Trial Outcomes & Findings for BI 10773 (Empagliflozin) Cardiovascular Outcome Event Trial in Type 2 Diabetes Mellitus Patients (EMPA-REG OUTCOME). (NCT NCT01131676)
NCT ID: NCT01131676
Last Updated: 2016-05-16
Results Overview
Time to the first occurrence of any of the following adjudicated components of the primary composite endpoint (3-point major adverse cardiovascular events (MACE)): cardiovascular (CV) death (including fatal stroke and fatal myocardial infarction (MI)), non-fatal MI (excluding silent MI), and non-fatal stroke. Percentage of patients with the event are presented.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
7064 participants
Primary outcome timeframe
From randomisation to individual end of observation, up to 4.6 years
Results posted on
2016-05-16
Participant Flow
Patients randomised to treatments in 1:1:1 ratio.
Randomisation stratified by:BMI at randomisation(\<30/≥30 kg/m2),HbA1c at screening (\<8.5%/ ≥8.5%);geographical region(North America including Australia and New Zealand,Latin America,Europe,Africa,Asia);renal function at screening (normal:eGFR ≥90 mL/min, mild impairment:60 mL/min ≤ eGFR ≤89 mL/min, moderate impairment:30 mL/min ≤ eGFR≤59 mL/min).
Participant milestones
| Measure |
Placebo
Oral administration of Placebo matching empagliflozin 10 mg or 25 mg (1 tablet once daily)
|
Empagliflozin 10 mg
Oral administration of Empagliflozin 10 mg (BI 10773) film coated tablets (1 tablet once daily)
|
Empagliflozin 25 mg
Oral administration of Empagliflozin 25 mg (BI 10773) film coated tablets (1 tablet once daily)
|
|---|---|---|---|
|
Discontinuation From Treatment
STARTED
|
2337
|
2347
|
2344
|
|
Discontinuation From Treatment
COMPLETED
|
1650
|
1790
|
1800
|
|
Discontinuation From Treatment
NOT COMPLETED
|
687
|
557
|
544
|
|
Discontinuation From Study (Treated Set)
STARTED
|
2333
|
2345
|
2342
|
|
Discontinuation From Study (Treated Set)
Final Vital Status (VS) Available
|
2316
|
2324
|
2327
|
|
Discontinuation From Study (Treated Set)
COMPLETED
|
2266
|
2264
|
2279
|
|
Discontinuation From Study (Treated Set)
NOT COMPLETED
|
67
|
81
|
63
|
Reasons for withdrawal
| Measure |
Placebo
Oral administration of Placebo matching empagliflozin 10 mg or 25 mg (1 tablet once daily)
|
Empagliflozin 10 mg
Oral administration of Empagliflozin 10 mg (BI 10773) film coated tablets (1 tablet once daily)
|
Empagliflozin 25 mg
Oral administration of Empagliflozin 25 mg (BI 10773) film coated tablets (1 tablet once daily)
|
|---|---|---|---|
|
Discontinuation From Treatment
Study drug stopped, reason missing
|
5
|
3
|
4
|
|
Discontinuation From Treatment
Not treated
|
4
|
2
|
2
|
|
Discontinuation From Treatment
Lack of Efficacy
|
11
|
1
|
0
|
|
Discontinuation From Treatment
Non compliant with protocol
|
15
|
15
|
12
|
|
Discontinuation From Treatment
Lost to Follow-up
|
15
|
9
|
6
|
|
Discontinuation From Treatment
Refusal to continue, not due to AE
|
172
|
118
|
122
|
|
Discontinuation From Treatment
Other than those specified
|
162
|
142
|
125
|
|
Discontinuation From Treatment
Adverse Event
|
303
|
267
|
273
|
|
Discontinuation From Study (Treated Set)
Consent withdrawn: Final VS available
|
23
|
35
|
25
|
|
Discontinuation From Study (Treated Set)
Consent withdrawn:Final VS not available
|
8
|
6
|
5
|
|
Discontinuation From Study (Treated Set)
Site closure: Final VS available
|
20
|
21
|
19
|
|
Discontinuation From Study (Treated Set)
Site closure:Final VS not available (NA)
|
5
|
9
|
7
|
|
Discontinuation From Study (Treated Set)
Lost to FU for 3PMACE:Final VS available
|
7
|
6
|
5
|
|
Discontinuation From Study (Treated Set)
Lost to FU for 3P-MACE:Final VS NA
|
4
|
4
|
2
|
Baseline Characteristics
BI 10773 (Empagliflozin) Cardiovascular Outcome Event Trial in Type 2 Diabetes Mellitus Patients (EMPA-REG OUTCOME).
Baseline characteristics by cohort
| Measure |
Placebo
n=2333 Participants
Oral administration of Placebo matching empagliflozin 10 mg or 25 mg (1 tablet once daily)
|
Empagliflozin 10 mg
n=2345 Participants
Oral administration of Empagliflozin 10 mg (BI 10773) film coated tablets (1 tablet once daily)
|
Empagliflozin 25 mg
n=2342 Participants
Oral administration of Empagliflozin 25 mg (BI 10773) film coated tablets (1 tablet once daily)
|
Total
n=7020 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
63.2 years
STANDARD_DEVIATION 8.8 • n=99 Participants
|
63.0 years
STANDARD_DEVIATION 8.6 • n=107 Participants
|
63.2 years
STANDARD_DEVIATION 8.6 • n=206 Participants
|
63.1 years
STANDARD_DEVIATION 8.6 • n=7 Participants
|
|
Sex: Female, Male
Female
|
653 Participants
n=99 Participants
|
692 Participants
n=107 Participants
|
659 Participants
n=206 Participants
|
2004 Participants
n=7 Participants
|
|
Sex: Female, Male
Male
|
1680 Participants
n=99 Participants
|
1653 Participants
n=107 Participants
|
1683 Participants
n=206 Participants
|
5016 Participants
n=7 Participants
|
PRIMARY outcome
Timeframe: From randomisation to individual end of observation, up to 4.6 yearsPopulation: TS
Time to the first occurrence of any of the following adjudicated components of the primary composite endpoint (3-point major adverse cardiovascular events (MACE)): cardiovascular (CV) death (including fatal stroke and fatal myocardial infarction (MI)), non-fatal MI (excluding silent MI), and non-fatal stroke. Percentage of patients with the event are presented.
Outcome measures
| Measure |
Empagliflozin 10 mg
n=2345 Participants
Oral administration of Empagliflozin 10 mg (BI 10773) film coated tablets (1 tablet once daily)
|
Placebo
n=2333 Participants
Oral administration of Placebo matching empagliflozin 10 mg or 25 mg (1 tablet once daily)
|
Empagliflozin 25 mg
n=2342 Participants
Oral administration of Empagliflozin 25 mg (BI 10773) film coated tablets (1 tablet once daily)
|
All Empagliflozin
n=4687 Participants
Patients who received either 10 mg or 25 mg of empagliflozin were pooled into a common empagliflozin treatment group
|
|---|---|---|---|---|
|
Time to the First Occurrence of Any of the Following Adjudicated Components of the Primary Composite Endpoint (3-point MACE): CV Death (Including Fatal Stroke and Fatal MI), Non-fatal MI (Excluding Silent MI), and Non-fatal Stroke.
|
10.4 percentage of participants
|
12.1 percentage of participants
|
10.5 percentage of participants
|
10.5 percentage of participants
|
SECONDARY outcome
Timeframe: From randomisation to individual end of observation, up to 4.6 yearsPopulation: TS
The composite of all events adjudicated (4-point MACE): cardiovascular death (including fatal stroke and fatal myocardial infarction), non-fatal myocardial infarction (excluding silent MI), non-fatal stroke and hospitalization for unstable angina pectoris.This is a key secondary endpoint of the trial. Percentage of patients with the event are presented.
Outcome measures
| Measure |
Empagliflozin 10 mg
n=2345 Participants
Oral administration of Empagliflozin 10 mg (BI 10773) film coated tablets (1 tablet once daily)
|
Placebo
n=2333 Participants
Oral administration of Placebo matching empagliflozin 10 mg or 25 mg (1 tablet once daily)
|
Empagliflozin 25 mg
n=2342 Participants
Oral administration of Empagliflozin 25 mg (BI 10773) film coated tablets (1 tablet once daily)
|
All Empagliflozin
n=4687 Participants
Patients who received either 10 mg or 25 mg of empagliflozin were pooled into a common empagliflozin treatment group
|
|---|---|---|---|---|
|
Percentage of Participants With the Composite of All Events Adjudicated (4-point MACE): CV Death (Including Fatal Stroke and Fatal MI), Non-fatal MI (Excluding Silent MI), Non-fatal Stroke and Hospitalization for Unstable Angina Pectoris
|
12.8 percentage of participants
|
14.3 percentage of participants
|
12.8 percentage of participants
|
12.8 percentage of participants
|
SECONDARY outcome
Timeframe: From randomisation to individual end of observation, up to 4.6 yearsPopulation: TS (evaluable cases)
Silent MI; defined as presence in the ECG of: * Any Q-wave in leads V2-V3 ≥0.02 seconds or QS complex in leads V2 and V3 * Q-wave ≥0.03 seconds and ≥0.1 mV deep or QS complex in leads I, II, aVL, aVF, or V4-V6 in any two leads of a contiguous lead grouping (I, aVL, V6; V4-V6; II, III, and aVF) * R-wave ≥0.04 seconds in V1-V2 and R/S ≥1 with a concordant positive T-wave in the absence of a conduction defect. It was also required that there had been no adjudicated and confirmed event of either acute MI, hospitalisation for unstable angina, coronary revascularisation procedures or stent thrombosis following randomisation up to and including the date of the specified ECG measurement. Percentage of patients with the event are presented.
Outcome measures
| Measure |
Empagliflozin 10 mg
n=1174 Participants
Oral administration of Empagliflozin 10 mg (BI 10773) film coated tablets (1 tablet once daily)
|
Placebo
n=1211 Participants
Oral administration of Placebo matching empagliflozin 10 mg or 25 mg (1 tablet once daily)
|
Empagliflozin 25 mg
n=1204 Participants
Oral administration of Empagliflozin 25 mg (BI 10773) film coated tablets (1 tablet once daily)
|
All Empagliflozin
n=2378 Participants
Patients who received either 10 mg or 25 mg of empagliflozin were pooled into a common empagliflozin treatment group
|
|---|---|---|---|---|
|
Percentage of Participants With Silent MI
|
1.6 percentage of participants
|
1.2 percentage of participants
|
1.6 percentage of participants
|
1.6 percentage of participants
|
SECONDARY outcome
Timeframe: From randomisation to individual end of observation, up to 4.6 yearsPopulation: TS
Heart failure requiring hospitalisation (adjudicated). Percentage of patients with the event are presented.
Outcome measures
| Measure |
Empagliflozin 10 mg
n=2345 Participants
Oral administration of Empagliflozin 10 mg (BI 10773) film coated tablets (1 tablet once daily)
|
Placebo
n=2333 Participants
Oral administration of Placebo matching empagliflozin 10 mg or 25 mg (1 tablet once daily)
|
Empagliflozin 25 mg
n=2342 Participants
Oral administration of Empagliflozin 25 mg (BI 10773) film coated tablets (1 tablet once daily)
|
All Empagliflozin
n=4687 Participants
Patients who received either 10 mg or 25 mg of empagliflozin were pooled into a common empagliflozin treatment group
|
|---|---|---|---|---|
|
Percentage of Participants With Heart Failure Requiring Hospitalisation (Adjudicated)
|
2.6 percentage of participants
|
4.1 percentage of participants
|
2.8 percentage of participants
|
2.7 percentage of participants
|
SECONDARY outcome
Timeframe: From randomisation to individual end of observation, up to 4.6 yearsPopulation: TS (evaluable cases)
New onset albuminuria defined as urine albumin / creatinine ratio (UACR) ≥30 mg/g. Percentage of patients with the event are presented.
