Trial Outcomes & Findings for Dapagliflozin Evaluation to Improve the LIVEs of Patients With PReserved Ejection Fraction Heart Failure. (NCT NCT03619213)
NCT ID: NCT03619213
Last Updated: 2023-07-11
Results Overview
Dual primary efficacy Primary endpoint analysed in all patients randomised (Full analysis set). The analysis was assessed on Full Analysis Set, including events occurring on or prior to Primary Analysis Censoring Date.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
6263 participants
Primary outcome timeframe
Up to 42.1 months
Results posted on
2023-07-11
Participant Flow
Participant milestones
| Measure |
Dapa 10 mg
Dapagliflozin 10 mg tablets administered once daily per oral use
|
Placebo
Placebo tablet to match dapagliflozin 10 mg, given once daily per oral use
|
|---|---|---|
|
Overall Study
STARTED
|
3131
|
3132
|
|
Overall Study
COMPLETED
|
3121
|
3121
|
|
Overall Study
NOT COMPLETED
|
10
|
11
|
Reasons for withdrawal
| Measure |
Dapa 10 mg
Dapagliflozin 10 mg tablets administered once daily per oral use
|
Placebo
Placebo tablet to match dapagliflozin 10 mg, given once daily per oral use
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
2
|
1
|
|
Overall Study
Withdrawal by Subject
|
8
|
10
|
Baseline Characteristics
Dapagliflozin Evaluation to Improve the LIVEs of Patients With PReserved Ejection Fraction Heart Failure.
Baseline characteristics by cohort
| Measure |
Dapa 10 mg
n=3131 Participants
Dapagliflozin 10 mg tablets administered once daily per oral use
|
Placebo
n=3132 Participants
Placebo tablet to match dapagliflozin 10 mg, given once daily per oral use
|
Total
n=6263 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
71.8 Years
STANDARD_DEVIATION 9.6 • n=93 Participants
|
71.5 Years
STANDARD_DEVIATION 9.5 • n=4 Participants
|
71.7 Years
STANDARD_DEVIATION 9.6 • n=27 Participants
|
|
Age, Customized
<= 50
|
85 Participants
n=93 Participants
|
74 Participants
n=4 Participants
|
159 Participants
n=27 Participants
|
|
Age, Customized
> 50
|
3046 Participants
n=93 Participants
|
3058 Participants
n=4 Participants
|
6104 Participants
n=27 Participants
|
|
Age, Customized
<= 65
|
743 Participants
n=93 Participants
|
761 Participants
n=4 Participants
|
1504 Participants
n=27 Participants
|
|
Age, Customized
> 65
|
2388 Participants
n=93 Participants
|
2371 Participants
n=4 Participants
|
4759 Participants
n=27 Participants
|
|
Age, Customized
>65 - 75
|
1184 Participants
n=93 Participants
|
1228 Participants
n=4 Participants
|
2412 Participants
n=27 Participants
|
|
Age, Customized
> 75
|
1204 Participants
n=93 Participants
|
1143 Participants
n=4 Participants
|
2347 Participants
n=27 Participants
|
|
Sex: Female, Male
Female
|
1364 Participants
n=93 Participants
|
1383 Participants
n=4 Participants
|
2747 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
1767 Participants
n=93 Participants
|
1749 Participants
n=4 Participants
|
3516 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
632 Participants
n=93 Participants
|
598 Participants
n=4 Participants
|
1230 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
2499 Participants
n=93 Participants
|
2534 Participants
n=4 Participants
|
5033 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
White
|
2214 Participants
n=93 Participants
|
2225 Participants
n=4 Participants
|
4439 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
81 Participants
n=93 Participants
|
78 Participants
n=4 Participants
|
159 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
Asian
|
630 Participants
n=93 Participants
|
644 Participants
n=4 Participants
|
1274 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or other Pacific Islander
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
93 Participants
n=93 Participants
|
96 Participants
n=4 Participants
|
189 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
Other
|
113 Participants
n=93 Participants
|
89 Participants
n=4 Participants
|
202 Participants
n=27 Participants
|
|
Prior HF Hospitalization
Yes
|
1270 Participants
n=93 Participants
|
1269 Participants
n=4 Participants
|
2539 Participants
n=27 Participants
|
|
NYHA Class at Baseline
I
|
0 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
|
NYHA Class at Baseline
II
|
2314 Participants
n=93 Participants
|
2399 Participants
n=4 Participants
|
4713 Participants
n=27 Participants
|
|
NYHA Class at Baseline
III
|
807 Participants
n=93 Participants
|
724 Participants
n=4 Participants
|
1531 Participants
n=27 Participants
|
|
NYHA Class at Baseline
IV
|
10 Participants
n=93 Participants
|
8 Participants
n=4 Participants
|
18 Participants
n=27 Participants
|
|
Medical History of Type 2 Diabetes
Yes
|
1401 Participants
n=93 Participants
|
1405 Participants
n=4 Participants
|
2806 Participants
n=27 Participants
|
|
LVEF (%) at Baseline
|
54.0 Percentage of blood leaving the heart
STANDARD_DEVIATION 8.6 • n=93 Participants
|
54.3 Percentage of blood leaving the heart
STANDARD_DEVIATION 8.9 • n=4 Participants
|
54.2 Percentage of blood leaving the heart
STANDARD_DEVIATION 8.8 • n=27 Participants
|
PRIMARY outcome
Timeframe: Up to 42.1 monthsPopulation: Full analysis set
Dual primary efficacy Primary endpoint analysed in all patients randomised (Full analysis set). The analysis was assessed on Full Analysis Set, including events occurring on or prior to Primary Analysis Censoring Date.
Outcome measures
| Measure |
Dapa 10 mg
n=3131 Participants
Dapagliflozin 10 mg tablets administered once daily per oral use
|
Placebo
n=3132 Participants
Placebo tablet to match dapagliflozin 10 mg, given once daily per oral use
|
|---|---|---|
|
Subjects Included in the Composite Endpoint of CV Death, Hospitalization Due to Heart Failure or Urgent Visit Due to Heart Failure.
|
512 Participants
|
610 Participants
|
PRIMARY outcome
Timeframe: Up to 42.1 monthsPopulation: Full analysis set
Dual primary efficacy Primary endpoint analysed in all patients randomised with LVEF \< 60% at baseline. The analysis was assessed on Full Analysis Set, including events occurring on or prior to Primary Analysis Censoring Date.
Outcome measures
| Measure |
Dapa 10 mg
n=2200 Participants
Dapagliflozin 10 mg tablets administered once daily per oral use
|
Placebo
n=2172 Participants
Placebo tablet to match dapagliflozin 10 mg, given once daily per oral use
|
|---|---|---|
|
Subjects Included in the Composite Endpoint of CV Death, Hospitalization Due to Heart Failure or Urgent Visit Due to Heart Failure for LVEF <60% Subpopulation
|
381 Participants
|
440 Participants
|
SECONDARY outcome
Timeframe: Up to 42.1 monthsPopulation: Full analysis set population
Secondary efficacy Total number of heart failure events (first and recurrent) and cardiovascular death, analysed in all randomized patients. The analysis was assessed on Full Analysis Set, including events occurring on or prior to Primary Analysis Censoring Date.
Outcome measures
| Measure |
Dapa 10 mg
n=3131 Participants
Dapagliflozin 10 mg tablets administered once daily per oral use
|
Placebo
n=3132 Participants
Placebo tablet to match dapagliflozin 10 mg, given once daily per oral use
|
|---|---|---|
|
Events Included in the Composite Endpoint of CV Death or Recurrent Heart Failure Event (Hospitalization Due to Heart Failure or Urgent Heart Failure Visit)
|
815 Number of events
|
1057 Number of events
|
SECONDARY outcome
Timeframe: Up to 42.1 monthsPopulation: Full analysis set population
Secondary efficacy Total number of heart failure events (first and recurrent) and cardiovascular death, analysed in all randomized patients with LVEF \< 60% at baseline The analysis was assessed on Full Analysis Set, including events occurring on or prior to Primary Analysis Censoring Date.
Outcome measures
| Measure |
Dapa 10 mg
n=2200 Participants
Dapagliflozin 10 mg tablets administered once daily per oral use
|
Placebo
n=2172 Participants
Placebo tablet to match dapagliflozin 10 mg, given once daily per oral use
|
|---|---|---|
|
Events Included in the Composite Endpoint of CV Death or Recurrent Heart Failure Event (Hospitalization Due to Heart Failure or Urgent Heart Failure Visit) for LVEF <60% Subpopulation
|
605 Number of events
|
782 Number of events
|
SECONDARY outcome
Timeframe: Baseline and 8 months or death before 8 monthsPopulation: Full analysis set population, including only assessments performed or planned prior to March 11th, 2020, when COVID-19 was declared a pandemic by the WHO.
KCCQ is a 23-item, self-administered instrument that quantifies physical function, symptoms (frequency, severity and recent change), social function, self-efficacy and knowledge, and quality of life. The KCCQ Total Symptom Score incorporates the symptom domains into a single score. Scores are transformed to a range of 0-100, in which higher scores reflect better health status.
Outcome measures
| Measure |
Dapa 10 mg
n=1316 Participants
Dapagliflozin 10 mg tablets administered once daily per oral use
|
Placebo
n=1311 Participants
Placebo tablet to match dapagliflozin 10 mg, given once daily per oral use
|
|---|---|---|
|
Change From Baseline in the KCCQ Total Symptom Score at 8 Months
|
8.3 Scores on a scale
Standard Deviation 20.3
|
5.2 Scores on a scale
Standard Deviation 21.1
|
SECONDARY outcome
Timeframe: Up to 42.1 monthsPopulation: Full analysis set
Secondary efficacy The analysis was assessed on Full Analysis Set, including deaths occurring on or prior to Primary Analysis Censoring Date.
Outcome measures
| Measure |
Dapa 10 mg
n=3131 Participants
Dapagliflozin 10 mg tablets administered once daily per oral use
|
Placebo
n=3132 Participants
Placebo tablet to match dapagliflozin 10 mg, given once daily per oral use
|
|---|---|---|
|
Subjects Included in the Endpoint of Cardiovascular Death
|
231 Participants
|
261 Participants
|
SECONDARY outcome
Timeframe: Up to 42.1 monthsPopulation: Full analysis set
Secondary efficacy The analysis was assessed on Full Analysis Set, including deaths occurring on or prior to Primary Analysis Censoring Date.
