'Completed' in Participant Flow as they died after completing study hence, the event is captured in as 'All-Cause Mortality'.
|
0.00%
0/492 • From week 0 to week 52
All AEs are treatment emergent - AE with onset in datapoint set period defined as all observed data points from first date of study product until permanent discontinuation of treatment. AEs and All-Cause Mortality are assessed in Safety analysis set: all randomized participants who initiated study drug. 1 participant is counted in 'All-Cause Mortality' who was counted as 'Completed' in Participant Flow as they died after completing study hence, the event is captured in as 'All-Cause Mortality'.
|
|
Hepatobiliary disorders
Hepatic steatosis
|
0.40%
2/500 • Number of events 2 • From week 0 to week 52
All AEs are treatment emergent - AE with onset in datapoint set period defined as all observed data points from first date of study product until permanent discontinuation of treatment. AEs and All-Cause Mortality are assessed in Safety analysis set: all randomized participants who initiated study drug. 1 participant is counted in 'All-Cause Mortality' who was counted as 'Completed' in Participant Flow as they died after completing study hence, the event is captured in as 'All-Cause Mortality'.
|
0.00%
0/492 • From week 0 to week 52
All AEs are treatment emergent - AE with onset in datapoint set period defined as all observed data points from first date of study product until permanent discontinuation of treatment. AEs and All-Cause Mortality are assessed in Safety analysis set: all randomized participants who initiated study drug. 1 participant is counted in 'All-Cause Mortality' who was counted as 'Completed' in Participant Flow as they died after completing study hence, the event is captured in as 'All-Cause Mortality'.
|
|
Infections and infestations
Herpes zoster
|
0.00%
0/500 • From week 0 to week 52
All AEs are treatment emergent - AE with onset in datapoint set period defined as all observed data points from first date of study product until permanent discontinuation of treatment. AEs and All-Cause Mortality are assessed in Safety analysis set: all randomized participants who initiated study drug. 1 participant is counted in 'All-Cause Mortality' who was counted as 'Completed' in Participant Flow as they died after completing study hence, the event is captured in as 'All-Cause Mortality'.
|
0.20%
1/492 • Number of events 1 • From week 0 to week 52
All AEs are treatment emergent - AE with onset in datapoint set period defined as all observed data points from first date of study product until permanent discontinuation of treatment. AEs and All-Cause Mortality are assessed in Safety analysis set: all randomized participants who initiated study drug. 1 participant is counted in 'All-Cause Mortality' who was counted as 'Completed' in Participant Flow as they died after completing study hence, the event is captured in as 'All-Cause Mortality'.
|
|
Gastrointestinal disorders
Hiatus hernia
|
0.20%
1/500 • Number of events 1 • From week 0 to week 52
All AEs are treatment emergent - AE with onset in datapoint set period defined as all observed data points from first date of study product until permanent discontinuation of treatment. AEs and All-Cause Mortality are assessed in Safety analysis set: all randomized participants who initiated study drug. 1 participant is counted in 'All-Cause Mortality' who was counted as 'Completed' in Participant Flow as they died after completing study hence, the event is captured in as 'All-Cause Mortality'.
|
0.00%
0/492 • From week 0 to week 52
All AEs are treatment emergent - AE with onset in datapoint set period defined as all observed data points from first date of study product until permanent discontinuation of treatment. AEs and All-Cause Mortality are assessed in Safety analysis set: all randomized participants who initiated study drug. 1 participant is counted in 'All-Cause Mortality' who was counted as 'Completed' in Participant Flow as they died after completing study hence, the event is captured in as 'All-Cause Mortality'.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.40%
2/500 • Number of events 2 • From week 0 to week 52
All AEs are treatment emergent - AE with onset in datapoint set period defined as all observed data points from first date of study product until permanent discontinuation of treatment. AEs and All-Cause Mortality are assessed in Safety analysis set: all randomized participants who initiated study drug. 1 participant is counted in 'All-Cause Mortality' who was counted as 'Completed' in Participant Flow as they died after completing study hence, the event is captured in as 'All-Cause Mortality'.
|
0.00%
0/492 • From week 0 to week 52
All AEs are treatment emergent - AE with onset in datapoint set period defined as all observed data points from first date of study product until permanent discontinuation of treatment. AEs and All-Cause Mortality are assessed in Safety analysis set: all randomized participants who initiated study drug. 1 participant is counted in 'All-Cause Mortality' who was counted as 'Completed' in Participant Flow as they died after completing study hence, the event is captured in as 'All-Cause Mortality'.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/500 • From week 0 to week 52
All AEs are treatment emergent - AE with onset in datapoint set period defined as all observed data points from first date of study product until permanent discontinuation of treatment. AEs and All-Cause Mortality are assessed in Safety analysis set: all randomized participants who initiated study drug. 1 participant is counted in 'All-Cause Mortality' who was counted as 'Completed' in Participant Flow as they died after completing study hence, the event is captured in as 'All-Cause Mortality'.
|
0.20%
1/492 • Number of events 1 • From week 0 to week 52
All AEs are treatment emergent - AE with onset in datapoint set period defined as all observed data points from first date of study product until permanent discontinuation of treatment. AEs and All-Cause Mortality are assessed in Safety analysis set: all randomized participants who initiated study drug. 1 participant is counted in 'All-Cause Mortality' who was counted as 'Completed' in Participant Flow as they died after completing study hence, the event is captured in as 'All-Cause Mortality'.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.20%
1/500 • Number of events 1 • From week 0 to week 52
All AEs are treatment emergent - AE with onset in datapoint set period defined as all observed data points from first date of study product until permanent discontinuation of treatment. AEs and All-Cause Mortality are assessed in Safety analysis set: all randomized participants who initiated study drug. 1 participant is counted in 'All-Cause Mortality' who was counted as 'Completed' in Participant Flow as they died after completing study hence, the event is captured in as 'All-Cause Mortality'.
|
0.00%
0/492 • From week 0 to week 52
All AEs are treatment emergent - AE with onset in datapoint set period defined as all observed data points from first date of study product until permanent discontinuation of treatment. AEs and All-Cause Mortality are assessed in Safety analysis set: all randomized participants who initiated study drug. 1 participant is counted in 'All-Cause Mortality' who was counted as 'Completed' in Participant Flow as they died after completing study hence, the event is captured in as 'All-Cause Mortality'.
|
|
Vascular disorders
Hypotension
|
0.00%
0/500 • From week 0 to week 52
All AEs are treatment emergent - AE with onset in datapoint set period defined as all observed data points from first date of study product until permanent discontinuation of treatment. AEs and All-Cause Mortality are assessed in Safety analysis set: all randomized participants who initiated study drug. 1 participant is counted in 'All-Cause Mortality' who was counted as 'Completed' in Participant Flow as they died after completing study hence, the event is captured in as 'All-Cause Mortality'.
|
0.20%
1/492 • Number of events 1 • From week 0 to week 52
All AEs are treatment emergent - AE with onset in datapoint set period defined as all observed data points from first date of study product until permanent discontinuation of treatment. AEs and All-Cause Mortality are assessed in Safety analysis set: all randomized participants who initiated study drug. 1 participant is counted in 'All-Cause Mortality' who was counted as 'Completed' in Participant Flow as they died after completing study hence, the event is captured in as 'All-Cause Mortality'.
|
|
Vascular disorders
Iliac artery occlusion
|
0.00%
0/500 • From week 0 to week 52
All AEs are treatment emergent - AE with onset in datapoint set period defined as all observed data points from first date of study product until permanent discontinuation of treatment. AEs and All-Cause Mortality are assessed in Safety analysis set: all randomized participants who initiated study drug. 1 participant is counted in 'All-Cause Mortality' who was counted as 'Completed' in Participant Flow as they died after completing study hence, the event is captured in as 'All-Cause Mortality'.
|
0.20%
1/492 • Number of events 1 • From week 0 to week 52
All AEs are treatment emergent - AE with onset in datapoint set period defined as all observed data points from first date of study product until permanent discontinuation of treatment. AEs and All-Cause Mortality are assessed in Safety analysis set: all randomized participants who initiated study drug. 1 participant is counted in 'All-Cause Mortality' who was counted as 'Completed' in Participant Flow as they died after completing study hence, the event is captured in as 'All-Cause Mortality'.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.00%
0/500 • From week 0 to week 52
All AEs are treatment emergent - AE with onset in datapoint set period defined as all observed data points from first date of study product until permanent discontinuation of treatment. AEs and All-Cause Mortality are assessed in Safety analysis set: all randomized participants who initiated study drug. 1 participant is counted in 'All-Cause Mortality' who was counted as 'Completed' in Participant Flow as they died after completing study hence, the event is captured in as 'All-Cause Mortality'.
|
0.20%
1/492 • Number of events 1 • From week 0 to week 52
All AEs are treatment emergent - AE with onset in datapoint set period defined as all observed data points from first date of study product until permanent discontinuation of treatment. AEs and All-Cause Mortality are assessed in Safety analysis set: all randomized participants who initiated study drug. 1 participant is counted in 'All-Cause Mortality' who was counted as 'Completed' in Participant Flow as they died after completing study hence, the event is captured in as 'All-Cause Mortality'.
|
|
Gastrointestinal disorders
Intestinal metaplasia
|
0.20%
1/500 • Number of events 1 • From week 0 to week 52
All AEs are treatment emergent - AE with onset in datapoint set period defined as all observed data points from first date of study product until permanent discontinuation of treatment. AEs and All-Cause Mortality are assessed in Safety analysis set: all randomized participants who initiated study drug. 1 participant is counted in 'All-Cause Mortality' who was counted as 'Completed' in Participant Flow as they died after completing study hence, the event is captured in as 'All-Cause Mortality'.