Outcome measures
| Measure |
Empagliflozin 10 mg
n=1403 Participants
Oral administration of Empagliflozin 10 mg (BI 10773) film coated tablets (1 tablet once daily)
|
Placebo
n=1374 Participants
Oral administration of Placebo matching empagliflozin 10 mg or 25 mg (1 tablet once daily)
|
Empagliflozin 25 mg
n=1376 Participants
Oral administration of Empagliflozin 25 mg (BI 10773) film coated tablets (1 tablet once daily)
|
All Empagliflozin
n=2779 Participants
Patients who received either 10 mg or 25 mg of empagliflozin were pooled into a common empagliflozin treatment group
|
|---|---|---|---|---|
|
Percentage of Participants With New Onset Albuminuria
|
51.5 percentage of participants
|
51.2 percentage of participants
|
51.5 percentage of participants
|
51.5 percentage of participants
|
SECONDARY outcome
Timeframe: From randomisation to individual end of observation, up to 4.6 yearsPopulation: TS (evaluable cases)
New onset macroalbuminuria defined as UACR \>300 mg/g. Percentage of patients with the event are presented.
Outcome measures
| Measure |
Empagliflozin 10 mg
n=2037 Participants
Oral administration of Empagliflozin 10 mg (BI 10773) film coated tablets (1 tablet once daily)
|
Placebo
n=2033 Participants
Oral administration of Placebo matching empagliflozin 10 mg or 25 mg (1 tablet once daily)
|
Empagliflozin 25 mg
n=2054 Participants
Oral administration of Empagliflozin 25 mg (BI 10773) film coated tablets (1 tablet once daily)
|
All Empagliflozin
n=4091 Participants
Patients who received either 10 mg or 25 mg of empagliflozin were pooled into a common empagliflozin treatment group
|
|---|---|---|---|---|
|
Percentage of Participants With New Onset Macroalbuminuria
|
10.9 percentage of participants
|
16.2 percentage of participants
|
11.5 percentage of participants
|
11.2 percentage of participants
|
SECONDARY outcome
Timeframe: From randomisation to individual end of observation, up to 4.6 yearsPopulation: TS (evaluable cases)
Composite microvascular outcome defined as: * Initiation of retinal photocoagulation * Vitreous haemorrhage * Diabetes-related blindness, or * New or worsening nephropathy defined as: * New onset of macroalbuminuria; or * Doubling of serum creatinine level accompanied by an eGFR (based on modification of diet in renal disease (MDRD) formula) ≤45 mL/min/1.73m2; or * Initiation of continuous renal replacement therapy, or * Death due to renal disease. Percentage of patients with the event are presented.
Outcome measures
| Measure |
Empagliflozin 10 mg
n=2057 Participants
Oral administration of Empagliflozin 10 mg (BI 10773) film coated tablets (1 tablet once daily)
|
Placebo
n=2068 Participants
Oral administration of Placebo matching empagliflozin 10 mg or 25 mg (1 tablet once daily)
|
Empagliflozin 25 mg
n=2075 Participants
Oral administration of Empagliflozin 25 mg (BI 10773) film coated tablets (1 tablet once daily)
|
All Empagliflozin
n=4132 Participants
Patients who received either 10 mg or 25 mg of empagliflozin were pooled into a common empagliflozin treatment group
|
|---|---|---|---|---|
|
Percentage of Participants With the Composite Microvascular Outcome
|
13.9 percentage of participants
|
20.5 percentage of participants
|
14.1 percentage of participants
|
14.0 percentage of participants
|
Adverse Events
Placebo
Serious events: 988 serious events
Other events: 1690 other events
Deaths: 0 deaths
Empagliflozin 10 mg
Serious events: 876 serious events
Other events: 1556 other events
Deaths: 0 deaths
Empagliflozin 25 mg
Serious events: 913 serious events
Other events: 1551 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo
n=2333 participants at risk
Oral administration of Placebo matching empagliflozin 10 mg or 25 mg (1 tablet once daily)
|
Empagliflozin 10 mg
n=2345 participants at risk
Oral administration of Empagliflozin 10 mg (BI 10773) film coated tablets (1 tablet once daily)
|
Empagliflozin 25 mg
n=2342 participants at risk
Oral administration of Empagliflozin 25 mg (BI 10773) film coated tablets (1 tablet once daily)
|
|---|---|---|---|
|
Infections and infestations
Gangrene
|
0.34%
8/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.43%
10/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.26%
6/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Infections and infestations
Gastroenteritis
|
0.64%
15/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.77%
18/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.64%
15/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Infections and infestations
Gastroenteritis salmonella
|
0.00%
0/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Infections and infestations
Gastroenteritis viral
|
0.00%
0/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Infections and infestations
Gastrointestinal infection
|
0.04%
1/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Infections and infestations
Gastrointestinal protozoal infection
|
0.04%
1/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Infections and infestations
Giardiasis
|
0.00%
0/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Metabolism and nutrition disorders
Obesity
|
0.13%
3/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.09%
2/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Metabolism and nutrition disorders
Type 2 diabetes mellitus
|
0.09%
2/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.17%
4/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.21%
5/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.04%
1/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.09%
2/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.39%
9/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.13%
3/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.34%
8/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Infections and infestations
Erysipelas
|
0.39%
9/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.34%
8/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.21%
5/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Infections and infestations
Escherichia sepsis
|
0.09%
2/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.04%
1/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Infections and infestations
Escherichia urinary tract infection
|
0.04%
1/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Infections and infestations
Febrile infection
|
0.00%
0/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Infections and infestations
Furuncle
|
0.04%
1/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Infections and infestations
Endocarditis
|
0.04%
1/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Infections and infestations
Gallbladder empyema
|
0.04%
1/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
0.00%
0/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Infections and infestations
Diabetic foot infection
|
0.26%
6/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.21%
5/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.30%
7/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Infections and infestations
Diabetic gangrene
|
0.13%
3/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.09%
2/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Infections and infestations
Diverticulitis
|
0.13%
3/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.13%
3/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Infections and infestations
Ear infection
|
0.04%
1/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Infections and infestations
Eczema infected
|
0.04%
1/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Infections and infestations
Empyema
|
0.04%
1/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.04%
1/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.09%
2/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.09%
2/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Metabolism and nutrition disorders
Hypovolaemia
|
0.00%
0/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Metabolism and nutrition disorders
Insulin resistance
|
0.04%
1/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Psychiatric disorders
Completed suicide
|
0.00%
0/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Metabolism and nutrition disorders
Lactic acidosis
|
0.00%
0/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Metabolism and nutrition disorders
Lipomatosis
|
0.00%
0/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Metabolism and nutrition disorders
Metabolic acidosis
|
0.04%
1/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.09%
2/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Infections and infestations
Endophthalmitis
|
0.04%
1/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Infections and infestations
Enterocolitis infectious
|
0.04%
1/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Infections and infestations
Enterocolitis viral
|
0.00%
0/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.17%
4/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.26%
6/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign laryngeal neoplasm
|
0.00%
0/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Injury, poisoning and procedural complications
Periprosthetic fracture
|
0.04%
1/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Injury, poisoning and procedural complications
Perirenal haematoma
|
0.00%
0/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Blood and lymphatic system disorders
Anaemia
|
0.51%
12/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.34%
8/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.30%
7/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Blood and lymphatic system disorders
Coagulopathy
|
0.04%
1/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Blood and lymphatic system disorders
Haemorrhagic anaemia
|
0.00%
0/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.09%
2/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Blood and lymphatic system disorders
Hypereosinophilic syndrome
|
0.04%
1/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Blood and lymphatic system disorders
Hypochromic anaemia
|
0.04%
1/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Blood and lymphatic system disorders
Hypocoagulable state
|
0.00%
0/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
0.09%
2/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.17%
4/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Blood and lymphatic system disorders
Microcytic anaemia
|
0.00%
0/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.09%
2/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Blood and lymphatic system disorders
Normochromic normocytic anaemia
|
0.00%
0/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.04%
1/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Cardiac disorders
Acute coronary syndrome
|
0.43%
10/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.43%
10/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.60%
14/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Cardiac disorders
Acute myocardial infarction
|
1.8%
42/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
1.4%
32/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
2.0%
48/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Cardiac disorders
Angina pectoris
|
1.4%
32/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
1.5%
36/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
1.8%
42/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Cardiac disorders
Angina unstable
|
3.7%
87/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
3.5%
82/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
3.1%
73/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Cardiac disorders
Aortic valve disease
|
0.00%
0/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.09%
2/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Cardiac disorders
Aortic valve stenosis
|
0.04%
1/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.09%
2/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Cardiac disorders
Arrhythmia
|
0.09%
2/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.21%
5/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Cardiac disorders
Arteriosclerosis coronary artery
|
0.04%
1/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.26%
6/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Cardiac disorders
Atrial fibrillation
|
0.60%
14/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
1.1%
25/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.51%
12/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Cardiac disorders
Atrial flutter
|
0.21%
5/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.30%
7/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.17%
4/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Cardiac disorders
Atrial tachycardia
|
0.04%
1/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Cardiac disorders
Atrial thrombosis
|
0.00%
0/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Cardiac disorders
Atrioventricular block
|
0.13%
3/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.09%
2/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Cardiac disorders
Atrioventricular block complete
|
0.09%
2/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.09%
2/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.13%
3/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Cardiac disorders
Atrioventricular block first degree
|
0.04%
1/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Cardiac disorders
Atrioventricular block second degree
|
0.04%
1/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.09%
2/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Cardiac disorders
Bradyarrhythmia
|
0.00%
0/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Cardiac disorders
Bradycardia
|
0.47%
11/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.09%
2/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.17%
4/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Cardiac disorders
Bundle branch block bilateral
|
0.00%
0/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Cardiac disorders
Bundle branch block right
|
0.00%
0/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Cardiac disorders
Cardiac arrest
|
0.51%
12/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.26%
6/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.21%
5/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Cardiac disorders
Cardiac asthma
|
0.00%
0/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Cardiac disorders
Cardiac disorder
|
0.00%
0/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Cardiac disorders
Cardiac failure
|
2.4%
55/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
1.8%
42/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
1.0%
24/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Cardiac disorders
Cardiac failure acute
|
0.39%
9/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.17%
4/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.09%
2/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Cardiac disorders
Cardiac failure chronic
|
0.00%
0/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.17%
4/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.09%
2/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Cardiac disorders
Cardiac failure congestive
|
1.9%
45/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
1.3%
30/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
1.5%
35/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Cardiac disorders
Cardiac failure high output
|
0.00%
0/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Cardiac disorders
Cardio-respiratory arrest
|
0.26%
6/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.21%
5/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.09%
2/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Cardiac disorders
Cardiogenic shock
|
0.09%
2/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.09%
2/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.09%
2/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Cardiac disorders
Cardiomyopathy
|
0.09%
2/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Cardiac disorders
Cardiopulmonary failure
|
0.09%
2/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Cardiac disorders
Cardiorenal syndrome
|
0.00%
0/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Cardiac disorders
Cardiovascular disorder
|
0.04%
1/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Cardiac disorders
Cardiovascular insufficiency
|
0.00%
0/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Cardiac disorders
Congestive cardiomyopathy
|
0.00%
0/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Cardiac disorders
Coronary artery disease
|
2.0%
46/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.90%
21/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
1.2%
29/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Cardiac disorders
Coronary artery insufficiency
|
0.04%
1/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Cardiac disorders
Coronary artery occlusion
|
0.26%
6/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.13%
3/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.30%
7/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Cardiac disorders
Coronary artery stenosis
|
0.21%
5/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.21%
5/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.21%
5/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Cardiac disorders
Cyanosis
|
0.04%
1/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Cardiac disorders
Diastolic dysfunction
|
0.09%
2/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Cardiac disorders
Hypertensive cardiomyopathy
|
0.00%
0/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Cardiac disorders
Hypertensive heart disease
|
0.04%
1/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Cardiac disorders
Intracardiac thrombus
|
0.04%
1/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Cardiac disorders
Ischaemic cardiomyopathy
|
0.04%
1/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.17%
4/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Cardiac disorders
Left atrial dilatation
|
0.00%
0/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Cardiac disorders
Left ventricular dysfunction
|
0.04%
1/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.09%
2/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Cardiac disorders
Left ventricular failure
|
0.09%
2/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Cardiac disorders
Microvascular coronary artery disease
|
0.00%
0/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Cardiac disorders
Mitral valve incompetence
|
0.04%
1/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Cardiac disorders
Myocardial infarction
|
2.0%
47/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
2.1%
50/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
1.9%
44/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Cardiac disorders
Myocardial ischaemia
|
0.64%
15/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.21%
5/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.30%
7/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Cardiac disorders
Myocarditis
|
0.04%
1/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Cardiac disorders
Nodal arrhythmia
|
0.04%
1/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Cardiac disorders
Palpitations
|
0.00%
0/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.09%
2/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Cardiac disorders
Papillary muscle disorder
|
0.04%
1/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Cardiac disorders
Pericardial cyst
|
0.00%
0/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Cardiac disorders
Pericardial effusion
|
0.09%
2/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.09%
2/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Cardiac disorders
Pericarditis
|
0.00%
0/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Cardiac disorders
Postinfarction angina
|
0.04%
1/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Cardiac disorders
Right ventricular failure
|
0.04%
1/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Cardiac disorders
Silent myocardial infarction
|
0.04%
1/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.13%
3/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.13%
3/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Cardiac disorders
Sinus arrhythmia
|
0.04%
1/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Cardiac disorders
Sinus bradycardia
|
0.04%
1/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.09%
2/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Cardiac disorders
Sinus node dysfunction
|
0.26%
6/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.21%
5/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.13%
3/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.17%
4/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.21%
5/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Cardiac disorders
Systolic dysfunction
|
0.04%
1/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Cardiac disorders
Tachycardia
|
0.21%
5/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.13%
