Trial Outcomes & Findings for Registry for Ambulant Therapy With RAS-Inhibitors in Hypertension-patients in Germany (NCT NCT01454583)
NCT ID: NCT01454583
Last Updated: 2016-07-21
Results Overview
Relative change of systolic office blood pressure since baseline, i.e. SBP at baseline minus SBP after 1 year, the difference divided by the baseline value, multiplied by 100
Recruitment status
COMPLETED
Target enrollment
15337 participants
Primary outcome timeframe
baseline and 1 year
Results posted on
2016-07-21
Participant Flow
Participant milestones
| Measure |
Aliskiren
Patients treated with Aliskiren (DRI) at baseline. In the 3rd year period, only patients with Diabetes Mellitus (DM) or Heart Failure (HF) were considered.
|
ACE-I/ARB
Patients treated with ACE-I or ARB (ARB/ACE-I) at baseline. In the 3rd year period, only patients with Diabetes Mellitus (DM) or Heart Failure (HF) were considered.
|
No RAS-inhibition
Patients treated with no RAS-inhibition drugs at baseline. In the 3rd year period, only patients with Diabetes Mellitus (DM) or Heart Failure (HF) were considered.
|
|---|---|---|---|
|
1st Year
STARTED
|
10177
|
2696
|
2113
|
|
1st Year
COMPLETED
|
9120
|
2378
|
1933
|
|
1st Year
NOT COMPLETED
|
1057
|
318
|
180
|
|
2nd Year
STARTED
|
10177
|
2696
|
2113
|
|
2nd Year
COMPLETED
|
6212
|
1647
|
1376
|
|
2nd Year
NOT COMPLETED
|
3965
|
1049
|
737
|
|
3rd Year
STARTED
|
3791
|
982
|
582
|
|
3rd Year
COMPLETED
|
1832
|
470
|
285
|
|
3rd Year
NOT COMPLETED
|
1959
|
512
|
297
|
Reasons for withdrawal
| Measure |
Aliskiren
Patients treated with Aliskiren (DRI) at baseline. In the 3rd year period, only patients with Diabetes Mellitus (DM) or Heart Failure (HF) were considered.
|
ACE-I/ARB
Patients treated with ACE-I or ARB (ARB/ACE-I) at baseline. In the 3rd year period, only patients with Diabetes Mellitus (DM) or Heart Failure (HF) were considered.
|
No RAS-inhibition
Patients treated with no RAS-inhibition drugs at baseline. In the 3rd year period, only patients with Diabetes Mellitus (DM) or Heart Failure (HF) were considered.
|
|---|---|---|---|
|
1st Year
Lost to Follow-up
|
1057
|
318
|
180
|
|
2nd Year
Lost to Follow-up
|
3965
|
1049
|
737
|
|
3rd Year
Lost to Follow-up
|
1959
|
512
|
297
|
Baseline Characteristics
Registry for Ambulant Therapy With RAS-Inhibitors in Hypertension-patients in Germany
Baseline characteristics by cohort
| Measure |
Group A
n=10177 Participants
Patients treated with Aliskiren (DRI)
|
Group B
n=2696 Participants
Patients treated with ACE-I or ARB (ARB/ACE-I)
|
Group C
n=2113 Participants
Patients without any RAS inhibition (No-RAS-I)
|
Total
n=14986 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
5109 Participants
n=99 Participants
|
1300 Participants
n=107 Participants
|
1181 Participants
n=206 Participants
|
7590 Participants
n=7 Participants
|
|
Age, Categorical
>=65 years
|
5068 Participants
n=99 Participants
|
1396 Participants
n=107 Participants
|
932 Participants
n=206 Participants
|
7396 Participants
n=7 Participants
|
|
Age, Continuous
|
63.6 years
STANDARD_DEVIATION 12.06 • n=99 Participants
|
63.7 years
STANDARD_DEVIATION 11.92 • n=107 Participants
|
61.3 years
STANDARD_DEVIATION 13.36 • n=206 Participants
|
63.3 years
STANDARD_DEVIATION 12.26 • n=7 Participants
|
|
Sex: Female, Male
Female
|
4658 Participants
n=99 Participants
|
1229 Participants
n=107 Participants
|
1085 Participants
n=206 Participants
|
6972 Participants
n=7 Participants
|
|
Sex: Female, Male
Male
|
5519 Participants
n=99 Participants
|
1467 Participants
n=107 Participants
|
1028 Participants
n=206 Participants
|
8014 Participants
n=7 Participants
|
PRIMARY outcome
Timeframe: baseline and 1 yearRelative change of systolic office blood pressure since baseline, i.e. SBP at baseline minus SBP after 1 year, the difference divided by the baseline value, multiplied by 100
Outcome measures
| Measure |
Group B
n=2321 Participants
Patients treated with ACE-I or ARB (ARB/ACE-I)
|
Group C
n=1896 Participants
Patients without any RAS inhibition (No-RAS-I)
|
Group A
n=8880 Participants
Patients treated with Aliskiren (DRI)
|
|---|---|---|---|
|
Efficacy of Hypertension Treatment on Systolic Blood Pressure (SBP)
|
9.7 percent change
Standard Deviation 12.4
|
9.9 percent change
Standard Deviation 12.8
|
11.8 percent change
Standard Deviation 12.5
|
PRIMARY outcome
Timeframe: Baseline and 1 yearRelative change of diastolic office blood pressure since baseline, i.e. DBP at baseline minus DBP after 1 year, the difference divided by the baseline value, multiplied by 100
Outcome measures
| Measure |
Group B
n=2321 Participants
Patients treated with ACE-I or ARB (ARB/ACE-I)
|
Group C
n=1896 Participants
Patients without any RAS inhibition (No-RAS-I)
|
Group A
n=8880 Participants
Patients treated with Aliskiren (DRI)
|
|---|---|---|---|
|
Efficacy of Hypertension Treatment on Diastolic Blood Pressure (DBP)
|
7.7 percent change
Standard Deviation 12.9
|
8.0 percent change
Standard Deviation 13.5
|
8.9 percent change
Standard Deviation 13.0
|
PRIMARY outcome
Timeframe: Baseline and 2 yearsPopulation: Patients with RR measurement at baseline and 2 years follow-up
Relative change of systolic office blood pressure since baseline, i.e. SBP at baseline minus SBP after 2 years, the difference divided by the baseline value, multiplied by 100
Outcome measures
| Measure |
Group B
n=1610 Participants
Patients treated with ACE-I or ARB (ARB/ACE-I)
|
Group C
n=1345 Participants
Patients without any RAS inhibition (No-RAS-I)
|
Group A
n=6055 Participants
Patients treated with Aliskiren (DRI)
|
|---|---|---|---|
|
Efficacy of Hypertension Treatment on Systolic Blood Pressure (SBP)
|
10.0 percent change
Standard Deviation 13.5
|
10.4 percent change
Standard Deviation 12.7
|
12.8 percent change
Standard Deviation 12.9
|
PRIMARY outcome
Timeframe: Baseline and 2 yearsRelative change of diastolic office blood pressure since baseline, i.e. DBP at baseline minus DBP after 1 year, the difference divided by the baseline value, multiplied by 100
Outcome measures
| Measure |
Group B
n=1609 Participants
Patients treated with ACE-I or ARB (ARB/ACE-I)
|
Group C
n=1345 Participants
Patients without any RAS inhibition (No-RAS-I)
|
Group A
n=6054 Participants
Patients treated with Aliskiren (DRI)
|
|---|---|---|---|
|
Efficacy of Hypertension Treatment on Diastolic Office Blood Pressure (DBP)
|
8.5 percent change
Standard Deviation 13.5
|
8.9 percent change
Standard Deviation 13.4
|
10.3 percent change
Standard Deviation 13.0
|
PRIMARY outcome
Timeframe: Baseline and 3 yearsPopulation: Patients with DM or HF and RR measurement at baseline and 3 years follow-up
Relative change of systolic office blood pressure since baseline, i.e. SBP at baseline minus SBP after 3 years, the difference divided by the baseline value, multiplied by 100
Outcome measures
| Measure |
Group B
n=433 Participants
Patients treated with ACE-I or ARB (ARB/ACE-I)
|
Group C
n=264 Participants
Patients without any RAS inhibition (No-RAS-I)
|
Group A
n=1700 Participants
Patients treated with Aliskiren (DRI)
|
|---|---|---|---|
|
Efficacy of Hypertension Treatment on Systolic Blood Pressure (SBP)
|
8.9 percent change
Standard Deviation 14.2
|
9.4 percent change
Standard Deviation 13.1
|
12.0 percent change