|
0.00%
0/492 • From week 0 to week 52
All AEs are treatment emergent - AE with onset in datapoint set period defined as all observed data points from first date of study product until permanent discontinuation of treatment. AEs and All-Cause Mortality are assessed in Safety analysis set: all randomized participants who initiated study drug. 1 participant is counted in 'All-Cause Mortality' who was counted as 'Completed' in Participant Flow as they died after completing study hence, the event is captured in as 'All-Cause Mortality'.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Invasive ductal breast carcinoma
|
0.00%
0/500 • From week 0 to week 52
All AEs are treatment emergent - AE with onset in datapoint set period defined as all observed data points from first date of study product until permanent discontinuation of treatment. AEs and All-Cause Mortality are assessed in Safety analysis set: all randomized participants who initiated study drug. 1 participant is counted in 'All-Cause Mortality' who was counted as 'Completed' in Participant Flow as they died after completing study hence, the event is captured in as 'All-Cause Mortality'.
|
0.20%
1/492 • Number of events 1 • From week 0 to week 52
All AEs are treatment emergent - AE with onset in datapoint set period defined as all observed data points from first date of study product until permanent discontinuation of treatment. AEs and All-Cause Mortality are assessed in Safety analysis set: all randomized participants who initiated study drug. 1 participant is counted in 'All-Cause Mortality' who was counted as 'Completed' in Participant Flow as they died after completing study hence, the event is captured in as 'All-Cause Mortality'.
|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
0.00%
0/500 • From week 0 to week 52
All AEs are treatment emergent - AE with onset in datapoint set period defined as all observed data points from first date of study product until permanent discontinuation of treatment. AEs and All-Cause Mortality are assessed in Safety analysis set: all randomized participants who initiated study drug. 1 participant is counted in 'All-Cause Mortality' who was counted as 'Completed' in Participant Flow as they died after completing study hence, the event is captured in as 'All-Cause Mortality'.
|
0.20%
1/492 • Number of events 1 • From week 0 to week 52
All AEs are treatment emergent - AE with onset in datapoint set period defined as all observed data points from first date of study product until permanent discontinuation of treatment. AEs and All-Cause Mortality are assessed in Safety analysis set: all randomized participants who initiated study drug. 1 participant is counted in 'All-Cause Mortality' who was counted as 'Completed' in Participant Flow as they died after completing study hence, the event is captured in as 'All-Cause Mortality'.
|
|
Cardiac disorders
Ischaemic cardiomyopathy
|
0.20%
1/500 • Number of events 1 • From week 0 to week 52
All AEs are treatment emergent - AE with onset in datapoint set period defined as all observed data points from first date of study product until permanent discontinuation of treatment. AEs and All-Cause Mortality are assessed in Safety analysis set: all randomized participants who initiated study drug. 1 participant is counted in 'All-Cause Mortality' who was counted as 'Completed' in Participant Flow as they died after completing study hence, the event is captured in as 'All-Cause Mortality'.
|
0.00%
0/492 • From week 0 to week 52
All AEs are treatment emergent - AE with onset in datapoint set period defined as all observed data points from first date of study product until permanent discontinuation of treatment. AEs and All-Cause Mortality are assessed in Safety analysis set: all randomized participants who initiated study drug. 1 participant is counted in 'All-Cause Mortality' who was counted as 'Completed' in Participant Flow as they died after completing study hence, the event is captured in as 'All-Cause Mortality'.
|
|
Nervous system disorders
Ischaemic cerebral infarction
|
0.00%
0/500 • From week 0 to week 52
All AEs are treatment emergent - AE with onset in datapoint set period defined as all observed data points from first date of study product until permanent discontinuation of treatment. AEs and All-Cause Mortality are assessed in Safety analysis set: all randomized participants who initiated study drug. 1 participant is counted in 'All-Cause Mortality' who was counted as 'Completed' in Participant Flow as they died after completing study hence, the event is captured in as 'All-Cause Mortality'.
|
0.20%
1/492 • Number of events 1 • From week 0 to week 52
All AEs are treatment emergent - AE with onset in datapoint set period defined as all observed data points from first date of study product until permanent discontinuation of treatment. AEs and All-Cause Mortality are assessed in Safety analysis set: all randomized participants who initiated study drug. 1 participant is counted in 'All-Cause Mortality' who was counted as 'Completed' in Participant Flow as they died after completing study hence, the event is captured in as 'All-Cause Mortality'.
|
|
Nervous system disorders
Ischaemic stroke
|
0.20%
1/500 • Number of events 1 • From week 0 to week 52
All AEs are treatment emergent - AE with onset in datapoint set period defined as all observed data points from first date of study product until permanent discontinuation of treatment. AEs and All-Cause Mortality are assessed in Safety analysis set: all randomized participants who initiated study drug. 1 participant is counted in 'All-Cause Mortality' who was counted as 'Completed' in Participant Flow as they died after completing study hence, the event is captured in as 'All-Cause Mortality'.
|
0.00%
0/492 • From week 0 to week 52
All AEs are treatment emergent - AE with onset in datapoint set period defined as all observed data points from first date of study product until permanent discontinuation of treatment. AEs and All-Cause Mortality are assessed in Safety analysis set: all randomized participants who initiated study drug. 1 participant is counted in 'All-Cause Mortality' who was counted as 'Completed' in Participant Flow as they died after completing study hence, the event is captured in as 'All-Cause Mortality'.
|
|
Vascular disorders
Leriche syndrome
|
0.00%
0/500 • From week 0 to week 52
All AEs are treatment emergent - AE with onset in datapoint set period defined as all observed data points from first date of study product until permanent discontinuation of treatment. AEs and All-Cause Mortality are assessed in Safety analysis set: all randomized participants who initiated study drug. 1 participant is counted in 'All-Cause Mortality' who was counted as 'Completed' in Participant Flow as they died after completing study hence, the event is captured in as 'All-Cause Mortality'.
|
0.20%
1/492 • Number of events 1 • From week 0 to week 52
All AEs are treatment emergent - AE with onset in datapoint set period defined as all observed data points from first date of study product until permanent discontinuation of treatment. AEs and All-Cause Mortality are assessed in Safety analysis set: all randomized participants who initiated study drug. 1 participant is counted in 'All-Cause Mortality' who was counted as 'Completed' in Participant Flow as they died after completing study hence, the event is captured in as 'All-Cause Mortality'.
|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.00%
0/500 • From week 0 to week 52
All AEs are treatment emergent - AE with onset in datapoint set period defined as all observed data points from first date of study product until permanent discontinuation of treatment. AEs and All-Cause Mortality are assessed in Safety analysis set: all randomized participants who initiated study drug. 1 participant is counted in 'All-Cause Mortality' who was counted as 'Completed' in Participant Flow as they died after completing study hence, the event is captured in as 'All-Cause Mortality'.
|
0.20%
1/492 • Number of events 1 • From week 0 to week 52
All AEs are treatment emergent - AE with onset in datapoint set period defined as all observed data points from first date of study product until permanent discontinuation of treatment. AEs and All-Cause Mortality are assessed in Safety analysis set: all randomized participants who initiated study drug. 1 participant is counted in 'All-Cause Mortality' who was counted as 'Completed' in Participant Flow as they died after completing study hence, the event is captured in as 'All-Cause Mortality'.
|
|
Injury, poisoning and procedural complications
Limb injury
|
0.00%
0/500 • From week 0 to week 52
All AEs are treatment emergent - AE with onset in datapoint set period defined as all observed data points from first date of study product until permanent discontinuation of treatment. AEs and All-Cause Mortality are assessed in Safety analysis set: all randomized participants who initiated study drug. 1 participant is counted in 'All-Cause Mortality' who was counted as 'Completed' in Participant Flow as they died after completing study hence, the event is captured in as 'All-Cause Mortality'.
|
0.41%
2/492 • Number of events 2 • From week 0 to week 52
All AEs are treatment emergent - AE with onset in datapoint set period defined as all observed data points from first date of study product until permanent discontinuation of treatment. AEs and All-Cause Mortality are assessed in Safety analysis set: all randomized participants who initiated study drug. 1 participant is counted in 'All-Cause Mortality' who was counted as 'Completed' in Participant Flow as they died after completing study hence, the event is captured in as 'All-Cause Mortality'.
|
|
Nervous system disorders
Lumbar radiculopathy
|
0.20%
1/500 • Number of events 1 • From week 0 to week 52
All AEs are treatment emergent - AE with onset in datapoint set period defined as all observed data points from first date of study product until permanent discontinuation of treatment. AEs and All-Cause Mortality are assessed in Safety analysis set: all randomized participants who initiated study drug. 1 participant is counted in 'All-Cause Mortality' who was counted as 'Completed' in Participant Flow as they died after completing study hence, the event is captured in as 'All-Cause Mortality'.
|
0.00%
0/492 • From week 0 to week 52
All AEs are treatment emergent - AE with onset in datapoint set period defined as all observed data points from first date of study product until permanent discontinuation of treatment. AEs and All-Cause Mortality are assessed in Safety analysis set: all randomized participants who initiated study drug. 1 participant is counted in 'All-Cause Mortality' who was counted as 'Completed' in Participant Flow as they died after completing study hence, the event is captured in as 'All-Cause Mortality'.
|
|
Musculoskeletal and connective tissue disorders
Lumbar spinal stenosis
|
0.00%
0/500 • From week 0 to week 52
All AEs are treatment emergent - AE with onset in datapoint set period defined as all observed data points from first date of study product until permanent discontinuation of treatment. AEs and All-Cause Mortality are assessed in Safety analysis set: all randomized participants who initiated study drug. 1 participant is counted in 'All-Cause Mortality' who was counted as 'Completed' in Participant Flow as they died after completing study hence, the event is captured in as 'All-Cause Mortality'.