3/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Cardiac disorders
Tachycardia paroxysmal
|
0.04%
1/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Cardiac disorders
Trifascicular block
|
0.04%
1/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Cardiac disorders
Ventricular arrhythmia
|
0.09%
2/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Cardiac disorders
Ventricular extrasystoles
|
0.04%
1/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Cardiac disorders
Ventricular fibrillation
|
0.09%
2/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.09%
2/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Cardiac disorders
Ventricular tachycardia
|
0.34%
8/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.09%
2/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.21%
5/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Congenital, familial and genetic disorders
Atrial septal defect
|
0.00%
0/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Congenital, familial and genetic disorders
Congenital anomalies of ear ossicles
|
0.04%
1/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Congenital, familial and genetic disorders
Hydrocele
|
0.04%
1/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Congenital, familial and genetic disorders
Phimosis
|
0.04%
1/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.09%
2/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Congenital, familial and genetic disorders
Pyloric stenosis
|
0.04%
1/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Ear and labyrinth disorders
Cerumen impaction
|
0.00%
0/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Ear and labyrinth disorders
Deafness
|
0.00%
0/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Ear and labyrinth disorders
Deafness unilateral
|
0.04%
1/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Ear and labyrinth disorders
Sudden hearing loss
|
0.00%
0/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Ear and labyrinth disorders
Tinnitus
|
0.04%
1/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Ear and labyrinth disorders
Tympanic membrane perforation
|
0.04%
1/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Ear and labyrinth disorders
Vertigo
|
0.30%
7/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.09%
2/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.38%
9/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Ear and labyrinth disorders
Vertigo positional
|
0.26%
6/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.09%
2/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Endocrine disorders
Basedow's disease
|
0.00%
0/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Endocrine disorders
Goitre
|
0.04%
1/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.09%
2/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Endocrine disorders
Hyperparathyroidism
|
0.00%
0/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.09%
2/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Endocrine disorders
Hyperparathyroidism primary
|
0.00%
0/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Endocrine disorders
Hyperthyroidism
|
0.04%
1/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Eye disorders
Amaurosis
|
0.00%
0/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Eye disorders
Blindness
|
0.04%
1/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Eye disorders
Blindness unilateral
|
0.00%
0/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Eye disorders
Cataract
|
0.39%
9/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.55%
13/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.47%
11/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Eye disorders
Cataract cortical
|
0.04%
1/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Eye disorders
Corneal degeneration
|
0.00%
0/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Eye disorders
Diabetic retinopathy
|
0.17%
4/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.09%
2/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Eye disorders
Exfoliation syndrome
|
0.00%
0/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Eye disorders
Glaucoma
|
0.04%
1/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.13%
3/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.09%
2/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Eye disorders
Keratopathy
|
0.00%
0/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Eye disorders
Macular fibrosis
|
0.04%
1/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Eye disorders
Macular oedema
|
0.09%
2/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Eye disorders
Papilloedema
|
0.04%
1/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Eye disorders
Retinal artery occlusion
|
0.00%
0/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.09%
2/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Eye disorders
Retinal detachment
|
0.00%
0/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.17%
4/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.09%
2/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Eye disorders
Retinal haemorrhage
|
0.04%
1/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Eye disorders
Retinal tear
|
0.00%
0/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Eye disorders
Retinopathy
|
0.04%
1/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Eye disorders
Retinoschisis
|
0.00%
0/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Eye disorders
Visual acuity reduced
|
0.04%
1/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Eye disorders
Vitreous haemorrhage
|
0.17%
4/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.13%
3/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Eye disorders
Vitreous opacities
|
0.00%
0/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.13%
3/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Gastrointestinal disorders
Abdominal hernia
|
0.00%
0/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.09%
2/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.09%
2/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Gastrointestinal disorders
Abdominal hernia obstructive
|
0.00%
0/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Gastrointestinal disorders
Abdominal pain
|
0.21%
5/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.21%
5/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.09%
2/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Gastrointestinal disorders
Abdominal pain lower
|
0.00%
0/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.13%
3/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.09%
2/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Gastrointestinal disorders
Anal fissure
|
0.04%
1/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Gastrointestinal disorders
Anal fistula
|
0.00%
0/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.09%
2/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.09%
2/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Gastrointestinal disorders
Bezoar
|
0.00%
0/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Gastrointestinal disorders
Chronic gastritis
|
0.00%
0/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.09%
2/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.13%
3/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Gastrointestinal disorders
Colitis ischaemic
|
0.04%
1/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Gastrointestinal disorders
Colon dysplasia
|
0.04%
1/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Gastrointestinal disorders
Constipation
|
0.17%
4/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.09%
2/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.09%
2/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Gastrointestinal disorders
Crohn's disease
|
0.00%
0/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Gastrointestinal disorders
Dental caries
|
0.04%
1/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Gastrointestinal disorders
Diabetic gastroparesis
|
0.00%
0/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Gastrointestinal disorders
Diabetic gastropathy
|
0.04%
1/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Gastrointestinal disorders
Diarrhoea
|
0.26%
6/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.26%
6/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.17%
4/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Gastrointestinal disorders
Diverticulum
|
0.09%
2/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Gastrointestinal disorders
Diverticulum intestinal
|
0.00%
0/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.13%
3/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Gastrointestinal disorders
Duodenal perforation
|
0.00%
0/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Gastrointestinal disorders
Duodenal ulcer
|
0.09%
2/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.09%
2/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Gastrointestinal disorders
Duodenal ulcer haemorrhage
|
0.04%
1/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Gastrointestinal disorders
Duodenal ulcer perforation
|
0.04%
1/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Gastrointestinal disorders
Duodenitis
|
0.00%
0/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Gastrointestinal disorders
Dyspepsia
|
0.04%
1/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Gastrointestinal disorders
Dysphagia
|
0.09%
2/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Gastrointestinal disorders
Enteritis
|
0.04%
1/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Gastrointestinal disorders
Enterocolitis
|
0.04%
1/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Gastrointestinal disorders
Epigastric discomfort
|
0.04%
1/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Gastrointestinal disorders
Erosive duodenitis
|
0.04%
1/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Gastrointestinal disorders
Faecaloma
|
0.09%
2/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Gastrointestinal disorders
Food poisoning
|
0.04%
1/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.09%
2/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Gastrointestinal disorders
Gastric haemorrhage
|
0.04%
1/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Gastrointestinal disorders
Gastric perforation
|
0.00%
0/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Gastrointestinal disorders
Gastric polyps
|
0.00%
0/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Gastrointestinal disorders
Gastric ulcer
|
0.13%
3/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.09%
2/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Gastrointestinal disorders
Gastric ulcer haemorrhage
|
0.00%
0/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Gastrointestinal disorders
Gastric ulcer perforation
|
0.00%
0/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Gastrointestinal disorders
Gastritis
|
0.09%
2/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.09%
2/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.30%
7/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Gastrointestinal disorders
Gastritis erosive
|
0.04%
1/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Gastrointestinal disorders
Gastritis haemorrhagic
|
0.04%
1/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Gastrointestinal disorders
Gastroduodenal ulcer
|
0.00%
0/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Gastrointestinal disorders
Gastroduodenitis
|
0.04%
1/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Gastrointestinal disorders
Gastrointestinal angiodysplasia
|
0.04%
1/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Gastrointestinal disorders
Gastrointestinal disorder
|
0.00%
0/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.39%
9/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.17%
4/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.17%
4/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Gastrointestinal disorders
Gastrointestinal inflammation
|
0.00%
0/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.21%
5/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.30%
7/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.13%
3/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Gastrointestinal disorders
Gingival bleeding
|
0.04%
1/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Gastrointestinal disorders
Haematemesis
|
0.00%
0/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.09%
2/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Infections and infestations
Epididymitis
|
0.04%
1/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Gastrointestinal disorders
Haematochezia
|
0.04%
1/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Gastrointestinal disorders
Haemorrhoidal haemorrhage
|
0.04%
1/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.13%
3/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.09%
2/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Gastrointestinal disorders
Haemorrhoids thrombosed
|
0.00%
0/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Gastrointestinal disorders
Hiatus hernia
|
0.04%
1/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Gastrointestinal disorders
Ileus
|
0.00%
0/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Gastrointestinal disorders
Ileus paralytic
|
0.13%
3/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Gastrointestinal disorders
Impaired gastric emptying
|
0.00%
0/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.13%
3/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Gastrointestinal disorders
Incarcerated umbilical hernia
|
0.00%
0/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.13%
3/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.21%
5/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.17%
4/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Gastrointestinal disorders
Inguinal hernia strangulated
|
0.00%
0/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Gastrointestinal disorders
Intestinal haemorrhage
|
0.04%
1/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Gastrointestinal disorders
Intestinal ischaemia
|
0.09%
2/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.09%
2/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.21%
5/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.13%
3/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Gastrointestinal disorders
Intestinal perforation
|
0.09%
2/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Gastrointestinal disorders
Irritable bowel syndrome
|
0.00%
0/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Gastrointestinal disorders
Large intestinal ulcer
|
0.00%
0/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Gastrointestinal disorders
Large intestine perforation
|
0.00%
0/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Gastrointestinal disorders
Large intestine polyp
|
0.00%
0/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.21%
5/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Gastrointestinal disorders
Localised intraabdominal fluid collection
|
0.00%
0/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Gastrointestinal disorders
Lumbar hernia
|
0.00%
0/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Gastrointestinal disorders
Mallory-Weiss syndrome
|
0.04%
1/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Gastrointestinal disorders
Melaena
|
0.00%
0/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Gastrointestinal disorders
Mesenteric vein thrombosis
|
0.00%
0/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Gastrointestinal disorders
Nausea
|
0.09%
2/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.17%
4/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.09%
2/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Gastrointestinal disorders
Oesophageal stenosis
|
0.00%
0/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Gastrointestinal disorders
Oesophagitis
|
0.00%
0/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Gastrointestinal disorders
Pancreatitis
|
0.17%
4/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.13%
3/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.13%
3/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.13%
3/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.13%
3/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Gastrointestinal disorders
Pancreatitis chronic
|
0.04%
1/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Gastrointestinal disorders
Pancreatitis relapsing
|
0.04%
1/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Gastrointestinal disorders
Peptic ulcer
|
0.00%
0/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.09%
2/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Gastrointestinal disorders
Peptic ulcer haemorrhage
|
0.04%
1/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Gastrointestinal disorders
Peptic ulcer perforation
|
0.00%
0/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Gastrointestinal disorders
Peritoneal haemorrhage
|
0.00%
0/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.04%
1/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.09%
2/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.09%
2/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.04%
1/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.13%
3/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.09%
2/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Gastrointestinal disorders
Small intestinal perforation
|
0.04%
1/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Gastrointestinal disorders
Stress ulcer
|
0.04%
1/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Gastrointestinal disorders
Subileus
|
0.00%
0/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Gastrointestinal disorders
Thrombosis mesenteric vessel
|
0.00%
0/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Gastrointestinal disorders
Umbilical hernia
|
0.09%
2/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.13%
3/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
0.13%
3/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.09%
2/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.21%
5/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Gastrointestinal disorders
Varices oesophageal
|
0.00%
0/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Gastrointestinal disorders
Volvulus
|
0.04%
1/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Gastrointestinal disorders
Vomiting
|
0.09%
2/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.13%
3/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.17%
4/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
General disorders
Adverse drug reaction
|
0.00%
0/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
General disorders
Asthenia
|
0.00%
0/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.09%
2/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
General disorders
Cardiac death
|
0.13%
3/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.17%
4/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.09%
2/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
General disorders
Chest discomfort
|
0.17%
4/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.09%
2/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.13%
3/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
General disorders
Chest pain
|
1.2%
28/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
1.4%
32/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
1.4%
33/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
General disorders
Chills
|
0.04%
1/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
General disorders
Death
|
0.51%
12/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.43%
10/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.21%
5/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
General disorders
Device defective
|
0.04%
1/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
General disorders
Device deposit issue
|
0.04%
1/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
General disorders
Device difficult to use
|
0.04%
1/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
General disorders
Device malfunction
|
0.04%
1/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
General disorders
Device occlusion
|
0.00%
0/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.09%
2/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
General disorders
Drowning
|
0.00%
0/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
General disorders
Drug ineffective
|
0.00%
0/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
General disorders
Dysplasia
|
0.00%
0/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
General disorders
Extravasation
|
0.04%
1/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
General disorders
Fatigue
|
0.04%
1/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
General disorders
Feeling abnormal
|
0.04%
1/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
General disorders
Gait disturbance
|
0.04%
1/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
General disorders
General physical health deterioration
|
0.09%
2/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
General disorders