Outcome measures
| Measure |
Dapa 10 mg
n=3131 Participants
Dapagliflozin 10 mg tablets administered once daily per oral use
|
Placebo
n=3132 Participants
Placebo tablet to match dapagliflozin 10 mg, given once daily per oral use
|
|---|---|---|
|
Subjects Included in the Endpoint of All-cause Mortality
|
497 Participants
|
526 Participants
|
Adverse Events
Dapa 10 mg
Serious events: 1454 serious events
Other events: 464 other events
Deaths: 510 deaths
Placebo
Serious events: 1508 serious events
Other events: 485 other events
Deaths: 533 deaths
Serious adverse events
| Measure |
Dapa 10 mg
n=3126 participants at risk
Dapagliflozin 10 mg tablets administered once daily per oral use
|
Placebo
n=3127 participants at risk
Placebo tablet to match dapagliflozin 10 mg, given once daily per oral use
|
|---|---|---|
|
Blood and lymphatic system disorders
Hypochromic anaemia
|
0.03%
1/3126 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.06%
2/3127 • Number of events 2 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Ear and labyrinth disorders
Deafness
|
0.03%
1/3126 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.00%
0/3127 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Ear and labyrinth disorders
Meniere's disease
|
0.03%
1/3126 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.03%
1/3127 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Ear and labyrinth disorders
Tinnitus
|
0.00%
0/3126 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.03%
1/3127 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Ear and labyrinth disorders
Vertigo
|
0.06%
2/3126 • Number of events 3 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.10%
3/3127 • Number of events 3 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Ear and labyrinth disorders
Vertigo positional
|
0.10%
3/3126 • Number of events 3 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.03%
1/3127 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Endocrine disorders
Goitre
|
0.03%
1/3126 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.00%
0/3127 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Endocrine disorders
Hyperthyroidism
|
0.03%
1/3126 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.00%
0/3127 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Endocrine disorders
Hypothyroidism
|
0.00%
0/3126 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.06%
2/3127 • Number of events 2 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Eye disorders
Age-related macular degeneration
|
0.00%
0/3126 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.03%
1/3127 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Eye disorders
Amaurosis fugax
|
0.03%
1/3126 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.00%
0/3127 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Blood and lymphatic system disorders
Hypocoagulable state
|
0.00%
0/3126 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.03%
1/3127 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Eye disorders
Blindness
|
0.00%
0/3126 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.03%
1/3127 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Eye disorders
Cataract
|
0.32%
10/3126 • Number of events 12 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.16%
5/3127 • Number of events 7 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Eye disorders
Conjunctival haemorrhage
|
0.00%
0/3126 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.03%
1/3127 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Eye disorders
Diabetic retinopathy
|
0.06%
2/3126 • Number of events 2 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.00%
0/3127 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Eye disorders
Epiretinal membrane
|
0.03%
1/3126 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.00%
0/3127 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Eye disorders
Glaucoma
|
0.03%
1/3126 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.03%
1/3127 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Eye disorders
Lens dislocation
|
0.03%
1/3126 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.00%
0/3127 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Eye disorders
Macular rupture
|
0.00%
0/3126 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.03%
1/3127 • Number of events 2 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Eye disorders
Retinal artery occlusion
|
0.03%
1/3126 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.00%
0/3127 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Eye disorders
Retinal detachment
|
0.06%
2/3126 • Number of events 2 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.03%
1/3127 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
0.10%
3/3126 • Number of events 3 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.16%
5/3127 • Number of events 5 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Eye disorders
Visual impairment
|
0.03%
1/3126 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.00%
0/3127 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Eye disorders
Vitreous haemorrhage
|
0.00%
0/3126 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.06%
2/3127 • Number of events 2 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Eye disorders
Vitreous opacities
|
0.03%
1/3126 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.00%
0/3127 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Gastrointestinal disorders
Abdominal adhesions
|
0.03%
1/3126 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.00%
0/3127 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/3126 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.06%
2/3127 • Number of events 2 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Gastrointestinal disorders
Abdominal hernia
|
0.03%
1/3126 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.00%
0/3127 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Gastrointestinal disorders
Abdominal incarcerated hernia
|
0.03%
1/3126 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.00%
0/3127 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/3126 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.13%
4/3127 • Number of events 4 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Gastrointestinal disorders
Abdominal pain lower
|
0.00%
0/3126 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.03%
1/3127 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.03%
1/3126 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.06%
2/3127 • Number of events 2 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
0.00%
0/3126 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.03%
1/3127 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Gastrointestinal disorders
Acute abdomen
|
0.00%
0/3126 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.06%
2/3127 • Number of events 2 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Gastrointestinal disorders
Anal haemorrhage
|
0.03%
1/3126 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.00%
0/3127 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/3126 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.13%
4/3127 • Number of events 5 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Gastrointestinal disorders
Chronic gastritis
|
0.00%
0/3126 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.06%
2/3127 • Number of events 2 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Gastrointestinal disorders
Colitis
|
0.03%
1/3126 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.26%
8/3127 • Number of events 8 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Gastrointestinal disorders
Colitis ischaemic
|
0.00%
0/3126 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.06%
2/3127 • Number of events 2 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Gastrointestinal disorders
Colitis ulcerative
|
0.03%
1/3126 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.10%
3/3127 • Number of events 3 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Gastrointestinal disorders
Constipation
|
0.03%
1/3126 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.10%
3/3127 • Number of events 3 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.10%
3/3126 • Number of events 4 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.13%
4/3127 • Number of events 4 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Gastrointestinal disorders
Diverticular perforation
|
0.03%
1/3126 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.06%
2/3127 • Number of events 2 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Blood and lymphatic system disorders
Microcytic anaemia
|
0.03%
1/3126 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.06%
2/3127 • Number of events 2 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Gastrointestinal disorders
Diverticulum intestinal
|
0.00%
0/3126 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.06%
2/3127 • Number of events 2 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Gastrointestinal disorders
Diverticulum intestinal haemorrhagic
|
0.06%
2/3126 • Number of events 2 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.00%
0/3127 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Gastrointestinal disorders
Duodenal ulcer
|
0.00%
0/3126 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.06%
2/3127 • Number of events 2 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Gastrointestinal disorders
Duodenal ulcer haemorrhage
|
0.03%
1/3126 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.03%
1/3127 • Number of events 2 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Gastrointestinal disorders
Duodenitis
|
0.03%
1/3126 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.00%
0/3127 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/3126 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.03%
1/3127 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Gastrointestinal disorders
Dysphagia
|
0.03%
1/3126 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.00%
0/3127 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Gastrointestinal disorders
Enteritis
|
0.03%
1/3126 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.03%
1/3127 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Gastrointestinal disorders
Enterocolitis
|
0.00%
0/3126 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.03%
1/3127 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Gastrointestinal disorders
Enterovesical fistula
|
0.00%
0/3126 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.03%
1/3127 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Blood and lymphatic system disorders
Nephrogenic anaemia
|
0.00%
0/3126 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.03%
1/3127 • Number of events 2 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Gastrointestinal disorders
Erosive duodenitis
|
0.00%
0/3126 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.03%
1/3127 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Gastrointestinal disorders
Gastric antral vascular ectasia
|
0.03%
1/3126 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.00%
0/3127 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Gastrointestinal disorders
Gastric haemorrhage
|
0.03%
1/3126 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.00%
0/3127 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Gastrointestinal disorders
Gastric perforation
|
0.00%
0/3126 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.03%
1/3127 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Gastrointestinal disorders
Gastric polyps
|
0.03%
1/3126 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.06%
2/3127 • Number of events 2 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Gastrointestinal disorders
Gastric ulcer
|
0.10%
3/3126 • Number of events 3 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.16%
5/3127 • Number of events 5 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Gastrointestinal disorders
Gastric ulcer haemorrhage
|
0.06%
2/3126 • Number of events 2 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.10%
3/3127 • Number of events 3 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Gastrointestinal disorders
Gastritis
|
0.10%
3/3126 • Number of events 4 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.06%
2/3127 • Number of events 2 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Gastrointestinal disorders
Gastritis erosive
|
0.00%
0/3126 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.03%
1/3127 • Number of events 2 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Gastrointestinal disorders
Gastritis haemorrhagic
|
0.00%
0/3126 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.06%
2/3127 • Number of events 2 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Blood and lymphatic system disorders
Normocytic anaemia
|
0.03%
1/3126 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.00%
0/3127 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.45%
14/3126 • Number of events 14 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.48%
15/3127 • Number of events 17 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Gastrointestinal disorders
Gastrointestinal motility disorder
|
0.03%
1/3126 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.00%
0/3127 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Gastrointestinal disorders
Gastrointestinal necrosis
|
0.00%
0/3126 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.03%
1/3127 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Gastrointestinal disorders
Gastrointestinal perforation
|
0.00%
0/3126 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.03%
1/3127 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Gastrointestinal disorders
Gastrointestinal polyp haemorrhage
|
0.03%
1/3126 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.03%
1/3127 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Gastrointestinal disorders
Gastrointestinal ulcer haemorrhage
|
0.00%
0/3126 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.03%
1/3127 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Gastrointestinal disorders
Gastrointestinal vascular malformation haemorrhagic
|
0.03%
1/3126 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.00%
0/3127 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/3126 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.10%
3/3127 • Number of events 3 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Gastrointestinal disorders
Haematemesis
|
0.03%
1/3126 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.03%
1/3127 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Gastrointestinal disorders
Haematochezia
|
0.00%
0/3126 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.03%
1/3127 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Blood and lymphatic system disorders
Pancytopenia
|
0.03%
1/3126 • Number of events 2 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.03%
1/3127 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Gastrointestinal disorders
Haemoperitoneum
|
0.03%
1/3126 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.00%
0/3127 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Gastrointestinal disorders
Haemorrhagic erosive gastritis
|
0.03%
1/3126 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.00%
0/3127 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Gastrointestinal disorders
Haemorrhoidal haemorrhage
|
0.03%
1/3126 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.00%
0/3127 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.00%
0/3126 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.10%
3/3127 • Number of events 3 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Gastrointestinal disorders
Ileal perforation
|
0.00%
0/3126 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.03%
1/3127 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Gastrointestinal disorders
Ileus
|
0.03%
1/3126 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.10%
3/3127 • Number of events 3 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Gastrointestinal disorders
Impaired gastric emptying
|
0.03%
1/3126 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.00%
0/3127 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Gastrointestinal disorders
Incarcerated umbilical hernia
|
0.03%
1/3126 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.00%
0/3127 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.19%
6/3126 • Number of events 7 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.16%
5/3127 • Number of events 5 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Gastrointestinal disorders
Inguinal hernia strangulated
|
0.03%
1/3126 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.00%
0/3127 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Blood and lymphatic system disorders
Splenic cyst
|
0.00%
0/3126 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.03%
1/3127 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Gastrointestinal disorders
Intestinal haemorrhage
|
0.06%
2/3126 • Number of events 2 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.03%
1/3127 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Gastrointestinal disorders
Intestinal ischaemia
|
0.00%
0/3126 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.10%
3/3127 • Number of events 3 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.03%
1/3126 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.16%
5/3127 • Number of events 5 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Gastrointestinal disorders
Intra-abdominal haematoma
|
0.03%
1/3126 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.00%
0/3127 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Gastrointestinal disorders
Intra-abdominal haemorrhage
|
0.00%
0/3126 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.03%
1/3127 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Gastrointestinal disorders
Irritable bowel syndrome
|
0.03%
1/3126 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.00%
0/3127 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Gastrointestinal disorders
Ischaemic enteritis
|
0.00%
0/3126 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.03%
1/3127 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Gastrointestinal disorders
Large intestine polyp
|
0.03%
1/3126 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.35%
11/3127 • Number of events 12 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Gastrointestinal disorders
Lower gastrointestinal haemorrhage
|
0.16%
5/3126 • Number of events 5 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.13%
4/3127 • Number of events 5 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Gastrointestinal disorders
Mechanical ileus
|
0.00%
0/3126 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.03%
1/3127 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.10%
3/3126 • Number of events 3 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.03%
1/3127 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Gastrointestinal disorders
Melaena
|
0.03%
1/3126 • Number of events 2 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.06%
2/3127 • Number of events 2 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Gastrointestinal disorders
Mesenteric haemorrhage
|
0.03%
1/3126 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.00%
0/3127 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/3126 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.06%
2/3127 • Number of events 2 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Gastrointestinal disorders
Obstructive pancreatitis
|
0.03%
1/3126 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.06%
2/3127 • Number of events 2 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Gastrointestinal disorders
Oesophageal obstruction
|
0.00%
0/3126 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.03%
1/3127 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Gastrointestinal disorders
Oesophageal ulcer
|
0.03%
1/3126 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.00%
0/3127 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Gastrointestinal disorders
Oesophageal varices haemorrhage
|
0.00%
0/3126 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.03%
1/3127 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Gastrointestinal disorders
Pancreatic duct dilatation
|
0.03%
1/3126 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.00%
0/3127 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Gastrointestinal disorders
Pancreatitis
|
0.03%
1/3126 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.10%
3/3127 • Number of events 3 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.06%
2/3126 • Number of events 2 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.22%
7/3127 • Number of events 8 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.51%
16/3126 • Number of events 18 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.77%
24/3127 • Number of events 26 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Cardiac disorders
Acute coronary syndrome
|
0.06%
2/3126 • Number of events 2 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.03%
1/3127 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Gastrointestinal disorders
Pancreatitis chronic
|
0.06%
2/3126 • Number of events 2 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.00%
0/3127 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Gastrointestinal disorders
Pancreatitis necrotising
|
0.00%
0/3126 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.03%
1/3127 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Gastrointestinal disorders
Peptic ulcer
|
0.00%
0/3126 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.03%
1/3127 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Gastrointestinal disorders
Peptic ulcer haemorrhage
|
0.00%
0/3126 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.03%
1/3127 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Gastrointestinal disorders
Proctitis
|
0.00%
0/3126 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.03%
1/3127 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.00%
0/3126 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.06%
2/3127 • Number of events 2 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Gastrointestinal disorders
Rectal polyp
|
0.03%
1/3126 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.00%
0/3127 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Gastrointestinal disorders
Retching
|
0.00%
0/3126 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.03%
1/3127 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Gastrointestinal disorders
Salivary gland calculus
|
0.03%
1/3126 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.00%
0/3127 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.06%
2/3126 • Number of events 4 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.03%
1/3127 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Cardiac disorders
Acute left ventricular failure
|
0.32%
10/3126 • Number of events 12 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.51%
16/3127 • Number of events 19 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Gastrointestinal disorders
Strangulated umbilical hernia
|
0.06%
2/3126 • Number of events 2 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.00%
0/3127 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Gastrointestinal disorders
Stress ulcer
|
0.00%
0/3126 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.03%
1/3127 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Gastrointestinal disorders
Subileus
|
0.00%
0/3126 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.03%
1/3127 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Gastrointestinal disorders
Tooth impacted
|
0.00%
0/3126 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.03%
1/3127 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Gastrointestinal disorders
Umbilical hernia
|
0.00%
0/3126 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.03%
1/3127 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Gastrointestinal disorders
Umbilical hernia, obstructive
|
0.03%
1/3126 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.00%
0/3127 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
0.13%
4/3126 • Number of events 4 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.22%