Standard Deviation 13.4
|
PRIMARY outcome
Timeframe: Baseline and 3 yearsRelative change of diastolic office blood pressure since baseline, i.e. DBP at baseline minus DBP after 3 years, the difference divided by the baseline value, multiplied by 100
Outcome measures
| Measure |
Group B
n=433 Participants
Patients treated with ACE-I or ARB (ARB/ACE-I)
|
Group C
n=264 Participants
Patients without any RAS inhibition (No-RAS-I)
|
Group A
n=1700 Participants
Patients treated with Aliskiren (DRI)
|
|---|---|---|---|
|
Efficacy of Hypertension Treatment on Diastolic Blood Pressure (DBP)
|
6.2 percent change
Standard Deviation 14.2
|
6.4 percent change
Standard Deviation 14.2
|
9.1 percent change
Standard Deviation 13.6
|
SECONDARY outcome
Timeframe: Baseline and 1 yearPercentage of patients not having changed the therapy group after 1 year (DRI, ARB/ACE-I, or No-RAS-I, referring to their therapy at baseline)
Outcome measures
| Measure |
Group B
n=2378 Participants
Patients treated with ACE-I or ARB (ARB/ACE-I)
|
Group C
n=1933 Participants
Patients without any RAS inhibition (No-RAS-I)
|
Group A
n=9120 Participants
Patients treated with Aliskiren (DRI)
|
|---|---|---|---|
|
Therapy Adherence Regarding Drug Treatment
|
94.9 percentage of patients
|
85.0 percentage of patients
|
92.8 percentage of patients
|
SECONDARY outcome
Timeframe: Baseline and 2 yearsPercentage of patients not having changed the therapy group after 2 years (DRI, ARB/ACE-I, or No-RAS-I, referring to their therapy at baseline)
Outcome measures
| Measure |
Group B
n=1647 Participants
Patients treated with ACE-I or ARB (ARB/ACE-I)
|
Group C
n=1376 Participants
Patients without any RAS inhibition (No-RAS-I)
|
Group A
n=6212 Participants
Patients treated with Aliskiren (DRI)
|
|---|---|---|---|
|
Therapy Adherence Regarding Drug Treatment
|
89.7 percentage of patients
|
72.5 percentage of patients
|
85.2 percentage of patients
|
SECONDARY outcome
Timeframe: Baseline and 3 yearsPercentage of patients not having changed the therapy group after 3 years (DRI, ARB/ACE-I, or No-RAS-I, referring to their therapy at baseline)
Outcome measures
| Measure |
Group B
n=470 Participants
Patients treated with ACE-I or ARB (ARB/ACE-I)
|
Group C
n=285 Participants
Patients without any RAS inhibition (No-RAS-I)
|
Group A
n=1832 Participants
Patients treated with Aliskiren (DRI)
|
|---|---|---|---|
|
Therapy Adherence Regarding Drug Treatment
|
82.1 percentage of patients
|
60.7 percentage of patients
|
65.8 percentage of patients
|
SECONDARY outcome
Timeframe: 1 year follow upPercentage of participants that experienced at least one adverse event during the first year of observation period
Outcome measures
| Measure |
Group B
n=2696 Participants
Patients treated with ACE-I or ARB (ARB/ACE-I)
|
Group C
n=2113 Participants
Patients without any RAS inhibition (No-RAS-I)
|
Group A
n=10177 Participants
Patients treated with Aliskiren (DRI)
|
|---|---|---|---|
|
Adverse Events
|
4.1 percentage of patients
|
3.4 percentage of patients
|
5.3 percentage of patients
|
SECONDARY outcome
Timeframe: 2 years follow upPercentage of participants that experienced at least one adverse event during the first two years of observation period
Outcome measures
| Measure |
Group B
n=2696 Participants
Patients treated with ACE-I or ARB (ARB/ACE-I)
|
Group C
n=2113 Participants
Patients without any RAS inhibition (No-RAS-I)
|
Group A
n=10177 Participants
Patients treated with Aliskiren (DRI)
|
|---|---|---|---|
|
Adverse Events
|
6.6 percentage of patients
|
5.3 percentage of patients
|
7.2 percentage of patients
|
SECONDARY outcome
Timeframe: 3 years follow upPercentage of participants that experienced at least one adverse event during the three years of observation period
Outcome measures
| Measure |
Group B
n=982 Participants
Patients treated with ACE-I or ARB (ARB/ACE-I)
|
Group C
n=582 Participants
Patients without any RAS inhibition (No-RAS-I)
|
Group A
n=3791 Participants
Patients treated with Aliskiren (DRI)
|
|---|---|---|---|
|
Adverse Events
|
12.6 percentage of patients
|
9.5 percentage of patients
|
12.9 percentage of patients
|
SECONDARY outcome
Timeframe: Baseline and 1 yearRelative change of ambulatory, systolic 24h BP means since baseline, i.e. 24h SBP means at baseline minus corresponding means after 1 year, the differences divided by the baseline value, multiplied by 100. Mean SBP of a patient was calculated as the arithmetic mean of automatically recorded SBP values over a contiguous period of 24 h.
Outcome measures
| Measure |
Group B
n=532 Participants
Patients treated with ACE-I or ARB (ARB/ACE-I)
|
Group C
n=358 Participants
Patients without any RAS inhibition (No-RAS-I)
|
Group A
n=2015 Participants
Patients treated with Aliskiren (DRI)
|
|---|---|---|---|
|
Therapeutic Success of Hypertension Treatment on Systolic Blood Pressure (SBP) as Measured by 24-hour Blood Pressure Measurement
|
5.9 percent change
Standard Deviation 10.0
|
5.3 percent change
Standard Deviation 8.6
|
7.0 percent change
Standard Deviation 10.0
|
SECONDARY outcome
Timeframe: Baseline and 1 yearRelative change of ambulatory, diastolic 24h BP means since baseline, i.e. 24h DBP means at baseline minus corresponding means after 1 year, the differences divided by the baseline value, multiplied by 100. Mean DBP of a patient was calculated as the arithmetic mean of automatically recorded DBP values over a contiguous period of 24 h.
Outcome measures
| Measure |
Group B
n=532 Participants
Patients treated with ACE-I or ARB (ARB/ACE-I)
|
Group C
n=358 Participants
Patients without any RAS inhibition (No-RAS-I)
|
Group A
n=2015 Participants
Patients treated with Aliskiren (DRI)
|
|---|---|---|---|
|
Therapeutic Success of Hypertension Treatment on Diastolic Blood Pressure (DBP) as Measured by 24-hour Blood Pressure Measurement
|
5.2 percent change
Standard Deviation 11.4
|
5.9 percent change
Standard Deviation 10.1
|
6.5 percent change
Standard Deviation 11.9
|
SECONDARY outcome
Timeframe: Baseline and 2 yearsRelative change of ambulatory, systolic 24h BP means since baseline, i.e. 24h SBP means at baseline minus corresponding means after 2 years, the differences divided by the baseline value, multiplied by 100. Mean SBP of a patient was calculated as the arithmetic mean of automatically recorded SBP values over a contiguous period of 24 h.
Outcome measures
| Measure |
Group B
n=237 Participants
Patients treated with ACE-I or ARB (ARB/ACE-I)
|
Group C
n=186 Participants
Patients without any RAS inhibition (No-RAS-I)
|
Group A
n=988 Participants
Patients treated with Aliskiren (DRI)
|
|---|---|---|---|
|
Therapeutic Success of Hypertension Treatment on Systolic Blood Pressure (SBP) as Measured by 24-hour Blood Pressure Measurement
|
6.6 percent change
Standard Deviation 11.1
|
7.2 percent change
Standard Deviation 9.1
|
8.3 percent change
Standard Deviation 10.7
|
SECONDARY outcome
Timeframe: Baseline and 2 yearsRelative change of ambulatory, diastolic 24h BP means since baseline, i.e. 24h DBP means at baseline minus corresponding means after 2 years, the differences divided by the baseline value, multiplied by 100. Mean DBP of a patient was calculated as the arithmetic mean of automatically recorded DBP values over a contiguous period of 24 h.