Generalised oedema
|
0.04%
1/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
General disorders
Granuloma
|
0.04%
1/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
General disorders
Hernia
|
0.09%
2/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
General disorders
Impaired healing
|
0.00%
0/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
General disorders
Implant site necrosis
|
0.00%
0/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
General disorders
Malaise
|
0.04%
1/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
General disorders
Multi-organ failure
|
0.13%
3/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.09%
2/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
General disorders
Necrobiosis
|
0.04%
1/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
General disorders
Non-cardiac chest pain
|
0.26%
6/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.21%
5/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.64%
15/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
General disorders
Oedema peripheral
|
0.21%
5/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
General disorders
Oversensing
|
0.09%
2/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
General disorders
Pacemaker generated arrhythmia
|
0.00%
0/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
General disorders
Pain
|
0.04%
1/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
General disorders
Perforated ulcer
|
0.04%
1/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
General disorders
Peripheral swelling
|
0.09%
2/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
General disorders
Polyp
|
0.00%
0/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
General disorders
Pyrexia
|
0.21%
5/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.30%
7/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.09%
2/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
General disorders
Stent malfunction
|
0.00%
0/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
General disorders
Strangulated hernia
|
0.00%
0/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
General disorders
Sudden cardiac death
|
0.09%
2/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.09%
2/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.09%
2/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
General disorders
Sudden death
|
0.26%
6/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.34%
8/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.21%
5/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
General disorders
Systemic inflammatory response syndrome
|
0.00%
0/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
General disorders
Ulcer
|
0.00%
0/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Hepatobiliary disorders
Bile duct obstruction
|
0.00%
0/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Hepatobiliary disorders
Bile duct stone
|
0.00%
0/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.17%
4/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.09%
2/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Hepatobiliary disorders
Cholangitis
|
0.04%
1/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Hepatobiliary disorders
Cholecystitis
|
0.17%
4/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.17%
4/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.21%
5/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.17%
4/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.30%
7/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.26%
6/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Hepatobiliary disorders
Cholecystitis chronic
|
0.04%
1/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.30%
7/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.38%
9/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.51%
12/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Hepatobiliary disorders
Cholestasis
|
0.00%
0/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Hepatobiliary disorders
Gallbladder disorder
|
0.04%
1/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Hepatobiliary disorders
Hepatic cirrhosis
|
0.09%
2/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.09%
2/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.09%
2/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Hepatobiliary disorders
Hepatic failure
|
0.04%
1/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Hepatobiliary disorders
Hepatic function abnormal
|
0.00%
0/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Hepatobiliary disorders
Hepatic steatosis
|
0.00%
0/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Hepatobiliary disorders
Ischaemic hepatitis
|
0.04%
1/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Hepatobiliary disorders
Jaundice cholestatic
|
0.00%
0/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Hepatobiliary disorders
Non-alcoholic steatohepatitis
|
0.00%
0/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Hepatobiliary disorders
Portal hypertension
|
0.00%
0/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Hepatobiliary disorders
Post cholecystectomy syndrome
|
0.04%
1/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Hepatobiliary disorders
Sphincter of Oddi dysfunction
|
0.04%
1/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Immune system disorders
Anaphylactic reaction
|
0.00%
0/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Immune system disorders
Anaphylactic shock
|
0.00%
0/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Immune system disorders
Contrast media allergy
|
0.04%
1/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Immune system disorders
Food allergy
|
0.04%
1/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.09%
2/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Immune system disorders
Hypersensitivity
|
0.00%
0/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Immune system disorders
Iodine allergy
|
0.04%
1/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Infections and infestations
Abdominal abscess
|
0.00%
0/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.09%
2/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Infections and infestations
Abdominal wall abscess
|
0.00%
0/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.09%
2/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Infections and infestations
Abscess
|
0.00%
0/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Infections and infestations
Abscess limb
|
0.13%
3/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.26%
6/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.09%
2/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Infections and infestations
Abscess of eyelid
|
0.00%
0/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Infections and infestations
Acute sinusitis
|
0.00%
0/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.09%
2/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Infections and infestations
Amoebiasis
|
0.00%
0/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Infections and infestations
Amoebic dysentery
|
0.00%
0/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Infections and infestations
Anal abscess
|
0.04%
1/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Infections and infestations
Appendicitis
|
0.13%
3/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.21%
5/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.13%
3/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Infections and infestations
Appendicitis perforated
|
0.00%
0/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.09%
2/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Infections and infestations
Arteriosclerotic gangrene
|
0.00%
0/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Infections and infestations
Arthritis bacterial
|
0.04%
1/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.09%
2/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Infections and infestations
Atypical pneumonia
|
0.00%
0/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Infections and infestations
Bacteraemia
|
0.09%
2/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.13%
3/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Infections and infestations
Bacterial sepsis
|
0.00%
0/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Infections and infestations
Biliary tract infection
|
0.04%
1/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Infections and infestations
Bone abscess
|
0.04%
1/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Infections and infestations
Bronchiolitis
|
0.00%
0/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Infections and infestations
Bronchitis
|
0.43%
10/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.21%
5/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.21%
5/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Infections and infestations
Bronchitis viral
|
0.00%
0/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Infections and infestations
Bronchopneumonia
|
0.13%
3/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.13%
3/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Infections and infestations
Catheter site infection
|
0.00%
0/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Infections and infestations
Cellulitis
|
0.86%
20/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.47%
11/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.73%
17/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Infections and infestations
Cellulitis gangrenous
|
0.00%
0/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.09%
2/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Infections and infestations
Cellulitis of male external genital organ
|
0.00%
0/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Infections and infestations
Cellulitis staphylococcal
|
0.00%
0/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Infections and infestations
Cholecystitis infective
|
0.00%
0/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Infections and infestations
Chronic sinusitis
|
0.00%
0/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.13%
3/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Infections and infestations
Clostridium difficile colitis
|
0.04%
1/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Infections and infestations
Cutaneous larva migrans
|
0.04%
1/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Infections and infestations
Cystitis
|
0.09%
2/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Infections and infestations
Cystitis bacterial
|
0.04%
1/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Infections and infestations
Dengue fever
|
0.04%
1/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.09%
2/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Infections and infestations
Device related infection
|
0.04%
1/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Infections and infestations
Device related sepsis
|
0.04%
1/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Infections and infestations
H1N1 influenza
|
0.00%
0/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.09%
2/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Infections and infestations
Incision site infection
|
0.00%
0/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Infections and infestations
Infected skin ulcer
|
0.17%
4/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.09%
2/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.13%
3/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Infections and infestations
Infectious colitis
|
0.00%
0/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Infections and infestations
Infectious pleural effusion
|
0.00%
0/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Infections and infestations
Influenza
|
0.09%
2/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Infections and infestations
Infusion site infection
|
0.00%
0/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Infections and infestations
Inguinal hernia gangrenous
|
0.00%
0/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Infections and infestations
Intestinal fistula infection
|
0.00%
0/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Infections and infestations
Intestinal tuberculosis
|
0.04%
1/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Infections and infestations
Kidney infection
|
0.04%
1/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Infections and infestations
Klebsiella infection
|
0.00%
0/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Infections and infestations
Labyrinthitis
|
0.04%
1/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Infections and infestations
Liver abscess
|
0.00%
0/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Infections and infestations
Lobar pneumonia
|
0.13%
3/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Infections and infestations
Localised infection
|
0.21%
5/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.09%
2/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.17%
4/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Infections and infestations
Lower respiratory tract infection
|
0.17%
4/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.34%
8/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.09%
2/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Infections and infestations
Lower respiratory tract infection bacterial
|
0.09%
2/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Infections and infestations
Lung infection
|
0.00%
0/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.09%
2/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Infections and infestations
Lyme disease
|
0.00%
0/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Infections and infestations
Mediastinitis
|
0.09%
2/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Infections and infestations
Meningitis
|
0.04%
1/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Infections and infestations
Meningitis bacterial
|
0.00%
0/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Infections and infestations
Meningitis streptococcal
|
0.04%
1/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Infections and infestations
Meningitis tuberculous
|
0.04%
1/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Infections and infestations
Muscle abscess
|
0.00%
0/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Infections and infestations
Myelitis
|
0.00%
0/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Infections and infestations
Nasal abscess
|
0.00%
0/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Infections and infestations
Oesophageal candidiasis
|
0.00%
0/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Infections and infestations
Osteomyelitis
|
0.21%
5/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.21%
5/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.38%
9/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Infections and infestations
Osteomyelitis acute
|
0.00%
0/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Infections and infestations
Osteomyelitis bacterial
|
0.04%
1/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Infections and infestations
Osteomyelitis chronic
|
0.00%
0/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Infections and infestations
Otitis externa
|
0.04%
1/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Infections and infestations
Otitis media
|
0.04%
1/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Infections and infestations
Periodontitis
|
0.04%
1/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Infections and infestations
Peritonitis
|
0.04%
1/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.09%
2/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.13%
3/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Infections and infestations
Peritonsillar abscess
|
0.00%
0/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Infections and infestations
Pertussis
|
0.04%
1/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Infections and infestations
Pharyngotonsillitis
|
0.04%
1/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Infections and infestations
Pneumonia
|
2.3%
53/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
1.7%
41/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
1.6%
38/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Infections and infestations
Pneumonia bacterial
|
0.04%
1/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Infections and infestations
Pneumonia fungal
|
0.04%
1/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Infections and infestations
Pneumonia haemophilus
|
0.04%
1/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Infections and infestations
Pneumonia influenzal
|
0.00%
0/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Infections and infestations
Pneumonia pneumococcal
|
0.04%
1/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Infections and infestations
Post procedural infection
|
0.09%
2/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Infections and infestations
Post procedural sepsis
|
0.00%
0/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Infections and infestations
Postoperative wound infection
|
0.04%
1/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.09%
2/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Infections and infestations
Prostatic abscess
|
0.00%
0/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Infections and infestations
Pseudomonal sepsis
|
0.04%
1/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Infections and infestations
Psoas abscess
|
0.04%
1/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Infections and infestations
Pulmonary mycosis
|
0.04%
1/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Infections and infestations
Pulmonary tuberculosis
|
0.09%
2/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Infections and infestations
Pyelonephritis
|
0.09%
2/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.21%
5/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Infections and infestations
Pyelonephritis acute
|
0.26%
6/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.17%
4/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Infections and infestations
Pyelonephritis chronic
|
0.04%
1/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Infections and infestations
Respiratory tract infection
|
0.30%
7/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.09%
2/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Infections and infestations
Rhinitis
|
0.00%
0/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Infections and infestations
Rotavirus infection
|
0.00%
0/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Infections and infestations
Salmonellosis
|
0.09%
2/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Infections and infestations
Scrotal abscess
|
0.00%
0/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Infections and infestations
Sepsis
|
0.21%
5/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.30%
7/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.26%
6/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Infections and infestations
Septic encephalopathy
|
0.00%
0/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Infections and infestations
Septic shock
|
0.34%
8/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.09%
2/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.21%
5/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Infections and infestations
Sinusitis
|
0.04%
1/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Infections and infestations
Skin infection
|
0.04%
1/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Infections and infestations
Staphylococcal infection
|
0.00%
0/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.09%
2/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Infections and infestations
Staphylococcal sepsis
|
0.00%
0/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Infections and infestations
Staphylococcal skin infection
|
0.00%
0/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Infections and infestations
Subcutaneous abscess
|
0.04%
1/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.09%
2/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Infections and infestations
Tonsillitis
|
0.04%
1/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Infections and infestations
Tracheobronchitis
|
0.04%
1/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.09%
2/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Infections and infestations
Tuberculosis
|
0.00%
0/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Infections and infestations
Tuberculous pleurisy
|
0.04%
1/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Infections and infestations
Upper respiratory tract infection
|
0.09%
2/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.09%
2/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Infections and infestations
Urinary tract infection
|
0.69%
16/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.55%
13/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.68%
16/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Infections and infestations