7/3127 • Number of events 7 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Gastrointestinal disorders
Volvulus
|
0.00%
0/3126 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.03%
1/3127 • Number of events 2 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Gastrointestinal disorders
Vomiting
|
0.03%
1/3126 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.06%
2/3127 • Number of events 2 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
General disorders
Asthenia
|
0.16%
5/3126 • Number of events 5 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.13%
4/3127 • Number of events 4 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Cardiac disorders
Acute myocardial infarction
|
2.0%
63/3126 • Number of events 73 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
2.0%
63/3127 • Number of events 71 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
General disorders
Cardiac death
|
0.10%
3/3126 • Number of events 3 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.10%
3/3127 • Number of events 3 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
General disorders
Catheter site pain
|
0.00%
0/3126 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.03%
1/3127 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
General disorders
Chest discomfort
|
0.03%
1/3126 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.00%
0/3127 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
General disorders
Chest pain
|
0.22%
7/3126 • Number of events 8 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.29%
9/3127 • Number of events 9 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
General disorders
Death
|
1.7%
54/3126 • Number of events 54 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
1.7%
52/3127 • Number of events 52 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
General disorders
Feeling abnormal
|
0.00%
0/3126 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.03%
1/3127 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
General disorders
Gait disturbance
|
0.03%
1/3126 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.00%
0/3127 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
General disorders
General physical health deterioration
|
0.03%
1/3126 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.03%
1/3127 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
General disorders
Hypothermia
|
0.00%
0/3126 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.03%
1/3127 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
General disorders
Impaired healing
|
0.03%
1/3126 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.00%
0/3127 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Cardiac disorders
Acute right ventricular failure
|
0.03%
1/3126 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.00%
0/3127 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
General disorders
Incarcerated hernia
|
0.03%
1/3126 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.00%
0/3127 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
General disorders
Inflammation
|
0.03%
1/3126 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.00%
0/3127 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
General disorders
Malaise
|
0.03%
1/3126 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.06%
2/3127 • Number of events 2 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
General disorders
Medical device site joint inflammation
|
0.03%
1/3126 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.00%
0/3127 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
General disorders
Multimorbidity
|
0.00%
0/3126 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.03%
1/3127 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
General disorders
Multiple organ dysfunction syndrome
|
0.10%
3/3126 • Number of events 3 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.10%
3/3127 • Number of events 3 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
General disorders
Non-cardiac chest pain
|
0.22%
7/3126 • Number of events 11 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.22%
7/3127 • Number of events 8 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
General disorders
Oedema due to cardiac disease
|
0.00%
0/3126 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.03%
1/3127 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
General disorders
Oedema peripheral
|
0.00%
0/3126 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.03%
1/3127 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
General disorders
Peripheral swelling
|
0.00%
0/3126 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.03%
1/3127 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Cardiac disorders
Angina pectoris
|
0.58%
18/3126 • Number of events 20 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.61%
19/3127 • Number of events 21 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
General disorders
Procedural failure
|
0.03%
1/3126 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.00%
0/3127 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
General disorders
Prosthetic cardiac valve thrombosis
|
0.03%
1/3126 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.00%
0/3127 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
General disorders
Pyrexia
|
0.03%
1/3126 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.06%
2/3127 • Number of events 2 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
General disorders
Stent-graft endoleak
|
0.03%
1/3126 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.00%
0/3127 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
General disorders
Sudden cardiac death
|
0.83%
26/3126 • Number of events 26 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
1.2%
37/3127 • Number of events 37 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
General disorders
Sudden death
|
0.77%
24/3126 • Number of events 24 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.83%
26/3127 • Number of events 26 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
General disorders
Ulcer haemorrhage
|
0.03%
1/3126 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.00%
0/3127 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
General disorders
Vascular stent stenosis
|
0.03%
1/3126 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.00%
0/3127 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
General disorders
Vascular stent thrombosis
|
0.03%
1/3126 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.00%
0/3127 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Hepatobiliary disorders
Bile duct stone
|
0.13%
4/3126 • Number of events 5 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.03%
1/3127 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Cardiac disorders
Angina unstable
|
1.6%
49/3126 • Number of events 56 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
2.0%
62/3127 • Number of events 75 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Hepatobiliary disorders
Biliary colic
|
0.03%
1/3126 • Number of events 2 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.00%
0/3127 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Hepatobiliary disorders
Biliary dilatation
|
0.03%
1/3126 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.00%
0/3127 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Hepatobiliary disorders
Biliary obstruction
|
0.00%
0/3126 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.03%
1/3127 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Hepatobiliary disorders
Cholangitis
|
0.06%
2/3126 • Number of events 2 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.10%
3/3127 • Number of events 3 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Hepatobiliary disorders
Cholangitis acute
|
0.06%
2/3126 • Number of events 4 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.10%
3/3127 • Number of events 3 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Hepatobiliary disorders
Cholecystitis
|
0.26%
8/3126 • Number of events 8 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.22%
7/3127 • Number of events 8 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.10%
3/3126 • Number of events 3 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.19%
6/3127 • Number of events 6 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Hepatobiliary disorders
Cholecystitis chronic
|
0.06%
2/3126 • Number of events 2 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.00%
0/3127 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.16%
5/3126 • Number of events 5 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.10%
3/3127 • Number of events 3 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Hepatobiliary disorders
Congestive hepatopathy
|
0.06%
2/3126 • Number of events 2 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.03%
1/3127 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Cardiac disorders
Aortic valve incompetence
|
0.03%
1/3126 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.00%
0/3127 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Hepatobiliary disorders
Drug-induced liver injury
|
0.00%
0/3126 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.03%
1/3127 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Hepatobiliary disorders
Hepatic cirrhosis
|
0.06%
2/3126 • Number of events 2 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.13%
4/3127 • Number of events 4 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Hepatobiliary disorders
Hepatic failure
|
0.03%
1/3126 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.03%
1/3127 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Hepatobiliary disorders
Hepatic mass
|
0.03%
1/3126 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.00%
0/3127 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Hepatobiliary disorders
Hepatic vein thrombosis
|
0.00%
0/3126 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.03%
1/3127 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Hepatobiliary disorders
Hepatitis alcoholic
|
0.00%
0/3126 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.03%
1/3127 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Hepatobiliary disorders
Jaundice
|
0.06%
2/3126 • Number of events 2 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.00%
0/3127 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Hepatobiliary disorders
Jaundice cholestatic
|
0.00%
0/3126 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.03%
1/3127 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Hepatobiliary disorders
Liver disorder
|
0.00%
0/3126 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.03%
1/3127 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Immune system disorders
Amyloidosis
|
0.03%
1/3126 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.00%
0/3127 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Cardiac disorders
Aortic valve stenosis
|
0.03%
1/3126 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.19%
6/3127 • Number of events 6 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Immune system disorders
Contrast media allergy
|
0.06%
2/3126 • Number of events 2 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.00%
0/3127 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Immune system disorders
Heart transplant rejection
|
0.00%
0/3126 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.03%
1/3127 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Immune system disorders
Primary amyloidosis
|
0.03%
1/3126 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.00%
0/3127 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Infections and infestations
Abdominal sepsis
|
0.03%
1/3126 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.03%
1/3127 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Infections and infestations
Abscess
|
0.03%
1/3126 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.00%
0/3127 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Infections and infestations
Abscess limb
|
0.00%
0/3126 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.06%
2/3127 • Number of events 3 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Infections and infestations
Acinetobacter sepsis
|
0.00%
0/3126 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.03%
1/3127 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Infections and infestations
Acute endocarditis
|
0.03%
1/3126 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.00%
0/3127 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Infections and infestations
Anal abscess
|
0.03%
1/3126 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.00%
0/3127 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Infections and infestations
Appendicitis
|
0.06%
2/3126 • Number of events 2 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.19%
6/3127 • Number of events 6 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Cardiac disorders
Arrhythmia
|
0.03%
1/3126 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.06%
2/3127 • Number of events 2 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Infections and infestations
Appendicitis perforated
|
0.03%
1/3126 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.10%
3/3127 • Number of events 3 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Infections and infestations
Arthritis bacterial
|
0.03%
1/3126 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.03%
1/3127 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Infections and infestations
Asymptomatic covid-19
|
0.77%
24/3126 • Number of events 25 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.74%
23/3127 • Number of events 23 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Infections and infestations
Atypical pneumonia
|
0.06%
2/3126 • Number of events 2 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.03%
1/3127 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Infections and infestations
Bacteraemia
|
0.06%
2/3126 • Number of events 2 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.03%
1/3127 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Infections and infestations
Bacterial prostatitis
|
0.03%
1/3126 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.00%
0/3127 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Infections and infestations
Bacterial pyelonephritis
|
0.00%
0/3126 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.03%
1/3127 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Infections and infestations
Biliary tract infection
|
0.00%
0/3126 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.03%
1/3127 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Infections and infestations
Bronchitis
|
0.26%
8/3126 • Number of events 8 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.38%
12/3127 • Number of events 14 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Infections and infestations
Bronchitis viral
|
0.06%
2/3126 • Number of events 2 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.00%
0/3127 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Cardiac disorders
Arrhythmia supraventricular
|
0.03%
1/3126 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.00%
0/3127 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Infections and infestations
Bullous erysipelas
|
0.03%
1/3126 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.00%
0/3127 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Infections and infestations
Bursitis infective
|
0.00%
0/3126 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.03%
1/3127 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Infections and infestations
Covid-19
|
5.9%
183/3126 • Number of events 187 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
4.6%
144/3127 • Number of events 147 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Infections and infestations
Covid-19 pneumonia
|
2.8%
86/3126 • Number of events 86 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
2.8%
89/3127 • Number of events 91 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Infections and infestations
Cellulitis
|
1.1%
35/3126 • Number of events 44 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.70%
22/3127 • Number of events 30 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Infections and infestations
Cholangitis infective
|
0.03%
1/3126 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.00%
0/3127 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Infections and infestations
Clostridium difficile colitis
|
0.06%
2/3126 • Number of events 2 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.06%
2/3127 • Number of events 2 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Infections and infestations
Clostridium difficile infection
|
0.00%
0/3126 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.13%
4/3127 • Number of events 4 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Infections and infestations
Complicated appendicitis
|
0.03%
1/3126 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.00%
0/3127 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Infections and infestations
Coronavirus infection
|
0.00%
0/3126 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.06%
2/3127 • Number of events 2 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Blood and lymphatic system disorders
Anaemia macrocytic
|
0.00%
0/3126 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.03%
1/3127 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Cardiac disorders
Atrial fibrillation
|
2.2%
69/3126 • Number of events 82 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
1.8%
57/3127 • Number of events 62 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Infections and infestations
Coronavirus pneumonia
|
0.10%
3/3126 • Number of events 3 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.06%
2/3127 • Number of events 2 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Infections and infestations
Cystitis
|
0.10%
3/3126 • Number of events 3 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.06%
2/3127 • Number of events 2 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Infections and infestations
Cystitis bacterial
|
0.03%
1/3126 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.00%
0/3127 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Infections and infestations
Cystitis escherichia
|
0.00%
0/3126 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.03%
1/3127 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Infections and infestations
Device related infection
|
0.06%
2/3126 • Number of events 2 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.00%
0/3127 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Infections and infestations
Device related sepsis
|
0.00%
0/3126 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.03%
1/3127 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Infections and infestations
Diabetic foot infection
|
0.06%
2/3126 • Number of events 2 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.06%
2/3127 • Number of events 4 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Infections and infestations
Diabetic gangrene
|
0.03%
1/3126 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.06%
2/3127 • Number of events 4 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Infections and infestations
Diarrhoea infectious
|
0.03%
1/3126 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.00%
0/3127 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Infections and infestations
Diverticulitis
|
0.13%
4/3126 • Number of events 4 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.16%
5/3127 • Number of events 5 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Cardiac disorders
Atrial flutter
|
0.32%
10/3126 • Number of events 10 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.06%
2/3127 • Number of events 2 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Infections and infestations
Diverticulitis intestinal perforated
|
0.00%
0/3126 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.03%
1/3127 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Infections and infestations
Endocarditis
|
0.06%
2/3126 • Number of events 2 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.10%
3/3127 • Number of events 3 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Infections and infestations
Endocarditis bacterial
|
0.03%
1/3126 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.03%
1/3127 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Infections and infestations
Endocarditis enterococcal
|
0.00%
0/3126 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.06%
2/3127 • Number of events 2 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Infections and infestations
Enterococcal bacteraemia
|
0.03%
1/3126 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.00%
0/3127 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Infections and infestations
Enterococcal sepsis
|
0.03%
1/3126 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.00%
0/3127 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Infections and infestations
Erysipelas
|
0.19%
6/3126 • Number of events 6 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.13%
4/3127 • Number of events 4 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Infections and infestations
Escherichia bacteraemia
|
0.00%
0/3126 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.06%
2/3127 • Number of events 2 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Infections and infestations
Escherichia sepsis
|
0.03%
1/3126 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.03%
1/3127 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Infections and infestations
Escherichia urinary tract infection
|
0.00%
0/3126 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.03%
1/3127 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Cardiac disorders
Atrial tachycardia
|
0.19%
6/3126 • Number of events 7 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.03%
1/3127 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Infections and infestations
Furuncle
|
0.03%
1/3126 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.00%
0/3127 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Infections and infestations
Gangrene
|
0.13%
4/3126 • Number of events 4 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.13%
4/3127 • Number of events 4 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Infections and infestations
Gastroenteritis
|
0.22%
7/3126 • Number of events 7 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.26%
8/3127 • Number of events 8 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Infections and infestations
Gastroenteritis viral
|
0.03%
1/3126 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.00%
0/3127 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Infections and infestations
Gastrointestinal infection
|
0.03%
1/3126 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.06%
2/3127 • Number of events 2 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Infections and infestations
Hiv infection
|
0.00%
0/3126 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.03%
1/3127 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Infections and infestations
Haematoma infection
|
0.03%
1/3126 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.00%
0/3127 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Infections and infestations
Helicobacter gastritis
|
0.03%
1/3126 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.00%
0/3127 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Infections and infestations
Hepatitis c
|
0.00%
0/3126 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.03%
1/3127 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Infections and infestations
Hepatitis e
|
0.00%
0/3126 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.03%
1/3127 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Cardiac disorders
Atrial thrombosis
|
0.06%
2/3126 • Number of events 2 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.00%
0/3127 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Infections and infestations
Herpes zoster
|
0.03%
1/3126 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.06%
2/3127 • Number of events 2 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Infections and infestations