Outcome measures
| Measure |
Group B
n=237 Participants
Patients treated with ACE-I or ARB (ARB/ACE-I)
|
Group C
n=186 Participants
Patients without any RAS inhibition (No-RAS-I)
|
Group A
n=988 Participants
Patients treated with Aliskiren (DRI)
|
|---|---|---|---|
|
Therapeutic Success of Hypertension Treatment on Diastolic Blood Pressure (DBP) as Measured by 24-hour Blood Pressure Measurement
|
5.6 percent change
Standard Deviation 14.6
|
6.7 percent change
Standard Deviation 11.2
|
7.7 percent change
Standard Deviation 12.0
|
SECONDARY outcome
Timeframe: Baseline and 3 yearsRelative change of ambulatory, systolic 24h BP means since baseline, i.e. 24h SBP means at baseline minus corresponding means after 3 years, the differences divided by the baseline value, multiplied by 100. Mean SBP of a patient was calculated as the arithmetic mean of automatically recorded SBP values over a contiguous period of 24 h.
Outcome measures
| Measure |
Group B
n=51 Participants
Patients treated with ACE-I or ARB (ARB/ACE-I)
|
Group C
n=31 Participants
Patients without any RAS inhibition (No-RAS-I)
|
Group A
n=279 Participants
Patients treated with Aliskiren (DRI)
|
|---|---|---|---|
|
Therapeutic Success of Hypertension Treatment on Systolic Blood Pressure (SBP) as Measured by 24-hour Blood Pressure Measurement
|
6.1 percent change
Standard Deviation 11.2
|
7.3 percent change
Standard Deviation 11.8
|
7.9 percent change
Standard Deviation 12.4
|
SECONDARY outcome
Timeframe: Baseline and 3 yearsRelative change of ambulatory, diastolic 24h BP means since baseline, i.e. 24h DBP means at baseline minus corresponding means after 3 years, the differences divided by the baseline value, multiplied by 100. Mean DBP of a patient was calculated as the arithmetic mean of automatically recorded DBP values over a contiguous period of 24 h.
Outcome measures
| Measure |
Group B
n=51 Participants
Patients treated with ACE-I or ARB (ARB/ACE-I)
|
Group C
n=31 Participants
Patients without any RAS inhibition (No-RAS-I)
|
Group A
n=279 Participants
Patients treated with Aliskiren (DRI)
|
|---|---|---|---|
|
Therapeutic Success of Hypertension Treatment on Diastolic Blood Pressure (DBP) as Measured by 24-hour Blood Pressure Measurement
|
5.3 percent change
Standard Deviation 12.4
|
6.4 percent change
Standard Deviation 11.4
|
5.4 percent change
Standard Deviation 14.8
|
SECONDARY outcome
Timeframe: 1 year follow upImprovement of the estimated glomerular filtration rate (eGFR, using the CKD-EPI equation) by more than 2.5ml/min/1.73m², compared to baseline
Outcome measures
| Measure |
Group B
n=2302 Participants
Patients treated with ACE-I or ARB (ARB/ACE-I)
|
Group C
n=1893 Participants
Patients without any RAS inhibition (No-RAS-I)
|
Group A
n=8884 Participants
Patients treated with Aliskiren (DRI)
|
|---|---|---|---|
|
Influence of Anti-hypertensive Treatment on Renal Function
|
32.1 percentage of patients
|
34.1 percentage of patients
|
33.5 percentage of patients
|
SECONDARY outcome
Timeframe: 2 years follow upImprovement of the estimated glomerular filtration rate (eGFR, using the CKD-EPI equation) by more than 2.5ml/min/1.73m², compared to baseline
Outcome measures
| Measure |
Group B
n=1600 Participants
Patients treated with ACE-I or ARB (ARB/ACE-I)
|
Group C
n=1344 Participants
Patients without any RAS inhibition (No-RAS-I)
|
Group A
n=6039 Participants
Patients treated with Aliskiren (DRI)
|
|---|---|---|---|
|
Influence of Anti-hypertensive Treatment on Renal Function
|
32.6 percentage of patients
|
33.9 percentage of patients
|
32.8 percentage of patients
|
SECONDARY outcome
Timeframe: 3 years follow upImprovement of the estimated glomerular filtration rate (eGFR, using the CKD-EPI equation) by more than 2.5ml/min/1.73m², compared to baseline
Outcome measures
| Measure |
Group B
n=429 Participants
Patients treated with ACE-I or ARB (ARB/ACE-I)
|
Group C
n=262 Participants
Patients without any RAS inhibition (No-RAS-I)
|
Group A
n=1678 Participants
Patients treated with Aliskiren (DRI)
|
|---|---|---|---|
|
Influence of Anti-hypertensive Treatment on Renal Function
|
28.2 percentage of patients
|
28.6 percentage of patients
|
32.7 percentage of patients
|
Adverse Events
Group A
Serious events: 649 serious events
Other events: 211 other events
Deaths: 0 deaths
Group B
Serious events: 136 serious events
Other events: 41 other events
Deaths: 0 deaths
Group C
Serious events: 84 serious events
Other events: 14 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Group A
n=10177 participants at risk
Patients treated with Aliskiren (DRI)
|
Group B
n=2696 participants at risk
Patients treated with ACE-I or ARB (ARB/ACE-I)
|
Group C
n=2113 participants at risk
Patients without any RAS inhibition (No-RAS-I)
|
|---|---|---|---|
|
Cardiac disorders
Angina pectoris
|
0.48%
49/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.45%
12/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.24%
5/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Cardiac disorders
Cardiac failure
|
0.51%
52/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.37%
10/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.14%
3/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Cardiac disorders
Atrial fibrillation
|
0.45%
46/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.37%
10/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.05%
1/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Cardiac disorders
Coronary artery disease
|
0.35%
36/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.30%
8/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.09%
2/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Cardiac disorders
Myocardial infarction
|
0.27%
27/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.11%
3/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.33%
7/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Cardiac disorders
Acute myocardial infarction
|
0.14%
14/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.22%
6/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.05%
1/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Cardiac disorders
Left ventricular hypertrophy
|
0.17%
17/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.11%
3/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Cardiac disorders
Arrhythmia
|
0.10%
10/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.04%
1/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Cardiac disorders
Tachyarrhythmia
|
0.09%
9/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.04%
1/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Cardiac disorders
Angina unstable
|
0.09%
9/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Cardiac disorders
Atrioventricular block complete
|
0.05%
5/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.04%
1/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.05%
1/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Cardiac disorders
Cardiac arrest
|
0.04%
4/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.07%
2/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.05%
1/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Cardiac disorders
Tachycardia
|
0.07%
7/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Cardiac disorders
Coronary artery stenosis
|
0.06%
6/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Cardiac disorders
Left ventricular dysfunction
|
0.06%
6/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Cardiac disorders
Ventricular fibrillation
|
0.03%
3/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.07%
2/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.05%
1/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Cardiac disorders
Aortic valve stenosis
|
0.03%
3/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.04%
1/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.05%
1/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Cardiac disorders
Bradyarrhythmia
|
0.05%
5/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Cardiac disorders
Aortic valve incompetence
|
0.04%
4/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Cardiac disorders
Atrial flutter
|
0.03%
3/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.04%
1/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Cardiac disorders
Bradycardia
|
0.04%
4/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Cardiac disorders
Bundle branch block left
|
0.03%
3/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.04%
1/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Cardiac disorders
Cardiovascular disorder
|
0.03%
3/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.04%
1/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Cardiac disorders
Hypertensive heart disease
|
0.02%
2/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.04%
1/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.05%
1/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Cardiac disorders
Myocardial ischaemia
|
0.04%
4/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Cardiac disorders
Acute coronary syndrome
|
0.03%
3/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Cardiac disorders
Arteriosclerosis coronary artery
|
0.02%
2/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.04%
1/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Cardiac disorders
Atrioventricular block
|
0.02%
2/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.05%
1/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Cardiac disorders
Cardiac disorder
|
0.03%
3/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Cardiac disorders
Cardiogenic shock
|
0.03%
3/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Cardiac disorders
Congestive cardiomyopathy
|
0.02%
2/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.04%
1/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Cardiac disorders
Mitral valve incompetence
|
0.03%
3/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Cardiac disorders
Ventricular extrasystoles
|
0.02%
2/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.04%
1/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Cardiac disorders
Atrioventricular block second degree
|
0.02%
2/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Cardiac disorders
Cardiac failure chronic
|
0.02%
2/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Cardiac disorders
Cardiomyopathy
|
0.01%
1/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.04%
1/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Cardiac disorders
Cardiopulmonary failure
|
0.01%
1/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.04%
1/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Cardiac disorders
Coronary artery occlusion
|
0.02%
2/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Cardiac disorders
Coronary ostial stenosis
|
0.00%
0/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.07%
2/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Cardiac disorders
Ischaemic cardiomyopathy
|
0.02%
2/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Cardiac disorders
Left ventricular failure
|
0.02%
2/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Cardiac disorders
Right ventricular failure
|
0.02%
2/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Cardiac disorders
Supraventricular extrasystoles
|
0.02%
2/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Cardiac disorders
Acute left ventricular failure
|
0.01%
1/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Cardiac disorders
Adams-Stokes syndrome
|
0.01%
1/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Cardiac disorders
Aortic valve sclerosis
|
0.01%
1/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Cardiac disorders
Bifascicular block
|
0.01%
1/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Cardiac disorders
Cardiac failure acute
|
0.00%
0/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.05%
1/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Cardiac disorders
Cardiac failure congestive
|
0.00%
0/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.05%
1/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Cardiac disorders
Cardiomyopathy alcoholic
|
0.01%
1/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Cardiac disorders
Chordae tendinae rupture
|
0.01%
1/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Cardiac disorders
Conduction disorder
|
0.01%
1/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Cardiac disorders
Cor pulmonale
|
0.00%
0/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.05%
1/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Cardiac disorders
Coronary artery insufficiency
|
0.01%
1/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Cardiac disorders
Cyanosis
|
0.01%
1/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Cardiac disorders
Extrasystoles
|
0.01%
1/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Cardiac disorders
Heart alternation
|
0.01%
1/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Cardiac disorders
Intracardiac thrombus
|
0.01%
1/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Cardiac disorders
Myocardial rupture
|
0.01%
1/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Cardiac disorders
Palpitations
|
0.01%
1/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Cardiac disorders
Pericarditis
|
0.01%
1/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Cardiac disorders
Sick sinus syndrome
|
0.00%
0/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.04%
1/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Cardiac disorders
Sinoatrial block
|
0.01%
1/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Cardiac disorders
Sudden cardiac death
|
0.00%
0/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.05%
1/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Cardiac disorders
Supraventricular tachyarrhythmia
|
0.01%
1/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Cardiac disorders
Syncope
|
0.00%
0/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.04%
1/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Cardiac disorders
Tricuspid valve incompetence
|
0.01%
1/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Cardiac disorders
Ventricular dysfunction
|
0.00%