|
0.20%
1/492 • Number of events 1 • From week 0 to week 52
All AEs are treatment emergent - AE with onset in datapoint set period defined as all observed data points from first date of study product until permanent discontinuation of treatment. AEs and All-Cause Mortality are assessed in Safety analysis set: all randomized participants who initiated study drug. 1 participant is counted in 'All-Cause Mortality' who was counted as 'Completed' in Participant Flow as they died after completing study hence, the event is captured in as 'All-Cause Mortality'.
|
|
Injury, poisoning and procedural complications
Lumbar vertebral fracture
|
0.00%
0/500 • From week 0 to week 52
All AEs are treatment emergent - AE with onset in datapoint set period defined as all observed data points from first date of study product until permanent discontinuation of treatment. AEs and All-Cause Mortality are assessed in Safety analysis set: all randomized participants who initiated study drug. 1 participant is counted in 'All-Cause Mortality' who was counted as 'Completed' in Participant Flow as they died after completing study hence, the event is captured in as 'All-Cause Mortality'.
|
0.20%
1/492 • Number of events 1 • From week 0 to week 52
All AEs are treatment emergent - AE with onset in datapoint set period defined as all observed data points from first date of study product until permanent discontinuation of treatment. AEs and All-Cause Mortality are assessed in Safety analysis set: all randomized participants who initiated study drug. 1 participant is counted in 'All-Cause Mortality' who was counted as 'Completed' in Participant Flow as they died after completing study hence, the event is captured in as 'All-Cause Mortality'.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung adenocarcinoma
|
0.20%
1/500 • Number of events 1 • From week 0 to week 52
All AEs are treatment emergent - AE with onset in datapoint set period defined as all observed data points from first date of study product until permanent discontinuation of treatment. AEs and All-Cause Mortality are assessed in Safety analysis set: all randomized participants who initiated study drug. 1 participant is counted in 'All-Cause Mortality' who was counted as 'Completed' in Participant Flow as they died after completing study hence, the event is captured in as 'All-Cause Mortality'.
|
0.20%
1/492 • Number of events 1 • From week 0 to week 52
All AEs are treatment emergent - AE with onset in datapoint set period defined as all observed data points from first date of study product until permanent discontinuation of treatment. AEs and All-Cause Mortality are assessed in Safety analysis set: all randomized participants who initiated study drug. 1 participant is counted in 'All-Cause Mortality' who was counted as 'Completed' in Participant Flow as they died after completing study hence, the event is captured in as 'All-Cause Mortality'.
|
|
Respiratory, thoracic and mediastinal disorders
Lung infiltration
|
0.00%
0/500 • From week 0 to week 52
All AEs are treatment emergent - AE with onset in datapoint set period defined as all observed data points from first date of study product until permanent discontinuation of treatment. AEs and All-Cause Mortality are assessed in Safety analysis set: all randomized participants who initiated study drug. 1 participant is counted in 'All-Cause Mortality' who was counted as 'Completed' in Participant Flow as they died after completing study hence, the event is captured in as 'All-Cause Mortality'.
|
0.20%
1/492 • Number of events 1 • From week 0 to week 52
All AEs are treatment emergent - AE with onset in datapoint set period defined as all observed data points from first date of study product until permanent discontinuation of treatment. AEs and All-Cause Mortality are assessed in Safety analysis set: all randomized participants who initiated study drug. 1 participant is counted in 'All-Cause Mortality' who was counted as 'Completed' in Participant Flow as they died after completing study hence, the event is captured in as 'All-Cause Mortality'.
|
|
Metabolism and nutrition disorders
Metabolic acidosis
|
0.20%
1/500 • Number of events 1 • From week 0 to week 52
All AEs are treatment emergent - AE with onset in datapoint set period defined as all observed data points from first date of study product until permanent discontinuation of treatment. AEs and All-Cause Mortality are assessed in Safety analysis set: all randomized participants who initiated study drug. 1 participant is counted in 'All-Cause Mortality' who was counted as 'Completed' in Participant Flow as they died after completing study hence, the event is captured in as 'All-Cause Mortality'.
|
0.00%
0/492 • From week 0 to week 52
All AEs are treatment emergent - AE with onset in datapoint set period defined as all observed data points from first date of study product until permanent discontinuation of treatment. AEs and All-Cause Mortality are assessed in Safety analysis set: all randomized participants who initiated study drug. 1 participant is counted in 'All-Cause Mortality' who was counted as 'Completed' in Participant Flow as they died after completing study hence, the event is captured in as 'All-Cause Mortality'.
|
|
Blood and lymphatic system disorders
Microcytic anaemia
|
0.20%
1/500 • Number of events 1 • From week 0 to week 52
All AEs are treatment emergent - AE with onset in datapoint set period defined as all observed data points from first date of study product until permanent discontinuation of treatment. AEs and All-Cause Mortality are assessed in Safety analysis set: all randomized participants who initiated study drug. 1 participant is counted in 'All-Cause Mortality' who was counted as 'Completed' in Participant Flow as they died after completing study hence, the event is captured in as 'All-Cause Mortality'.
|
0.00%
0/492 • From week 0 to week 52
All AEs are treatment emergent - AE with onset in datapoint set period defined as all observed data points from first date of study product until permanent discontinuation of treatment. AEs and All-Cause Mortality are assessed in Safety analysis set: all randomized participants who initiated study drug. 1 participant is counted in 'All-Cause Mortality' who was counted as 'Completed' in Participant Flow as they died after completing study hence, the event is captured in as 'All-Cause Mortality'.
|
|
Gastrointestinal disorders
Nausea
|
0.60%
3/500 • Number of events 3 • From week 0 to week 52
All AEs are treatment emergent - AE with onset in datapoint set period defined as all observed data points from first date of study product until permanent discontinuation of treatment. AEs and All-Cause Mortality are assessed in Safety analysis set: all randomized participants who initiated study drug. 1 participant is counted in 'All-Cause Mortality' who was counted as 'Completed' in Participant Flow as they died after completing study hence, the event is captured in as 'All-Cause Mortality'.
|
0.61%
3/492 • Number of events 3 • From week 0 to week 52
All AEs are treatment emergent - AE with onset in datapoint set period defined as all observed data points from first date of study product until permanent discontinuation of treatment. AEs and All-Cause Mortality are assessed in Safety analysis set: all randomized participants who initiated study drug. 1 participant is counted in 'All-Cause Mortality' who was counted as 'Completed' in Participant Flow as they died after completing study hence, the event is captured in as 'All-Cause Mortality'.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/500 • From week 0 to week 52
All AEs are treatment emergent - AE with onset in datapoint set period defined as all observed data points from first date of study product until permanent discontinuation of treatment. AEs and All-Cause Mortality are assessed in Safety analysis set: all randomized participants who initiated study drug. 1 participant is counted in 'All-Cause Mortality' who was counted as 'Completed' in Participant Flow as they died after completing study hence, the event is captured in as 'All-Cause Mortality'.
|
0.20%
1/492 • Number of events 1 • From week 0 to week 52
All AEs are treatment emergent - AE with onset in datapoint set period defined as all observed data points from first date of study product until permanent discontinuation of treatment. AEs and All-Cause Mortality are assessed in Safety analysis set: all randomized participants who initiated study drug. 1 participant is counted in 'All-Cause Mortality' who was counted as 'Completed' in Participant Flow as they died after completing study hence, the event is captured in as 'All-Cause Mortality'.
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.20%
1/500 • Number of events 1 • From week 0 to week 52
All AEs are treatment emergent - AE with onset in datapoint set period defined as all observed data points from first date of study product until permanent discontinuation of treatment. AEs and All-Cause Mortality are assessed in Safety analysis set: all randomized participants who initiated study drug. 1 participant is counted in 'All-Cause Mortality' who was counted as 'Completed' in Participant Flow as they died after completing study hence, the event is captured in as 'All-Cause Mortality'.
|
0.20%
1/492 • Number of events 1 • From week 0 to week 52
All AEs are treatment emergent - AE with onset in datapoint set period defined as all observed data points from first date of study product until permanent discontinuation of treatment. AEs and All-Cause Mortality are assessed in Safety analysis set: all randomized participants who initiated study drug. 1 participant is counted in 'All-Cause Mortality' who was counted as 'Completed' in Participant Flow as they died after completing study hence, the event is captured in as 'All-Cause Mortality'.