Herpes zoster disseminated
|
0.03%
1/3126 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.00%
0/3127 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Infections and infestations
Implant site infection
|
0.03%
1/3126 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.00%
0/3127 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Infections and infestations
Infected skin ulcer
|
0.03%
1/3126 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.13%
4/3127 • Number of events 4 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Infections and infestations
Infection
|
0.03%
1/3126 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.10%
3/3127 • Number of events 3 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Infections and infestations
Infectious pleural effusion
|
0.10%
3/3126 • Number of events 3 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.06%
2/3127 • Number of events 2 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Infections and infestations
Infective exacerbation of bronchiectasis
|
0.00%
0/3126 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.06%
2/3127 • Number of events 2 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Infections and infestations
Influenza
|
0.13%
4/3126 • Number of events 4 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.16%
5/3127 • Number of events 5 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Infections and infestations
Intestinal gangrene
|
0.03%
1/3126 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.00%
0/3127 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Infections and infestations
Kidney infection
|
0.03%
1/3126 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.00%
0/3127 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Cardiac disorders
Atrioventricular block
|
0.03%
1/3126 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.10%
3/3127 • Number of events 3 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Infections and infestations
Klebsiella sepsis
|
0.00%
0/3126 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.03%
1/3127 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Infections and infestations
Large intestine infection
|
0.00%
0/3126 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.03%
1/3127 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Infections and infestations
Liver abscess
|
0.06%
2/3126 • Number of events 2 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.00%
0/3127 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Infections and infestations
Localised infection
|
0.10%
3/3126 • Number of events 3 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.03%
1/3127 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Infections and infestations
Lower respiratory tract infection
|
0.03%
1/3126 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.10%
3/3127 • Number of events 4 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Infections and infestations
Lower respiratory tract infection bacterial
|
0.00%
0/3126 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.03%
1/3127 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Infections and infestations
Lung abscess
|
0.03%
1/3126 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.03%
1/3127 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Infections and infestations
Lymph node tuberculosis
|
0.00%
0/3126 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.03%
1/3127 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Infections and infestations
Mediastinitis
|
0.00%
0/3126 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.03%
1/3127 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Infections and infestations
Middle east respiratory syndrome
|
0.03%
1/3126 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.00%
0/3127 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Cardiac disorders
Atrioventricular block complete
|
0.22%
7/3126 • Number of events 7 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.13%
4/3127 • Number of events 4 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/3126 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.03%
1/3127 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Infections and infestations
Necrotising fasciitis
|
0.00%
0/3126 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.03%
1/3127 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Infections and infestations
Ophthalmic herpes zoster
|
0.03%
1/3126 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.00%
0/3127 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Infections and infestations
Orchitis
|
0.00%
0/3126 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.03%
1/3127 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Infections and infestations
Osteomyelitis
|
0.22%
7/3126 • Number of events 7 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.22%
7/3127 • Number of events 8 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Infections and infestations
Osteomyelitis chronic
|
0.03%
1/3126 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.00%
0/3127 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Infections and infestations
Pancreas infection
|
0.00%
0/3126 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.03%
1/3127 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Infections and infestations
Pelvic abscess
|
0.00%
0/3126 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.03%
1/3127 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Infections and infestations
Pelvic inflammatory disease
|
0.00%
0/3126 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.03%
1/3127 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Infections and infestations
Periodontitis
|
0.03%
1/3126 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.06%
2/3127 • Number of events 2 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Cardiac disorders
Atrioventricular block second degree
|
0.03%
1/3126 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.03%
1/3127 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Infections and infestations
Peritonitis
|
0.06%
2/3126 • Number of events 2 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.00%
0/3127 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Infections and infestations
Peritonitis bacterial
|
0.00%
0/3126 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.03%
1/3127 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Infections and infestations
Peritonsillar abscess
|
0.03%
1/3126 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.00%
0/3127 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Infections and infestations
Pharyngitis
|
0.03%
1/3126 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.00%
0/3127 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Infections and infestations
Pneumonia
|
3.6%
113/3126 • Number of events 123 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
3.4%
106/3127 • Number of events 129 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Infections and infestations
Pneumonia aspiration
|
0.22%
7/3126 • Number of events 7 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.26%
8/3127 • Number of events 8 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Infections and infestations
Pneumonia bacterial
|
0.10%
3/3126 • Number of events 3 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.22%
7/3127 • Number of events 7 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Infections and infestations
Pneumonia pseudomonal
|
0.06%
2/3126 • Number of events 2 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.00%
0/3127 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Infections and infestations
Pneumonia viral
|
0.03%
1/3126 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.10%
3/3127 • Number of events 3 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Infections and infestations
Post procedural infection
|
0.03%
1/3126 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.00%
0/3127 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Cardiac disorders
Atrioventricular dissociation
|
0.00%
0/3126 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.03%
1/3127 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Infections and infestations
Postoperative wound infection
|
0.10%
3/3126 • Number of events 3 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.03%
1/3127 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Infections and infestations
Prosthetic valve endocarditis
|
0.00%
0/3126 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.03%
1/3127 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Infections and infestations
Pulmonary sepsis
|
0.06%
2/3126 • Number of events 2 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.00%
0/3127 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Infections and infestations
Pulmonary tuberculosis
|
0.00%
0/3126 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.03%
1/3127 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Infections and infestations
Pyelonephritis
|
0.06%
2/3126 • Number of events 2 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.10%
3/3127 • Number of events 4 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Infections and infestations
Pyelonephritis acute
|
0.06%
2/3126 • Number of events 2 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.00%
0/3127 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Infections and infestations
Pyelonephritis chronic
|
0.06%
2/3126 • Number of events 2 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.00%
0/3127 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Infections and infestations
Respiratory syncytial virus bronchitis
|
0.03%
1/3126 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.00%
0/3127 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Infections and infestations
Respiratory tract infection
|
0.03%
1/3126 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.13%
4/3127 • Number of events 4 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Infections and infestations
Sepsis
|
0.51%
16/3126 • Number of events 17 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.64%
20/3127 • Number of events 21 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Cardiac disorders
Bradyarrhythmia
|
0.06%
2/3126 • Number of events 2 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.06%
2/3127 • Number of events 2 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Infections and infestations
Septic phlebitis
|
0.00%
0/3126 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.03%
1/3127 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Infections and infestations
Septic shock
|
0.54%
17/3126 • Number of events 17 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.54%
17/3127 • Number of events 18 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Infections and infestations
Sinusitis
|
0.00%
0/3126 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.03%
1/3127 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Infections and infestations
Skin infection
|
0.06%
2/3126 • Number of events 2 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.00%
0/3127 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Infections and infestations
Soft tissue infection
|
0.00%
0/3126 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.03%
1/3127 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Infections and infestations
Spontaneous bacterial peritonitis
|
0.03%
1/3126 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.00%
0/3127 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Infections and infestations
Staphylococcal bacteraemia
|
0.03%
1/3126 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.03%
1/3127 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Infections and infestations
Staphylococcal infection
|
0.06%
2/3126 • Number of events 2 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.06%
2/3127 • Number of events 2 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Infections and infestations
Streptococcal infection
|
0.00%
0/3126 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.03%
1/3127 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Infections and infestations
Subcutaneous abscess
|
0.03%
1/3126 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.00%
0/3127 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Cardiac disorders
Bradycardia
|
0.35%
11/3126 • Number of events 11 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.42%
13/3127 • Number of events 13 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Infections and infestations
Suspected covid-19
|
0.54%
17/3126 • Number of events 17 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.51%
16/3127 • Number of events 16 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Infections and infestations
Testicular abscess
|
0.00%
0/3126 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.03%
1/3127 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Infections and infestations
Tracheobronchitis
|
0.00%
0/3126 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.03%
1/3127 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Infections and infestations
Tuberculosis
|
0.00%
0/3126 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.06%
2/3127 • Number of events 2 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.13%
4/3126 • Number of events 4 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.06%
2/3127 • Number of events 2 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Infections and infestations
Urinary tract infection
|
1.3%
40/3126 • Number of events 49 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
1.1%
33/3127 • Number of events 34 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Infections and infestations
Urosepsis
|
0.26%
8/3126 • Number of events 8 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.35%
11/3127 • Number of events 12 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Infections and infestations
Viral infection
|
0.03%
1/3126 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.00%
0/3127 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Infections and infestations
Viral myositis
|
0.03%
1/3126 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.00%
0/3127 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Infections and infestations
Viral pericarditis
|
0.03%
1/3126 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.00%
0/3127 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Blood and lymphatic system disorders
Blood loss anaemia
|
0.13%
4/3126 • Number of events 4 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.19%
6/3127 • Number of events 6 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Cardiac disorders
Bundle branch block left
|
0.00%
0/3126 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.06%
2/3127 • Number of events 2 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Infections and infestations
Vulval cellulitis
|
0.00%
0/3126 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.03%
1/3127 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Infections and infestations
Wound infection
|
0.06%
2/3126 • Number of events 2 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.10%
3/3127 • Number of events 3 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Infections and infestations
Wound sepsis
|
0.00%
0/3126 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.03%
1/3127 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Injury, poisoning and procedural complications
Abdominal injury
|
0.00%
0/3126 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.03%
1/3127 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Injury, poisoning and procedural complications
Abdominal wound dehiscence
|
0.00%
0/3126 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.03%
1/3127 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Injury, poisoning and procedural complications
Acetabulum fracture
|
0.03%
1/3126 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.03%
1/3127 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.13%
4/3126 • Number of events 4 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.10%
3/3127 • Number of events 3 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Injury, poisoning and procedural complications
Arteriovenous fistula site complication
|
0.03%
1/3126 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.00%
0/3127 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Injury, poisoning and procedural complications
Back injury
|
0.03%
1/3126 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.00%
0/3127 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Injury, poisoning and procedural complications
Brain contusion
|
0.00%
0/3126 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.03%
1/3127 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Cardiac disorders
Cardiac amyloidosis
|
0.00%
0/3126 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.03%
1/3127 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Injury, poisoning and procedural complications
Burns third degree
|
0.00%
0/3126 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.03%
1/3127 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Injury, poisoning and procedural complications
Cervical vertebral fracture
|
0.00%
0/3126 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.03%
1/3127 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Injury, poisoning and procedural complications
Clavicle fracture
|
0.00%
0/3126 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.03%
1/3127 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Injury, poisoning and procedural complications
Comminuted fracture
|
0.00%
0/3126 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.03%
1/3127 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Injury, poisoning and procedural complications
Compression fracture
|
0.06%
2/3126 • Number of events 3 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.00%
0/3127 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Injury, poisoning and procedural complications
Concussion
|
0.06%
2/3126 • Number of events 2 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.00%
0/3127 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.03%
1/3126 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.10%
3/3127 • Number of events 3 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Injury, poisoning and procedural complications
Coronary artery restenosis
|
0.00%
0/3126 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.03%
1/3127 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Injury, poisoning and procedural complications
Coronary bypass stenosis
|
0.03%
1/3126 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.00%
0/3127 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Injury, poisoning and procedural complications
Craniocerebral injury
|
0.03%
1/3126 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.03%
1/3127 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Cardiac disorders
Cardiac arrest
|
0.58%
18/3126 • Number of events 18 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.54%
17/3127 • Number of events 17 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Injury, poisoning and procedural complications
Eschar
|
0.00%
0/3126 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.03%
1/3127 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Injury, poisoning and procedural complications
Eye injury
|
0.00%
0/3126 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.03%
1/3127 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Injury, poisoning and procedural complications
Fall
|
0.16%
5/3126 • Number of events 5 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.22%
7/3127 • Number of events 7 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Injury, poisoning and procedural complications
Femoral neck fracture
|
0.19%
6/3126 • Number of events 6 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.16%
5/3127 • Number of events 5 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.32%
10/3126 • Number of events 10 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.35%
11/3127 • Number of events 12 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Injury, poisoning and procedural complications
Fibula fracture
|
0.03%
1/3126 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.03%
1/3127 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Injury, poisoning and procedural complications
Foot fracture
|
0.00%
0/3126 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.06%
2/3127 • Number of events 2 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Injury, poisoning and procedural complications
Forearm fracture
|
0.00%
0/3126 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.03%
1/3127 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Injury, poisoning and procedural complications
Fracture
|
0.03%
1/3126 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.00%
0/3127 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Injury, poisoning and procedural complications
Fractured sacrum
|
0.03%
1/3126 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.03%
1/3127 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Cardiac disorders
Cardiac disorder
|
0.00%
0/3126 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.03%
1/3127 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Injury, poisoning and procedural complications
Head injury
|
0.00%
0/3126 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.19%
6/3127 • Number of events 6 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Injury, poisoning and procedural complications
Heat illness
|
0.03%
1/3126 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.03%
1/3127 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.32%
10/3126 • Number of events 10 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.22%
7/3127 • Number of events 7 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Injury, poisoning and procedural complications
Humerus fracture
|
0.10%
3/3126 • Number of events 3 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.19%
6/3127 • Number of events 6 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Injury, poisoning and procedural complications
Incarcerated incisional hernia
|
0.03%
1/3126 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.00%
0/3127 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Injury, poisoning and procedural complications
Incision site haemorrhage
|
0.00%
0/3126 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.03%
1/3127 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Injury, poisoning and procedural complications
Incisional hernia
|
0.06%
2/3126 • Number of events 2 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.00%
0/3127 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Injury, poisoning and procedural complications
Limb injury
|
0.06%
2/3126 • Number of events 2 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.10%
3/3127 • Number of events 3 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Injury, poisoning and procedural complications
Lower limb fracture
|
0.00%
0/3126 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.10%
3/3127 • Number of events 3 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Injury, poisoning and procedural complications
Lumbar vertebral fracture
|
0.03%
1/3126 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.03%
1/3127 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Cardiac disorders
Cardiac failure
|
9.9%
308/3126 • Number of events 458 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
12.1%
377/3127 • Number of events 581 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Injury, poisoning and procedural complications
Meniscus injury
|
0.00%
0/3126 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.03%
1/3127 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Injury, poisoning and procedural complications
Multiple fractures
|
0.00%
0/3126 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.06%
2/3127 • Number of events 2 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Injury, poisoning and procedural complications
Multiple injuries
|
0.03%
1/3126 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.03%
1/3127 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Injury, poisoning and procedural complications