0/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.04%
1/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Cardiac disorders
Ventricular failure
|
0.01%
1/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Cardiac disorders
Ventricular hypertrophy
|
0.01%
1/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Cardiac disorders
Ventricular tachycardia
|
0.01%
1/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Investigations
Blood pressure increased
|
0.40%
41/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.15%
4/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.05%
1/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Investigations
Blood creatinine increased
|
0.13%
13/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.07%
2/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Investigations
Electrocardiogram QRS complex prolonged
|
0.13%
13/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.05%
1/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Investigations
Blood pressure decreased
|
0.11%
11/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.04%
1/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Investigations
Catheterisation cardiac
|
0.08%
8/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.07%
2/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.05%
1/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Investigations
Blood pressure systolic increased
|
0.09%
9/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Investigations
Glycosylated haemoglobin increased
|
0.09%
9/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Investigations
Blood glucose increased
|
0.07%
7/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.04%
1/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Skin and subcutaneous tissue disorders
Petechiae
|
0.01%
1/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Investigations
Blood pressure diastolic decreased
|
0.07%
7/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.05%
1/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Investigations
Electrocardiogram QT prolonged
|
0.07%
7/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.04%
1/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Investigations
Angiogram
|
0.06%
6/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.04%
1/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Investigations
Arteriogram coronary
|
0.05%
5/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.04%
1/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.05%
1/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Investigations
Heart rate decreased
|
0.06%
6/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.04%
1/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Investigations
Blood triglycerides increased
|
0.06%
6/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Investigations
Blood potassium increased
|
0.05%
5/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Investigations
Haemoglobin decreased
|
0.04%
4/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.04%
1/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Skin and subcutaneous tissue disorders
Pigmentation disorder
|
0.01%
1/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Investigations
Arthroscopy
|
0.02%
2/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.04%
1/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Investigations
Liver function test abnormal
|
0.02%
2/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.04%
1/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Investigations
Albumin urine present
|
0.02%
2/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Investigations
C-reactive protein increased
|
0.01%
1/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.05%
1/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Investigations
Creatinine urine increased
|
0.01%
1/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.04%
1/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Investigations
Heart rate increased
|
0.02%
2/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.01%
1/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Investigations
Laboratory test abnormal
|
0.02%
2/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Investigations
Alanine aminotransferase increased
|
0.01%
1/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Investigations
Arterial catheterisation
|
0.01%
1/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Investigations
Aspartate aminotransferase increased
|
0.01%
1/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Investigations
Blood alkaline phosphatase increased
|
0.01%
1/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Investigations
Blood bilirubin increased
|
0.01%
1/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Investigations
Blood cholesterol increased
|
0.01%
1/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.01%
1/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Investigations
Blood glucose abnormal
|
0.01%
1/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Investigations
Blood potassium
|
0.01%
1/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Investigations
Blood pressure diastolic increased
|
0.01%
1/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Investigations
Blood pressure systolic decreased
|
0.01%
1/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Investigations
Blood sodium increased
|
0.01%
1/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Investigations
Cardiac enzymes increased
|
0.01%
1/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Investigations
Coagulation factor decreased
|
0.01%
1/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Investigations
Ejection fraction abnormal
|
0.01%
1/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Investigations
Electrocardiogram QRS complex abnormal
|
0.01%
1/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Investigations
Electrocardiogram abnormal
|
0.01%
1/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Investigations
Endoscopy upper gastrointestinal tract
|
0.01%
1/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Investigations
Gamma-glutamyltransferase increased
|
0.01%
1/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Investigations
General physical condition abnormal
|
0.01%
1/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Investigations
Hepatic enzyme increased
|
0.01%
1/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Investigations
LDL/HDL ratio increased
|
0.01%
1/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Investigations
Pathology test
|
0.01%
1/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Investigations
QRS axis
|
0.01%
1/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Investigations
Urine albumin/creatinine ratio increased
|
0.01%
1/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Investigations
Weight increased
|
0.01%
1/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Vascular disorders
Hypertensive crisis
|
0.76%
77/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.33%
9/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.19%
4/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Vascular disorders
Hypertension
|
0.40%
41/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.15%
4/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.19%
4/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Vascular disorders
Peripheral arterial occlusive disease
|
0.11%
11/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.04%
1/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Vascular disorders
Circulatory collapse
|
0.07%
7/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.04%
1/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Vascular disorders
Blood pressure inadequately controlled
|
0.05%
5/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.04%
1/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Vascular disorders
Hypotension
|
0.05%
5/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Skin and subcutaneous tissue disorders
Swelling face
|
0.01%
1/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Vascular disorders
Arterial occlusive disease
|
0.03%
3/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Vascular disorders
Deep vein thrombosis
|
0.03%
3/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Vascular disorders
Infarction
|
0.03%
3/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Vascular disorders
Venous insufficiency
|
0.01%
1/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.04%
1/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.05%
1/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Vascular disorders
Venous thrombosis
|
0.02%
2/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.05%
1/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Vascular disorders
Aneurysm
|
0.02%
2/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Vascular disorders
Aortic aneurysm
|
0.02%
2/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Vascular disorders
Aortic aneurysm rupture
|
0.00%
0/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.09%
2/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Vascular disorders
Aortic arteriosclerosis
|
0.02%
2/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Vascular disorders
Aortic dissection
|
0.00%
0/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.04%
1/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.05%
1/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Vascular disorders
Aortic stenosis
|
0.02%
2/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Vascular disorders
Arteriosclerosis
|
0.02%
2/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Vascular disorders
Blood pressure fluctuation
|
0.02%
2/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Vascular disorders
Pelvic venous thrombosis
|
0.02%
2/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Vascular disorders
Thrombophlebitis
|
0.01%
1/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.04%
1/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Vascular disorders
Thrombosis
|
0.02%
2/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Vascular disorders
Antiphospholipid syndrome
|
0.00%
0/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.04%
1/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Vascular disorders
Arterial haemorrhage
|
0.01%
1/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Vascular disorders
Arterial stenosis
|
0.01%
1/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Vascular disorders
Cerebrovascular accident
|
0.00%
0/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.05%
1/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Vascular disorders
Embolism
|
0.01%
1/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Vascular disorders
Femoral artery occlusion
|
0.01%
1/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Vascular disorders
Haematoma
|
0.01%
1/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Vascular disorders
Haemorrhage
|
0.01%
1/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Vascular disorders
Hypertensive emergency
|
0.01%
1/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Vascular disorders
Intermittent claudication
|
0.01%
1/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Vascular disorders
Leriche syndrome
|
0.01%
1/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Vascular disorders
Lymphocele
|
0.01%
1/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Vascular disorders
Macroangiopathy
|
0.01%
1/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Vascular disorders
Malignant hypertension
|
0.01%
1/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Vascular disorders
Peripheral vascular disorder
|
0.01%
1/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Vascular disorders
Vascular compression
|
0.00%
0/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.04%
1/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Vascular disorders
Venous stenosis
|
0.01%
1/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Vascular disorders
Withdrawal hypertension
|
0.00%
0/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.04%
1/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.07%
7/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.40%
41/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.19%
5/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.52%
11/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Nervous system disorders
Syncope
|
0.14%
14/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.15%
4/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Nervous system disorders
Transient ischaemic attack
|
0.16%
16/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.07%
2/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Nervous system disorders
Dizziness
|
0.07%
7/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.07%
2/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.05%
1/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Nervous system disorders
Hemiparesis
|
0.07%
7/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.04%
1/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Nervous system disorders
Cerebral infarction
|
0.02%
2/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.11%
3/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.05%
1/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Nervous system disorders
Aphasia
|
0.04%
4/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.04%
1/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Nervous system disorders
Carotid artery stenosis
|
0.05%
5/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Nervous system disorders
Cerebral ischaemia
|
0.05%
5/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Nervous system disorders
Cerebral haemorrhage
|
0.03%
3/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Nervous system disorders
Coma
|
0.02%
2/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.04%
1/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Nervous system disorders
Diabetic neuropathy
|
0.01%
1/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.07%