Urinary tract infection fungal
|
0.00%
0/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.13%
3/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Infections and infestations
Urinary tract infection pseudomonal
|
0.00%
0/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Infections and infestations
Urosepsis
|
0.13%
3/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.26%
6/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.47%
11/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Infections and infestations
Vaginal cellulitis
|
0.00%
0/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Infections and infestations
Varicella
|
0.04%
1/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Infections and infestations
Vestibular neuronitis
|
0.09%
2/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Infections and infestations
Viral infection
|
0.00%
0/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.09%
2/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.21%
5/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Infections and infestations
Wound infection
|
0.13%
3/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.17%
4/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.13%
3/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Infections and infestations
Wound sepsis
|
0.00%
0/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Injury, poisoning and procedural complications
Accident at work
|
0.04%
1/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Injury, poisoning and procedural complications
Acetabulum fracture
|
0.00%
0/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Injury, poisoning and procedural complications
Anaemia postoperative
|
0.09%
2/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Injury, poisoning and procedural complications
Animal bite
|
0.00%
0/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.09%
2/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.17%
4/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.09%
2/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Injury, poisoning and procedural complications
Avulsion fracture
|
0.00%
0/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Injury, poisoning and procedural complications
Back injury
|
0.04%
1/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Injury, poisoning and procedural complications
Brain contusion
|
0.04%
1/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Injury, poisoning and procedural complications
Cardiac procedure complication
|
0.00%
0/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Injury, poisoning and procedural complications
Chemical poisoning
|
0.04%
1/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Injury, poisoning and procedural complications
Chest injury
|
0.00%
0/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Injury, poisoning and procedural complications
Clavicle fracture
|
0.04%
1/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Injury, poisoning and procedural complications
Concussion
|
0.00%
0/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.09%
2/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.09%
2/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Injury, poisoning and procedural complications
Contusion
|
0.17%
4/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.09%
2/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.09%
2/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Injury, poisoning and procedural complications
Coronary artery restenosis
|
0.17%
4/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.17%
4/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.09%
2/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Injury, poisoning and procedural complications
Craniocerebral injury
|
0.00%
0/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.09%
2/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Injury, poisoning and procedural complications
Deep vein thrombosis postoperative
|
0.00%
0/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Injury, poisoning and procedural complications
Facial bones fracture
|
0.09%
2/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Injury, poisoning and procedural complications
Fall
|
0.69%
16/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.38%
9/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.68%
16/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Injury, poisoning and procedural complications
Femoral neck fracture
|
0.04%
1/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.09%
2/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.13%
3/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.09%
2/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Injury, poisoning and procedural complications
Fibula fracture
|
0.09%
2/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Injury, poisoning and procedural complications
Foot fracture
|
0.04%
1/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Injury, poisoning and procedural complications
Fracture displacement
|
0.00%
0/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Injury, poisoning and procedural complications
Gastrointestinal anastomotic complication
|
0.04%
1/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Injury, poisoning and procedural complications
Graft thrombosis
|
0.00%
0/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Injury, poisoning and procedural complications
Gun shot wound
|
0.00%
0/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Injury, poisoning and procedural complications
Hand fracture
|
0.04%
1/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Injury, poisoning and procedural complications
Head injury
|
0.09%
2/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.09%
2/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.30%
7/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Injury, poisoning and procedural complications
Humerus fracture
|
0.00%
0/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.09%
2/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.13%
3/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Injury, poisoning and procedural complications
Incisional hernia
|
0.00%
0/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Injury, poisoning and procedural complications
Injury
|
0.04%
1/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Injury, poisoning and procedural complications
Intentional overdose
|
0.00%
0/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Injury, poisoning and procedural complications
Intestinal anastomosis complication
|
0.04%
1/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Injury, poisoning and procedural complications
Joint dislocation
|
0.00%
0/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.09%
2/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Injury, poisoning and procedural complications
Joint injury
|
0.04%
1/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Injury, poisoning and procedural complications
Kidney rupture
|
0.04%
1/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Injury, poisoning and procedural complications
Laceration
|
0.04%
1/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Injury, poisoning and procedural complications
Ligament rupture
|
0.04%
1/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
0.09%
2/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Injury, poisoning and procedural complications
Limb injury
|
0.04%
1/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Injury, poisoning and procedural complications
Lower limb fracture
|
0.09%
2/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Injury, poisoning and procedural complications
Meniscus injury
|
0.13%
3/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Injury, poisoning and procedural complications
Multiple fractures
|
0.04%
1/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Injury, poisoning and procedural complications
Multiple injuries
|
0.04%
1/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Injury, poisoning and procedural complications
Muscle injury
|
0.00%
0/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Injury, poisoning and procedural complications
Open fracture
|
0.04%
1/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Injury, poisoning and procedural complications
Overdose
|
0.04%
1/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Injury, poisoning and procedural complications
Pelvic fracture
|
0.00%
0/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Injury, poisoning and procedural complications
Periorbital contusion
|
0.00%
0/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Injury, poisoning and procedural complications
Peripheral artery restenosis
|
0.04%
1/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.09%
2/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Injury, poisoning and procedural complications
Post laminectomy syndrome
|
0.00%
0/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Injury, poisoning and procedural complications
Post procedural discomfort
|
0.00%
0/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Injury, poisoning and procedural complications
Post procedural haematuria
|
0.04%
1/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Injury, poisoning and procedural complications
Post procedural haemorrhage
|
0.00%
0/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.13%
3/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Injury, poisoning and procedural complications
Postoperative ileus
|
0.00%
0/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Injury, poisoning and procedural complications
Pubis fracture
|
0.04%
1/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Injury, poisoning and procedural complications
Radius fracture
|
0.04%
1/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.13%
3/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.26%
6/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.17%
4/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.17%
4/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.26%
6/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.26%
6/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.38%
9/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Injury, poisoning and procedural complications
Scar
|
0.00%
0/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Injury, poisoning and procedural complications
Seroma
|
0.00%
0/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Injury, poisoning and procedural complications
Skin abrasion
|
0.00%
0/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Injury, poisoning and procedural complications
Spinal column injury
|
0.00%
0/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Injury, poisoning and procedural complications
Spinal compression fracture
|
0.04%
1/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.13%
3/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Injury, poisoning and procedural complications
Spinal fracture
|
0.00%
0/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Injury, poisoning and procedural complications
Splenic rupture
|
0.00%
0/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Injury, poisoning and procedural complications
Stab wound
|
0.00%
0/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Injury, poisoning and procedural complications
Subdural haematoma
|
0.09%
2/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.09%
2/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Injury, poisoning and procedural complications
Subdural haemorrhage
|
0.09%
2/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Injury, poisoning and procedural complications
Tendon injury
|
0.00%
0/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Injury, poisoning and procedural complications
Tendon rupture
|
0.04%
1/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Injury, poisoning and procedural complications
Thoracic vertebral fracture
|
0.04%
1/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Injury, poisoning and procedural complications
Tibia fracture
|
0.30%
7/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.09%
2/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Injury, poisoning and procedural complications
Tongue injury
|
0.04%
1/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Injury, poisoning and procedural complications
Toxicity to various agents
|
0.09%
2/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.09%
2/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Injury, poisoning and procedural complications
Traumatic haematoma
|
0.04%
1/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Injury, poisoning and procedural complications
Traumatic haemorrhage
|
0.04%
1/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Injury, poisoning and procedural complications
Traumatic intracranial haemorrhage
|
0.09%
2/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Injury, poisoning and procedural complications
Traumatic liver injury
|
0.04%
1/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Injury, poisoning and procedural complications
Traumatic renal injury
|
0.00%
0/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Injury, poisoning and procedural complications
Ulna fracture
|
0.00%
0/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Injury, poisoning and procedural complications
Upper limb fracture
|
0.00%
0/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.09%
2/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Injury, poisoning and procedural complications
Vascular graft occlusion
|
0.09%
2/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.13%
3/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Injury, poisoning and procedural complications
Vascular graft thrombosis
|
0.00%
0/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Injury, poisoning and procedural complications
Vascular pseudoaneurysm
|
0.00%
0/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.09%
2/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Injury, poisoning and procedural complications
Wound
|
0.09%
2/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.13%
3/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Injury, poisoning and procedural complications
Wound dehiscence
|
0.00%
0/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Injury, poisoning and procedural complications
Wrist fracture
|
0.00%
0/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Investigations
Angiogram
|
0.04%
1/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Investigations
Angiogram normal
|
0.04%
1/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Investigations
Anticoagulation drug level above therapeutic
|
0.00%
0/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Investigations
Arteriogram coronary
|
0.09%
2/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Investigations
Biopsy lung
|
0.04%
1/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Investigations
Blood calcium decreased
|
0.04%
1/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Investigations
Blood creatine phosphokinase MB increased
|
0.04%
1/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Investigations
Blood creatine phosphokinase increased
|
0.00%
0/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.09%
2/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Investigations
Blood creatinine increased
|
0.09%
2/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.09%
2/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Investigations
Blood glucose fluctuation
|
0.04%
1/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Investigations
Blood lactate dehydrogenase increased
|
0.04%
1/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Investigations
Blood magnesium decreased
|
0.04%
1/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Investigations
Blood potassium increased
|
0.09%
2/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Investigations
Blood pressure increased
|
0.09%
2/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Investigations
Blood pressure orthostatic decreased
|
0.00%
0/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Investigations
Blood urea increased
|
0.00%
0/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Investigations
C-reactive protein increased
|
0.00%
0/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.09%
2/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Investigations
Cardiac murmur
|
0.00%
0/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Investigations
Cardiac stress test abnormal
|
0.00%
0/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Investigations
Catheterisation cardiac
|
0.04%
1/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.09%
2/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Investigations
Ejection fraction decreased
|
0.04%
1/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Investigations
Electrocardiogram T wave inversion
|
0.00%
0/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Investigations
Haemoglobin decreased
|
0.09%
2/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Investigations
Heart rate irregular
|
0.04%
1/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Investigations
Hepatic enzyme increased
|
0.04%
1/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.13%
3/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Investigations
Lipase increased
|
0.09%
2/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Investigations
Liver function test abnormal
|
0.00%
0/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Investigations
Oxygen consumption increased
|
0.04%
1/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Investigations
Physical examination
|
0.00%
0/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Investigations
Prostatic specific antigen increased
|
0.00%
0/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Investigations
Scan myocardial perfusion abnormal
|
0.09%
2/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Investigations
Smear cervix abnormal
|
0.04%
1/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Investigations
Transaminases increased
|
0.00%
0/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Investigations
Troponin I increased
|
0.04%
1/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Investigations
Troponin increased
|
0.04%
1/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Investigations
Weight decreased
|
0.00%
0/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.09%
2/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Investigations
White blood cell count increased
|
0.00%
0/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Metabolism and nutrition disorders
Dehydration
|
0.21%
5/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.21%
5/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.21%
5/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.26%
6/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.13%
3/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.09%
2/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Metabolism and nutrition disorders
Diabetes mellitus inadequate control
|
0.26%
6/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.34%
8/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.13%
3/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Metabolism and nutrition disorders
Diabetic complication
|
0.00%
0/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Metabolism and nutrition disorders
Diabetic ketoacidosis
|
0.00%
0/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.13%
3/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Metabolism and nutrition disorders
Diabetic metabolic decompensation
|
0.04%
1/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Metabolism and nutrition disorders
Fluid overload
|
0.04%
1/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Metabolism and nutrition disorders
Gout
|
0.00%
0/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.09%
2/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.60%
14/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.21%
5/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.13%
3/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.21%
5/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.09%
2/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.13%
3/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Metabolism and nutrition disorders
Hypernatraemia
|
0.04%
1/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Metabolism and nutrition disorders
Hypervolaemia
|
0.00%
0/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.73%
17/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.43%
10/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.38%
9/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Musculoskeletal and connective tissue disorders
Bone fistula
|
0.00%
0/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Musculoskeletal and connective tissue disorders
Bursitis
|
0.00%
0/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Musculoskeletal and connective tissue disorders
Cervical spinal stenosis
|
0.04%
1/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.09%
2/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Musculoskeletal and connective tissue disorders