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/500 • From week 0 to week 52
All AEs are treatment emergent - AE with onset in datapoint set period defined as all observed data points from first date of study product until permanent discontinuation of treatment. AEs and All-Cause Mortality are assessed in Safety analysis set: all randomized participants who initiated study drug. 1 participant is counted in 'All-Cause Mortality' who was counted as 'Completed' in Participant Flow as they died after completing study hence, the event is captured in as 'All-Cause Mortality'.
|
0.61%
3/492 • Number of events 3 • From week 0 to week 52
All AEs are treatment emergent - AE with onset in datapoint set period defined as all observed data points from first date of study product until permanent discontinuation of treatment. AEs and All-Cause Mortality are assessed in Safety analysis set: all randomized participants who initiated study drug. 1 participant is counted in 'All-Cause Mortality' who was counted as 'Completed' in Participant Flow as they died after completing study hence, the event is captured in as 'All-Cause Mortality'.
|
|
Gastrointestinal disorders
Oesophagitis
|
0.20%
1/500 • Number of events 1 • From week 0 to week 52
All AEs are treatment emergent - AE with onset in datapoint set period defined as all observed data points from first date of study product until permanent discontinuation of treatment. AEs and All-Cause Mortality are assessed in Safety analysis set: all randomized participants who initiated study drug. 1 participant is counted in 'All-Cause Mortality' who was counted as 'Completed' in Participant Flow as they died after completing study hence, the event is captured in as 'All-Cause Mortality'.
|
0.00%
0/492 • From week 0 to week 52
All AEs are treatment emergent - AE with onset in datapoint set period defined as all observed data points from first date of study product until permanent discontinuation of treatment. AEs and All-Cause Mortality are assessed in Safety analysis set: all randomized participants who initiated study drug. 1 participant is counted in 'All-Cause Mortality' who was counted as 'Completed' in Participant Flow as they died after completing study hence, the event is captured in as 'All-Cause Mortality'.
|
|
Vascular disorders
Orthostatic hypotension
|
0.00%
0/500 • From week 0 to week 52
All AEs are treatment emergent - AE with onset in datapoint set period defined as all observed data points from first date of study product until permanent discontinuation of treatment. AEs and All-Cause Mortality are assessed in Safety analysis set: all randomized participants who initiated study drug. 1 participant is counted in 'All-Cause Mortality' who was counted as 'Completed' in Participant Flow as they died after completing study hence, the event is captured in as 'All-Cause Mortality'.
|
0.20%
1/492 • Number of events 1 • From week 0 to week 52
All AEs are treatment emergent - AE with onset in datapoint set period defined as all observed data points from first date of study product until permanent discontinuation of treatment. AEs and All-Cause Mortality are assessed in Safety analysis set: all randomized participants who initiated study drug. 1 participant is counted in 'All-Cause Mortality' who was counted as 'Completed' in Participant Flow as they died after completing study hence, the event is captured in as 'All-Cause Mortality'.
|
|
Infections and infestations
Osteomyelitis
|
0.20%
1/500 • Number of events 1 • From week 0 to week 52
All AEs are treatment emergent - AE with onset in datapoint set period defined as all observed data points from first date of study product until permanent discontinuation of treatment. AEs and All-Cause Mortality are assessed in Safety analysis set: all randomized participants who initiated study drug. 1 participant is counted in 'All-Cause Mortality' who was counted as 'Completed' in Participant Flow as they died after completing study hence, the event is captured in as 'All-Cause Mortality'.
|
0.00%
0/492 • From week 0 to week 52
All AEs are treatment emergent - AE with onset in datapoint set period defined as all observed data points from first date of study product until permanent discontinuation of treatment. AEs and All-Cause Mortality are assessed in Safety analysis set: all randomized participants who initiated study drug. 1 participant is counted in 'All-Cause Mortality' who was counted as 'Completed' in Participant Flow as they died after completing study hence, the event is captured in as 'All-Cause Mortality'.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic carcinoma
|
0.20%
1/500 • Number of events 1 • From week 0 to week 52
All AEs are treatment emergent - AE with onset in datapoint set period defined as all observed data points from first date of study product until permanent discontinuation of treatment. AEs and All-Cause Mortality are assessed in Safety analysis set: all randomized participants who initiated study drug. 1 participant is counted in 'All-Cause Mortality' who was counted as 'Completed' in Participant Flow as they died after completing study hence, the event is captured in as 'All-Cause Mortality'.
|
0.00%
0/492 • From week 0 to week 52
All AEs are treatment emergent - AE with onset in datapoint set period defined as all observed data points from first date of study product until permanent discontinuation of treatment. AEs and All-Cause Mortality are assessed in Safety analysis set: all randomized participants who initiated study drug. 1 participant is counted in 'All-Cause Mortality' who was counted as 'Completed' in Participant Flow as they died after completing study hence, the event is captured in as 'All-Cause Mortality'.
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.20%
1/500 • Number of events 1 • From week 0 to week 52
All AEs are treatment emergent - AE with onset in datapoint set period defined as all observed data points from first date of study product until permanent discontinuation of treatment. AEs and All-Cause Mortality are assessed in Safety analysis set: all randomized participants who initiated study drug. 1 participant is counted in 'All-Cause Mortality' who was counted as 'Completed' in Participant Flow as they died after completing study hence, the event is captured in as 'All-Cause Mortality'.
|
0.00%
0/492 • From week 0 to week 52
All AEs are treatment emergent - AE with onset in datapoint set period defined as all observed data points from first date of study product until permanent discontinuation of treatment. AEs and All-Cause Mortality are assessed in Safety analysis set: all randomized participants who initiated study drug. 1 participant is counted in 'All-Cause Mortality' who was counted as 'Completed' in Participant Flow as they died after completing study hence, the event is captured in as 'All-Cause Mortality'.
|
|
Vascular disorders
Peripheral arterial occlusive disease
|
0.20%
1/500 • Number of events 1 • From week 0 to week 52
All AEs are treatment emergent - AE with onset in datapoint set period defined as all observed data points from first date of study product until permanent discontinuation of treatment. AEs and All-Cause Mortality are assessed in Safety analysis set: all randomized participants who initiated study drug. 1 participant is counted in 'All-Cause Mortality' who was counted as 'Completed' in Participant Flow as they died after completing study hence, the event is captured in as 'All-Cause Mortality'.
|
0.00%
0/492 • From week 0 to week 52
All AEs are treatment emergent - AE with onset in datapoint set period defined as all observed data points from first date of study product until permanent discontinuation of treatment. AEs and All-Cause Mortality are assessed in Safety analysis set: all randomized participants who initiated study drug. 1 participant is counted in 'All-Cause Mortality' who was counted as 'Completed' in Participant Flow as they died after completing study hence, the event is captured in as 'All-Cause Mortality'.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.20%
1/500 • Number of events 1 • From week 0 to week 52
All AEs are treatment emergent - AE with onset in datapoint set period defined as all observed data points from first date of study product until permanent discontinuation of treatment. AEs and All-Cause Mortality are assessed in Safety analysis set: all randomized participants who initiated study drug. 1 participant is counted in 'All-Cause Mortality' who was counted as 'Completed' in Participant Flow as they died after completing study hence, the event is captured in as 'All-Cause Mortality'.
|
0.00%
0/492 • From week 0 to week 52
All AEs are treatment emergent - AE with onset in datapoint set period defined as all observed data points from first date of study product until permanent discontinuation of treatment. AEs and All-Cause Mortality are assessed in Safety analysis set: all randomized participants who initiated study drug. 1 participant is counted in 'All-Cause Mortality' who was counted as 'Completed' in Participant Flow as they died after completing study hence, the event is captured in as 'All-Cause Mortality'.
|
|
Infections and infestations
Pneumonia
|
0.40%
2/500 • Number of events 2 • From week 0 to week 52
All AEs are treatment emergent - AE with onset in datapoint set period defined as all observed data points from first date of study product until permanent discontinuation of treatment. AEs and All-Cause Mortality are assessed in Safety analysis set: all randomized participants who initiated study drug. 1 participant is counted in 'All-Cause Mortality' who was counted as 'Completed' in Participant Flow as they died after completing study hence, the event is captured in as 'All-Cause Mortality'.
|
1.0%
5/492 • Number of events 5 • From week 0 to week 52
All AEs are treatment emergent - AE with onset in datapoint set period defined as all observed data points from first date of study product until permanent discontinuation of treatment. AEs and All-Cause Mortality are assessed in Safety analysis set: all randomized participants who initiated study drug. 1 participant is counted in 'All-Cause Mortality' who was counted as 'Completed' in Participant Flow as they died after completing study hence, the event is captured in as 'All-Cause Mortality'.
|
|
Infections and infestations
Pneumonia aspiration
|
0.00%
0/500 • From week 0 to week 52
All AEs are treatment emergent - AE with onset in datapoint set period defined as all observed data points from first date of study product until permanent discontinuation of treatment. AEs and All-Cause Mortality are assessed in Safety analysis set: all randomized participants who initiated study drug. 1 participant is counted in 'All-Cause Mortality' who was counted as 'Completed' in Participant Flow as they died after completing study hence, the event is captured in as 'All-Cause Mortality'.
|
0.20%
1/492 • Number of events 1 • From week 0 to week 52
All AEs are treatment emergent - AE with onset in datapoint set period defined as all observed data points from first date of study product until permanent discontinuation of treatment. AEs and All-Cause Mortality are assessed in Safety analysis set: all randomized participants who initiated study drug. 1 participant is counted in 'All-Cause Mortality' who was counted as 'Completed' in Participant Flow as they died after completing study hence, the event is captured in as 'All-Cause Mortality'.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.20%
1/500 • Number of events 1 • From week 0 to week 52
All AEs are treatment emergent - AE with onset in datapoint set period defined as all observed data points from first date of study product until permanent discontinuation of treatment. AEs and All-Cause Mortality are assessed in Safety analysis set: all randomized participants who initiated study drug. 1 participant is counted in 'All-Cause Mortality' who was counted as 'Completed' in Participant Flow as they died after completing study hence, the event is captured in as 'All-Cause Mortality'.
|
0.00%
0/492 • From week 0 to week 52
All AEs are treatment emergent - AE with onset in datapoint set period defined as all observed data points from first date of study product until permanent discontinuation of treatment. AEs and All-Cause Mortality are assessed in Safety analysis set: all randomized participants who initiated study drug. 1 participant is counted in 'All-Cause Mortality' who was counted as 'Completed' in Participant Flow as they died after completing study hence, the event is captured in as 'All-Cause Mortality'.