2/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Nervous system disorders
Headache
|
0.01%
1/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.04%
1/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.05%
1/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Nervous system disorders
Loss of consciousness
|
0.03%
3/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Nervous system disorders
Parkinson's disease
|
0.02%
2/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.05%
1/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Nervous system disorders
Autonomic nervous system imbalance
|
0.01%
1/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.04%
1/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Nervous system disorders
Carotid artery occlusion
|
0.02%
2/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Nervous system disorders
Convulsion
|
0.02%
2/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Nervous system disorders
Dementia
|
0.02%
2/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Nervous system disorders
Hypoxic-ischaemic encephalopathy
|
0.01%
1/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.05%
1/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Nervous system disorders
Ischaemic stroke
|
0.02%
2/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Nervous system disorders
Speech disorder
|
0.02%
2/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Nervous system disorders
Thalamic infarction
|
0.01%
1/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.05%
1/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Nervous system disorders
Amnesia
|
0.01%
1/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Nervous system disorders
Apallic syndrome
|
0.01%
1/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Nervous system disorders
Brain injury
|
0.01%
1/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Nervous system disorders
Brain stem infarction
|
0.01%
1/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Nervous system disorders
Brain stem ischaemia
|
0.01%
1/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Nervous system disorders
Brain stem stroke
|
0.01%
1/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Nervous system disorders
Carotid artery dissection
|
0.01%
1/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Nervous system disorders
Cerebellar infarction
|
0.01%
1/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Nervous system disorders
Cerebral artery embolism
|
0.01%
1/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Nervous system disorders
Cerebral disorder
|
0.01%
1/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Nervous system disorders
Coma hepatic
|
0.01%
1/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Nervous system disorders
Dementia Alzheimer's type
|
0.01%
1/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Nervous system disorders
Demyelination
|
0.00%
0/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.04%
1/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Nervous system disorders
Disturbance in attention
|
0.01%
1/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Nervous system disorders
Dysarthria
|
0.01%
1/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Nervous system disorders
Embolic stroke
|
0.01%
1/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Nervous system disorders
Epilepsy
|
0.01%
1/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Nervous system disorders
Facial paresis
|
0.01%
1/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Nervous system disorders
Haemorrhage intracranial
|
0.01%
1/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Nervous system disorders
Hemiplegia
|
0.01%
1/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Nervous system disorders
Hepatic encephalopathy
|
0.01%
1/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Nervous system disorders
Hypertonia
|
0.01%
1/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Nervous system disorders
Hypotonia
|
0.01%
1/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Nervous system disorders
IIIrd nerve paresis
|
0.00%
0/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.04%
1/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Nervous system disorders
Intercostal neuralgia
|
0.01%
1/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Nervous system disorders
Memory impairment
|
0.00%
0/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.04%
1/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Nervous system disorders
Monoplegia
|
0.01%
1/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Nervous system disorders
Movement disorder
|
0.01%
1/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Nervous system disorders
Muscle spasticity
|
0.01%
1/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Nervous system disorders
Myelitis
|
0.00%
0/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.04%
1/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Nervous system disorders
Nervous system disorder
|
0.01%
1/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Nervous system disorders
Neurological symptom
|
0.01%
1/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Nervous system disorders
Orthostatic intolerance
|
0.00%
0/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.04%
1/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Nervous system disorders
Paralysis
|
0.01%
1/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Nervous system disorders
Paresis
|
0.01%
1/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Nervous system disorders
Parkinsonism
|
0.01%
1/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Nervous system disorders
Polyneuropathy
|
0.00%
0/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.04%
1/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Nervous system disorders
Somnolence
|
0.00%
0/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.04%
1/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Nervous system disorders
VIIth nerve paralysis
|
0.01%
1/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
General disorders
Death
|
0.14%
14/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.26%
7/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.66%
14/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
General disorders
Chest pain
|
0.13%
13/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.07%
2/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.09%
2/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
General disorders
Sudden cardiac death
|
0.13%
13/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.11%
3/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.05%
1/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
General disorders
Condition aggravated
|
0.12%
12/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.05%
1/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
General disorders
Multi-organ failure
|
0.08%
8/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
General disorders
Chest discomfort
|
0.06%
6/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.05%
1/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
General disorders
Oedema peripheral
|
0.06%
6/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.04%
1/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
General disorders
Pyrexia
|
0.06%
6/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
General disorders
General physical health deterioration
|
0.04%
4/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.05%
1/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
General disorders
Pain
|
0.02%
2/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.04%
1/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.05%
1/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
General disorders
Asthenia
|
0.03%
3/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
General disorders
Cardiac death
|
0.03%
3/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
General disorders
Oedema
|
0.03%
3/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
General disorders
Gait disturbance
|
0.02%
2/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
General disorders
Inflammation
|
0.02%
2/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
General disorders
Sudden death
|
0.01%
1/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.04%
1/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
General disorders
Accidental death
|
0.00%
0/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.05%
1/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
General disorders
Concomitant disease progression
|
0.01%
1/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
General disorders
Device failure
|
0.00%
0/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.04%
1/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
General disorders
Drug ineffective
|
0.01%
1/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
General disorders
Drug intolerance
|
0.01%
1/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
General disorders
Drug therapeutic incompatibility
|
0.01%
1/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
General disorders
Fatigue
|
0.01%
1/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
General disorders
Generalised oedema
|
0.01%
1/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
General disorders
Malaise
|
0.01%
1/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
General disorders
No adverse event
|
0.00%
0/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.04%
1/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
General disorders
Ulcer
|
0.01%
1/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.40%
41/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.07%
2/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.14%
3/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.10%
10/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.04%
1/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.05%
1/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.10%
10/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.05%
1/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
0.06%
6/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.04%
1/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.07%
7/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
0.05%
5/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.04%
1/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.03%
3/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.04%
1/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.03%
3/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Respiratory, thoracic and mediastinal disorders
Hyperventilation
|
0.03%
3/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Respiratory, thoracic and mediastinal disorders
Emphysema
|
0.01%
1/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.05%
1/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Respiratory, thoracic and mediastinal disorders
Lung disorder
|
0.02%
2/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
0.01%
1/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.04%
1/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary congestion
|
0.02%
2/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory distress
|
0.00%
0/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.09%
2/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Respiratory, thoracic and mediastinal disorders
Sleep apnoea syndrome
|
0.02%
2/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.01%
1/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
0.01%
1/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.01%
1/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchial disorder
|
0.00%
0/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.05%
1/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchial secretion retention
|
0.01%
1/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic respiratory failure
|
0.01%
1/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.01%
1/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea at rest
|
0.01%
1/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.01%
1/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Respiratory, thoracic and mediastinal disorders
Interstitial lung disease
|
0.01%
1/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Respiratory, thoracic and mediastinal disorders
Obstructive airways disorder
|
0.01%
1/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural disorder
|
0.01%
1/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Respiratory, thoracic and mediastinal disorders
Snoring
|
0.00%
0/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.04%
1/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Respiratory, thoracic and mediastinal disorders
Stridor
|
0.01%
1/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Surgical and medical procedures
Percutaneous coronary intervention
|
0.22%
22/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.04%
1/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.05%
1/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Surgical and medical procedures
Coronary angioplasty
|
0.10%
10/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.04%
1/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.05%
1/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Surgical and medical procedures
Stent placement
|
0.10%
10/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.04%
1/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.05%
1/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Surgical and medical procedures
Surgery
|
0.08%
8/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.07%
2/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Surgical and medical procedures
Vascular graft
|
0.08%
8/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.04%
1/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.05%
1/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Surgical and medical procedures
Coronary arterial stent insertion
|
0.04%
4/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.11%
3/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.05%