Costochondritis
|
0.00%
0/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Musculoskeletal and connective tissue disorders
Dactylitis
|
0.00%
0/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Musculoskeletal and connective tissue disorders
Dupuytren's contracture
|
0.04%
1/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Musculoskeletal and connective tissue disorders
Fistula
|
0.00%
0/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.04%
1/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.09%
2/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Musculoskeletal and connective tissue disorders
Foot deformity
|
0.09%
2/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Musculoskeletal and connective tissue disorders
Fracture delayed union
|
0.00%
0/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Musculoskeletal and connective tissue disorders
Fracture nonunion
|
0.00%
0/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Musculoskeletal and connective tissue disorders
Gouty arthritis
|
0.00%
0/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Musculoskeletal and connective tissue disorders
Gouty tophus
|
0.00%
0/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc compression
|
0.00%
0/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc degeneration
|
0.00%
0/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc disorder
|
0.04%
1/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.43%
10/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.17%
4/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.26%
6/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Musculoskeletal and connective tissue disorders
Lower extremity mass
|
0.00%
0/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Musculoskeletal and connective tissue disorders
Lumbar spinal stenosis
|
0.09%
2/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.13%
3/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Musculoskeletal and connective tissue disorders
Muscle tightness
|
0.04%
1/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Musculoskeletal and connective tissue disorders
Muscle twitching
|
0.04%
1/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.09%
2/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.09%
2/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.09%
2/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal disorder
|
0.04%
1/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.13%
3/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.09%
2/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.13%
3/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.13%
3/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.09%
2/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Musculoskeletal and connective tissue disorders
Myofascial pain syndrome
|
0.00%
0/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Musculoskeletal and connective tissue disorders
Myositis
|
0.00%
0/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.09%
2/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Musculoskeletal and connective tissue disorders
Neuropathic arthropathy
|
0.04%
1/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.09%
2/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Musculoskeletal and connective tissue disorders
Osteitis
|
0.04%
1/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Musculoskeletal and connective tissue disorders
Osteitis deformans
|
0.00%
0/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.64%
15/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.64%
15/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.73%
17/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Musculoskeletal and connective tissue disorders
Osteomalacia
|
0.04%
1/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Musculoskeletal and connective tissue disorders
Osteonecrosis
|
0.00%
0/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Musculoskeletal and connective tissue disorders
Osteoporosis
|
0.00%
0/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Musculoskeletal and connective tissue disorders
Osteoporotic fracture
|
0.04%
1/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.17%
4/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.13%
3/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.26%
6/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Musculoskeletal and connective tissue disorders
Pathological fracture
|
0.04%
1/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Musculoskeletal and connective tissue disorders
Periarthritis
|
0.00%
0/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.13%
3/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Musculoskeletal and connective tissue disorders
Rhabdomyolysis
|
0.09%
2/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.21%
5/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Musculoskeletal and connective tissue disorders
Rotator cuff syndrome
|
0.04%
1/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.26%
6/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Musculoskeletal and connective tissue disorders
Spinal column stenosis
|
0.26%
6/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.09%
2/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Musculoskeletal and connective tissue disorders
Spinal osteoarthritis
|
0.13%
3/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.09%
2/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Musculoskeletal and connective tissue disorders
Spinal pain
|
0.00%
0/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Musculoskeletal and connective tissue disorders
Spondylitis
|
0.04%
1/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Musculoskeletal and connective tissue disorders
Spondylolisthesis
|
0.00%
0/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Musculoskeletal and connective tissue disorders
Synovitis
|
0.00%
0/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Musculoskeletal and connective tissue disorders
Tendonitis
|
0.04%
1/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Musculoskeletal and connective tissue disorders
Tenosynovitis stenosans
|
0.00%
0/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Musculoskeletal and connective tissue disorders
Trigger finger
|
0.00%
0/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acoustic neuroma
|
0.00%
0/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.13%
3/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acute lymphocytic leukaemia
|
0.00%
0/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acute myeloid leukaemia
|
0.00%
0/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma
|
0.00%
0/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma gastric
|
0.09%
2/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma of colon
|
0.09%
2/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.09%
2/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.09%
2/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma pancreas
|
0.09%
2/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.13%
3/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.13%
3/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenoma benign
|
0.00%
0/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Anogenital warts
|
0.00%
0/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
B-cell lymphoma
|
0.04%
1/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
0.69%
16/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.64%
15/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.51%
12/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basosquamous carcinoma
|
0.00%
0/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign hepatic neoplasm
|
0.04%
1/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign lung neoplasm
|
0.09%
2/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign neoplasm of adrenal gland
|
0.00%
0/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign neoplasm of bladder
|
0.04%
1/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign neoplasm of prostate
|
0.04%
1/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign neoplasm of thyroid gland
|
0.00%
0/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign pancreatic neoplasm
|
0.00%
0/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign respiratory tract neoplasm
|
0.00%
0/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign uterine neoplasm
|
0.00%
0/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bile duct cancer
|
0.00%
0/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder cancer
|
0.00%
0/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.21%
5/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder cancer recurrent
|
0.00%
0/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder transitional cell carcinoma
|
0.00%
0/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bone cancer
|
0.04%
1/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bone giant cell tumour benign
|
0.00%
0/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bowen's disease
|
0.00%
0/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.09%
2/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Brain neoplasm
|
0.00%
0/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.09%
2/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.09%
2/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.09%
2/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bronchial carcinoma
|
0.00%
0/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cardiac myxoma
|
0.04%
1/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cervix carcinoma
|
0.00%
0/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cholesteatoma
|
0.04%
1/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Chronic lymphocytic leukaemia
|
0.00%
0/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.13%
3/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Clear cell renal cell carcinoma
|
0.13%
3/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.09%
2/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon adenoma
|
0.04%
1/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer
|
0.09%
2/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.21%
5/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer metastatic
|
0.04%
1/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.13%
3/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon neoplasm
|
0.04%
1/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colorectal adenocarcinoma
|
0.00%
0/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colorectal cancer
|
0.00%
0/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Endometrial cancer
|
0.00%
0/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Fibroadenoma of breast
|
0.04%
1/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Fibrosarcoma
|
0.00%
0/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Follicular thyroid cancer
|
0.00%
0/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastric cancer
|
0.00%
0/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastrointestinal stromal tumour
|
0.00%
0/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Genital neoplasm malignant female
|
0.00%
0/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Haemangioma of bone
|
0.00%
0/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Haemangioma of liver
|
0.04%
1/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hepatic neoplasm
|
0.00%
0/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hepatocellular carcinoma
|
0.04%
1/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.13%
3/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hodgkin's disease stage I
|
0.04%
1/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Intraductal proliferative breast lesion
|
0.00%
0/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Invasive ductal breast carcinoma
|
0.00%
0/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Keratoacanthoma
|
0.00%
0/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.09%
2/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Large cell lung cancer
|
0.04%
1/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Laryngeal cancer
|
0.00%
0/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.09%
2/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Laryngeal squamous cell carcinoma
|
0.00%
0/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.09%
2/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lipoma
|
0.00%
0/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung adenocarcinoma
|
0.09%
2/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.21%
5/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.13%
3/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung cancer metastatic
|
0.00%
0/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung carcinoma cell type unspecified stage III
|
0.04%
1/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm malignant
|
0.13%
3/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.30%
7/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung squamous cell carcinoma stage III
|
0.04%
1/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lymphocytic lymphoma
|
0.04%
1/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lymphoma
|
0.00%
0/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lymphoproliferative disorder
|
0.00%
0/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant melanoma
|
0.04%
1/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.13%
3/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.13%
3/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant melanoma in situ
|
0.00%
0/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant neoplasm of unknown primary site
|
0.04%
1/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant neoplasm progression
|
0.00%
0/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Meningioma
|
0.00%
0/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.09%
2/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to bone
|
0.00%
0/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.09%
2/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to liver
|
0.13%
3/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.21%
5/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.21%
5/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to lung
|
0.04%
1/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.09%
2/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.09%
2/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to lymph nodes
|
0.00%
0/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to neck
|
0.00%
0/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to peritoneum
|
0.00%
0/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to pleura
|
0.04%
1/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastasis
|
0.00%
0/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastatic malignant melanoma
|
0.04%
1/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastatic renal cell carcinoma
|
0.00%
0/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Myelodysplastic syndrome
|
0.04%
1/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Nasopharyngeal cancer
|
0.00%
0/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.09%
2/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neuroendocrine carcinoma
|
0.04%
1/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neuroendocrine carcinoma of the skin
|
0.00%
0/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Non-Hodgkin's lymphoma
|
0.04%
1/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Non-Hodgkin's lymphoma stage IV
|
0.00%
0/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Oesophageal adenocarcinoma
|
0.04%
1/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Oesophageal carcinoma
|
0.09%
2/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
POEMS syndrome
|
0.00%
0/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic carcinoma
|
0.00%
0/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.09%
2/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.09%
2/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Papillary serous endometrial carcinoma
|
0.00%
0/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Papillary thyroid cancer
|
0.04%
1/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Parathyroid tumour benign
|
0.04%
1/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Penile squamous cell carcinoma
|
0.00%
0/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pituitary tumour benign
|
0.00%
0/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Plasma cell myeloma
|
0.04%
1/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.09%
2/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.39%
9/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.47%
11/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.38%
9/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer recurrent
|
0.00%
0/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostatic adenoma
|
0.00%
0/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.09%
2/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Rectal adenocarcinoma
|
0.00%
0/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.17%
4/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.13%
3/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Rectal cancer
|
0.00%
0/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.13%
3/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal cancer
|
0.00%
0/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal cancer metastatic
|
0.00%
0/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal cell carcinoma
|
0.04%
1/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.09%
2/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal cell carcinoma stage I
|
0.00%
0/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal cell carcinoma stage II
|
0.04%
1/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Salivary gland adenoma
|
0.00%
0/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Salivary gland neoplasm
|
0.04%
1/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Sarcoma
|
0.00%
0/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Skin cancer
|
0.04%
1/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Small cell carcinoma
|
0.04%
1/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Small cell lung cancer
|
0.00%
0/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Splenic marginal zone lymphoma
|
0.00%
0/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma
|
0.13%
3/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.26%
6/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.13%
3/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of lung
|
0.04%
1/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.13%
3/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of skin
|
0.30%
7/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.17%
4/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.13%
3/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of the oral cavity
|
0.04%
1/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Thyroid neoplasm
|
0.00%
0/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tongue neoplasm malignant stage unspecified
|
0.00%
0/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Transitional cell carcinoma
|
0.13%
3/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour haemorrhage
|
0.00%
0/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine cancer
|
0.00%
0/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine leiomyoma
|
0.00%
0/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Nervous system disorders
Altered state of consciousness
|
0.00%
0/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Nervous system disorders
Amnesia
|
0.04%
1/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Nervous system disorders
Aphasia
|
0.04%
1/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Nervous system disorders
Autonomic neuropathy
|
0.04%
1/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Nervous system disorders
Balance disorder
|
0.04%
1/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Nervous system disorders
Brain oedema
|
0.00%
0/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Nervous system disorders
Brain stem haemorrhage
|
0.00%
0/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Nervous system disorders
Brain stem infarction
|
0.00%
0/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.09%
2/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Nervous system disorders
Brain stem ischaemia
|
0.04%
1/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Nervous system disorders
Brain stem stroke
|
0.00%
0/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Nervous system disorders
Carotid arteriosclerosis
|
0.04%
1/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Nervous system disorders
Carotid artery disease
|
0.00%
0/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Nervous system disorders
Carotid artery occlusion
|
0.04%
1/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.17%
4/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Nervous system disorders
Carotid artery stenosis
|
0.43%