|
|
Renal and urinary disorders
Pollakiuria
|
0.20%
1/500 • Number of events 1 • From week 0 to week 52
All AEs are treatment emergent - AE with onset in datapoint set period defined as all observed data points from first date of study product until permanent discontinuation of treatment. AEs and All-Cause Mortality are assessed in Safety analysis set: all randomized participants who initiated study drug. 1 participant is counted in 'All-Cause Mortality' who was counted as 'Completed' in Participant Flow as they died after completing study hence, the event is captured in as 'All-Cause Mortality'.
|
0.00%
0/492 • From week 0 to week 52
All AEs are treatment emergent - AE with onset in datapoint set period defined as all observed data points from first date of study product until permanent discontinuation of treatment. AEs and All-Cause Mortality are assessed in Safety analysis set: all randomized participants who initiated study drug. 1 participant is counted in 'All-Cause Mortality' who was counted as 'Completed' in Participant Flow as they died after completing study hence, the event is captured in as 'All-Cause Mortality'.
|
|
Metabolism and nutrition disorders
Polydipsia
|
0.20%
1/500 • Number of events 1 • From week 0 to week 52
All AEs are treatment emergent - AE with onset in datapoint set period defined as all observed data points from first date of study product until permanent discontinuation of treatment. AEs and All-Cause Mortality are assessed in Safety analysis set: all randomized participants who initiated study drug. 1 participant is counted in 'All-Cause Mortality' who was counted as 'Completed' in Participant Flow as they died after completing study hence, the event is captured in as 'All-Cause Mortality'.
|
0.00%
0/492 • From week 0 to week 52
All AEs are treatment emergent - AE with onset in datapoint set period defined as all observed data points from first date of study product until permanent discontinuation of treatment. AEs and All-Cause Mortality are assessed in Safety analysis set: all randomized participants who initiated study drug. 1 participant is counted in 'All-Cause Mortality' who was counted as 'Completed' in Participant Flow as they died after completing study hence, the event is captured in as 'All-Cause Mortality'.
|
|
Injury, poisoning and procedural complications
Post procedural haematoma
|
0.20%
1/500 • Number of events 1 • From week 0 to week 52
All AEs are treatment emergent - AE with onset in datapoint set period defined as all observed data points from first date of study product until permanent discontinuation of treatment. AEs and All-Cause Mortality are assessed in Safety analysis set: all randomized participants who initiated study drug. 1 participant is counted in 'All-Cause Mortality' who was counted as 'Completed' in Participant Flow as they died after completing study hence, the event is captured in as 'All-Cause Mortality'.
|
0.00%
0/492 • From week 0 to week 52
All AEs are treatment emergent - AE with onset in datapoint set period defined as all observed data points from first date of study product until permanent discontinuation of treatment. AEs and All-Cause Mortality are assessed in Safety analysis set: all randomized participants who initiated study drug. 1 participant is counted in 'All-Cause Mortality' who was counted as 'Completed' in Participant Flow as they died after completing study hence, the event is captured in as 'All-Cause Mortality'.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.40%
2/500 • Number of events 2 • From week 0 to week 52
All AEs are treatment emergent - AE with onset in datapoint set period defined as all observed data points from first date of study product until permanent discontinuation of treatment. AEs and All-Cause Mortality are assessed in Safety analysis set: all randomized participants who initiated study drug. 1 participant is counted in 'All-Cause Mortality' who was counted as 'Completed' in Participant Flow as they died after completing study hence, the event is captured in as 'All-Cause Mortality'.
|
0.41%
2/492 • Number of events 2 • From week 0 to week 52
All AEs are treatment emergent - AE with onset in datapoint set period defined as all observed data points from first date of study product until permanent discontinuation of treatment. AEs and All-Cause Mortality are assessed in Safety analysis set: all randomized participants who initiated study drug. 1 participant is counted in 'All-Cause Mortality' who was counted as 'Completed' in Participant Flow as they died after completing study hence, the event is captured in as 'All-Cause Mortality'.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary artery dilatation
|
0.20%
1/500 • Number of events 1 • From week 0 to week 52
All AEs are treatment emergent - AE with onset in datapoint set period defined as all observed data points from first date of study product until permanent discontinuation of treatment. AEs and All-Cause Mortality are assessed in Safety analysis set: all randomized participants who initiated study drug. 1 participant is counted in 'All-Cause Mortality' who was counted as 'Completed' in Participant Flow as they died after completing study hence, the event is captured in as 'All-Cause Mortality'.
|
0.00%
0/492 • From week 0 to week 52
All AEs are treatment emergent - AE with onset in datapoint set period defined as all observed data points from first date of study product until permanent discontinuation of treatment. AEs and All-Cause Mortality are assessed in Safety analysis set: all randomized participants who initiated study drug. 1 participant is counted in 'All-Cause Mortality' who was counted as 'Completed' in Participant Flow as they died after completing study hence, the event is captured in as 'All-Cause Mortality'.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.40%
2/500 • Number of events 2 • From week 0 to week 52
All AEs are treatment emergent - AE with onset in datapoint set period defined as all observed data points from first date of study product until permanent discontinuation of treatment. AEs and All-Cause Mortality are assessed in Safety analysis set: all randomized participants who initiated study drug. 1 participant is counted in 'All-Cause Mortality' who was counted as 'Completed' in Participant Flow as they died after completing study hence, the event is captured in as 'All-Cause Mortality'.
|
0.00%
0/492 • From week 0 to week 52
All AEs are treatment emergent - AE with onset in datapoint set period defined as all observed data points from first date of study product until permanent discontinuation of treatment. AEs and All-Cause Mortality are assessed in Safety analysis set: all randomized participants who initiated study drug. 1 participant is counted in 'All-Cause Mortality' who was counted as 'Completed' in Participant Flow as they died after completing study hence, the event is captured in as 'All-Cause Mortality'.
|
|
Infections and infestations
Pyelonephritis
|
0.00%
0/500 • From week 0 to week 52
All AEs are treatment emergent - AE with onset in datapoint set period defined as all observed data points from first date of study product until permanent discontinuation of treatment. AEs and All-Cause Mortality are assessed in Safety analysis set: all randomized participants who initiated study drug. 1 participant is counted in 'All-Cause Mortality' who was counted as 'Completed' in Participant Flow as they died after completing study hence, the event is captured in as 'All-Cause Mortality'.
|
0.41%
2/492 • Number of events 2 • From week 0 to week 52
All AEs are treatment emergent - AE with onset in datapoint set period defined as all observed data points from first date of study product until permanent discontinuation of treatment. AEs and All-Cause Mortality are assessed in Safety analysis set: all randomized participants who initiated study drug. 1 participant is counted in 'All-Cause Mortality' who was counted as 'Completed' in Participant Flow as they died after completing study hence, the event is captured in as 'All-Cause Mortality'.
|
|
General disorders
Pyrexia
|
0.20%
1/500 • Number of events 1 • From week 0 to week 52
All AEs are treatment emergent - AE with onset in datapoint set period defined as all observed data points from first date of study product until permanent discontinuation of treatment. AEs and All-Cause Mortality are assessed in Safety analysis set: all randomized participants who initiated study drug. 1 participant is counted in 'All-Cause Mortality' who was counted as 'Completed' in Participant Flow as they died after completing study hence, the event is captured in as 'All-Cause Mortality'.
|
0.00%
0/492 • From week 0 to week 52
All AEs are treatment emergent - AE with onset in datapoint set period defined as all observed data points from first date of study product until permanent discontinuation of treatment. AEs and All-Cause Mortality are assessed in Safety analysis set: all randomized participants who initiated study drug. 1 participant is counted in 'All-Cause Mortality' who was counted as 'Completed' in Participant Flow as they died after completing study hence, the event is captured in as 'All-Cause Mortality'.
|
|
Skin and subcutaneous tissue disorders
Rash pruritic
|
0.00%
0/500 • From week 0 to week 52
All AEs are treatment emergent - AE with onset in datapoint set period defined as all observed data points from first date of study product until permanent discontinuation of treatment. AEs and All-Cause Mortality are assessed in Safety analysis set: all randomized participants who initiated study drug. 1 participant is counted in 'All-Cause Mortality' who was counted as 'Completed' in Participant Flow as they died after completing study hence, the event is captured in as 'All-Cause Mortality'.
|
0.20%
1/492 • Number of events 1 • From week 0 to week 52
All AEs are treatment emergent - AE with onset in datapoint set period defined as all observed data points from first date of study product until permanent discontinuation of treatment. AEs and All-Cause Mortality are assessed in Safety analysis set: all randomized participants who initiated study drug. 1 participant is counted in 'All-Cause Mortality' who was counted as 'Completed' in Participant Flow as they died after completing study hence, the event is captured in as 'All-Cause Mortality'.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory distress
|
0.00%
0/500 • From week 0 to week 52
All AEs are treatment emergent - AE with onset in datapoint set period defined as all observed data points from first date of study product until permanent discontinuation of treatment. AEs and All-Cause Mortality are assessed in Safety analysis set: all randomized participants who initiated study drug. 1 participant is counted in 'All-Cause Mortality' who was counted as 'Completed' in Participant Flow as they died after completing study hence, the event is captured in as 'All-Cause Mortality'.
|
0.20%
1/492 • Number of events 1 • From week 0 to week 52
All AEs are treatment emergent - AE with onset in datapoint set period defined as all observed data points from first date of study product until permanent discontinuation of treatment. AEs and All-Cause Mortality are assessed in Safety analysis set: all randomized participants who initiated study drug. 1 participant is counted in 'All-Cause Mortality' who was counted as 'Completed' in Participant Flow as they died after completing study hence, the event is captured in as 'All-Cause Mortality'.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/500 • From week 0 to week 52
All AEs are treatment emergent - AE with onset in datapoint set period defined as all observed data points from first date of study product until permanent discontinuation of treatment. AEs and All-Cause Mortality are assessed in Safety analysis set: all randomized participants who initiated study drug. 1 participant is counted in 'All-Cause Mortality' who was counted as 'Completed' in Participant Flow as they died after completing study hence, the event is captured in as 'All-Cause Mortality'.