1/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Surgical and medical procedures
Coronary artery bypass
|
0.06%
6/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.07%
2/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Surgical and medical procedures
Implantable defibrillator insertion
|
0.08%
8/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Surgical and medical procedures
Rehabilitation therapy
|
0.06%
6/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.04%
1/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Surgical and medical procedures
Angioplasty
|
0.04%
4/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.04%
1/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Surgical and medical procedures
Cardiac pacemaker insertion
|
0.04%
4/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.05%
1/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Surgical and medical procedures
Arterial stent insertion
|
0.03%
3/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.04%
1/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Surgical and medical procedures
Cardioversion
|
0.01%
1/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.11%
3/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Surgical and medical procedures
Hospitalisation
|
0.00%
0/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.07%
2/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.09%
2/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Surgical and medical procedures
Aortic valve replacement
|
0.01%
1/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.04%
1/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Surgical and medical procedures
Cholecystectomy
|
0.01%
1/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.04%
1/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Surgical and medical procedures
Colectomy
|
0.02%
2/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Surgical and medical procedures
Dialysis
|
0.01%
1/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.05%
1/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Surgical and medical procedures
Haemodialysis
|
0.02%
2/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Surgical and medical procedures
Knee arthroplasty
|
0.01%
1/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.05%
1/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Surgical and medical procedures
Sigmoidectomy
|
0.01%
1/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.04%
1/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Surgical and medical procedures
Varicose vein operation
|
0.02%
2/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Surgical and medical procedures
Adrenalectomy
|
0.01%
1/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Surgical and medical procedures
Aortic bypass
|
0.00%
0/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.05%
1/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Surgical and medical procedures
Bursa removal
|
0.01%
1/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Surgical and medical procedures
Cardiac pacemaker revision
|
0.00%
0/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.05%
1/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Surgical and medical procedures
Cardiac rehabilitation therapy
|
0.01%
1/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Surgical and medical procedures
Carotid artery stent insertion
|
0.01%
1/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Surgical and medical procedures
Cataract operation
|
0.01%
1/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Surgical and medical procedures
Catheter placement
|
0.01%
1/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Surgical and medical procedures
Central venous catheterisation
|
0.01%
1/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Surgical and medical procedures
Cerebrovascular operation
|
0.01%
1/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Surgical and medical procedures
Eye operation
|
0.01%
1/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Surgical and medical procedures
Female genital operation
|
0.01%
1/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Surgical and medical procedures
Gastrostomy tube insertion
|
0.01%
1/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Surgical and medical procedures
Haematoma evacuation
|
0.01%
1/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Surgical and medical procedures
Inguinal hernia repair
|
0.00%
0/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.04%
1/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Surgical and medical procedures
Knee operation
|
0.01%
1/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Surgical and medical procedures
Lymphadenectomy
|
0.01%
1/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Surgical and medical procedures
Malignant tumour excision
|
0.01%
1/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Surgical and medical procedures
Mastectomy
|
0.01%
1/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Surgical and medical procedures
Mechanical ventilation
|
0.01%
1/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Surgical and medical procedures
Mitral valve repair
|
0.01%
1/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Surgical and medical procedures
Peripheral artery angioplasty
|
0.01%
1/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Surgical and medical procedures
Phlebectomy
|
0.00%
0/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.05%
1/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Surgical and medical procedures
Resuscitation
|
0.01%
1/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Surgical and medical procedures
Spinal fusion surgery
|
0.00%
0/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.05%
1/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Surgical and medical procedures
Therapeutic procedure
|
0.01%
1/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Surgical and medical procedures
Tracheostomy
|
0.01%
1/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Surgical and medical procedures
Tumour excision
|
0.00%
0/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.04%
1/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Infections and infestations
Pneumonia
|
0.18%
18/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.04%
1/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.09%
2/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Infections and infestations
Sepsis
|
0.08%
8/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.11%
3/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Infections and infestations
Infection
|
0.04%
4/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.05%
1/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Infections and infestations
Bronchopneumonia
|
0.03%
3/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Infections and infestations
Gastroenteritis
|
0.02%
2/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.05%
1/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Infections and infestations
Diverticulitis
|
0.01%
1/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.04%
1/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Infections and infestations
Intervertebral discitis
|
0.02%
2/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Infections and infestations
Urosepsis
|
0.00%
0/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.04%
1/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.05%
1/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Infections and infestations
Cellulitis
|
0.01%
1/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Infections and infestations
Encephalitis herpes
|
0.01%
1/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Infections and infestations
Endocarditis
|
0.01%
1/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Infections and infestations
Enterocolitis bacterial
|
0.01%
1/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Infections and infestations
Erysipelas
|
0.00%
0/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.04%
1/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Infections and infestations
Gangrene
|
0.00%
0/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.04%
1/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Infections and infestations
Gastroenteritis norovirus
|
0.01%
1/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Infections and infestations
Gastrointestinal infection
|
0.01%
1/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Infections and infestations
Hepatitis B
|
0.01%
1/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Infections and infestations
Infectious peritonitis
|
0.01%
1/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Infections and infestations
Infectious pleural effusion
|
0.01%
1/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Infections and infestations
Lung infection
|
0.01%
1/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Infections and infestations
Meningitis
|
0.01%
1/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Infections and infestations
Meningitis herpes
|
0.00%
0/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.04%
1/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Infections and infestations
Osteomyelitis chronic
|
0.01%
1/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Infections and infestations
Pneumococcal sepsis
|
0.01%
1/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Infections and infestations
Pneumocystis jiroveci infection
|
0.01%
1/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Infections and infestations
Pneumonia klebsiella
|
0.01%
1/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Infections and infestations
Septic shock
|
0.01%
1/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Infections and infestations
Staphylococcal infection
|
0.01%
1/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Infections and infestations
Staphylococcal sepsis
|
0.01%
1/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Infections and infestations
Urinary tract infection
|
0.01%
1/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Infections and infestations
Wound infection
|
0.01%
1/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.06%
6/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.07%
2/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer
|
0.05%
5/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.07%
2/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.05%
1/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bronchial carcinoma
|
0.04%
4/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.05%
1/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.04%
4/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.04%
1/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to liver
|
0.03%
3/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.05%
1/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastatic neoplasm
|
0.03%
3/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.05%
1/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Brain neoplasm
|
0.03%
3/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to peritoneum
|
0.03%
3/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasm progression
|
0.02%
2/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.04%
1/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal cancer
|
0.02%
2/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.04%
1/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma
|
0.01%
1/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.05%
1/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastrointestinal carcinoma
|
0.02%
2/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hepatic cancer metastatic
|
0.01%
1/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.04%
1/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm malignant
|
0.01%
1/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.05%
1/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastasis
|
0.02%
2/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasm
|
0.01%
1/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.04%
1/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Non-Hodgkin's lymphoma
|
0.02%
2/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Oesophageal carcinoma
|
0.01%
1/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.05%
1/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ovarian cancer
|
0.01%
1/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.04%
1/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Rectal cancer
|
0.01%
1/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.04%
1/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Small cell lung cancer stage unspecified
|
0.02%
2/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Abdominal neoplasm
|
0.01%
1/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acute myeloid leukaemia
|
0.01%
1/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adrenal neoplasm
|
0.01%
1/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
0.01%
1/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign neoplasm
|
0.01%
1/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bile duct cancer
|
0.01%
1/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder cancer
|
0.01%
1/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer metastatic
|
0.01%
1/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Chronic lymphocytic leukaemia
|
0.01%
1/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon adenoma
|
0.00%
0/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.04%
1/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Endometrial cancer
|
0.01%
1/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Extranodal marginal zone B-cell lymphoma (MALT type)
|
0.01%
1/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastric cancer
|
0.00%
0/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.04%
1/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastrointestinal stromal tumour
|
0.00%
0/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.04%