10/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.30%
7/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.51%
12/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Nervous system disorders
Carotid artery thrombosis
|
0.00%
0/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Nervous system disorders
Carpal tunnel syndrome
|
0.13%
3/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Nervous system disorders
Central nervous system inflammation
|
0.00%
0/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Nervous system disorders
Cerebellar infarction
|
0.04%
1/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.09%
2/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.09%
2/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Nervous system disorders
Cerebral arteriosclerosis
|
0.04%
1/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Nervous system disorders
Cerebral artery occlusion
|
0.04%
1/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Nervous system disorders
Cerebral artery stenosis
|
0.00%
0/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Nervous system disorders
Cerebral ataxia
|
0.04%
1/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Nervous system disorders
Cerebral infarction
|
0.30%
7/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.30%
7/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.47%
11/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Nervous system disorders
Cerebral ischaemia
|
0.04%
1/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.13%
3/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Nervous system disorders
Cerebrovascular accident
|
1.3%
31/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
2.0%
46/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
1.6%
37/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Nervous system disorders
Cerebrovascular disorder
|
0.09%
2/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Nervous system disorders
Cerebrovascular insufficiency
|
0.00%
0/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Nervous system disorders
Cervical cord compression
|
0.04%
1/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Nervous system disorders
Cervical myelopathy
|
0.04%
1/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.09%
2/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Nervous system disorders
Cervical radiculopathy
|
0.09%
2/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Nervous system disorders
Cognitive disorder
|
0.00%
0/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.09%
2/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Nervous system disorders
Complex partial seizures
|
0.04%
1/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Nervous system disorders
Coordination abnormal
|
0.00%
0/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Nervous system disorders
Dementia Alzheimer's type
|
0.00%
0/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Nervous system disorders
Diabetic neuropathy
|
0.09%
2/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.09%
2/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Nervous system disorders
Dizziness
|
0.21%
5/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.34%
8/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.21%
5/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Nervous system disorders
Dysarthria
|
0.00%
0/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Nervous system disorders
Embolic cerebral infarction
|
0.00%
0/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Nervous system disorders
Embolic stroke
|
0.13%
3/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Nervous system disorders
Encephalopathy
|
0.04%
1/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Nervous system disorders
Epilepsy
|
0.00%
0/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.09%
2/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.09%
2/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Nervous system disorders
Generalised tonic-clonic seizure
|
0.00%
0/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Nervous system disorders
Guillain-Barre syndrome
|
0.04%
1/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Nervous system disorders
Haemorrhage intracranial
|
0.09%
2/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Nervous system disorders
Haemorrhagic cerebral infarction
|
0.04%
1/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Nervous system disorders
Haemorrhagic stroke
|
0.17%
4/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Nervous system disorders
Headache
|
0.09%
2/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Nervous system disorders
Hemiparesis
|
0.00%
0/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.09%
2/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Nervous system disorders
Hemiplegia
|
0.00%
0/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Nervous system disorders
Hydrocephalus
|
0.00%
0/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Nervous system disorders
Hypercapnic coma
|
0.04%
1/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Nervous system disorders
Hyperkinesia
|
0.04%
1/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Nervous system disorders
Hypertensive encephalopathy
|
0.09%
2/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Nervous system disorders
Hypoaesthesia
|
0.04%
1/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Nervous system disorders
Hypoglycaemic coma
|
0.00%
0/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Nervous system disorders
Hypotonia
|
0.00%
0/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Nervous system disorders
IIIrd nerve paralysis
|
0.00%
0/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Nervous system disorders
Intercostal neuralgia
|
0.04%
1/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.09%
2/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Nervous system disorders
Ischaemic cerebral infarction
|
0.04%
1/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Nervous system disorders
Ischaemic stroke
|
0.94%
22/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.77%
18/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.85%
20/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Nervous system disorders
Lacunar infarction
|
0.09%
2/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.09%
2/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Nervous system disorders
Leukoencephalopathy
|
0.00%
0/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Nervous system disorders
Loss of consciousness
|
0.09%
2/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.09%
2/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Nervous system disorders
Lumbar radiculopathy
|
0.04%
1/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Nervous system disorders
Metabolic encephalopathy
|
0.00%
0/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Nervous system disorders
Migraine
|
0.04%
1/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Nervous system disorders
Mononeuritis
|
0.04%
1/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Nervous system disorders
Monoplegia
|
0.04%
1/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Nervous system disorders
Muscle spasticity
|
0.00%
0/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Nervous system disorders
Myelitis transverse
|
0.00%
0/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Nervous system disorders
Myelopathy
|
0.00%
0/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Nervous system disorders
Myoclonus
|
0.00%
0/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Nervous system disorders
Nerve root compression
|
0.00%
0/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Nervous system disorders
Neuroleptic malignant syndrome
|
0.04%
1/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Nervous system disorders
Neuropathy peripheral
|
0.09%
2/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Nervous system disorders
Paraesthesia
|
0.04%
1/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Nervous system disorders
Paraparesis
|
0.00%
0/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Nervous system disorders
Paraplegia
|
0.00%
0/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Nervous system disorders
Parkinson's disease
|
0.04%
1/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Nervous system disorders
Partial seizures
|
0.09%
2/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Nervous system disorders
Peripheral motor neuropathy
|
0.04%
1/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Nervous system disorders
Peroneal nerve palsy
|
0.04%
1/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Nervous system disorders
Petit mal epilepsy
|
0.00%
0/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Nervous system disorders
Piriformis syndrome
|
0.04%
1/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Nervous system disorders
Presyncope
|
0.00%
0/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Nervous system disorders
Radiculopathy
|
0.00%
0/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Nervous system disorders
Sciatica
|
0.04%
1/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.09%
2/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Nervous system disorders
Seizure
|
0.17%
4/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.30%
7/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.21%
5/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Nervous system disorders
Sensory disturbance
|
0.00%
0/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Nervous system disorders
Spinal cord compression
|
0.00%
0/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Nervous system disorders
Spinal epidural haematoma
|
0.00%
0/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Nervous system disorders
Spondylitic myelopathy
|
0.00%
0/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Nervous system disorders
Subarachnoid haemorrhage
|
0.13%
3/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.13%
3/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.09%
2/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Nervous system disorders
Subdural hygroma
|
0.04%
1/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Nervous system disorders
Syncope
|
0.34%
8/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.38%
9/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.77%
18/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Nervous system disorders
Thalamic infarction
|
0.04%
1/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Nervous system disorders
Thrombotic cerebral infarction
|
0.04%
1/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Nervous system disorders
Thrombotic stroke
|
0.00%
0/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Nervous system disorders
Transient ischaemic attack
|
0.99%
23/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.98%
23/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
1.3%
30/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Nervous system disorders
VIIth nerve paralysis
|
0.04%
1/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Nervous system disorders
Vascular encephalopathy
|
0.04%
1/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Nervous system disorders
Vertebral artery dissection
|
0.00%
0/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Nervous system disorders
Vertebral artery stenosis
|
0.00%
0/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Nervous system disorders
Vertebrobasilar insufficiency
|
0.13%
3/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Nervous system disorders
Vocal cord paresis
|
0.00%
0/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Psychiatric disorders
Anxiety
|
0.17%
4/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Psychiatric disorders
Confusional state
|
0.09%
2/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.13%
3/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Psychiatric disorders
Delirium
|
0.00%
0/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.09%
2/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Psychiatric disorders
Depression
|
0.21%
5/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Psychiatric disorders
Hallucination
|
0.00%
0/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Psychiatric disorders
Major depression
|
0.00%
0/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Psychiatric disorders
Mental status changes
|
0.17%
4/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Psychiatric disorders
Rapid eye movements sleep abnormal
|
0.00%
0/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Psychiatric disorders
Substance abuse
|
0.00%
0/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Psychiatric disorders
Suicidal ideation
|
0.00%
0/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Psychiatric disorders
Suicide attempt
|
0.04%
1/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Renal and urinary disorders
Acute kidney injury
|
1.4%
32/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
1.1%
26/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.81%
19/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Renal and urinary disorders
Acute prerenal failure
|
0.09%
2/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Renal and urinary disorders
Albuminuria
|
0.04%
1/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Renal and urinary disorders
Anuria
|
0.04%
1/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Renal and urinary disorders
Bladder neck sclerosis
|
0.04%
1/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Renal and urinary disorders
Bladder outlet obstruction
|
0.00%
0/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Renal and urinary disorders
Calculus bladder
|
0.00%
0/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Renal and urinary disorders
Calculus ureteric
|
0.17%
4/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.09%
2/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Renal and urinary disorders
Calculus urinary
|
0.09%
2/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Renal and urinary disorders
Chronic kidney disease
|
0.13%
3/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.09%
2/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.17%
4/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Renal and urinary disorders
Cystitis glandularis
|
0.00%
0/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Renal and urinary disorders
Cystitis haemorrhagic
|
0.04%
1/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Renal and urinary disorders
Diabetic nephropathy
|
0.09%
2/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.09%
2/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.09%
2/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Renal and urinary disorders
Dysuria
|
0.04%
1/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Renal and urinary disorders
Haematuria
|
0.17%
4/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.09%
2/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Renal and urinary disorders
Hydronephrosis
|
0.09%
2/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.09%
2/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Renal and urinary disorders
Hypertensive nephropathy
|
0.00%
0/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Renal and urinary disorders
Lower urinary tract symptoms
|
0.00%
0/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Renal and urinary disorders
Microalbuminuria
|
0.00%
0/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Renal and urinary disorders
Nephritis
|
0.00%
0/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.13%
3/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.13%
3/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.30%
7/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Renal and urinary disorders
Nephropathy
|
0.04%
1/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Renal and urinary disorders
Nephrotic syndrome
|
0.00%
0/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Renal and urinary disorders
Obstructive uropathy
|
0.00%
0/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Renal and urinary disorders
Oliguria
|
0.04%
1/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Renal and urinary disorders
Polyuria
|
0.04%
1/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Renal and urinary disorders
Renal artery arteriosclerosis
|
0.04%
1/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Renal and urinary disorders
Renal artery stenosis
|
0.00%
0/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Renal and urinary disorders
Renal colic
|
0.04%
1/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Renal and urinary disorders
Renal cyst
|
0.00%
0/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Renal and urinary disorders
Renal failure
|
0.43%
10/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.09%
2/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.17%
4/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Renal and urinary disorders
Renal impairment
|
0.09%
2/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.09%
2/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.17%
4/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Renal and urinary disorders
Renal infarct
|
0.00%
0/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.09%
2/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Renal and urinary disorders
Renal tubular necrosis
|
0.04%
1/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Renal and urinary disorders
Stress urinary incontinence
|
0.04%
1/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Renal and urinary disorders
Tubulointerstitial nephritis
|
0.00%
0/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Renal and urinary disorders
Ureteric obstruction
|
0.00%
0/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.09%
2/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Renal and urinary disorders
Urethral stenosis
|
0.09%
2/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.17%
4/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Renal and urinary disorders
Urinary bladder haemorrhage
|
0.00%
0/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Renal and urinary disorders
Urinary bladder polyp
|
0.09%
2/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Renal and urinary disorders
Urinary incontinence
|
0.09%
2/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Renal and urinary disorders
Urinary retention
|
0.13%
3/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.17%
4/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.21%
5/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Renal and urinary disorders
Urinary tract obstruction
|
0.00%
0/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Reproductive system and breast disorders
Benign prostatic hyperplasia
|
0.26%
6/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.34%
8/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.43%
10/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Reproductive system and breast disorders
Cystocele
|
0.00%
0/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Reproductive system and breast disorders
Endometrial hyperplasia
|
0.04%
1/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Reproductive system and breast disorders
Fibrocystic breast disease
|
0.00%
0/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Reproductive system and breast disorders
Genital prolapse
|
0.00%
0/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Reproductive system and breast disorders
Gynaecomastia
|
0.00%
0/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Reproductive system and breast disorders
Menorrhagia
|
0.00%
0/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Reproductive system and breast disorders
Ovarian cyst
|
0.00%
0/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Reproductive system and breast disorders
Prostatic obstruction
|
0.04%
1/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Reproductive system and breast disorders
Prostatism
|
0.00%
0/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.09%
2/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Reproductive system and breast disorders
Prostatitis
|
0.09%
2/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.09%
2/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.09%
2/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Reproductive system and breast disorders
Uterine polyp
|
0.00%
0/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Reproductive system and breast disorders
Uterine prolapse
|
0.00%
0/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Reproductive system and breast disorders
Uterovaginal prolapse
|
0.00%
0/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Reproductive system and breast disorders
Vaginal prolapse
|
0.04%
1/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Acute pulmonary oedema
|
0.21%
5/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.30%
7/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory distress syndrome
|
0.09%
2/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.17%
4/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.21%