|
0.41%
2/492 • Number of events 2 • From week 0 to week 52
All AEs are treatment emergent - AE with onset in datapoint set period defined as all observed data points from first date of study product until permanent discontinuation of treatment. AEs and All-Cause Mortality are assessed in Safety analysis set: all randomized participants who initiated study drug. 1 participant is counted in 'All-Cause Mortality' who was counted as 'Completed' in Participant Flow as they died after completing study hence, the event is captured in as 'All-Cause Mortality'.
|
|
Musculoskeletal and connective tissue disorders
Rhabdomyolysis
|
0.00%
0/500 • From week 0 to week 52
All AEs are treatment emergent - AE with onset in datapoint set period defined as all observed data points from first date of study product until permanent discontinuation of treatment. AEs and All-Cause Mortality are assessed in Safety analysis set: all randomized participants who initiated study drug. 1 participant is counted in 'All-Cause Mortality' who was counted as 'Completed' in Participant Flow as they died after completing study hence, the event is captured in as 'All-Cause Mortality'.
|
0.20%
1/492 • Number of events 1 • From week 0 to week 52
All AEs are treatment emergent - AE with onset in datapoint set period defined as all observed data points from first date of study product until permanent discontinuation of treatment. AEs and All-Cause Mortality are assessed in Safety analysis set: all randomized participants who initiated study drug. 1 participant is counted in 'All-Cause Mortality' who was counted as 'Completed' in Participant Flow as they died after completing study hence, the event is captured in as 'All-Cause Mortality'.
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.40%
2/500 • Number of events 2 • From week 0 to week 52
All AEs are treatment emergent - AE with onset in datapoint set period defined as all observed data points from first date of study product until permanent discontinuation of treatment. AEs and All-Cause Mortality are assessed in Safety analysis set: all randomized participants who initiated study drug. 1 participant is counted in 'All-Cause Mortality' who was counted as 'Completed' in Participant Flow as they died after completing study hence, the event is captured in as 'All-Cause Mortality'.
|
0.20%
1/492 • Number of events 1 • From week 0 to week 52
All AEs are treatment emergent - AE with onset in datapoint set period defined as all observed data points from first date of study product until permanent discontinuation of treatment. AEs and All-Cause Mortality are assessed in Safety analysis set: all randomized participants who initiated study drug. 1 participant is counted in 'All-Cause Mortality' who was counted as 'Completed' in Participant Flow as they died after completing study hence, the event is captured in as 'All-Cause Mortality'.
|
|
Nervous system disorders
Seizure like phenomena
|
0.20%
1/500 • Number of events 1 • From week 0 to week 52
All AEs are treatment emergent - AE with onset in datapoint set period defined as all observed data points from first date of study product until permanent discontinuation of treatment. AEs and All-Cause Mortality are assessed in Safety analysis set: all randomized participants who initiated study drug. 1 participant is counted in 'All-Cause Mortality' who was counted as 'Completed' in Participant Flow as they died after completing study hence, the event is captured in as 'All-Cause Mortality'.
|
0.00%
0/492 • From week 0 to week 52
All AEs are treatment emergent - AE with onset in datapoint set period defined as all observed data points from first date of study product until permanent discontinuation of treatment. AEs and All-Cause Mortality are assessed in Safety analysis set: all randomized participants who initiated study drug. 1 participant is counted in 'All-Cause Mortality' who was counted as 'Completed' in Participant Flow as they died after completing study hence, the event is captured in as 'All-Cause Mortality'.
|
|
Infections and infestations
Sepsis
|
0.40%
2/500 • Number of events 2 • From week 0 to week 52
All AEs are treatment emergent - AE with onset in datapoint set period defined as all observed data points from first date of study product until permanent discontinuation of treatment. AEs and All-Cause Mortality are assessed in Safety analysis set: all randomized participants who initiated study drug. 1 participant is counted in 'All-Cause Mortality' who was counted as 'Completed' in Participant Flow as they died after completing study hence, the event is captured in as 'All-Cause Mortality'.
|
1.0%
5/492 • Number of events 5 • From week 0 to week 52
All AEs are treatment emergent - AE with onset in datapoint set period defined as all observed data points from first date of study product until permanent discontinuation of treatment. AEs and All-Cause Mortality are assessed in Safety analysis set: all randomized participants who initiated study drug. 1 participant is counted in 'All-Cause Mortality' who was counted as 'Completed' in Participant Flow as they died after completing study hence, the event is captured in as 'All-Cause Mortality'.
|
|
Infections and infestations
Septic shock
|
0.00%
0/500 • From week 0 to week 52
All AEs are treatment emergent - AE with onset in datapoint set period defined as all observed data points from first date of study product until permanent discontinuation of treatment. AEs and All-Cause Mortality are assessed in Safety analysis set: all randomized participants who initiated study drug. 1 participant is counted in 'All-Cause Mortality' who was counted as 'Completed' in Participant Flow as they died after completing study hence, the event is captured in as 'All-Cause Mortality'.
|
0.20%
1/492 • Number of events 1 • From week 0 to week 52
All AEs are treatment emergent - AE with onset in datapoint set period defined as all observed data points from first date of study product until permanent discontinuation of treatment. AEs and All-Cause Mortality are assessed in Safety analysis set: all randomized participants who initiated study drug. 1 participant is counted in 'All-Cause Mortality' who was counted as 'Completed' in Participant Flow as they died after completing study hence, the event is captured in as 'All-Cause Mortality'.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Small cell lung cancer
|
0.00%
0/500 • From week 0 to week 52
All AEs are treatment emergent - AE with onset in datapoint set period defined as all observed data points from first date of study product until permanent discontinuation of treatment. AEs and All-Cause Mortality are assessed in Safety analysis set: all randomized participants who initiated study drug. 1 participant is counted in 'All-Cause Mortality' who was counted as 'Completed' in Participant Flow as they died after completing study hence, the event is captured in as 'All-Cause Mortality'.
|
0.20%
1/492 • Number of events 1 • From week 0 to week 52
All AEs are treatment emergent - AE with onset in datapoint set period defined as all observed data points from first date of study product until permanent discontinuation of treatment. AEs and All-Cause Mortality are assessed in Safety analysis set: all randomized participants who initiated study drug. 1 participant is counted in 'All-Cause Mortality' who was counted as 'Completed' in Participant Flow as they died after completing study hence, the event is captured in as 'All-Cause Mortality'.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.20%
1/500 • Number of events 1 • From week 0 to week 52
All AEs are treatment emergent - AE with onset in datapoint set period defined as all observed data points from first date of study product until permanent discontinuation of treatment. AEs and All-Cause Mortality are assessed in Safety analysis set: all randomized participants who initiated study drug. 1 participant is counted in 'All-Cause Mortality' who was counted as 'Completed' in Participant Flow as they died after completing study hence, the event is captured in as 'All-Cause Mortality'.
|
0.20%
1/492 • Number of events 1 • From week 0 to week 52
All AEs are treatment emergent - AE with onset in datapoint set period defined as all observed data points from first date of study product until permanent discontinuation of treatment. AEs and All-Cause Mortality are assessed in Safety analysis set: all randomized participants who initiated study drug. 1 participant is counted in 'All-Cause Mortality' who was counted as 'Completed' in Participant Flow as they died after completing study hence, the event is captured in as 'All-Cause Mortality'.
|
|
Musculoskeletal and connective tissue disorders
Spinal osteoarthritis
|
0.00%
0/500 • From week 0 to week 52
All AEs are treatment emergent - AE with onset in datapoint set period defined as all observed data points from first date of study product until permanent discontinuation of treatment. AEs and All-Cause Mortality are assessed in Safety analysis set: all randomized participants who initiated study drug. 1 participant is counted in 'All-Cause Mortality' who was counted as 'Completed' in Participant Flow as they died after completing study hence, the event is captured in as 'All-Cause Mortality'.
|
0.20%
1/492 • Number of events 1 • From week 0 to week 52
All AEs are treatment emergent - AE with onset in datapoint set period defined as all observed data points from first date of study product until permanent discontinuation of treatment. AEs and All-Cause Mortality are assessed in Safety analysis set: all randomized participants who initiated study drug. 1 participant is counted in 'All-Cause Mortality' who was counted as 'Completed' in Participant Flow as they died after completing study hence, the event is captured in as 'All-Cause Mortality'.
|
|
Injury, poisoning and procedural complications
Subdural haematoma
|
0.20%
1/500 • Number of events 1 • From week 0 to week 52
All AEs are treatment emergent - AE with onset in datapoint set period defined as all observed data points from first date of study product until permanent discontinuation of treatment. AEs and All-Cause Mortality are assessed in Safety analysis set: all randomized participants who initiated study drug. 1 participant is counted in 'All-Cause Mortality' who was counted as 'Completed' in Participant Flow as they died after completing study hence, the event is captured in as 'All-Cause Mortality'.
|
0.00%
0/492 • From week 0 to week 52
All AEs are treatment emergent - AE with onset in datapoint set period defined as all observed data points from first date of study product until permanent discontinuation of treatment. AEs and All-Cause Mortality are assessed in Safety analysis set: all randomized participants who initiated study drug. 1 participant is counted in 'All-Cause Mortality' who was counted as 'Completed' in Participant Flow as they died after completing study hence, the event is captured in as 'All-Cause Mortality'.