1/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Glioblastoma
|
0.01%
1/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hepatic neoplasm malignant
|
0.01%
1/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lipoma
|
0.01%
1/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lymphoma
|
0.01%
1/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant neoplasm of ampulla of Vater
|
0.01%
1/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to central nervous system
|
0.01%
1/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to lung
|
0.01%
1/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to lymph nodes
|
0.01%
1/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to oesophagus
|
0.01%
1/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to prostate
|
0.01%
1/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastatic carcinoma of the bladder
|
0.01%
1/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Mycosis fungoides
|
0.01%
1/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Myelodysplastic syndrome
|
0.01%
1/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasm malignant
|
0.01%
1/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasm prostate
|
0.00%
0/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.04%
1/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Oncologic complication
|
0.00%
0/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.05%
1/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ovarian cancer metastatic
|
0.01%
1/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ovarian cancer recurrent
|
0.01%
1/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic carcinoma metastatic
|
0.01%
1/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Paraneoplastic syndrome
|
0.00%
0/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.05%
1/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Plasmacytoma
|
0.01%
1/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer recurrent
|
0.00%
0/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.04%
1/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostatic adenoma
|
0.01%
1/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Refractory anaemia
|
0.01%
1/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal cell carcinoma
|
0.01%
1/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Thyroid adenoma
|
0.01%
1/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour haemorrhage
|
0.00%
0/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.04%
1/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine cancer
|
0.01%
1/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Gastrointestinal disorders
Ascites
|
0.02%
2/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.07%
2/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.03%
3/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.04%
1/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.03%
3/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.02%
2/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.04%
1/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Gastrointestinal disorders
Ileus
|
0.01%
1/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.09%
2/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Gastrointestinal disorders
Nausea
|
0.03%
3/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Gastrointestinal disorders
Colitis ulcerative
|
0.00%
0/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.09%
2/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.01%
1/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.04%
1/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Gastrointestinal disorders
Vomiting
|
0.02%
2/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.05%
1/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Gastrointestinal disorders
Abdominal hernia
|
0.00%
0/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.04%
1/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.04%
1/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Gastrointestinal disorders
Anal fistula
|
0.00%
0/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.05%
1/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Gastrointestinal disorders
Anal haemorrhage
|
0.01%
1/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Gastrointestinal disorders
Colitis ischaemic
|
0.01%
1/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Gastrointestinal disorders
Diverticulum
|
0.01%
1/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Gastrointestinal disorders
Diverticulum intestinal
|
0.01%
1/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Gastrointestinal disorders
Dysphagia
|
0.01%
1/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Gastrointestinal disorders
Femoral hernia
|
0.00%
0/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.05%
1/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Gastrointestinal disorders
Gastric mucosal lesion
|
0.01%
1/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Gastrointestinal disorders
Gastric ulcer
|
0.01%
1/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Gastrointestinal disorders
Gastric ulcer haemorrhage
|
0.01%
1/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Gastrointestinal disorders
Gastritis
|
0.01%
1/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Gastrointestinal disorders
Gastritis erosive
|
0.01%
1/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.04%
1/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Gastrointestinal disorders
Lip swelling
|
0.01%
1/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Gastrointestinal disorders
Mouth haemorrhage
|
0.01%
1/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Gastrointestinal disorders
Pancreatic insufficiency
|
0.01%
1/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Gastrointestinal disorders
Pancreatic pseudocyst
|
0.01%
1/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Gastrointestinal disorders
Pancreatitis
|
0.00%
0/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.05%
1/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.01%
1/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Gastrointestinal disorders
Small intestinal perforation
|
0.01%
1/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Gastrointestinal disorders
Umbilical hernia
|
0.01%
1/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
0.01%
1/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.19%
19/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.11%
3/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.06%
6/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.04%
1/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Metabolism and nutrition disorders
Cachexia
|
0.03%
3/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.04%
1/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.03%
3/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.03%
3/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.02%
2/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Metabolism and nutrition disorders
Hyperlipidaemia
|
0.02%
2/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
0.02%
2/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.02%
2/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Metabolism and nutrition disorders
Type 2 diabetes mellitus
|
0.02%
2/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Metabolism and nutrition disorders
Electrolyte imbalance
|
0.01%
1/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Metabolism and nutrition disorders
Fluid overload
|
0.01%
1/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Metabolism and nutrition disorders
Fluid retention
|
0.01%
1/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Metabolism and nutrition disorders
Gout
|
0.01%
1/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.01%
1/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.01%
1/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Metabolism and nutrition disorders
Hypoproteinaemia
|
0.01%
1/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Metabolism and nutrition disorders
Hypovolaemia
|
0.01%
1/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Metabolism and nutrition disorders
Metabolic syndrome
|
0.01%
1/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Metabolism and nutrition disorders
Obesity
|
0.01%
1/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Metabolism and nutrition disorders
Shock hypoglycaemic
|
0.01%
1/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.02%
2/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.04%
1/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.09%
2/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.04%
4/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Musculoskeletal and connective tissue disorders
Bone disorder
|
0.02%
2/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Musculoskeletal and connective tissue disorders
Bursitis
|
0.01%
1/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.04%
1/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Musculoskeletal and connective tissue disorders
Chondromalacia
|
0.01%
1/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.04%
1/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.02%
2/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Musculoskeletal and connective tissue disorders
Limb discomfort
|
0.02%
2/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.01%
1/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Musculoskeletal and connective tissue disorders
Arthropathy
|
0.01%
1/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Musculoskeletal and connective tissue disorders
Fistula
|
0.01%
1/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Musculoskeletal and connective tissue disorders
Gouty arthritis
|
0.01%
1/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Musculoskeletal and connective tissue disorders
Lumbar spinal stenosis
|
0.01%
1/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.01%
1/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal discomfort
|
0.01%
1/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.04%
1/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Musculoskeletal and connective tissue disorders
Pain in jaw
|
0.01%
1/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Musculoskeletal and connective tissue disorders
Periarthritis
|
0.01%
1/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Musculoskeletal and connective tissue disorders
Rheumatoid arthritis
|
0.01%
1/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Musculoskeletal and connective tissue disorders
Spinal disorder
|
0.01%
1/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Renal and urinary disorders
Renal failure
|
0.15%
15/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.11%
3/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.05%
1/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Renal and urinary disorders
Renal failure acute
|
0.06%
6/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.07%
2/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.05%
1/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Renal and urinary disorders
Renal failure chronic
|
0.07%
7/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.09%
2/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Renal and urinary disorders
Nephropathy
|
0.03%
3/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.07%
2/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Renal and urinary disorders
Diabetic nephropathy
|
0.02%
2/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.04%
1/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.01%
1/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.04%
1/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Renal and urinary disorders
Renal colic
|
0.01%
1/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.04%
1/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Renal and urinary disorders
Urinary retention
|
0.02%
2/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Renal and urinary disorders
Albuminuria
|
0.01%
1/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Renal and urinary disorders
Calculus urethral
|
0.01%
1/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Renal and urinary disorders
Hypertensive nephropathy
|
0.01%
1/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Renal and urinary disorders
Incontinence
|
0.01%
1/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Renal and urinary disorders
Nephroangiosclerosis
|
0.01%
1/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Renal and urinary disorders
Nephrotic syndrome
|
0.01%
1/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Renal and urinary disorders
Renal artery stenosis
|
0.01%
1/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Renal and urinary disorders
Renal disorder
|
0.01%
1/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Renal and urinary disorders
Urinary tract obstruction
|
0.01%
1/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Injury, poisoning and procedural complications
Fall
|
0.08%
8/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.07%
2/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Injury, poisoning and procedural complications
Accident
|
0.01%
1/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.05%
1/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Injury, poisoning and procedural complications
Femoral neck fracture
|
0.02%
2/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Injury, poisoning and procedural complications
In-stent coronary artery restenosis
|
0.02%
2/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Injury, poisoning and procedural complications
Radius fracture
|
0.02%
2/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Injury, poisoning and procedural complications
Wound
|
0.02%
2/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Injury, poisoning and procedural complications
Anastomotic ulcer haemorrhage
|
0.00%
0/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.04%
1/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Injury, poisoning and procedural complications
Arterial restenosis
|
0.01%