Open fracture
|
0.00%
0/3126 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.03%
1/3127 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Injury, poisoning and procedural complications
Overdose
|
0.00%
0/3126 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.03%
1/3127 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Injury, poisoning and procedural complications
Patella fracture
|
0.03%
1/3126 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.03%
1/3127 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Injury, poisoning and procedural complications
Pelvic fracture
|
0.00%
0/3126 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.06%
2/3127 • Number of events 2 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Injury, poisoning and procedural complications
Penis injury
|
0.03%
1/3126 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.00%
0/3127 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Injury, poisoning and procedural complications
Periprosthetic fracture
|
0.03%
1/3126 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.03%
1/3127 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Injury, poisoning and procedural complications
Post procedural complication
|
0.06%
2/3126 • Number of events 2 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.03%
1/3127 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Cardiac disorders
Cardiac failure acute
|
1.8%
57/3126 • Number of events 73 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
2.0%
63/3127 • Number of events 90 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Injury, poisoning and procedural complications
Post procedural haematoma
|
0.03%
1/3126 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.03%
1/3127 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Injury, poisoning and procedural complications
Post procedural hypotension
|
0.03%
1/3126 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.00%
0/3127 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Injury, poisoning and procedural complications
Post procedural myocardial infarction
|
0.03%
1/3126 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.00%
0/3127 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Injury, poisoning and procedural complications
Post procedural swelling
|
0.00%
0/3126 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.03%
1/3127 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Injury, poisoning and procedural complications
Post-traumatic pain
|
0.03%
1/3126 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.00%
0/3127 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Injury, poisoning and procedural complications
Postoperative respiratory failure
|
0.00%
0/3126 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.03%
1/3127 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Injury, poisoning and procedural complications
Procedural pain
|
0.03%
1/3126 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.00%
0/3127 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Injury, poisoning and procedural complications
Procedural pneumothorax
|
0.03%
1/3126 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.00%
0/3127 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Injury, poisoning and procedural complications
Radius fracture
|
0.06%
2/3126 • Number of events 2 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.03%
1/3127 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Injury, poisoning and procedural complications
Repetitive strain injury
|
0.03%
1/3126 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.00%
0/3127 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Cardiac disorders
Cardiac failure chronic
|
0.74%
23/3126 • Number of events 32 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.83%
26/3127 • Number of events 44 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.03%
1/3126 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.10%
3/3127 • Number of events 3 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.10%
3/3126 • Number of events 3 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.03%
1/3127 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Injury, poisoning and procedural complications
Skin laceration
|
0.03%
1/3126 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.00%
0/3127 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Injury, poisoning and procedural complications
Spinal compression fracture
|
0.35%
11/3126 • Number of events 11 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.16%
5/3127 • Number of events 5 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Injury, poisoning and procedural complications
Spinal cord injury
|
0.00%
0/3126 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.03%
1/3127 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Injury, poisoning and procedural complications
Spinal fracture
|
0.06%
2/3126 • Number of events 2 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.00%
0/3127 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Injury, poisoning and procedural complications
Splenic rupture
|
0.00%
0/3126 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.03%
1/3127 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Injury, poisoning and procedural complications
Stomal hernia
|
0.03%
1/3126 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.00%
0/3127 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Injury, poisoning and procedural complications
Subdural haematoma
|
0.13%
4/3126 • Number of events 4 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.13%
4/3127 • Number of events 4 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Injury, poisoning and procedural complications
Subdural haemorrhage
|
0.06%
2/3126 • Number of events 2 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.00%
0/3127 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Cardiac disorders
Cardiac failure congestive
|
2.0%
63/3126 • Number of events 86 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
2.6%
82/3127 • Number of events 116 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Injury, poisoning and procedural complications
Tendon rupture
|
0.00%
0/3126 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.03%
1/3127 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Injury, poisoning and procedural complications
Tibia fracture
|
0.03%
1/3126 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.00%
0/3127 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Injury, poisoning and procedural complications
Toxicity to various agents
|
0.00%
0/3126 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.13%
4/3127 • Number of events 4 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Injury, poisoning and procedural complications
Traumatic haematoma
|
0.03%
1/3126 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.00%
0/3127 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Injury, poisoning and procedural complications
Traumatic haemothorax
|
0.00%
0/3126 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.03%
1/3127 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Injury, poisoning and procedural complications
Traumatic intracranial haemorrhage
|
0.00%
0/3126 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.06%
2/3127 • Number of events 2 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Injury, poisoning and procedural complications
Ulna fracture
|
0.00%
0/3126 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.03%
1/3127 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Injury, poisoning and procedural complications
Vascular graft occlusion
|
0.03%
1/3126 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.03%
1/3127 • Number of events 4 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Injury, poisoning and procedural complications
Vascular graft stenosis
|
0.03%
1/3126 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.00%
0/3127 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Injury, poisoning and procedural complications
Vascular graft thrombosis
|
0.03%
1/3126 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.03%
1/3127 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Cardiac disorders
Cardiac failure high output
|
0.00%
0/3126 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.03%
1/3127 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Injury, poisoning and procedural complications
Vascular pseudoaneurysm
|
0.00%
0/3126 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.03%
1/3127 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Injury, poisoning and procedural complications
Wound haemorrhage
|
0.03%
1/3126 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.00%
0/3127 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Investigations
Anticoagulation drug level above therapeutic
|
0.00%
0/3126 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.06%
2/3127 • Number of events 2 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Investigations
Blood creatinine increased
|
0.03%
1/3126 • Number of events 2 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.00%
0/3127 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Investigations
Ejection fraction decreased
|
0.06%
2/3126 • Number of events 2 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.03%
1/3127 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Investigations
Electrocardiogram qrs complex prolonged
|
0.03%
1/3126 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.00%
0/3127 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Investigations
Electrocardiogram qt prolonged
|
0.03%
1/3126 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.00%
0/3127 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Investigations
Fibrin d dimer increased
|
0.03%
1/3126 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.00%
0/3127 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Investigations
Hepatic enzyme increased
|
0.03%
1/3126 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.00%
0/3127 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Investigations
International normalised ratio increased
|
0.00%
0/3126 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.03%
1/3127 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Cardiac disorders
Cardiac valve disease
|
0.06%
2/3126 • Number of events 2 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.10%
3/3127 • Number of events 3 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Investigations
Peripheral pulse decreased
|
0.03%
1/3126 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.00%
0/3127 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Investigations
Sars-cov-2 antibody test positive
|
0.00%
0/3126 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.03%
1/3127 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Investigations
Sars-cov-2 test positive
|
0.03%
1/3126 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.00%
0/3127 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Investigations
Systemic lupus erythematosus disease activity index abnormal
|
0.00%
0/3126 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.03%
1/3127 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Investigations
Weight decreased
|
0.03%
1/3126 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.00%
0/3127 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Metabolism and nutrition disorders
Cachexia
|
0.03%
1/3126 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.00%
0/3127 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Metabolism and nutrition disorders
Calciphylaxis
|
0.00%
0/3126 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.03%
1/3127 • Number of events 2 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.03%
1/3126 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.10%
3/3127 • Number of events 3 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.19%
6/3126 • Number of events 6 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.26%
8/3127 • Number of events 8 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Metabolism and nutrition disorders
Diabetes mellitus inadequate control
|
0.45%
14/3126 • Number of events 17 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.58%
18/3127 • Number of events 18 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Blood and lymphatic system disorders
Coagulopathy
|
0.06%
2/3126 • Number of events 2 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.13%
4/3127 • Number of events 5 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Cardiac disorders
Cardiac ventricular thrombosis
|
0.03%
1/3126 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.06%
2/3127 • Number of events 2 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Metabolism and nutrition disorders
Diabetic ketoacidosis
|
0.10%
3/3126 • Number of events 4 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.10%
3/3127 • Number of events 3 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Metabolism and nutrition disorders
Electrolyte imbalance
|
0.00%
0/3126 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.06%
2/3127 • Number of events 2 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Metabolism and nutrition disorders
Gout
|
0.13%
4/3126 • Number of events 4 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.13%
4/3127 • Number of events 4 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.00%
0/3126 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.06%
2/3127 • Number of events 3 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.19%
6/3126 • Number of events 6 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.22%
7/3127 • Number of events 8 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Metabolism and nutrition disorders
Hyperglycaemic hyperosmolar nonketotic syndrome
|
0.03%
1/3126 • Number of events 2 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.10%
3/3127 • Number of events 3 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.35%
11/3126 • Number of events 12 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.13%
4/3127 • Number of events 4 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Metabolism and nutrition disorders
Hypernatraemia
|
0.03%
1/3126 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.03%
1/3127 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Metabolism and nutrition disorders
Hypervolaemia
|
0.00%
0/3126 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.10%
3/3127 • Number of events 3 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
0.03%
1/3126 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.00%
0/3127 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Cardiac disorders
Cardio-respiratory arrest
|
0.10%
3/3126 • Number of events 3 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.16%
5/3127 • Number of events 5 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
0.00%
0/3126 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.03%
1/3127 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.29%
9/3126 • Number of events 9 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.10%
3/3127 • Number of events 3 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.32%
10/3126 • Number of events 10 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.06%
2/3127 • Number of events 2 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
0.03%
1/3126 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.00%
0/3127 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.22%
7/3126 • Number of events 7 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.26%
8/3127 • Number of events 12 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Metabolism and nutrition disorders
Hypoproteinaemia
|
0.03%
1/3126 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.00%
0/3127 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Metabolism and nutrition disorders
Hypovolaemia
|
0.13%
4/3126 • Number of events 4 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.00%
0/3127 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Metabolism and nutrition disorders
Ketosis
|
0.03%
1/3126 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.00%
0/3127 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Metabolism and nutrition disorders
Lactic acidosis
|
0.03%
1/3126 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.03%
1/3127 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Metabolism and nutrition disorders
Latent autoimmune diabetes in adults
|
0.00%
0/3126 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.03%
1/3127 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Cardiac disorders
Cardiogenic shock
|
0.29%
9/3126 • Number of events 9 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.38%
12/3127 • Number of events 12 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Metabolism and nutrition disorders
Marasmus
|
0.03%
1/3126 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.06%
2/3127 • Number of events 2 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Metabolism and nutrition disorders
Metabolic acidosis
|
0.03%
1/3126 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.16%
5/3127 • Number of events 5 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Metabolism and nutrition disorders
Metabolic syndrome
|
0.03%
1/3126 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.00%
0/3127 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Metabolism and nutrition disorders
Type 2 diabetes mellitus
|
0.00%
0/3126 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.32%
10/3127 • Number of events 10 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.03%
1/3126 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.13%
4/3127 • Number of events 4 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/3126 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.10%
3/3127 • Number of events 4 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Musculoskeletal and connective tissue disorders
Axial spondyloarthritis
|
0.00%
0/3126 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.03%
1/3127 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.10%
3/3126 • Number of events 3 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.13%
4/3127 • Number of events 4 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Musculoskeletal and connective tissue disorders
Bursitis
|
0.00%
0/3126 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.03%
1/3127 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Musculoskeletal and connective tissue disorders
Cervical spinal stenosis
|
0.03%
1/3126 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.00%
0/3127 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Cardiac disorders
Cardiomegaly
|
0.03%
1/3126 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.03%
1/3127 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Musculoskeletal and connective tissue disorders
Chondrocalcinosis pyrophosphate
|
0.00%
0/3126 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.03%
1/3127 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Musculoskeletal and connective tissue disorders
Compartment syndrome
|
0.00%
0/3126 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.03%
1/3127 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Musculoskeletal and connective tissue disorders
Exostosis
|
0.00%
0/3126 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.03%
1/3127 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Musculoskeletal and connective tissue disorders
Gouty arthritis
|
0.03%
1/3126 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.00%
0/3127 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Musculoskeletal and connective tissue disorders
Haemarthrosis
|
0.06%
2/3126 • Number of events 3 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.03%
1/3127 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Musculoskeletal and connective tissue disorders
Hypertrophic osteoarthropathy
|
0.00%
0/3126 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.03%
1/3127 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Musculoskeletal and connective tissue disorders
Immobilisation syndrome
|
0.00%
0/3126 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.03%
1/3127 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc disorder
|
0.03%
1/3126 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.00%
0/3127 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.22%
7/3126 • Number of events 8 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.03%
1/3127 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Musculoskeletal and connective tissue disorders
Lumbar spinal stenosis
|
0.06%
2/3126 • Number of events 2 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.13%
4/3127 • Number of events 4 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Cardiac disorders
Cardiomyopathy
|
0.00%
0/3126 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.03%
1/3127 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Musculoskeletal and connective tissue disorders
Mobility decreased
|
0.03%
1/3126 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.00%
0/3127 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/3126 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.06%
2/3127 • Number of events 2 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.06%
2/3126 • Number of events 2 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.10%
3/3127 • Number of events 3 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Musculoskeletal and connective tissue disorders
Myositis
|
0.03%
1/3126 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.00%
0/3127 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Musculoskeletal and connective tissue disorders
Oligoarthritis
|
0.00%
0/3126 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.03%
1/3127 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.29%
9/3126 • Number of events 9 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.26%
8/3127 • Number of events 9 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Musculoskeletal and connective tissue disorders
Osteochondrosis
|
0.00%
0/3126 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.03%
1/3127 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Musculoskeletal and connective tissue disorders
Osteonecrosis
|
0.03%
1/3126 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.03%
1/3127 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Musculoskeletal and connective tissue disorders
Osteonecrosis of jaw
|
0.00%
0/3126 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.03%
1/3127 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/3126 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.10%
3/3127 • Number of events 3 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Cardiac disorders
Cardiomyopathy alcoholic
|
0.03%
1/3126 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.00%
0/3127 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Musculoskeletal and connective tissue disorders
Pathological fracture
|
0.03%
1/3126 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.00%
0/3127 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Musculoskeletal and connective tissue disorders
Polyarthritis
|
0.00%
0/3126 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.03%
1/3127 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Musculoskeletal and connective tissue disorders
Polymyalgia rheumatica
|
0.03%
1/3126 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.03%
1/3127 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Musculoskeletal and connective tissue disorders
Rhabdomyolysis
|
0.00%
0/3126 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.06%
2/3127 • Number of events 2 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Musculoskeletal and connective tissue disorders
Rheumatoid arthritis
|
0.03%
1/3126 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.00%
0/3127 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Musculoskeletal and connective tissue disorders
Rotator cuff syndrome
|
0.00%
0/3126 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.06%
2/3127 • Number of events 2 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Musculoskeletal and connective tissue disorders
Spinal osteoarthritis
|
0.00%