|
|
Psychiatric disorders
Suicide attempt
|
0.20%
1/500 • Number of events 1 • From week 0 to week 52
All AEs are treatment emergent - AE with onset in datapoint set period defined as all observed data points from first date of study product until permanent discontinuation of treatment. AEs and All-Cause Mortality are assessed in Safety analysis set: all randomized participants who initiated study drug. 1 participant is counted in 'All-Cause Mortality' who was counted as 'Completed' in Participant Flow as they died after completing study hence, the event is captured in as 'All-Cause Mortality'.
|
0.00%
0/492 • From week 0 to week 52
All AEs are treatment emergent - AE with onset in datapoint set period defined as all observed data points from first date of study product until permanent discontinuation of treatment. AEs and All-Cause Mortality are assessed in Safety analysis set: all randomized participants who initiated study drug. 1 participant is counted in 'All-Cause Mortality' who was counted as 'Completed' in Participant Flow as they died after completing study hence, the event is captured in as 'All-Cause Mortality'.
|
|
Nervous system disorders
Syncope
|
0.00%
0/500 • From week 0 to week 52
All AEs are treatment emergent - AE with onset in datapoint set period defined as all observed data points from first date of study product until permanent discontinuation of treatment. AEs and All-Cause Mortality are assessed in Safety analysis set: all randomized participants who initiated study drug. 1 participant is counted in 'All-Cause Mortality' who was counted as 'Completed' in Participant Flow as they died after completing study hence, the event is captured in as 'All-Cause Mortality'.
|
1.0%
5/492 • Number of events 5 • From week 0 to week 52
All AEs are treatment emergent - AE with onset in datapoint set period defined as all observed data points from first date of study product until permanent discontinuation of treatment. AEs and All-Cause Mortality are assessed in Safety analysis set: all randomized participants who initiated study drug. 1 participant is counted in 'All-Cause Mortality' who was counted as 'Completed' in Participant Flow as they died after completing study hence, the event is captured in as 'All-Cause Mortality'.
|
|
Cardiac disorders
Tachycardia
|
0.20%
1/500 • Number of events 1 • From week 0 to week 52
All AEs are treatment emergent - AE with onset in datapoint set period defined as all observed data points from first date of study product until permanent discontinuation of treatment. AEs and All-Cause Mortality are assessed in Safety analysis set: all randomized participants who initiated study drug. 1 participant is counted in 'All-Cause Mortality' who was counted as 'Completed' in Participant Flow as they died after completing study hence, the event is captured in as 'All-Cause Mortality'.
|
0.00%
0/492 • From week 0 to week 52
All AEs are treatment emergent - AE with onset in datapoint set period defined as all observed data points from first date of study product until permanent discontinuation of treatment. AEs and All-Cause Mortality are assessed in Safety analysis set: all randomized participants who initiated study drug. 1 participant is counted in 'All-Cause Mortality' who was counted as 'Completed' in Participant Flow as they died after completing study hence, the event is captured in as 'All-Cause Mortality'.
|
|
Infections and infestations
Tonsillitis
|
0.20%
1/500 • Number of events 1 • From week 0 to week 52
All AEs are treatment emergent - AE with onset in datapoint set period defined as all observed data points from first date of study product until permanent discontinuation of treatment. AEs and All-Cause Mortality are assessed in Safety analysis set: all randomized participants who initiated study drug. 1 participant is counted in 'All-Cause Mortality' who was counted as 'Completed' in Participant Flow as they died after completing study hence, the event is captured in as 'All-Cause Mortality'.
|
0.00%
0/492 • From week 0 to week 52
All AEs are treatment emergent - AE with onset in datapoint set period defined as all observed data points from first date of study product until permanent discontinuation of treatment. AEs and All-Cause Mortality are assessed in Safety analysis set: all randomized participants who initiated study drug. 1 participant is counted in 'All-Cause Mortality' who was counted as 'Completed' in Participant Flow as they died after completing study hence, the event is captured in as 'All-Cause Mortality'.
|
|
Nervous system disorders
Toxic encephalopathy
|
0.20%
1/500 • Number of events 1 • From week 0 to week 52
All AEs are treatment emergent - AE with onset in datapoint set period defined as all observed data points from first date of study product until permanent discontinuation of treatment. AEs and All-Cause Mortality are assessed in Safety analysis set: all randomized participants who initiated study drug. 1 participant is counted in 'All-Cause Mortality' who was counted as 'Completed' in Participant Flow as they died after completing study hence, the event is captured in as 'All-Cause Mortality'.
|
0.00%
0/492 • From week 0 to week 52
All AEs are treatment emergent - AE with onset in datapoint set period defined as all observed data points from first date of study product until permanent discontinuation of treatment. AEs and All-Cause Mortality are assessed in Safety analysis set: all randomized participants who initiated study drug. 1 participant is counted in 'All-Cause Mortality' who was counted as 'Completed' in Participant Flow as they died after completing study hence, the event is captured in as 'All-Cause Mortality'.
|
|
Nervous system disorders
Transient ischaemic attack
|
0.00%
0/500 • From week 0 to week 52
All AEs are treatment emergent - AE with onset in datapoint set period defined as all observed data points from first date of study product until permanent discontinuation of treatment. AEs and All-Cause Mortality are assessed in Safety analysis set: all randomized participants who initiated study drug. 1 participant is counted in 'All-Cause Mortality' who was counted as 'Completed' in Participant Flow as they died after completing study hence, the event is captured in as 'All-Cause Mortality'.
|
0.20%
1/492 • Number of events 1 • From week 0 to week 52
All AEs are treatment emergent - AE with onset in datapoint set period defined as all observed data points from first date of study product until permanent discontinuation of treatment. AEs and All-Cause Mortality are assessed in Safety analysis set: all randomized participants who initiated study drug. 1 participant is counted in 'All-Cause Mortality' who was counted as 'Completed' in Participant Flow as they died after completing study hence, the event is captured in as 'All-Cause Mortality'.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Transitional cell carcinoma
|
0.20%
1/500 • Number of events 1 • From week 0 to week 52
All AEs are treatment emergent - AE with onset in datapoint set period defined as all observed data points from first date of study product until permanent discontinuation of treatment. AEs and All-Cause Mortality are assessed in Safety analysis set: all randomized participants who initiated study drug. 1 participant is counted in 'All-Cause Mortality' who was counted as 'Completed' in Participant Flow as they died after completing study hence, the event is captured in as 'All-Cause Mortality'.
|
0.00%
0/492 • From week 0 to week 52
All AEs are treatment emergent - AE with onset in datapoint set period defined as all observed data points from first date of study product until permanent discontinuation of treatment. AEs and All-Cause Mortality are assessed in Safety analysis set: all randomized participants who initiated study drug. 1 participant is counted in 'All-Cause Mortality' who was counted as 'Completed' in Participant Flow as they died after completing study hence, the event is captured in as 'All-Cause Mortality'.
|
|
Investigations
Troponin increased
|
0.00%
0/500 • From week 0 to week 52
All AEs are treatment emergent - AE with onset in datapoint set period defined as all observed data points from first date of study product until permanent discontinuation of treatment. AEs and All-Cause Mortality are assessed in Safety analysis set: all randomized participants who initiated study drug. 1 participant is counted in 'All-Cause Mortality' who was counted as 'Completed' in Participant Flow as they died after completing study hence, the event is captured in as 'All-Cause Mortality'.
|
0.20%
1/492 • Number of events 1 • From week 0 to week 52
All AEs are treatment emergent - AE with onset in datapoint set period defined as all observed data points from first date of study product until permanent discontinuation of treatment. AEs and All-Cause Mortality are assessed in Safety analysis set: all randomized participants who initiated study drug. 1 participant is counted in 'All-Cause Mortality' who was counted as 'Completed' in Participant Flow as they died after completing study hence, the event is captured in as 'All-Cause Mortality'.
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
0.20%
1/500 • Number of events 1 • From week 0 to week 52
All AEs are treatment emergent - AE with onset in datapoint set period defined as all observed data points from first date of study product until permanent discontinuation of treatment. AEs and All-Cause Mortality are assessed in Safety analysis set: all randomized participants who initiated study drug. 1 participant is counted in 'All-Cause Mortality' who was counted as 'Completed' in Participant Flow as they died after completing study hence, the event is captured in as 'All-Cause Mortality'.
|
0.00%
0/492 • From week 0 to week 52
All AEs are treatment emergent - AE with onset in datapoint set period defined as all observed data points from first date of study product until permanent discontinuation of treatment. AEs and All-Cause Mortality are assessed in Safety analysis set: all randomized participants who initiated study drug. 1 participant is counted in 'All-Cause Mortality' who was counted as 'Completed' in Participant Flow as they died after completing study hence, the event is captured in as 'All-Cause Mortality'.
|
|
Renal and urinary disorders
Ureterolithiasis
|
0.20%
1/500 • Number of events 1 • From week 0 to week 52
All AEs are treatment emergent - AE with onset in datapoint set period defined as all observed data points from first date of study product until permanent discontinuation of treatment. AEs and All-Cause Mortality are assessed in Safety analysis set: all randomized participants who initiated study drug. 1 participant is counted in 'All-Cause Mortality' who was counted as 'Completed' in Participant Flow as they died after completing study hence, the event is captured in as 'All-Cause Mortality'.
|
0.00%
0/492 • From week 0 to week 52
All AEs are treatment emergent - AE with onset in datapoint set period defined as all observed data points from first date of study product until permanent discontinuation of treatment. AEs and All-Cause Mortality are assessed in Safety analysis set: all randomized participants who initiated study drug. 1 participant is counted in 'All-Cause Mortality' who was counted as 'Completed' in Participant Flow as they died after completing study hence, the event is captured in as 'All-Cause Mortality'.