1/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Injury, poisoning and procedural complications
Arteriovenous fistula thrombosis
|
0.00%
0/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.04%
1/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Injury, poisoning and procedural complications
Cardiac valve replacement complication
|
0.00%
0/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.04%
1/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Injury, poisoning and procedural complications
Compression fracture
|
0.01%
1/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Injury, poisoning and procedural complications
Excoriation
|
0.01%
1/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.01%
1/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Injury, poisoning and procedural complications
Fibula fracture
|
0.01%
1/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Injury, poisoning and procedural complications
Fracture
|
0.00%
0/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.04%
1/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Injury, poisoning and procedural complications
Head injury
|
0.01%
1/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Injury, poisoning and procedural complications
Humerus fracture
|
0.01%
1/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Injury, poisoning and procedural complications
Implant site reaction
|
0.00%
0/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.04%
1/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Injury, poisoning and procedural complications
Joint dislocation
|
0.01%
1/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Injury, poisoning and procedural complications
Joint injury
|
0.00%
0/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.04%
1/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Injury, poisoning and procedural complications
Meniscus lesion
|
0.00%
0/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.04%
1/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Injury, poisoning and procedural complications
Post laminectomy syndrome
|
0.01%
1/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Injury, poisoning and procedural complications
Post procedural fistula
|
0.00%
0/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.05%
1/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Injury, poisoning and procedural complications
Post procedural haemorrhage
|
0.00%
0/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.04%
1/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Injury, poisoning and procedural complications
Seroma
|
0.01%
1/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Injury, poisoning and procedural complications
Spinal fracture
|
0.01%
1/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Injury, poisoning and procedural complications
Tendon rupture
|
0.01%
1/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Psychiatric disorders
Depression
|
0.06%
6/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.15%
4/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Psychiatric disorders
Mental disorder
|
0.03%
3/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Psychiatric disorders
Alcohol abuse
|
0.02%
2/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Psychiatric disorders
Anxiety
|
0.02%
2/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Psychiatric disorders
Completed suicide
|
0.01%
1/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.04%
1/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Psychiatric disorders
Panic attack
|
0.01%
1/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.05%
1/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Psychiatric disorders
Stress
|
0.02%
2/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Psychiatric disorders
Agoraphobia
|
0.01%
1/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Psychiatric disorders
Confusional state
|
0.01%
1/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Psychiatric disorders
Delirium tremens
|
0.01%
1/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Psychiatric disorders
Disorientation
|
0.01%
1/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Psychiatric disorders
Drug dependence
|
0.01%
1/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Psychiatric disorders
Expressive language disorder
|
0.01%
1/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Psychiatric disorders
Generalised anxiety disorder
|
0.01%
1/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Psychiatric disorders
Insomnia
|
0.01%
1/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Psychiatric disorders
Panic disorder
|
0.01%
1/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Psychiatric disorders
Psychiatric symptom
|
0.01%
1/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Psychiatric disorders
Psychotic disorder
|
0.01%
1/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Psychiatric disorders
Schizophrenia
|
0.01%
1/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Psychiatric disorders
Social phobia
|
0.01%
1/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Psychiatric disorders
Somatoform disorder
|
0.01%
1/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Psychiatric disorders
Withdrawal syndrome
|
0.01%
1/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Skin and subcutaneous tissue disorders
Angioedema
|
0.03%
3/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
0.03%
3/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Skin and subcutaneous tissue disorders
Diabetic foot
|
0.02%
2/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Skin and subcutaneous tissue disorders
Dermatitis allergic
|
0.00%
0/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.04%
1/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
0.03%
3/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Blood and lymphatic system disorders
Anaemia of malignant disease
|
0.01%
1/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Blood and lymphatic system disorders
Idiopathic thrombocytopenic purpura
|
0.01%
1/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
0.00%
0/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.04%
1/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Blood and lymphatic system disorders
Nephrogenic anaemia
|
0.01%
1/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.01%
1/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.01%
1/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.04%
1/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Hepatobiliary disorders
Acute hepatic failure
|
0.01%
1/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Hepatobiliary disorders
Cholangitis
|
0.01%
1/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.04%
1/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.01%
1/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Hepatobiliary disorders
Cholestasis
|
0.01%
1/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Hepatobiliary disorders
Hepatic cirrhosis
|
0.01%
1/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Hepatobiliary disorders
Hepatic failure
|
0.01%
1/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Hepatobiliary disorders
Hepatomegaly
|
0.01%
1/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Hepatobiliary disorders
Hepatorenal syndrome
|
0.01%
1/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Eye disorders
Amaurosis fugax
|
0.02%
2/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.04%
1/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Eye disorders
Cataract
|
0.02%
2/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Eye disorders
Blindness unilateral
|
0.01%
1/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Eye disorders
Diabetic retinopathy
|
0.00%
0/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.04%
1/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Eye disorders
Eyelid oedema
|
0.01%
1/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Eye disorders
Glaucoma
|
0.00%
0/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.04%
1/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Eye disorders
Ocular ischaemic syndrome
|
0.00%
0/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.05%
1/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Eye disorders
Ocular vascular disorder
|
0.01%
1/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Ear and labyrinth disorders
Vertigo
|
0.03%
3/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.04%
1/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Ear and labyrinth disorders
Tinnitus
|
0.00%
0/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.04%
1/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Ear and labyrinth disorders
Vertigo positional
|
0.01%
1/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Reproductive system and breast disorders
Benign prostatic hyperplasia
|
0.02%
2/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Reproductive system and breast disorders
Breast calcifications
|
0.01%
1/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Reproductive system and breast disorders
Erectile dysfunction
|
0.01%
1/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Reproductive system and breast disorders
Prostatic atrophy
|
0.01%
1/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Reproductive system and breast disorders
Prostatitis
|
0.00%
0/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.04%
1/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Immune system disorders
Antiphospholipid syndrome
|
0.00%
0/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.04%
1/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Immune system disorders
Transplant rejection
|
0.01%
1/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Endocrine disorders
Hyperthyroidism
|
0.02%
2/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Endocrine disorders
Hyperparathyroidism secondary
|
0.01%
1/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Congenital, familial and genetic disorders
Heart disease congenital
|
0.01%
1/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Congenital, familial and genetic disorders
Preternatural anus
|
0.00%
0/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.04%
1/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Social circumstances
Joint prosthesis user
|
0.01%
1/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
Other adverse events
| Measure |
Group A
n=10177 participants at risk
Patients treated with Aliskiren (DRI)
|
Group B
n=2696 participants at risk
Patients treated with ACE-I or ARB (ARB/ACE-I)
|
Group C
n=2113 participants at risk
Patients without any RAS inhibition (No-RAS-I)
|
|---|---|---|---|
|
Cardiac disorders
Left ventricular hypertrophy
|
0.12%
12/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.04%
1/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.09%
2/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Cardiac disorders
Atrial fibrillation
|
0.01%
1/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.11%
3/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Investigations
Blood creatinine increased
|
0.26%
26/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.15%
4/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.05%
1/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Investigations
Blood cholesterol increased
|
0.20%
20/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.04%
1/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.14%
3/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Investigations
Blood glucose increased
|
0.21%
21/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.11%
3/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Investigations
Blood triglycerides increased
|
0.17%
17/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.09%
2/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Investigations
C-reactive protein increased
|
0.17%
17/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.04%
1/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.05%
1/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Investigations
Haemoglobin decreased
|
0.14%
14/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.07%
2/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.05%
1/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Investigations
Blood pressure increased
|
0.12%
12/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.11%
3/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.05%
1/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Investigations
Electrocardiogram QRS complex prolonged
|
0.13%
13/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.07%
2/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Investigations
Glycosylated haemoglobin increased
|
0.12%
12/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.11%
3/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Vascular disorders
Hypertension
|
0.03%
3/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.11%
3/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Nervous system disorders
Dizziness
|
0.08%
8/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.15%
4/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.33%
34/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.15%
4/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.09%
2/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Infections and infestations
Tracheobronchitis
|
0.01%
1/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.11%
3/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.05%
1/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.00%
0/10177 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.15%
4/2696 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
0.00%
0/2113 • Baseline to 2 years follow up
The total of affected participants refer to all patients with any SAE, regardless of event frequencies. Patients with a given SAE are only counted for SAE occurring at least 10 times in the total group.
|
Additional Information
Professor Dr. Uwe Zeymer
Foundation Stiftung Institut fuer Herzinfarktforschung Ludwigshafen, Germany
Phone: +49 621 503 2813
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place