0/3126 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.06%
2/3127 • Number of events 3 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Musculoskeletal and connective tissue disorders
Spinal pain
|
0.06%
2/3126 • Number of events 2 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.00%
0/3127 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Musculoskeletal and connective tissue disorders
Spinal stenosis
|
0.06%
2/3126 • Number of events 2 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.06%
2/3127 • Number of events 2 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Musculoskeletal and connective tissue disorders
Spinal synovial cyst
|
0.03%
1/3126 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.00%
0/3127 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Cardiac disorders
Cardiopulmonary failure
|
0.10%
3/3126 • Number of events 3 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.10%
3/3127 • Number of events 3 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Musculoskeletal and connective tissue disorders
Systemic lupus erythematosus
|
0.03%
1/3126 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.00%
0/3127 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Musculoskeletal and connective tissue disorders
Tenosynovitis stenosans
|
0.03%
1/3126 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.00%
0/3127 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acute leukaemia
|
0.03%
1/3126 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.00%
0/3127 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acute myeloid leukaemia
|
0.00%
0/3126 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.06%
2/3127 • Number of events 2 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma
|
0.03%
1/3126 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.00%
0/3127 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma gastric
|
0.03%
1/3126 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.03%
1/3127 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma metastatic
|
0.00%
0/3126 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.03%
1/3127 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma of colon
|
0.19%
6/3126 • Number of events 6 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.13%
4/3127 • Number of events 4 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma pancreas
|
0.03%
1/3126 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.06%
2/3127 • Number of events 2 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adrenal gland cancer metastatic
|
0.00%
0/3126 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.03%
1/3127 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Cardiac disorders
Cardiorenal syndrome
|
0.03%
1/3126 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.03%
1/3127 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adrenal neoplasm
|
0.03%
1/3126 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.00%
0/3127 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adult t-cell lymphoma/leukaemia
|
0.00%
0/3126 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.03%
1/3127 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
B-cell lymphoma
|
0.03%
1/3126 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.00%
0/3127 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
0.13%
4/3126 • Number of events 4 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.06%
2/3127 • Number of events 2 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign neoplasm
|
0.00%
0/3126 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.03%
1/3127 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bile duct cancer
|
0.03%
1/3126 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.00%
0/3127 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder cancer
|
0.03%
1/3126 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.13%
4/3127 • Number of events 4 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder cancer recurrent
|
0.00%
0/3126 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.03%
1/3127 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder neoplasm
|
0.03%
1/3126 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.03%
1/3127 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder transitional cell carcinoma
|
0.06%
2/3126 • Number of events 2 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.00%
0/3127 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Cardiac disorders
Cardiovascular insufficiency
|
0.03%
1/3126 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.00%
0/3127 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder transitional cell carcinoma recurrent
|
0.03%
1/3126 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.00%
0/3127 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Brain neoplasm
|
0.06%
2/3126 • Number of events 2 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.00%
0/3127 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.06%
2/3126 • Number of events 2 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.13%
4/3127 • Number of events 5 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer metastatic
|
0.03%
1/3126 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.06%
2/3127 • Number of events 3 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer recurrent
|
0.00%
0/3126 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.03%
1/3127 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast neoplasm
|
0.00%
0/3126 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.03%
1/3127 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bronchial carcinoma
|
0.00%
0/3126 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.03%
1/3127 • Number of events 2 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cervix carcinoma
|
0.00%
0/3126 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.03%
1/3127 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Chronic lymphocytic leukaemia
|
0.03%
1/3126 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.06%
2/3127 • Number of events 2 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Chronic myelomonocytic leukaemia
|
0.03%
1/3126 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.03%
1/3127 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Cardiac disorders
Chronic coronary syndrome
|
0.10%
3/3126 • Number of events 3 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.00%
0/3127 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon adenoma
|
0.13%
4/3126 • Number of events 4 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.06%
2/3127 • Number of events 2 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer
|
0.19%
6/3126 • Number of events 6 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.29%
9/3127 • Number of events 9 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer metastatic
|
0.03%
1/3126 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.00%
0/3127 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer recurrent
|
0.00%
0/3126 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.03%
1/3127 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon neoplasm
|
0.03%
1/3126 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.03%
1/3127 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colorectal adenocarcinoma
|
0.03%
1/3126 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.00%
0/3127 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colorectal cancer
|
0.00%
0/3126 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.06%
2/3127 • Number of events 2 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colorectal cancer metastatic
|
0.03%
1/3126 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.03%
1/3127 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Diffuse large b-cell lymphoma
|
0.03%
1/3126 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.03%
1/3127 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ductal adenocarcinoma of pancreas
|
0.03%
1/3126 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.00%
0/3127 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Blood and lymphatic system disorders
Deficiency anaemia
|
0.00%
0/3126 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.03%
1/3127 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Cardiac disorders
Chronic left ventricular failure
|
0.00%
0/3126 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.03%
1/3127 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Endometrial cancer
|
0.03%
1/3126 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.00%
0/3127 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Endometrial cancer metastatic
|
0.03%
1/3126 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.00%
0/3127 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Essential thrombocythaemia
|
0.00%
0/3126 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.03%
1/3127 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Fallopian tube cancer
|
0.03%
1/3126 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.00%
0/3127 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Follicular lymphoma
|
0.03%
1/3126 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.00%
0/3127 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastric cancer
|
0.10%
3/3126 • Number of events 3 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.06%
2/3127 • Number of events 2 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastric neoplasm
|
0.03%
1/3126 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.00%
0/3127 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastrointestinal lymphoma
|
0.03%
1/3126 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.00%
0/3127 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastrointestinal tract adenoma
|
0.00%
0/3126 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.03%
1/3127 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Glioblastoma
|
0.03%
1/3126 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.00%
0/3127 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Cardiac disorders
Congestive cardiomyopathy
|
0.03%
1/3126 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.03%
1/3127 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hepatic cancer
|
0.03%
1/3126 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.03%
1/3127 • Number of events 2 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hepatocellular carcinoma
|
0.06%
2/3126 • Number of events 2 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.03%
1/3127 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Intracranial meningioma malignant
|
0.03%
1/3126 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.00%
0/3127 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Invasive breast carcinoma
|
0.03%
1/3126 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.00%
0/3127 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Invasive ductal breast carcinoma
|
0.03%
1/3126 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.06%
2/3127 • Number of events 2 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Joint neoplasm
|
0.00%
0/3126 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.03%
1/3127 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Laryngeal squamous cell carcinoma
|
0.03%
1/3126 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.00%
0/3127 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Leukaemia
|
0.00%
0/3126 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.03%
1/3127 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung adenocarcinoma
|
0.10%
3/3126 • Number of events 3 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.10%
3/3127 • Number of events 3 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung adenocarcinoma stage i
|
0.03%
1/3126 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.00%
0/3127 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Cardiac disorders
Coronary artery disease
|
0.29%
9/3126 • Number of events 9 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.45%
14/3127 • Number of events 16 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung cancer metastatic
|
0.06%
2/3126 • Number of events 2 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.10%
3/3127 • Number of events 3 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm
|
0.03%
1/3126 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.06%
2/3127 • Number of events 2 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm malignant
|
0.13%
4/3126 • Number of events 4 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.22%
7/3127 • Number of events 7 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung squamous cell carcinoma stage iv
|
0.00%
0/3126 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.03%
1/3127 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lymphoma
|
0.03%
1/3126 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.03%
1/3127 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lymphoplasmacytoid lymphoma/immunocytoma
|
0.00%
0/3126 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.03%
1/3127 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lymphoproliferative disorder
|
0.00%
0/3126 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.03%
1/3127 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant melanoma
|
0.13%
4/3126 • Number of events 4 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.00%
0/3127 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant neoplasm of unknown primary site
|
0.00%
0/3126 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.03%
1/3127 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Mediastinum neoplasm
|
0.00%
0/3126 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.03%
1/3127 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Cardiac disorders
Coronary artery occlusion
|
0.03%
1/3126 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.00%
0/3127 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Meningioma
|
0.03%
1/3126 • Number of events 2 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.00%
0/3127 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to bone
|
0.00%
0/3126 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.06%
2/3127 • Number of events 2 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to liver
|
0.06%
2/3126 • Number of events 2 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.00%
0/3127 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastatic carcinoma of the bladder
|
0.00%
0/3126 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.03%
1/3127 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastatic gastric cancer
|
0.03%
1/3126 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.00%
0/3127 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Myelodysplastic syndrome
|
0.03%
1/3126 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.03%
1/3127 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Myeloproliferative neoplasm
|
0.00%
0/3126 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.03%
1/3127 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasm prostate
|
0.03%
1/3126 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.03%
1/3127 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Non-small cell lung cancer
|
0.03%
1/3126 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.06%
2/3127 • Number of events 2 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Non-small cell lung cancer stage iv
|
0.00%
0/3126 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.03%
1/3127 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Cardiac disorders
Coronary artery stenosis
|
0.10%
3/3126 • Number of events 3 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.06%
2/3127 • Number of events 2 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Oesophageal carcinoma
|
0.06%
2/3126 • Number of events 2 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.03%
1/3127 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Oesophageal neoplasm
|
0.00%
0/3126 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.06%
2/3127 • Number of events 2 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Oropharyngeal squamous cell carcinoma
|
0.00%
0/3126 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.03%
1/3127 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ovarian cancer metastatic
|
0.03%
1/3126 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.00%
0/3127 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ovarian neoplasm
|
0.00%
0/3126 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.03%
1/3127 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic carcinoma
|
0.10%
3/3126 • Number of events 3 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.13%
4/3127 • Number of events 4 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic neoplasm
|
0.03%
1/3126 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.03%
1/3127 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Parathyroid tumour benign
|
0.03%
1/3126 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.00%
0/3127 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Plasma cell myeloma
|
0.03%
1/3126 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.10%
3/3127 • Number of events 3 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Plasmacytoma
|
0.00%
0/3126 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.03%
1/3127 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Cardiac disorders
Frederick's syndrome
|
0.00%
0/3126 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.03%
1/3127 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pleural mesothelioma
|
0.03%
1/3126 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.00%
0/3127 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.16%
5/3126 • Number of events 5 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.22%
7/3127 • Number of events 7 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer metastatic
|
0.03%
1/3126 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.10%
3/3127 • Number of events 3 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer recurrent
|
0.03%
1/3126 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.00%
0/3127 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Rectal adenocarcinoma
|
0.10%
3/3126 • Number of events 3 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.06%
2/3127 • Number of events 2 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Rectal cancer
|
0.03%
1/3126 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.03%
1/3127 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Rectal neoplasm
|
0.00%
0/3126 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.03%
1/3127 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Refractory cytopenia with unilineage dysplasia
|
0.00%
0/3126 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.03%
1/3127 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal cancer
|
0.10%
3/3126 • Number of events 3 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.06%
2/3127 • Number of events 2 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal cancer metastatic
|
0.03%
1/3126 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.00%
0/3127 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Cardiac disorders
Heart valve incompetence
|
0.03%
1/3126 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.00%
0/3127 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal neoplasm
|
0.10%
3/3126 • Number of events 3 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.03%
1/3127 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Sarcoma
|
0.00%
0/3126 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.03%
1/3127 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Seborrhoeic keratosis
|
0.00%
0/3126 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.03%
1/3127 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Small cell lung cancer
|
0.03%
1/3126 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.00%
0/3127 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Small cell lung cancer extensive stage
|
0.00%
0/3126 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.03%
1/3127 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Small intestine carcinoma
|
0.03%
1/3126 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.00%
0/3127 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Soft tissue neoplasm
|
0.03%
1/3126 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.00%
0/3127 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma
|
0.03%
1/3126 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.03%
1/3127 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of lung
|
0.03%
1/3126 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.03%
1/3127 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of skin
|
0.06%
2/3126 • Number of events 2 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.03%
1/3127 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Cardiac disorders
Hypertensive cardiomyopathy
|
0.03%
1/3126 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.00%
0/3127 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of the vulva
|
0.03%
1/3126 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.00%
0/3127 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Thyroid cancer
|
0.06%
2/3126 • Number of events 2 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.00%
0/3127 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Transitional cell carcinoma
|
0.03%
1/3126 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.06%
2/3127 • Number of events 2 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Triple negative breast cancer
|
0.00%
0/3126 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.03%
1/3127 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour associated fever
|
0.03%
1/3126 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.00%
0/3127 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour embolism
|
0.03%
1/3126 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.00%
0/3127 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour perforation
|
0.03%
1/3126 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.00%
0/3127 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine cancer
|
0.06%
2/3126 • Number of events 2 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.00%
0/3127 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine neoplasm
|
0.03%
1/3126 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.00%
0/3127 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Waldenstrom's macroglobulinaemia
|
0.03%
1/3126 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.03%
1/3127 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Cardiac disorders
Ischaemic cardiomyopathy
|
0.03%
1/3126 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.10%
3/3127 • Number of events 4 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Nervous system disorders
Altered state of consciousness
|
0.03%
1/3126 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.03%
1/3127 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Nervous system disorders
Ataxia
|
0.03%
1/3126 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.00%
0/3127 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Nervous system disorders
Bell's palsy
|
0.00%
0/3126 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.03%
1/3127 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Nervous system disorders
Brain oedema
|
0.03%
1/3126 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.06%
2/3127 • Number of events 2 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Nervous system disorders
Brain stem infarction
|
0.16%
5/3126 • Number of events 5 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.03%
1/3127 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Nervous system disorders
Carotid artery occlusion
|
0.00%
0/3126 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.03%
1/3127 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Nervous system disorders
Carotid artery stenosis
|
0.10%
3/3126 • Number of events 3 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.03%
1/3127 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Nervous system disorders
Carotid artery thrombosis
|
0.00%
0/3126 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.03%
1/3127 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Nervous system disorders