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/500 • From week 0 to week 52
All AEs are treatment emergent - AE with onset in datapoint set period defined as all observed data points from first date of study product until permanent discontinuation of treatment. AEs and All-Cause Mortality are assessed in Safety analysis set: all randomized participants who initiated study drug. 1 participant is counted in 'All-Cause Mortality' who was counted as 'Completed' in Participant Flow as they died after completing study hence, the event is captured in as 'All-Cause Mortality'.
|
0.20%
1/492 • Number of events 1 • From week 0 to week 52
All AEs are treatment emergent - AE with onset in datapoint set period defined as all observed data points from first date of study product until permanent discontinuation of treatment. AEs and All-Cause Mortality are assessed in Safety analysis set: all randomized participants who initiated study drug. 1 participant is counted in 'All-Cause Mortality' who was counted as 'Completed' in Participant Flow as they died after completing study hence, the event is captured in as 'All-Cause Mortality'.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/500 • From week 0 to week 52
All AEs are treatment emergent - AE with onset in datapoint set period defined as all observed data points from first date of study product until permanent discontinuation of treatment. AEs and All-Cause Mortality are assessed in Safety analysis set: all randomized participants who initiated study drug. 1 participant is counted in 'All-Cause Mortality' who was counted as 'Completed' in Participant Flow as they died after completing study hence, the event is captured in as 'All-Cause Mortality'.
|
0.20%
1/492 • Number of events 1 • From week 0 to week 52
All AEs are treatment emergent - AE with onset in datapoint set period defined as all observed data points from first date of study product until permanent discontinuation of treatment. AEs and All-Cause Mortality are assessed in Safety analysis set: all randomized participants who initiated study drug. 1 participant is counted in 'All-Cause Mortality' who was counted as 'Completed' in Participant Flow as they died after completing study hence, the event is captured in as 'All-Cause Mortality'.
|
|
Infections and infestations
Urosepsis
|
0.00%
0/500 • From week 0 to week 52
All AEs are treatment emergent - AE with onset in datapoint set period defined as all observed data points from first date of study product until permanent discontinuation of treatment. AEs and All-Cause Mortality are assessed in Safety analysis set: all randomized participants who initiated study drug. 1 participant is counted in 'All-Cause Mortality' who was counted as 'Completed' in Participant Flow as they died after completing study hence, the event is captured in as 'All-Cause Mortality'.
|
0.20%
1/492 • Number of events 1 • From week 0 to week 52
All AEs are treatment emergent - AE with onset in datapoint set period defined as all observed data points from first date of study product until permanent discontinuation of treatment. AEs and All-Cause Mortality are assessed in Safety analysis set: all randomized participants who initiated study drug. 1 participant is counted in 'All-Cause Mortality' who was counted as 'Completed' in Participant Flow as they died after completing study hence, the event is captured in as 'All-Cause Mortality'.
|
|
Reproductive system and breast disorders
Uterine prolapse
|
0.20%
1/500 • Number of events 1 • From week 0 to week 52
All AEs are treatment emergent - AE with onset in datapoint set period defined as all observed data points from first date of study product until permanent discontinuation of treatment. AEs and All-Cause Mortality are assessed in Safety analysis set: all randomized participants who initiated study drug. 1 participant is counted in 'All-Cause Mortality' who was counted as 'Completed' in Participant Flow as they died after completing study hence, the event is captured in as 'All-Cause Mortality'.
|
0.00%
0/492 • From week 0 to week 52
All AEs are treatment emergent - AE with onset in datapoint set period defined as all observed data points from first date of study product until permanent discontinuation of treatment. AEs and All-Cause Mortality are assessed in Safety analysis set: all randomized participants who initiated study drug. 1 participant is counted in 'All-Cause Mortality' who was counted as 'Completed' in Participant Flow as they died after completing study hence, the event is captured in as 'All-Cause Mortality'.
|
|
Ear and labyrinth disorders
Vertigo
|
0.20%
1/500 • Number of events 1 • From week 0 to week 52
All AEs are treatment emergent - AE with onset in datapoint set period defined as all observed data points from first date of study product until permanent discontinuation of treatment. AEs and All-Cause Mortality are assessed in Safety analysis set: all randomized participants who initiated study drug. 1 participant is counted in 'All-Cause Mortality' who was counted as 'Completed' in Participant Flow as they died after completing study hence, the event is captured in as 'All-Cause Mortality'.
|
0.00%
0/492 • From week 0 to week 52
All AEs are treatment emergent - AE with onset in datapoint set period defined as all observed data points from first date of study product until permanent discontinuation of treatment. AEs and All-Cause Mortality are assessed in Safety analysis set: all randomized participants who initiated study drug. 1 participant is counted in 'All-Cause Mortality' who was counted as 'Completed' in Participant Flow as they died after completing study hence, the event is captured in as 'All-Cause Mortality'.
|
|
Eye disorders
Vision blurred
|
0.20%
1/500 • Number of events 1 • From week 0 to week 52
All AEs are treatment emergent - AE with onset in datapoint set period defined as all observed data points from first date of study product until permanent discontinuation of treatment. AEs and All-Cause Mortality are assessed in Safety analysis set: all randomized participants who initiated study drug. 1 participant is counted in 'All-Cause Mortality' who was counted as 'Completed' in Participant Flow as they died after completing study hence, the event is captured in as 'All-Cause Mortality'.
|
0.00%
0/492 • From week 0 to week 52
All AEs are treatment emergent - AE with onset in datapoint set period defined as all observed data points from first date of study product until permanent discontinuation of treatment. AEs and All-Cause Mortality are assessed in Safety analysis set: all randomized participants who initiated study drug. 1 participant is counted in 'All-Cause Mortality' who was counted as 'Completed' in Participant Flow as they died after completing study hence, the event is captured in as 'All-Cause Mortality'.
|
|
Gastrointestinal disorders
Vomiting
|
0.20%
1/500 • Number of events 1 • From week 0 to week 52
All AEs are treatment emergent - AE with onset in datapoint set period defined as all observed data points from first date of study product until permanent discontinuation of treatment. AEs and All-Cause Mortality are assessed in Safety analysis set: all randomized participants who initiated study drug. 1 participant is counted in 'All-Cause Mortality' who was counted as 'Completed' in Participant Flow as they died after completing study hence, the event is captured in as 'All-Cause Mortality'.
|
0.41%
2/492 • Number of events 2 • From week 0 to week 52
All AEs are treatment emergent - AE with onset in datapoint set period defined as all observed data points from first date of study product until permanent discontinuation of treatment. AEs and All-Cause Mortality are assessed in Safety analysis set: all randomized participants who initiated study drug. 1 participant is counted in 'All-Cause Mortality' who was counted as 'Completed' in Participant Flow as they died after completing study hence, the event is captured in as 'All-Cause Mortality'.
|
Other adverse events
| Measure |
Oral Semaglutide
n=500 participants at risk
Participants received oral semaglutide in addition to background metformin monotherapy for 52 weeks.
|
Other Oral Glucose-lowering Medication
n=492 participants at risk
Participants received one other oral glucose-lowering medication in addition to background metformin monotherapy for 52 weeks.
|
|---|---|---|
|
Infections and infestations
COVID-19
|
8.8%
44/500 • Number of events 44 • From week 0 to week 52
All AEs are treatment emergent - AE with onset in datapoint set period defined as all observed data points from first date of study product until permanent discontinuation of treatment. AEs and All-Cause Mortality are assessed in Safety analysis set: all randomized participants who initiated study drug. 1 participant is counted in 'All-Cause Mortality' who was counted as 'Completed' in Participant Flow as they died after completing study hence, the event is captured in as 'All-Cause Mortality'.
|
7.5%
37/492 • Number of events 40 • From week 0 to week 52
All AEs are treatment emergent - AE with onset in datapoint set period defined as all observed data points from first date of study product until permanent discontinuation of treatment. AEs and All-Cause Mortality are assessed in Safety analysis set: all randomized participants who initiated study drug. 1 participant is counted in 'All-Cause Mortality' who was counted as 'Completed' in Participant Flow as they died after completing study hence, the event is captured in as 'All-Cause Mortality'.
|
|
Gastrointestinal disorders
Nausea
|
7.6%
38/500 • Number of events 40 • From week 0 to week 52
All AEs are treatment emergent - AE with onset in datapoint set period defined as all observed data points from first date of study product until permanent discontinuation of treatment. AEs and All-Cause Mortality are assessed in Safety analysis set: all randomized participants who initiated study drug. 1 participant is counted in 'All-Cause Mortality' who was counted as 'Completed' in Participant Flow as they died after completing study hence, the event is captured in as 'All-Cause Mortality'.
|
2.0%
10/492 • Number of events 11 • From week 0 to week 52
All AEs are treatment emergent - AE with onset in datapoint set period defined as all observed data points from first date of study product until permanent discontinuation of treatment. AEs and All-Cause Mortality are assessed in Safety analysis set: all randomized participants who initiated study drug. 1 participant is counted in 'All-Cause Mortality' who was counted as 'Completed' in Participant Flow as they died after completing study hence, the event is captured in as 'All-Cause Mortality'.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee At the end of the trial, one or more scientific publications may be prepared collaboratively by the investigator(s) and Novo Nordisk. Novo Nordisk reserves the right to postpone publication and/or communication for up to 60 days to protect intellectual property.
- Publication restrictions are in place
Restriction type: OTHER