5/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.13%
3/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Allergic sinusitis
|
0.00%
0/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.26%
6/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.17%
4/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.09%
2/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
0.00%
0/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.13%
3/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Bronchial disorder
|
0.04%
1/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Bronchial secretion retention
|
0.00%
0/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Bronchiectasis
|
0.00%
0/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Bronchitis chronic
|
0.00%
0/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.09%
2/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm
|
0.09%
2/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.47%
11/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.26%
6/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.43%
10/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.60%
14/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.26%
6/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.38%
9/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
0.09%
2/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Emphysema
|
0.00%
0/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.04%
1/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.13%
3/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.09%
2/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.17%
4/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Haemothorax
|
0.04%
1/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Hydrothorax
|
0.04%
1/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.04%
1/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.09%
2/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Idiopathic pulmonary fibrosis
|
0.04%
1/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Interstitial lung disease
|
0.00%
0/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.09%
2/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal oedema
|
0.00%
0/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Lung disorder
|
0.04%
1/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Lung infiltration
|
0.04%
1/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Mediastinal haematoma
|
0.00%
0/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Nasal polyps
|
0.00%
0/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Obstructive airways disorder
|
0.00%
0/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Paranasal cyst
|
0.00%
0/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.17%
4/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.17%
4/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Pleural fibrosis
|
0.00%
0/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Pleurisy
|
0.00%
0/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Pleuritic pain
|
0.04%
1/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
0.09%
2/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Vascular disorders
Iliac artery occlusion
|
0.04%
1/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.09%
2/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.04%
1/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.04%
1/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary arterial hypertension
|
0.04%
1/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary congestion
|
0.00%
0/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.09%
2/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary fibrosis
|
0.00%
0/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary hypertension
|
0.21%
5/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.09%
2/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary mass
|
0.04%
1/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
0.21%
5/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.09%
2/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary thrombosis
|
0.00%
0/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary toxicity
|
0.04%
1/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory arrest
|
0.00%
0/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory distress
|
0.00%
0/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.39%
9/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.09%
2/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.17%
4/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Sinus disorder
|
0.00%
0/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Sleep apnoea syndrome
|
0.17%
4/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Status asthmaticus
|
0.00%
0/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Upper airway obstruction
|
0.00%
0/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Vocal cord polyp
|
0.00%
0/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Vocal cord thickening
|
0.00%
0/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Skin and subcutaneous tissue disorders
Angioedema
|
0.04%
1/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.13%
3/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Skin and subcutaneous tissue disorders
Cold sweat
|
0.00%
0/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Skin and subcutaneous tissue disorders
Dermal cyst
|
0.04%
1/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
0.04%
1/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Skin and subcutaneous tissue disorders
Diabetic bullosis
|
0.04%
1/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Skin and subcutaneous tissue disorders
Diabetic foot
|
0.51%
12/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.43%
10/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.47%
11/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.00%
0/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Skin and subcutaneous tissue disorders
Erythrodermic psoriasis
|
0.00%
0/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Skin and subcutaneous tissue disorders
Ingrowing nail
|
0.04%
1/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Skin and subcutaneous tissue disorders
Leukoplakia
|
0.00%
0/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Skin and subcutaneous tissue disorders
Neuropathic ulcer
|
0.04%
1/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Skin and subcutaneous tissue disorders
Pemphigus
|
0.00%
0/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Skin and subcutaneous tissue disorders
Skin fibrosis
|
0.00%
0/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Skin and subcutaneous tissue disorders
Skin necrosis
|
0.04%
1/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
0.43%
10/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.26%
6/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.47%
11/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Skin and subcutaneous tissue disorders
Skin ulcer haemorrhage
|
0.00%
0/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Social circumstances
Physical assault
|
0.00%
0/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Surgical and medical procedures
Angioplasty
|
0.04%
1/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Surgical and medical procedures
Coronary angioplasty
|
0.13%
3/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.09%
2/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Surgical and medical procedures
Coronary arterial stent insertion
|
0.04%
1/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.09%
2/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Surgical and medical procedures
Coronary artery bypass
|
0.17%
4/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.13%
3/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.17%
4/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Surgical and medical procedures
Coronary revascularisation
|
0.21%
5/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.09%
2/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.17%
4/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Surgical and medical procedures
Fracture treatment
|
0.04%
1/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Surgical and medical procedures
Percutaneous coronary intervention
|
0.00%
0/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.09%
2/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.13%
3/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Surgical and medical procedures
Prophylaxis
|
0.04%
1/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Surgical and medical procedures
Stent placement
|
0.00%
0/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.09%
2/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Vascular disorders
Accelerated hypertension
|
0.00%
0/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Vascular disorders
Aneurysm
|
0.00%
0/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Vascular disorders
Angiopathy
|
0.04%
1/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Vascular disorders
Aortic aneurysm
|
0.04%
1/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.13%
3/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.17%
4/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Vascular disorders
Aortic arteriosclerosis
|
0.04%
1/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Vascular disorders
Aortic dissection
|
0.04%
1/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Vascular disorders
Aortic stenosis
|
0.17%
4/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.09%
2/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.13%
3/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Vascular disorders
Arterial disorder
|
0.17%
4/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Vascular disorders
Arterial haemorrhage
|
0.00%
0/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Vascular disorders
Arterial occlusive disease
|
0.00%
0/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Vascular disorders
Arterial stenosis
|
0.13%
3/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Vascular disorders
Arteriosclerosis
|
0.09%
2/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Vascular disorders
Arteriovenous fistula
|
0.04%
1/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Vascular disorders
Arteritis
|
0.00%
0/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.13%
3/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Vascular disorders
Deep vein thrombosis
|
0.21%
5/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.13%
3/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.43%
10/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Vascular disorders
Diabetic microangiopathy
|
0.04%
1/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Vascular disorders
Embolism
|
0.04%
1/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Vascular disorders
Embolism arterial
|
0.00%
0/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Vascular disorders
Extremity necrosis
|
0.21%
5/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.17%
4/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.34%
8/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Vascular disorders
Femoral artery embolism
|
0.00%
0/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Vascular disorders
Femoral artery occlusion
|
0.04%
1/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.13%
3/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.21%
5/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Vascular disorders
Haematoma
|
0.00%
0/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.09%
2/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Vascular disorders
Haemorrhage
|
0.04%
1/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Vascular disorders
Hypertension
|
0.43%
10/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.17%
4/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.30%
7/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Vascular disorders
Hypertensive crisis
|
0.34%
8/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.13%
3/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.17%
4/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Vascular disorders
Hypertensive emergency
|
0.09%
2/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Vascular disorders
Hypotension
|
0.39%
9/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.21%
5/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.17%
4/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Vascular disorders
Hypovolaemic shock
|
0.09%
2/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Vascular disorders
Infarction
|
0.04%
1/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.09%
2/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Vascular disorders
Intermittent claudication
|
0.09%
2/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.17%
4/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.21%
5/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Vascular disorders
Ischaemia
|
0.09%
2/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.09%
2/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Vascular disorders
Leriche syndrome
|
0.04%
1/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Vascular disorders
Malignant hypertension
|
0.00%
0/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Vascular disorders
Orthostatic hypotension
|
0.09%
2/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.13%
3/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Vascular disorders
Peripheral arterial occlusive disease
|
0.99%
23/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
1.2%
28/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
1.3%
30/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Vascular disorders
Peripheral artery aneurysm
|
0.04%
1/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Vascular disorders
Peripheral artery stenosis
|
0.26%
6/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.13%
3/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.38%
9/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Vascular disorders
Peripheral artery thrombosis
|
0.00%
0/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Vascular disorders
Peripheral coldness
|
0.00%
0/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Vascular disorders
Peripheral embolism
|
0.04%
1/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Vascular disorders
Peripheral ischaemia
|
0.39%
9/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.17%
4/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.47%
11/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Vascular disorders
Peripheral vascular disorder
|
0.34%
8/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.13%
3/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.26%
6/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Vascular disorders
Peripheral venous disease
|
0.04%
1/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Vascular disorders
Subclavian artery stenosis
|
0.00%
0/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Vascular disorders
Thrombophlebitis
|
0.09%
2/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Vascular disorders
Thrombophlebitis superficial
|
0.04%
1/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Vascular disorders
Thrombosis
|
0.09%
2/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.09%
2/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.09%
2/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Vascular disorders
Varicose ulceration
|
0.04%
1/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Vascular disorders
Varicose vein
|
0.09%
2/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Vascular disorders
Vascular calcification
|
0.04%
1/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Vascular disorders
Vascular insufficiency
|
0.00%
0/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Vascular disorders
Venous occlusion
|
0.04%
1/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Vascular disorders
Venous thrombosis
|
0.00%
0/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Vascular disorders
Venous thrombosis limb
|
0.00%
0/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.00%
0/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
0.04%
1/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
Other adverse events
| Measure |
Placebo
n=2333 participants at risk
Oral administration of Placebo matching empagliflozin 10 mg or 25 mg (1 tablet once daily)
|
Empagliflozin 10 mg
n=2345 participants at risk
Oral administration of Empagliflozin 10 mg (BI 10773) film coated tablets (1 tablet once daily)
|
Empagliflozin 25 mg
n=2342 participants at risk
Oral administration of Empagliflozin 25 mg (BI 10773) film coated tablets (1 tablet once daily)
|
|---|---|---|---|
|
Gastrointestinal disorders
Constipation
|
4.7%
109/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
3.9%
91/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
5.1%
119/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Gastrointestinal disorders
Diarrhoea
|
7.3%
171/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
6.2%
145/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
6.1%
144/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
General disorders
Oedema peripheral
|
6.6%
155/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
3.6%
84/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
3.2%
75/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Infections and infestations
Bronchitis
|
7.0%
164/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
5.5%
129/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
5.0%
117/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Infections and infestations
Influenza
|
7.1%
165/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
5.7%
134/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
6.4%
149/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Infections and infestations
Nasopharyngitis
|
9.3%
217/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
9.0%
210/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
9.4%
220/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Infections and infestations
Upper respiratory tract infection
|
8.5%
199/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
8.1%
191/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
7.5%
175/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Infections and infestations
Urinary tract infection
|
14.7%
344/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
14.5%
339/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
14.4%
337/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
18.1%
423/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
9.3%
217/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
8.6%
202/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
29.4%
685/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
29.6%
694/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
28.7%
673/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
5.6%
130/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
4.6%
107/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
6.3%
148/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
6.3%
148/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
6.4%
149/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
7.1%
166/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
5.7%
133/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
4.9%
114/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
4.3%
101/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Nervous system disorders
Dizziness
|
6.5%
151/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
7.2%
170/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
7.4%
173/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Nervous system disorders
Headache
|
5.3%
123/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
4.3%
100/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
5.3%
124/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
6.3%
146/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
5.1%
119/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
4.6%
108/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
|
Vascular disorders
Hypertension
|
9.0%
210/2333 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
6.6%
154/2345 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
7.5%
176/2342 • All AEs, serious and non-serious, occurring during the course of the clinical trial (from randomisation through the follow-up period); up to 5 years
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Boehringer Ingelheim (BI) acknowledges that investigators have the right to publish the study results. Investigators shall provide BI with a copy of any publication or presentation for review prior to any submission. Such review will be done with regard to proprietary information, information related to patentable inventions, medical, scientific, and statistical accuracy within 60 days. BI may request a delay of the publication in order to protect BI's intellectual property rights
- Publication restrictions are in place
Restriction type: OTHER