Carpal tunnel syndrome
|
0.00%
0/3126 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.03%
1/3127 • Number of events 2 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Nervous system disorders
Cerebellar infarction
|
0.00%
0/3126 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.06%
2/3127 • Number of events 2 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Cardiac disorders
Left ventricular failure
|
0.16%
5/3126 • Number of events 5 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.26%
8/3127 • Number of events 8 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Nervous system disorders
Cerebral arteriosclerosis
|
0.03%
1/3126 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.00%
0/3127 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Nervous system disorders
Cerebral haematoma
|
0.00%
0/3126 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.06%
2/3127 • Number of events 2 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Nervous system disorders
Cerebral haemorrhage
|
0.06%
2/3126 • Number of events 2 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.13%
4/3127 • Number of events 4 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Nervous system disorders
Cerebral infarction
|
0.35%
11/3126 • Number of events 11 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.35%
11/3127 • Number of events 11 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.16%
5/3126 • Number of events 5 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.10%
3/3127 • Number of events 3 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Nervous system disorders
Cerebrovascular disorder
|
0.06%
2/3126 • Number of events 2 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.00%
0/3127 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Nervous system disorders
Cervical cord compression
|
0.03%
1/3126 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.00%
0/3127 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Nervous system disorders
Cognitive disorder
|
0.06%
2/3126 • Number of events 2 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.03%
1/3127 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Nervous system disorders
Cubital tunnel syndrome
|
0.03%
1/3126 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.00%
0/3127 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Nervous system disorders
Dementia alzheimer's type
|
0.03%
1/3126 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.00%
0/3127 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Blood and lymphatic system disorders
Disseminated intravascular coagulation
|
0.03%
1/3126 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.03%
1/3127 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Cardiac disorders
Microvascular coronary artery disease
|
0.00%
0/3126 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.03%
1/3127 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Nervous system disorders
Depressed level of consciousness
|
0.03%
1/3126 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.00%
0/3127 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Nervous system disorders
Dizziness
|
0.16%
5/3126 • Number of events 5 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.10%
3/3127 • Number of events 3 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Nervous system disorders
Drop attacks
|
0.03%
1/3126 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.00%
0/3127 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Nervous system disorders
Embolic cerebral infarction
|
0.03%
1/3126 • Number of events 2 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.00%
0/3127 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Nervous system disorders
Embolic stroke
|
0.22%
7/3126 • Number of events 7 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.16%
5/3127 • Number of events 5 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Nervous system disorders
Encephalopathy
|
0.00%
0/3126 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.06%
2/3127 • Number of events 2 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Nervous system disorders
Epilepsy
|
0.06%
2/3126 • Number of events 2 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.10%
3/3127 • Number of events 3 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Nervous system disorders
Focal dyscognitive seizures
|
0.03%
1/3126 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.00%
0/3127 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Nervous system disorders
Generalised tonic-clonic seizure
|
0.03%
1/3126 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.00%
0/3127 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Nervous system disorders
Haemorrhagic stroke
|
0.32%
10/3126 • Number of events 10 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.29%
9/3127 • Number of events 10 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Cardiac disorders
Mitral valve calcification
|
0.03%
1/3126 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.00%
0/3127 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Nervous system disorders
Hemiparesis
|
0.03%
1/3126 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.03%
1/3127 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Nervous system disorders
Hepatic encephalopathy
|
0.10%
3/3126 • Number of events 3 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.00%
0/3127 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Nervous system disorders
Hypoaesthesia
|
0.06%
2/3126 • Number of events 2 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.00%
0/3127 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Nervous system disorders
Hypoxic-ischaemic encephalopathy
|
0.00%
0/3126 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.03%
1/3127 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Nervous system disorders
Intracranial haematoma
|
0.03%
1/3126 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.00%
0/3127 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Nervous system disorders
Ischaemic cerebral infarction
|
0.03%
1/3126 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.03%
1/3127 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Nervous system disorders
Ischaemic stroke
|
2.2%
70/3126 • Number of events 76 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
2.1%
65/3127 • Number of events 70 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Nervous system disorders
Lacunar infarction
|
0.03%
1/3126 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.10%
3/3127 • Number of events 3 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Nervous system disorders
Lacunar stroke
|
0.00%
0/3126 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.03%
1/3127 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Nervous system disorders
Loss of consciousness
|
0.03%
1/3126 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.06%
2/3127 • Number of events 2 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Cardiac disorders
Mitral valve disease
|
0.06%
2/3126 • Number of events 2 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.00%
0/3127 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Nervous system disorders
Metabolic encephalopathy
|
0.03%
1/3126 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.03%
1/3127 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Nervous system disorders
Myelopathy
|
0.00%
0/3126 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.03%
1/3127 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Nervous system disorders
Myoclonic epilepsy
|
0.00%
0/3126 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.03%
1/3127 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Nervous system disorders
Myoclonus
|
0.03%
1/3126 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.03%
1/3127 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Nervous system disorders
Myxoedema coma
|
0.03%
1/3126 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.00%
0/3127 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Nervous system disorders
Parkinson's disease
|
0.00%
0/3126 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.13%
4/3127 • Number of events 4 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Nervous system disorders
Parkinsonism
|
0.03%
1/3126 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.00%
0/3127 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Nervous system disorders
Partial seizures
|
0.03%
1/3126 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.00%
0/3127 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Nervous system disorders
Peripheral sensorimotor neuropathy
|
0.00%
0/3126 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.03%
1/3127 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Nervous system disorders
Polyneuropathy alcoholic
|
0.00%
0/3126 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.03%
1/3127 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Cardiac disorders
Mitral valve incompetence
|
0.26%
8/3126 • Number of events 9 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.19%
6/3127 • Number of events 7 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Nervous system disorders
Post stroke epilepsy
|
0.00%
0/3126 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.03%
1/3127 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Nervous system disorders
Presyncope
|
0.13%
4/3126 • Number of events 4 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.03%
1/3127 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Nervous system disorders
Quadriparesis
|
0.03%
1/3126 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.00%
0/3127 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Nervous system disorders
Radiculopathy
|
0.03%
1/3126 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.00%
0/3127 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Nervous system disorders
Sciatica
|
0.03%
1/3126 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.00%
0/3127 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Nervous system disorders
Seizure
|
0.16%
5/3126 • Number of events 5 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.06%
2/3127 • Number of events 2 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Nervous system disorders
Spinal stroke
|
0.03%
1/3126 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.00%
0/3127 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Nervous system disorders
Spondylitic myelopathy
|
0.00%
0/3126 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.06%
2/3127 • Number of events 2 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Nervous system disorders
Status epilepticus
|
0.06%
2/3126 • Number of events 2 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.06%
2/3127 • Number of events 2 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Nervous system disorders
Subarachnoid haemorrhage
|
0.00%
0/3126 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.03%
1/3127 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Cardiac disorders
Mitral valve stenosis
|
0.00%
0/3126 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.10%
3/3127 • Number of events 3 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Nervous system disorders
Syncope
|
0.58%
18/3126 • Number of events 18 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.67%
21/3127 • Number of events 21 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Nervous system disorders
Thalamic infarction
|
0.00%
0/3126 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.03%
1/3127 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Nervous system disorders
Thrombotic cerebral infarction
|
0.00%
0/3126 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.03%
1/3127 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Nervous system disorders
Thrombotic stroke
|
0.03%
1/3126 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.00%
0/3127 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Nervous system disorders
Toxic encephalopathy
|
0.03%
1/3126 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.00%
0/3127 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Nervous system disorders
Transient ischaemic attack
|
0.19%
6/3126 • Number of events 7 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.16%
5/3127 • Number of events 5 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Nervous system disorders
Tremor
|
0.03%
1/3126 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.00%
0/3127 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Nervous system disorders
Trigeminal neuralgia
|
0.00%
0/3126 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.03%
1/3127 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Nervous system disorders
Uraemic encephalopathy
|
0.00%
0/3126 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.03%
1/3127 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Nervous system disorders
Vascular encephalopathy
|
0.00%
0/3126 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.03%
1/3127 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Cardiac disorders
Myocardial fibrosis
|
0.03%
1/3126 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.00%
0/3127 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Nervous system disorders
Vertebrobasilar stroke
|
0.00%
0/3126 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.03%
1/3127 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Product Issues
Device dislocation
|
0.00%
0/3126 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.03%
1/3127 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Product Issues
Device failure
|
0.06%
2/3126 • Number of events 2 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.00%
0/3127 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Product Issues
Device fastener issue
|
0.00%
0/3126 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.03%
1/3127 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Product Issues
Device malfunction
|
0.03%
1/3126 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.03%
1/3127 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Product Issues
Device occlusion
|
0.03%
1/3126 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.00%
0/3127 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Product Issues
Device power source issue
|
0.03%
1/3126 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.00%
0/3127 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Psychiatric disorders
Anxiety
|
0.03%
1/3126 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.00%
0/3127 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Psychiatric disorders
Bipolar disorder
|
0.00%
0/3126 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.06%
2/3127 • Number of events 2 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Psychiatric disorders
Completed suicide
|
0.03%
1/3126 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.03%
1/3127 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Cardiac disorders
Myocardial infarction
|
0.48%
15/3126 • Number of events 16 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.58%
18/3127 • Number of events 19 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Psychiatric disorders
Confusional state
|
0.06%
2/3126 • Number of events 4 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.03%
1/3127 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Psychiatric disorders
Delirium
|
0.00%
0/3126 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.06%
2/3127 • Number of events 2 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Psychiatric disorders
Delirium tremens
|
0.03%
1/3126 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.00%
0/3127 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Psychiatric disorders
Delusion
|
0.03%
1/3126 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.00%
0/3127 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Psychiatric disorders
Depression
|
0.00%
0/3126 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.03%
1/3127 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Psychiatric disorders
Major depression
|
0.03%
1/3126 • Number of events 2 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.00%
0/3127 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Psychiatric disorders
Mental status changes
|
0.06%
2/3126 • Number of events 2 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.22%
7/3127 • Number of events 9 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Psychiatric disorders
Organic brain syndrome
|
0.06%
2/3126 • Number of events 2 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.03%
1/3127 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Psychiatric disorders
Psychogenic respiratory distress
|
0.00%
0/3126 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.03%
1/3127 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Psychiatric disorders
Psychomotor retardation
|
0.00%
0/3126 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.03%
1/3127 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Cardiac disorders
Myocardial ischaemia
|
0.06%
2/3126 • Number of events 2 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.13%
4/3127 • Number of events 4 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Psychiatric disorders
Substance abuse
|
0.00%
0/3126 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.03%
1/3127 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Psychiatric disorders
Suicidal ideation
|
0.03%
1/3126 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.00%
0/3127 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Psychiatric disorders
Suicide attempt
|
0.00%
0/3126 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.03%
1/3127 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Renal and urinary disorders
Acute kidney injury
|
1.7%
54/3126 • Number of events 64 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
2.0%
63/3127 • Number of events 78 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Renal and urinary disorders
Calculus urinary
|
0.03%
1/3126 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.03%
1/3127 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Renal and urinary disorders
Chronic kidney disease
|
0.38%
12/3126 • Number of events 12 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.32%
10/3127 • Number of events 12 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Renal and urinary disorders
Cystitis glandularis
|
0.03%
1/3126 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.00%
0/3127 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Renal and urinary disorders
Cystitis haemorrhagic
|
0.00%
0/3126 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.03%
1/3127 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Renal and urinary disorders
Dysuria
|
0.03%
1/3126 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.00%
0/3127 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Renal and urinary disorders
End stage renal disease
|
0.13%
4/3126 • Number of events 5 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.13%
4/3127 • Number of events 7 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Cardiac disorders
Myxomatous mitral valve degeneration
|
0.00%
0/3126 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.03%
1/3127 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Renal and urinary disorders
Glomerulonephritis
|
0.00%
0/3126 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.03%
1/3127 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Renal and urinary disorders
Haematuria
|
0.16%
5/3126 • Number of events 6 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.22%
7/3127 • Number of events 7 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Renal and urinary disorders
Hydronephrosis
|
0.00%
0/3126 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.03%
1/3127 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.06%
2/3126 • Number of events 2 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.10%
3/3127 • Number of events 3 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Renal and urinary disorders
Nephropathy toxic
|
0.06%
2/3126 • Number of events 2 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.06%
2/3127 • Number of events 2 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Renal and urinary disorders
Nephrotic syndrome
|
0.03%
1/3126 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.03%
1/3127 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Renal and urinary disorders
Obstructive nephropathy
|
0.03%
1/3126 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.00%
0/3127 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Renal and urinary disorders
Polyuria
|
0.03%
1/3126 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.00%
0/3127 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Renal and urinary disorders
Prerenal failure
|
0.03%
1/3126 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.03%
1/3127 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Renal and urinary disorders
Renal amyloidosis
|
0.03%
1/3126 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.00%
0/3127 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Cardiac disorders
Nodal rhythm
|
0.00%
0/3126 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.03%
1/3127 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Renal and urinary disorders
Renal colic
|
0.00%
0/3126 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.03%
1/3127 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Renal and urinary disorders
Renal cyst
|
0.03%
1/3126 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.00%
0/3127 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Renal and urinary disorders
Renal cyst ruptured
|
0.00%
0/3126 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.03%
1/3127 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Renal and urinary disorders
Renal failure
|
0.29%
9/3126 • Number of events 9 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.35%
11/3127 • Number of events 11 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Renal and urinary disorders
Renal haemorrhage
|
0.03%
1/3126 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.00%
0/3127 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Renal and urinary disorders
Renal impairment
|
0.22%
7/3126 • Number of events 7 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.22%
7/3127 • Number of events 7 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Renal and urinary disorders
Renal injury
|
0.00%
0/3126 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.03%
1/3127 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Renal and urinary disorders
Tubulointerstitial nephritis
|
0.06%
2/3126 • Number of events 2 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.00%
0/3127 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Renal and urinary disorders
Urinary fistula
|
0.03%
1/3126 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.00%
0/3127 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Renal and urinary disorders
Urinary retention
|
0.06%
2/3126 • Number of events 2 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.00%
0/3127 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Blood and lymphatic system disorders
Evans syndrome
|
0.03%
1/3126 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.00%
0/3127 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Cardiac disorders
Palpitations
|
0.03%
1/3126 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.00%
0/3127 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Renal and urinary disorders
Urinary tract inflammation
|
0.03%
1/3126 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.00%
0/3127 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Renal and urinary disorders
Urinary tract obstruction
|
0.00%
0/3126 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.06%
2/3127 • Number of events 2 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Reproductive system and breast disorders
Abnormal uterine bleeding
|
0.03%
1/3126 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.00%
0/3127 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Reproductive system and breast disorders
Acquired phimosis
|
0.03%
1/3126 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.03%
1/3127 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Reproductive system and breast disorders
Benign prostatic hyperplasia
|
0.13%
4/3126 • Number of events 4 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.10%
3/3127 • Number of events 3 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Reproductive system and breast disorders
Breast mass
|
0.00%
0/3126 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.03%
1/3127 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Reproductive system and breast disorders
Endometrial atrophy
|
0.00%
0/3126 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.03%
1/3127 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Reproductive system and breast disorders
Heavy menstrual bleeding
|
0.03%
1/3126 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.00%
0/3127 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Reproductive system and breast disorders
Intermenstrual bleeding
|
0.00%
0/3126 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.03%
1/3127 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Reproductive system and breast disorders
Prostatomegaly
|
0.03%
1/3126 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.00%
0/3127 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Cardiac disorders
Pericardial effusion
|
0.00%
0/3126 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.06%
2/3127 • Number of events 2 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Reproductive system and breast disorders
Scrotal ulcer
|
0.00%
0/3126 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.03%
1/3127 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Reproductive system and breast disorders
Uterine prolapse
|
0.03%
1/3126 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.00%
0/3127 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Reproductive system and breast disorders
Vulvovaginal inflammation
|
0.03%
1/3126 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.00%
0/3127 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Respiratory, thoracic and mediastinal disorders
Acute pulmonary oedema
|
0.26%
8/3126 • Number of events 8 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.19%
6/3127 • Number of events 7 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory distress syndrome
|
0.03%
1/3126 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.03%
1/3127 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.51%
16/3126 • Number of events 19 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.54%
17/3127 • Number of events 20 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Respiratory, thoracic and mediastinal disorders
Allergic respiratory symptom
|
0.03%
1/3126 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.00%
0/3127 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Respiratory, thoracic and mediastinal disorders
Asphyxia
|
0.03%
1/3126 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.00%
0/3127 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
0.03%
1/3126 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.00%
0/3127 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.10%
3/3126 • Number of events 4 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.29%
9/3127 • Number of events 11 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Cardiac disorders
Pericarditis
|
0.03%
1/3126 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.00%
0/3127 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchiectasis
|
0.03%
1/3126 • Number of events 3 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.00%
0/3127 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Respiratory, thoracic and mediastinal disorders
Choking
|
0.03%
1/3126 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.00%
0/3127 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.67%
21/3126 • Number of events 30 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.58%
18/3127 • Number of events 26 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic respiratory disease
|
0.06%
2/3126 • Number of events 2 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.00%
0/3127 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic respiratory failure
|
0.03%
1/3126 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.00%
0/3127 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.03%
1/3126 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.00%
0/3127 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.10%
3/3126 • Number of events 3 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.16%
5/3127 • Number of events 5 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
0.06%
2/3126 • Number of events 2 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.06%
2/3127 • Number of events 2 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/3126 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.03%
1/3127 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.06%
2/3126 • Number of events 2 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.10%
3/3127 • Number of events 3 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Cardiac disorders
Right ventricular failure
|
0.00%
0/3126 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.06%
2/3127 • Number of events 4 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Respiratory, thoracic and mediastinal disorders
Haemothorax
|
0.00%
0/3126 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.03%
1/3127 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/3126 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.06%
2/3127 • Number of events 2 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Respiratory, thoracic and mediastinal disorders
Interstitial lung disease
|
0.10%
3/3126 • Number of events 3 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.13%
4/3127 • Number of events 5 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal stenosis
|
0.00%
0/3126 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.03%
1/3127 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Respiratory, thoracic and mediastinal disorders
Lung disorder
|
0.00%
0/3126 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.06%
2/3127 • Number of events 2 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Respiratory, thoracic and mediastinal disorders
Lung opacity
|
0.03%
1/3126 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.00%
0/3127 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Respiratory, thoracic and mediastinal disorders
Nocturnal dyspnoea
|
0.00%
0/3126 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.03%
1/3127 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Respiratory, thoracic and mediastinal disorders
Platypnoea
|
0.00%
0/3126 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.03%
1/3127 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.26%
8/3126 • Number of events 10 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.22%
7/3127 • Number of events 8 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Respiratory, thoracic and mediastinal disorders
Pleurisy
|
0.03%
1/3126 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.03%
1/3127 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Cardiac disorders
Sinoatrial block
|
0.03%
1/3126 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.00%
0/3127 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.06%
2/3126 • Number of events 2 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.03%
1/3127 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.35%
11/3126 • Number of events 11 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.29%
9/3127 • Number of events 9 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary fibrosis
|
0.03%
1/3126 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.03%
1/3127 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary hilum mass
|
0.03%
1/3126 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.00%
0/3127 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary hypertension
|
0.10%
3/3126 • Number of events 3 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.03%
1/3127 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary mass
|
0.06%
2/3126 • Number of events 2 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.06%
2/3127 • Number of events 2 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
0.16%
5/3126 • Number of events 6 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.16%
5/3127 • Number of events 5 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory arrest
|
0.00%
0/3126 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.03%
1/3127 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory distress
|
0.00%
0/3126 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.06%
2/3127 • Number of events 2 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.32%
10/3126 • Number of events 11 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.54%
17/3127 • Number of events 19 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Cardiac disorders
Sinus bradycardia
|
0.03%
1/3126 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.03%
1/3127 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Respiratory, thoracic and mediastinal disorders
Sleep apnoea syndrome
|
0.03%
1/3126 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.00%
0/3127 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Respiratory, thoracic and mediastinal disorders
Sputum retention
|
0.03%
1/3126 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.00%
0/3127 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Skin and subcutaneous tissue disorders
Angioedema
|
0.03%
1/3126 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.00%
0/3127 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Skin and subcutaneous tissue disorders
Cutaneous vasculitis
|
0.00%
0/3126 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.03%
1/3127 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Skin and subcutaneous tissue disorders
Decubitus ulcer
|
0.06%
2/3126 • Number of events 2 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.03%
1/3127 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Skin and subcutaneous tissue disorders
Dermatitis allergic
|
0.00%
0/3126 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.03%
1/3127 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Skin and subcutaneous tissue disorders
Dermatitis atopic
|
0.03%
1/3126 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.00%
0/3127 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Skin and subcutaneous tissue disorders
Diabetic foot
|
0.10%
3/3126 • Number of events 5 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.19%
6/3127 • Number of events 8 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Skin and subcutaneous tissue disorders
Drug eruption
|
0.03%
1/3126 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.00%
0/3127 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/3126 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.03%
1/3127 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Cardiac disorders
Sinus node dysfunction
|
0.29%
9/3126 • Number of events 9 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.35%
11/3127 • Number of events 11 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Skin and subcutaneous tissue disorders
Skin discolouration
|
0.00%
0/3126 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.03%
1/3127 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Skin and subcutaneous tissue disorders
Skin necrosis
|
0.00%
0/3126 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.03%
1/3127 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
0.13%
4/3126 • Number of events 4 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.13%
4/3127 • Number of events 5 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Skin and subcutaneous tissue disorders
Subcutaneous emphysema
|
0.00%
0/3126 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.03%
1/3127 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.03%
1/3126 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.00%
0/3127 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Social circumstances
Cardiac assistance device user
|
0.00%
0/3126 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.03%
1/3127 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Vascular disorders
Aortic aneurysm
|
0.10%
3/3126 • Number of events 3 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.03%
1/3127 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Vascular disorders
Aortic aneurysm rupture
|
0.00%
0/3126 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.03%
1/3127 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Vascular disorders
Aortic dissection
|
0.03%
1/3126 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.03%
1/3127 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Vascular disorders
Aortic stenosis
|
0.13%
4/3126 • Number of events 4 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.16%
5/3127 • Number of events 5 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Cardiac disorders
Stress cardiomyopathy
|
0.00%
0/3126 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.03%
1/3127 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Vascular disorders
Bleeding varicose vein
|
0.00%
0/3126 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.03%
1/3127 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Vascular disorders
Circulatory collapse
|
0.03%
1/3126 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.00%
0/3127 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Vascular disorders
Deep vein thrombosis
|
0.10%
3/3126 • Number of events 3 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.03%
1/3127 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Vascular disorders
Extremity necrosis
|
0.00%
0/3126 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.06%
2/3127 • Number of events 2 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Vascular disorders
Femoral artery aneurysm
|
0.00%
0/3126 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.03%
1/3127 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Vascular disorders
Femoral artery embolism
|
0.00%
0/3126 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.03%
1/3127 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Vascular disorders
Haematocoele
|
0.00%
0/3126 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.03%
1/3127 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Vascular disorders
Haematoma
|
0.06%
2/3126 • Number of events 2 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.10%
3/3127 • Number of events 3 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Vascular disorders
Haemorrhage
|
0.00%
0/3126 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.03%
1/3127 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Vascular disorders
Hypertension
|
0.45%
14/3126 • Number of events 16 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.29%
9/3127 • Number of events 10 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.06%
2/3126 • Number of events 2 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.06%
2/3127 • Number of events 3 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Vascular disorders
Hypertensive crisis
|
0.10%
3/3126 • Number of events 3 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.03%
1/3127 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Vascular disorders
Hypertensive emergency
|
0.03%
1/3126 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.03%
1/3127 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Vascular disorders
Hypertensive urgency
|
0.13%
4/3126 • Number of events 4 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.10%
3/3127 • Number of events 3 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Vascular disorders
Hypotension
|
0.32%
10/3126 • Number of events 10 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.19%
6/3127 • Number of events 6 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Vascular disorders
Hypovolaemic shock
|
0.00%
0/3126 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.03%
1/3127 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Vascular disorders
Iliac artery stenosis
|
0.00%
0/3126 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.03%
1/3127 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Vascular disorders
Lymphoedema
|
0.06%
2/3126 • Number of events 2 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.00%
0/3127 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Vascular disorders
Malignant hypertension
|
0.03%
1/3126 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.00%
0/3127 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Vascular disorders
Orthostatic hypotension
|
0.10%
3/3126 • Number of events 3 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.00%
0/3127 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Vascular disorders
Peripheral arterial occlusive disease
|
0.77%
24/3126 • Number of events 24 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.58%
18/3127 • Number of events 21 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Cardiac disorders
Tachyarrhythmia
|
0.03%
1/3126 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.00%
0/3127 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Vascular disorders
Peripheral artery aneurysm
|
0.00%
0/3126 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.03%
1/3127 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Vascular disorders
Peripheral artery occlusion
|
0.13%
4/3126 • Number of events 4 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.10%
3/3127 • Number of events 3 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Vascular disorders
Peripheral artery stenosis
|
0.06%
2/3126 • Number of events 2 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.06%
2/3127 • Number of events 2 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Vascular disorders
Peripheral artery thrombosis
|
0.06%
2/3126 • Number of events 2 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.03%
1/3127 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Vascular disorders
Peripheral embolism
|
0.06%
2/3126 • Number of events 2 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.06%
2/3127 • Number of events 2 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Vascular disorders
Peripheral ischaemia
|
0.16%
5/3126 • Number of events 7 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.29%
9/3127 • Number of events 12 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Vascular disorders
Peripheral vascular disorder
|
0.00%
0/3126 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.03%
1/3127 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Vascular disorders
Shock
|
0.03%
1/3126 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.00%
0/3127 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Vascular disorders
Shock haemorrhagic
|
0.06%
2/3126 • Number of events 2 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.00%
0/3127 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Vascular disorders
Thrombosis
|
0.03%
1/3126 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.06%
2/3127 • Number of events 2 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Blood and lymphatic system disorders
Haemolytic anaemia
|
0.00%
0/3126 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.03%
1/3127 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Cardiac disorders
Tachycardia
|
0.03%
1/3126 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.00%
0/3127 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Vascular disorders
Varicose ulceration
|
0.03%
1/3126 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.00%
0/3127 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Vascular disorders
Varicose vein
|
0.03%
1/3126 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.00%
0/3127 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Vascular disorders
Vascular insufficiency
|
0.03%
1/3126 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.00%
0/3127 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Vascular disorders
Venous thrombosis limb
|
0.00%
0/3126 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.03%
1/3127 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Vascular disorders
Vessel perforation
|
0.03%
1/3126 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.00%
0/3127 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Cardiac disorders
Tachycardia induced cardiomyopathy
|
0.00%
0/3126 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.03%
1/3127 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Cardiac disorders
Torsade de pointes
|
0.06%
2/3126 • Number of events 2 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.00%
0/3127 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Cardiac disorders
Trifascicular block
|
0.00%
0/3126 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.03%
1/3127 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Cardiac disorders
Ventricular arrhythmia
|
0.00%
0/3126 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.03%
1/3127 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Cardiac disorders
Ventricular fibrillation
|
0.19%
6/3126 • Number of events 6 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.19%
6/3127 • Number of events 6 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Cardiac disorders
Ventricular tachycardia
|
0.42%
13/3126 • Number of events 15 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.42%
13/3127 • Number of events 16 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Congenital, familial and genetic disorders
Congenital hypercoagulation
|
0.00%
0/3126 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.03%
1/3127 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Congenital, familial and genetic disorders
Patent ductus arteriosus
|
0.00%
0/3126 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.03%
1/3127 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Congenital, familial and genetic disorders
Retinal arteriovenous malformation
|
0.00%
0/3126 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
0.03%
1/3127 • Number of events 1 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
Other adverse events
| Measure |
Dapa 10 mg
n=3126 participants at risk
Dapagliflozin 10 mg tablets administered once daily per oral use
|
Placebo
n=3127 participants at risk
Placebo tablet to match dapagliflozin 10 mg, given once daily per oral use
|
|---|---|---|
|
Cardiac disorders
Atrial fibrillation
|
2.8%
86/3126 • Number of events 103 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
2.0%
61/3127 • Number of events 70 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Infections and infestations
Urinary tract infection
|
3.6%
113/3126 • Number of events 142 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
3.6%
112/3127 • Number of events 128 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Cardiac disorders
Cardiac failure
|
5.7%
179/3126 • Number of events 240 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
6.8%
214/3127 • Number of events 255 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Vascular disorders
Hypertension
|
2.7%
84/3126 • Number of events 104 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
3.3%
102/3127 • Number of events 136 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
|
Vascular disorders
Hypotension
|
2.2%
69/3126 • Number of events 80 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
2.0%
61/3127 • Number of events 68 • [All-cause mortality]: From randomization until end of study, up to 42.2 months. [Serious AE and other AE] From first dose until end of study, up to 42.2 months.
\[All-cause mortality\]: Full analysis set (all randomized patients). \[Serious AE and other AE\] Safety analysis set (patients who received at least 1 dose of study drug). Serious AEs, AEs leading to discontinuation/ amputation/ preceding events/ potential endpoint/ interruption of study drug, non-serious AEs including myocardial infarction, unstable angina, stroke, major hypoglycaemic events, potential DKA and amputation were collected systematically. Other AEs were non-systematically collected.
|
Additional Information
AstraZeneca Clinical Study Information Center
AstraZeneca AB
Phone: 877-240-9479
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place